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Tuesday, October 25, 2016

Valsartán

Valsartán may be available in the countries listed below.

Ingredient matches for Valsartán

Valsartan

Valsartan is reported as an ingredient of Valsartán in the following countries:

Venezuela

International Drug Name Search

Acetilcisteina ratiopharm

Acetilcisteina ratiopharm may be available in the countries listed below.

Ingredient matches for Acetilcisteina ratiopharm

Acetylcysteine

Acetylcysteine is reported as an ingredient of Acetilcisteina ratiopharm in the following countries:

Italy

Spain

International Drug Name Search

Commonly used brand name(s)

In the U.S.

ME-500

Available Dosage Forms:

Powder

Tablet

Capsule

Liquid

Therapeutic Class: Amino Acid Supplement

Uses For methionine

Racemethionine is used to make the urine more acidic. Making the urine more acidic helps to relieve skin irritation in incontinent (loss of bladder control) adults and diaper rash in infants. methionine also helps to control strong urine odor.

Racemethionine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, racemethionine may be used to treat acetaminophen poisoning when the preferred medicine for treatment is not available.

Before Using methionine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methionine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methionine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

methionine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of racemethionine in the elderly with use in other age groups, methionine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of methionine

You should not take more of methionine, or take it more often, than your doctor ordered. You should also make sure that you get enough protein in your diet. This is especially important in infants. Infants who get too much racemethionine and not enough protein may not gain weight as they should. If you have any questions about this, ask your health care professional.

Take racemethionine with, or just after, meals.

For patients taking racemethionine capsules:

If you are unable to swallow the capsule, the contents may be added to juice, water, or warm milk or infant formula.

For patients taking racemethionine oral solution:

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Make certain your health care professional knows if you are on any special diet, such as a low-protein diet.

Dosing

The dose of methionine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methionine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For making urine more acidic:
- For oral dosage form (capsules):
  - Adults and teenagers—The usual dose is 200 milligrams (mg) three or four times a day.
  - Children—The usual dose is the contents of 1 capsule (200 mg) added to a warm bottle of milk or formula in the evening, or added to a glass of juice or water.
- For oral dosage form (oral solution):
  - Adults and children older than 14 months of age—The usual dose is 2⅔ teaspoonfuls (200 mg) three or four times a day.
  - Children 6 to 14 months of age—The usual dose is 1 teaspoonful (75 mg) four times a day for three to five days.
  - Children 2 to 6 months of age—The usual dose is 1 teaspoonful (75 mg) three times a day for three to five days.
  - Children up to 2 months of age—Dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults and teenagers—The usual dose is 500 mg three or four times a day.
  - Children—The capsule or oral solution is the recommended dosage form for this age group.

Missed Dose

If you miss a dose of methionine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using methionine

If your rash has not improved after 10 days, check with your doctor.

methionine Side Effects

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: methionine side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More methionine resources

Methionine Side Effects (in more detail)
Methionine Use in Pregnancy & Breastfeeding
Methionine Drug Interactions
Methionine Support Group
0 Reviews · Be the first to review/rate this drug

Methionine MedFacts Consumer Leaflet (Wolters Kluwer)

Megasin

Megasin may be available in the countries listed below.

Ingredient matches for Megasin

Ofloxacin

Ofloxacin is reported as an ingredient of Megasin in the following countries:

Portugal

International Drug Name Search

Boniva Intravenous

Generic Name: ibandronate (Intravenous route)

eye-BAN-droe-nate

Commonly used brand name(s)

In the U.S.

Boniva

In Canada

Bondronat

Available Dosage Forms:

Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For Boniva

Ibandronate injection is used to treat osteoporosis (thinning of the bone) in women after menopause.

This medicine is available only with your doctor's prescription.

Before Using Boniva

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibandronate injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibandronate injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Dairy Food

food

Proper Use of ibandronate

This section provides information on the proper use of a number of products that contain ibandronate. It may not be specific to Boniva. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine is usually given once every 3 months. If you missed a dose, call your doctor to make another appointment as soon as possible.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Precautions While Using Boniva

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). It is recommended that you receive calcium and vitamin D supplements while receiving this medicine.

It is important that you tell all of your health care providers that you are receiving ibandronate injection. If you are having dental procedures while using ibandronate injection, you may have an increased chance of getting a severe problem with your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Boniva Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

blurred vision

difficulty with moving

dizziness

headache

muscle pain or stiffness

nervousness

pain in the joints

pounding in the ears

slow or fast heartbeat

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

difficulty with breathing

ear congestion

fever

frequent urge to urinate

general feeling of discomfort or illness

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

muscle cramping

nasal congestion

nausea

pain in the arms or legs

pain, swelling, or redness in the joints

runny nose

shivering

shortness of breath

sneezing

sore throat

sweating

swollen joints

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

wheezing

Incidence not known

Blurred vision or other change in vision

decreased vision

eye pain

eye redness

eye tenderness

increased tearing

sensitivity of the eye to light

severe eye pain

tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach cramps

bone pain

confusion

convulsions

difficulty with breathing

drowsiness

irregular heartbeats

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms (tetany) or twitching seizures

numbness and tingling around the mouth, fingertips, or feet

trembling

tremor

trouble breathing

More common

Abdominal or stomach pain

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

constipation

diarrhea

discouragement

feeling sad or empty

heartburn

indigestion

irritability

lack of appetite

loss of interest or pleasure

rash

red streaks on the skin

sleeplessness

stomach discomfort, upset, or pain

stuffy nose

swelling, tenderness, or pain at the injection site

tenderness in the stomach area

tiredness

trouble concentrating

unable to sleep

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Boniva Intravenous side effects (in more detail)

More Boniva Intravenous resources

Boniva Intravenous Side Effects (in more detail)
Boniva Intravenous Use in Pregnancy & Breastfeeding
Drug Images
Boniva Intravenous Drug Interactions
Boniva Intravenous Support Group
12 Reviews for Boniva Intravenous - Add your own review/rating

Compare Boniva Intravenous with other medications

Osteoporosis
Prevention of Osteoporosis

Vorst-M

Vorst-M may be available in the countries listed below.

Ingredient matches for Vorst-M

Sildenafil

Sildenafil is reported as an ingredient of Vorst-M in the following countries:

Argentina

International Drug Name Search

Monday, October 24, 2016

Tequin Tablets

Generic Name: Gatifloxacin (ga-ti-FLOKS-a-sin)
Brand Name: Tequin

Tequin is used for:

Treating infections caused by certain bacteria.

Tequin is a fluoroquinolone antibiotic. It works by stopping the production of proteins that bacteria need to survive.

Do NOT use Tequin if:

you are allergic to any ingredient in Tequin or to similar medicines (eg, ciprofloxacin)

you have low blood potassium or diabetes

you or a family member have a rare heart condition known as congenital prolongation of the QTc interval

you are taking certain medicines for heart rhythm disturbances (eg, quinidine, procainamide, amiodarone, sotalol), cisapride, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), pimozide, or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tequin:

Some medical conditions may interact with Tequin. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have heart problems, including a slow heartbeat, a history of lack of blood supply to your heart, or hardening of the arteries

if you have a history of low blood potassium levels, diabetes, or kidney or liver problems

if you have Alzheimer disease, tendonitis, or a history of seizures

if you have a central nervous system disease or increased pressure in the head

Some MEDICINES MAY INTERACT with Tequin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antidepressants (eg, amitriptyline), antihistamines (eg, diphenhydramine, loratadine), arsenic, azole antifungals (eg, ketoconazole), certain medicines for heart rhythm disturbances (eg, quinidine, procainamide, amiodarone, sotalol), cisapride, diuretics (eg, hydrochlorothiazide, furosemide), droperidol, ketolide antibiotics (eg, telithromycin, macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), pimozide , or ziprasidone because the risk of side effects, such as racing heartbeat, dizziness, fainting, life-threatening irregular heartbeat leading to unconsciousness, may be increased

Probenecid because it may increase the risk of Tequin's side effects

Digoxin because the risk of its side effects may be increased by Tequin

Anticoagulants (eg, warfarin) because the risk of side effects, including bleeding, may be increased

Insulin, sulfonylureas (eg, glyburide), or other medicines for diabetes because the risk of blood sugar changes may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tequin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tequin:

Use Tequin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tequin may be taken with or without food.

Tequin works best if it is taken at the same time each day.

Tequin should be taken 4 hours before any other medicines or dietary supplements that contain aluminum, buffered didanosine, calcium, iron, magnesium, sucralfate, or zinc.

Swallow whole. Do not break, crush, or chew before swallowing.

To clear up your infection completely, continue using Tequin for the full course of treatment even if you feel better in a few days.

If you have trouble swallowing, talk with your doctor about taking the oral solution.

Do not miss any doses of Tequin. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tequin.

Important safety information:

Tequin may cause dizziness, drowsiness, or changes in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tequin. Using Tequin alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Tequin is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).

It is important to use Tequin for the full course of treatment. Failure to do so may decrease the effectiveness of Tequin and may increase the risk that the bacteria will no longer be sensitive to Tequin and will not be able to be treated by this or certain other antibiotics in the future.

Long-term or repeated use of Tequin may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.

If severe diarrhea, stomach pain/cramps, or bloody stools occur, contact your doctor immediately. This could be a symptom of a serious side effect requiring immediate medical attention. Do not treat diarrhea without consulting your doctor.

Tequin may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tequin. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.

Tequin may cause low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting) or high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor). If these symptoms occur, tell your doctor immediately.

Use Tequin with caution in the ELDERLY because they may be more sensitive to its effects, especially blood sugar changes.

Tequin is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Tequin during pregnancy. It is unknown if Tequin is excreted in breast milk. If you are or will be breast-feeding while you are using Tequin, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Tequin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; headache; mild diarrhea; nausea; stomachache; vaginal irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; changes in mood or behavior; chest pain or pounding in the chest; confusion; depression; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fruity breath odor; hallucinations; hoarseness; lightheadedness; loss of consciousness; nervousness; nightmares; pale skin; paranoia; restlessness; seizures; severe or continuous diarrhea; sleeplessness; stomach pain/cramps; sweating; tendon or joint pain or swelling; tremors; unusual or severe drowsiness or dizziness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Tequin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately.

Proper storage of Tequin:

Store Tequin at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Tequin out of the reach of children and away from pets.

General information:

If you have any questions about Tequin, please talk with your doctor, pharmacist, or other health care provider.

Tequin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tequin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Tequin resources

Tequin Side Effects (in more detail)
Tequin Use in Pregnancy & Breastfeeding
Drug Images
Tequin Drug Interactions
Tequin Support Group
0 Reviews for Tequin - Add your own review/rating

Compare Tequin with other medications

Anthrax
Anthrax Prophylaxis
Bladder Infection
Bronchitis
Gonococcal Infection, Uncomplicated
Kidney Infections
Otitis Media
Pneumonia
Sinusitis
Skin Infection
Tuberculosis, Active
Urinary Tract Infection

Ferralet 90

Pronunciation: EYE-urn/FOE-lik AS-id/SYE-an-oh-koe-BAL-a-min/VYE-ta-min C/ DOK-ue-sate
Generic Name: Iron/Folic Acid/Cyanocobalamin/Vitamin C/Docusate
Brand Name: Ferralet 90

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

Ferralet 90 is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

Ferralet 90 is a vitamin, folic acid, iron, and stool softener combination. It works by providing vitamins, folic acid, and iron to the body. The stool softener helps prevent constipation that sometimes may occur with iron products.

Do NOT use Ferralet 90 if:

you are allergic to any ingredient in Ferralet 90

you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis), hemolytic anemia, or you have high levels of iron in your blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ferralet 90:

Some medical conditions may interact with Ferralet 90. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have pernicious anemia or a history of other blood problems (eg, porphyria, thalassemia)

if you have a peptic ulcer or stomach or bowel problems (eg, ulcerative colitis)

if you have glucose-6-phosphate-dehydrogenase (G6PD) deficiency, a bleeding problem, have had multiple blood transfusions, or are receiving dialysis

if you have a history of seizures

Some MEDICINES MAY INTERACT with Ferralet 90. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluorouracil because the risk of its side effects may be increased by Ferralet 90

Hydantoins (eg, phenytoin), levodopa, methyldopa, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ferralet 90

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferralet 90 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ferralet 90:

Use Ferralet 90 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Ferralet 90 by mouth 2 hours after meals.

Swallow Ferralet 90 whole. Do not crush or chew before swallowing.

If you also take antacids, a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), levodopa, methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), ask your doctor or pharmacist how to take it with Ferralet 90.

If you miss a dose of Ferralet 90, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ferralet 90.

Important safety information:

Do NOT take more than the recommended dose without checking with your doctor.

Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Ferralet 90 unless your doctor tells you to.

Ferralet 90 has folic acid and iron in it. Before you start any new medicine, check the label to see if it also has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Ferralet 90 has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.

This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.

Ferralet 90 may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Ferralet 90.

Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Ferralet 90. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Ferralet 90 should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ferralet 90 while you are pregnant. Ferralet 90 is found in breast milk. If you are or will be breast-feeding while you use Ferralet 90, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ferralet 90:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ferralet 90 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of Ferralet 90:

Store Ferralet 90 at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ferralet 90 out of the reach of children and away from pets.

General information:

If you have any questions about Ferralet 90, please talk with your doctor, pharmacist, or other health care provider.

Ferralet 90 is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ferralet 90. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Ferralet 90 resources

Ferralet 90 Side Effects (in more detail)
Ferralet 90 Use in Pregnancy & Breastfeeding
Ferralet 90 Drug Interactions
Ferralet 90 Support Group
0 Reviews for Ferralet 90 - Add your own review/rating

Ferralet 90 Prescribing Information (FDA)

multivitamin with iron Concise Consumer Information (Cerner Multum)

Allbee-C 800 with Iron Concise Consumer Information (Cerner Multum)

Ferotrin Prescribing Information (FDA)

Ferrex 150 Forte Prescribing Information (FDA)

Ferrex 150 Forte Plus Prescribing Information (FDA)

Ferrex 28 Prescribing Information (FDA)

FerroGels Forte Prescribing Information (FDA)

Hematogen Forte Prescribing Information (FDA)

Integra F Prescribing Information (FDA)

Integra Plus Prescribing Information (FDA)

Irospan 24/6 Prescribing Information (FDA)

NovaFerrum Prescribing Information (FDA)

Tricon Prescribing Information (FDA)

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Anemia
Vitamin/Mineral Supplementation and Deficiency

Calciferol

Generic Name: ergocalciferol (vitamin D2) (ER goe kal SIF e role)

Brand Names: Calcidol, Calciferol, Drisdol, Vitamin D2

What is ergocalciferol?

Ergocalciferol is vitamin D2. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Ergocalciferol is used to treat hypoparathyroidism (decreased functioning of the parathyroid glands).

Ergocalciferol is also used to treat rickets (softening of the bones caused by vitamin D deficiency) or low levels of phosphate in the blood (hypophosphatemia).

Ergocalciferol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ergocalciferol?

Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before you take this medication, tell your doctor if you are allergic to any drugs or dyes, or if you have heart disease, coronary artery disease, kidney disease, or an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.

What should I discuss with my healthcare provider before taking ergocalciferol?

Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or

any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure you can safely take ergocalciferol, tell your doctor if you have any of these other conditions:

heart disease;

coronary artery disease;

kidney disease; or

an electrolyte imbalance.

FDA pregnancy category C. It is not known whether ergocalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ergocalciferol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ergocalciferol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To be sure this medication is helping your condition, your blood will need to be tested often. You may also need x-rays. Visit your doctor regularly.

Ergocalciferol is only part of a complete program of treatment that may also include other medications and a special diet. It is very important to follow the medication and diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

What should I avoid while taking ergocalciferol?

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

Ergocalciferol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;

chest pain, feeling short of breath; or

early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ergocalciferol?

Tell your doctor about all other medicines you use, especially:

sucralfate (Carafate);

mineral oil (sometimes taken as a laxative);

seizure medication;

steroids (prednisone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with ergocalciferol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calciferol resources

Calciferol Side Effects (in more detail)
Calciferol Use in Pregnancy & Breastfeeding
Calciferol Drug Interactions
Calciferol Support Group
0 Reviews for Calciferol - Add your own review/rating

Calciferol Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Calciferol Advanced Consumer (Micromedex) - Includes Dosage Information

Ergocalciferol Prescribing Information (FDA)

Drisdol Prescribing Information (FDA)

Drisdol Monograph (AHFS DI)

Drisdol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Calciferol with other medications

Familial Hypophosphatemia
Hypocalcemia
Hypoparathyroidism
Hypophosphatemia
Osteomalacia
Renal Osteodystrophy
Rickets
Vitamin D Deficiency
Vitamin/Mineral Supplementation and Deficiency

Where can I get more information?

Your pharmacist can provide more information about ergocalciferol.

See also: Calciferol side effects (in more detail)

Tepanil

diethylpropion hydrochloride

Dosage Form: Ten-Tab Controlled Release Tablets

CIV

Tepanil Description

Diethylpropion hydrochloride, a sympathomimetic agent. Chemically, diethylpropion hydrochloride is 1-phenyl-2-diethylamino-1-propanone hydrochloride.

Structural formula: C13H18NO HCl

Molecular weight: 241.76

Each tablet contains diethylpropion hydrochloride 75 mg in a controlled-release formulation. Diethylpropion hydrochloride tablets also contain: carbomer, mannitol, povidone, tartaric acid and zinc stearate.

Diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorexic agent.

Tepanil - Clinical Pharmacology

Diethylpropion hydrochloride is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Tolerance has been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics”. It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects may be involved, for example.

Adult obese subjects instructed in dietary management and treated with “anorectic” drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients averages some fraction of a pound a week. However, individual weight loss may vary substantially from patient to patient. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician/investigator relationship, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas most studies cited are restricted to a few weeks duration. Thus, the total impact of drug-induced weight loss over that of diet alone is unknown.

Diethylpropion is rapidly absorbed from the GI tract after oral administration and is extensively metabolized through a complex pathway of biotransformation involving N-dealkylation and reduction. Many of these metabolites are biologically active and may participate in the therapeutic action of these drugs. Due to the varying lipid solubilities of these metabolites, their circulating levels are affected by urinary pH. Diethylpropion and/or its active metabolites are believed to cross the blood-brain barrier and the placenta (see Labor and Delivery).

Diethylpropion and its metabolites are excreted mainly by the kidney. It has been reported that between 75-106% of the dose is recovered in the urine within 48 hours after dosing. Using a phosphorescence assay that is specific for basic compounds containing a benzoyl group, the plasma half-life of the aminoketone metabolites is estimated to be between 4 to 6 hours.

The controlled-release characteristics of Diethlpropion have been demonstrated by studies in humans in which plasma levels of diethylpropion-related material were measured by phosphorescence analysis. Plasma levels obtained with the 75 mg Diethylpropion formulation administered once daily indicated a more gradual release than the standard formulation, however, it has not been shown superior in effectiveness to the same dosage of the standard, non-controlled-release formulation.

Indications and Usage for Tepanil

Diethylpropion hydrochloride tablets are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regiment of weight reduction based on caloric restriction. The usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described (see CLINICAL PHARMACOLOGY).

Contraindications

Diethylpropion hydrochloride should not be used in patients with advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension, a history of drug abuse, or those in an agitated state (see PRECAUTIONS).

Diethylpropion hydrochloride should not be given during, or within fourteen days following, the administration of monoamine oxidase inhibitors; hypertensive crises may result.

Warnings

If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.

Precautions

General Precautions:

Caution is to be exercised in prescribing Diethylpropion hydrochloride for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. They should not be administered to patients with severe hypertension. Reports suggest that Diethylpropion hydrochloride may increase convulsions in some epileptics. Therefore, epileptics receiving them should be carefully monitored. Titration of dose or discontinuance of drug may be necessary. The least amount feasible should be prescribed or dispensed at one time to minimize the possibility of an overdose.

Information for Patients:

Diethylpropion hydrochloride may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore by cautioned accordingly. When central nervous system-active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.

Drug Interactions:

Antidiabetic drug requirements, i.e., insulin, may be altered in association with the use of Diethylpropion hydrochloride and the concomitant dietary regimen. Concurrent use with general anesthetics may result in arrhythmias. The presser effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs, i.e., guanethidine, a-methyldopa. Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Diethylpropion hydrochloride has not been evaluated for carcinogenicity, mutagenicity, or impairment of fertility.

Pregnancy: Teratogenic Effects: - Pregnancy Category B:

Reproduction studies have been performed in rats at doses up to nine times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. However, no adequate and well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pregnancy: Nonteratogenic Effects:

Abuse during pregnancy may result in withdrawal symptoms in the neonate.

Labor and Delivery:

Diethylpropion hydrochloride has no recognized use during labor and delivery, and its effect during these processes are unknown. Diethylpropion and /or its active metabolites are believed to cross the placenta.

Nursing Mothers:

It is not known whether diethylpropion is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when Diethylpropion hydrochloride is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 16 have not been established.

Adverse Reactions

The following adverse effects, listed by organ system, have been associated with the use of Diethylpropion hydrochloride.

Cardiovascular:

Precordial pain, arrhythmia, ECG changes (one published report described T-wave changes in the ECG of a healthy young male after ingestion of diethylpropion hydrochloride), tachycardia, elevation of blood pressure, palpitation.

Central Nervous System:

In a few epileptics an increase in convulsive episodes has been reported: dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and rarely, psychotic episodes at recommended doses.

Gastrointestinal:

Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation.

Allergic:

Urticaria, rash, ecchymosis, erythema.

Endocrine:

Impotence, changes in libido, gynecomastia, menstrual upset.

Hematopoietic System:

Bone marrow depression, agranulocytosis, leukopenia.

Other:

Dysuria, dyspnea, hair loss, muscle pain, increased sweating, polyuria.

DRUG ABUSE AND DEPENDENCE:

Controlled Substance:

Diethylpropion is a schedule IV controlled substance.

Abuse:

Diethylpropion has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused. The possibility of abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with varying degrees of psychologic dependence and social dysfunction which, in the case of certain drugs, may be severe. There are reports of patients who have increased the dosage to many times that recommended.

Dependence:

There have been reports of subjects becoming psychologically dependent on diethylpropion. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

The reported oral LD50, for diethylpropion hydrochloride in mice is 620 mg/kg. In rats 250 mg/kg and in dogs 225 mg/kg.

Symptoms:

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma.

Treatment:

Management of acute Diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard: Intravenous phentolamine (Regitine®) has been suggested on pharmacologic grounds for possible acute, severe hypertension. If this complicates diethylpropion hydrochloride overdosage.

Tepanil Dosage and Administration

Diethylpropion hydrochloride 75 mg (controlled release) tablets: One tablet daily, swallowed whole, in mid-morning.

How is Tepanil Supplied

Diethylpropion hydrochloride 75 mg tablets are oval, white, domed, imprinted “2690V” on one side and plain on the other.

Diethylpropion hydrochloride 75 mg tablets are supplied in bottles of 100 and 250.

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at controlled room temperature, 15°- 30°C (59°- 86°F).

CAUTION:

Federal law prohibits dispensing without prescription.

Manufactured by:

3M Pharmaceuticals

Northridge, CA 91324

Manufactured for:

Qualitest Products, Inc.

IN99

Rev 2/95

R1

Tepanil
diethylpropion hydrochloride tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0536-3701
Route of Administration	ORAL	DEA Schedule	CIV

INGREDIENTS
Name (Active Moiety)	Type	Strength
diethylpropion hydrochloride (diethylpropion)	Active	75 MILLIGRAM In 1 TABLET
carbomer	Inactive
mannitol	Inactive
povidone	Inactive
tartaric acid	Inactive
zinc stearate	Inactive

Product Characteristics
Color	WHITE (WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	12mm
Flavor		Imprint Code	2690V
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0536-3701-01	100 TABLET In 1 BOTTLE	None
2	0536-3701-02	250 TABLET In 1 BOTTLE	None

Revised: 07/2006Qualitest Products, Inc.

More Tepanil resources

Tepanil Side Effects (in more detail)
Tepanil Dosage
Tepanil Use in Pregnancy & Breastfeeding
Tepanil Drug Interactions
Tepanil Support Group
0 Reviews for Tepanil - Add your own review/rating

Compare Tepanil with other medications

Obesity

Friday, October 21, 2016

Factrel injectable

Generic Name: gonadorelin (injectable) (gon ah doe REH lin)

Brand Names: Factrel

What is gonadorelin?

Gonadorelin is a man-made protein that is like a hormone in the body called gonadotropin-releasing hormone (GnRH). GnRH causes the pituitary gland to release other hormones including luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH are important for proper development in children and fertility in adults.

Gonadorelin is used to test how well the hypothalamus and pituitary glands are working.

Gonadorelin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about gonadorelin?

Before using gonadorelin, tell your doctor if you have any other medical conditions or if you take any medications, including herbal products. You may not be able to take gonadorelin, or you may require a dosage adjustment or special monitoring.

What should I discuss with my healthcare provider before taking gonadorelin?

Gonadorelin is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take gonadorelin without first talking to your doctor if you are pregnant. It is not known whether gonadorelin passes into breast milk. Do not take gonadorelin without first talking to your doctor if you are breast-feeding a baby.

How should I take gonadorelin?

Gonadorelin is administered by a healthcare professional as a subcutaneous (under the skin) or intravenous (into a vein) injection.

Blood samples will be drawn before and after administration of gonadorelin to measure hormone levels in the body.

Your healthcare provider will store gonadorelin as directed by the manufacturer. If you are storing gonadorelin at home, your healthcare provider will provide storage instructions.

What happens if I miss a dose?

Missing a dose of gonadorelin should not occur as it is used for testing purposes only.

What happens if I overdose?

An overdose of gonadorelin is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a gonadorelin overdose are not known.

What should I avoid while taking gonadorelin?

There are no restrictions on food, beverages, or activity during treatment with gonadorelin unless otherwise directed by your doctor.

Gonadorelin side effects

If you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to gonadorelin, seek emergency medical attention.

Other less serious side effects may also occur. Notify your doctor if you experience

headache;

flushing;

nausea or abdominal discomfort;

dizziness or lightheadedness;

pain, swelling, or itching at the injection site; or

skin rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect gonadorelin?

Other medicines that affect hormone levels in the body may affect test results following treatment with gonadorelin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with gonadorelin.

More Factrel resources

Factrel Side Effects (in more detail)
Factrel Use in Pregnancy & Breastfeeding
Factrel Drug Interactions
Factrel Support Group
0 Reviews for Factrel - Add your own review/rating

Compare Factrel with other medications

Amenorrhea
Gonadotropin Deficiency

Where can I get more information?

Your pharmacist has additional information about gonadorelin written for health professionals that you may read.

What does my medication look like?

Gonadorelin is available with a prescription under the brand name Factrel. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: Factrel side effects (in more detail)

Novolin Flexpen 50R

Novolin Flexpen 50R may be available in the countries listed below.

Ingredient matches for Novolin Flexpen 50R

Insulin Injection, Biphasic Isophane

Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Novolin Flexpen 50R in the following countries:

China

International Drug Name Search

Bumex Tablets

Pronunciation: bue-MET-a-nide
Generic Name: Bumetanide
Brand Name: Generic only. No brands available.

This is a strong "water pill" (diuretic). Using too much of Bumex can lead to serious water and mineral loss. Therefore, it is important that you be monitored by your doctor. Tell your doctor right away if you become very thirsty, have a dry mouth, become confused, or develop muscle cramps/weakness.

Bumex is used for:

Treating swelling caused by excess body water associated with heart failure or kidney or liver disease. It may also be used for other conditions as determined by your doctor.

Bumex is a loop diuretic. It works by forcing the kidney to eliminate sodium, potassium, and water.

Do NOT use Bumex if:

you are allergic to any ingredient in Bumex

you have no urine formation

you have kidney disease and a significant decrease in urine formation to less than 16 oz/day (500 mL/day)

you have severe depletion of blood electrolytes (minerals in the blood [eg, sodium, calcium, potassium, chlorine, magnesium, bicarbonate])

you have brain and nervous system problems caused by severe liver disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bumex:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have excess fluid in or around your abdomen, hearing problems, high blood levels of nitrogen, diabetes, liver or kidney problems, low urine output, or high levels or uric acid

if you are dehydrated or have had a heart attack

if you have had a severe allergic reaction to sulfamethoxazole (a sulfa antibiotic) or any other sulfonamide medicine (eg, acetazolamide, celecoxib, hydrochlorothiazide, glyburide, probenecid, sulfamethoxazole, valdecoxib, zonisamide)

if you have a skin rash or have ever developed a severe skin rash from taking another medicine

Some MEDICINES MAY INTERACT with Bumex. Tell your health care provider if you are taking any of the following medicines.

Aminoglycosides (eg, gentamicin) because the risk of hearing loss may be increased

Ibuprofen, probenecid, or indomethacin because they may decrease Bumex's effectiveness

Chloral hydrate, digitalis glycosides, or lithium because their actions and the risk of their side effects may be increased by Bumex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bumex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bumex:

Use Bumex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Bumex by mouth with or without food.

Bumex may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.

If you miss a dose of Bumex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bumex.

Important safety information:

Bumex may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Bumex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Bumex may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Bumex may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Bumex. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

Diabetes patients - Bumex may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including kidney function, serum urea nitrogen (BUN), and electrolyte levels, may be performed while you use Bumex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Bumex with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood pressure.

Bumex should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bumex while you are pregnant. It is not known if Bumex is found in breast milk. Do not breast-feed while taking Bumex.

Possible side effects of Bumex:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness or lightheadedness when sitting up or standing; drowsiness; headache; low blood pressure.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; diarrhea; excessive urination; extreme thirst or dry mouth; hearing loss; kidney failure; loss of appetite; muscle pain or cramps; nausea; rapid or irregular heartbeat; red, blistered, swollen, or peeling skin; restlessness; ringing in the ears; unusual tiredness or weakness; vomiting.

See also: Bumex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; dry mouth; excessive urination followed by a decrease in amount of urine; loss of appetite; muscle cramps; stomach cramps; weak or irregular heartbeat; weakness.

Proper storage of Bumex:

Store Bumex at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bumex out of the reach of children and away from pets.

General information:

If you have any questions about Bumex, please talk with your doctor, pharmacist, or other health care provider.

Bumex is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bumex. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

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Indomethacin Injection

Dosage Form: injection, powder, lyophilized, for solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Indomethacin Injection

Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly or pulmonary plethora on chest x-ray.

Indomethacin Injection Dosage and Administration

For intravenous administration only.

Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions (5.7)].

Dosage according to age is as follows:

AGE at 1st dose	DOSAGE (mg/kg)
Less than 48 hours	1st 0.2	2nd 0.1	3rd 0.1
2 to 7 days	0.2	0.2	0.2
Over 7 days	0.2	0.25	0.25

If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above.

If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus.

Directions for Use

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.

Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.

Further dilution with intravenous infusion solutions is not recommended.

Dosage Forms and Strengths

Indomethacin for Injection is supplied in single use vials containing 1 mg of indomethacin as a sterile lyophilized powder or plug for reconstitution.

Contraindications

Indomethacin for Injection is contraindicated in neonates:

With proven or suspected infection that is untreated

Who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding

With thrombocytopenia or coagulation defects

With or who are suspected of having necrotizing enterocolitis

With significant impairment of renal function

With congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).

Warnings and Precautions

Infection

Indomethacin may mask the usual signs and symptoms of infection. Therefore, the physician must be continually on the alert for this and should use the drug with extra care in the presence of existing controlled infection.

Hepatic Reactions

Severe hepatic reactions have been reported in adults treated chronically with oral indomethacin for arthritic disorders. [For further information, see package insert for oral indomethacin.] If clinical signs and symptoms consistent with liver disease develop in the neonate, or if systemic manifestations occur, discontinue Indomethacin for Injection.

Platelet Aggregation

Indomethacin for Injection may inhibit platelet aggregation. In one small study, platelet aggregation was grossly abnormal after indomethacin therapy (given orally to premature infants to close the ductus arteriosus). Platelet aggregation returned to normal by the tenth day. Observe premature infants for signs of bleeding.

Gastrointestinal Effects

In the collaborative study, major gastrointestinal bleeding was no more common in neonates receiving indomethacin than in neonates on placebo. However, minor gastrointestinal bleeding (i.e., chemical detection of blood in the stool) was more commonly noted in neonates treated with indomethacin. Severe gastrointestinal effects have been reported in adults with various arthritic disorders treated chronically with oral indomethacin. [For further information, see package insert for oral indomethacin.]

Central Nervous System Effects

Prematurity per se is associated with an increased incidence of spontaneous intraventricular hemorrhage. Because indomethacin may inhibit platelet aggregation, the potential for intraventricular bleeding may be increased. However, in the large multicenter study of Indomethacin for Injection, the incidence of intraventricular hemorrhage in neonates treated with Indomethacin for Injection was not significantly higher than in the control neonates.

Renal Effects

Indomethacin for Injection may cause significant reduction in urine output (50 percent or more) with concomitant elevations of blood urea nitrogen and creatinine, and reductions in glomerular filtration rate and creatinine clearance. These effects in most neonates are transient, disappearing with cessation of therapy with Indomethacin for Injection. However, because adequate renal function can depend upon renal prostaglandin synthesis, Indomethacin for Injection may precipitate renal insufficiency, including acute renal failure, especially in neonates with other conditions that may adversely affect renal function (e.g., extracellular volume depletion from any cause, congestive heart failure, sepsis, concomitant use of any nephrotoxic drug, hepatic dysfunction). When significant suppression of urine volume occurs after a dose of Indomethacin for Injection, do not give additional doses until urine output returns to normal levels.

Indomethacin for Injection in pre-term infants may suppress water excretion to a greater extent than sodium excretion. When this occurs, a significant reduction in serum sodium values (i.e., hyponatremia) may result. Monitor renal function and serum electrolyte levels during therapy with Indomethacin for Injection [see Dosage and Administration (2)].

Administration

Administer Indomethacin for Injection carefully to avoid extravascular injection or leakage as the solution may be irritating to tissue.

Adverse Reactions

Clinical Trials Experience

In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, in those neonates treated with indomethacin (n=206), there was a statistically significantly greater incidence of bleeding problems, including gross or microscopic bleeding into the gastrointestinal tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy. There was no statistically significant difference between treatment groups in intracranial hemorrhage.

The neonates treated with Indomethacin for Injection also had a significantly higher incidence of transient oliguria and elevations of serum creatinine (greater than or equal to 1.8 mg/dL) than did the neonates treated with placebo.

The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with Indomethacin for Injection were no greater than in placebo controls and were statistically significantly lower than in surgically-treated neonates.

The following additional adverse reactions in neonates have been reported from the collaborative study, anecdotal case reports, from other studies using rectal, oral, or intravenous indomethacin for treatment of patent ductus arteriosus or in marketed use. The rates are calculated from a database that contains experience of 849 indomethacin-treated neonates reported in the medical literature, regardless of the route of administration. One year follow-up is available on 175 neonates and shows no long-term sequelae which could be attributed to indomethacin. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after Indomethacin for Injection than after placebo. Reactions marked with a single asterisk (*) occurred in 3 to 9 percent of indomethacin-treated neonates; those marked with a double asterisk (**) occurred in 3 to 9 percent of both indomethacin- and placebo-treated neonates. Unmarked reactions occurred in less than 3 percent of neonates.

Renal: renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia.

Cardiovascular: intracranial bleeding**, pulmonary hypertension.

Gastrointestinal: gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis.

Metabolic: hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention).

Coagulation: decreased platelet aggregation [see Warnings and Precautions (5.3)].

The following adverse reactions have also been reported in neonates treated with indomethacin, however, a causal relationship to therapy with Indomethacin for Injection has not been established:

Cardiovascular: bradycardia.

Respiratory: apnea, exacerbation of pre-existing pulmonary infection.

Metabolic: acidosis/alkalosis.

Hematologic: disseminated intravascular coagulation, thrombocytopenia.

Ophthalmic: retrolental fibroplasia. **

A variety of additional adverse experiences have been reported in adults treated with oral indomethacin for moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute painful shoulder and acute gouty arthritis (see package insert for oral indomethacin for additional information concerning adverse reactions and other cautionary statements). Their relevance to the pre-term infant receiving indomethacin for patent ductus arteriosus is unknown, however, the possibility exists that these experiences may be associated with the use of Indomethacin for Injection in preterm infants.

Drug Interactions

As renal function may be reduced by Indomethacin for Injection, consider reducing the dosage of those medications that rely on adequate renal function for their elimination.

Digoxin

Because the half-life of digoxin (given frequently to pre-term infants with patent ductus arteriosus and associated cardiac failure) may be prolonged when given concomitantly with indomethacin, observe neonates receiving concomitant digoxin closely; frequent ECGs and serum digoxin levels may be required to prevent or detect digoxin toxicity early.

Anticoagulants

Indomethacin usually does not influence the hypoprothrombinemia produced by anticoagulants. When indomethacin is added to anticoagulants, monitor prothrombin time closely. In post-marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and Indomethacin for Injection.

Furosemide

Therapy with indomethacin may blunt the natriuretic effect of furosemide. This response has been attributed to inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs. In a study of 19 premature infants with patent ductus arteriosus treated with either Indomethacin for Injection alone or a combination of Indomethacin for Injection and furosemide, results showed that neonates receiving both Indomethacin for Injection and furosemide had significantly higher urinary output, higher levels of sodium and chloride excretion, and higher glomerular filtration rates than did those receiving Indomethacin for Injection alone. In this study, therapy with furosemide helped to maintain renal function in the premature infant when Indomethacin for Injection was added.

Aminoglycosides

In one study of premature infants treated with Indomethacin for Injection and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated.

Drugs that Act on the Renin-Angiotensin System

In some patients with compromised renal function, the co-administration of an NSAID and an ACE inhibitor or angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.

Indomethacin Injection Description

Sterile Indomethacin for Injection for intravenous administration is lyophilized indomethacin for injection. Each vial of indomethacin for injection contains 1 mg indomethacin; 0.29 mg monobasic sodium phosphate, 0.41 mg dibasic sodium phosphate and not more than 0.24 mg of sodium hydroxide (used for converting indomethacin base to the sodium salt) as a white to yellow lyophilized powder or plug. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial.

The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles. The pH of the product does not meet the USP monograph [FD&C Act Chapter V, SEC. 501. [21USC §351](b)].

Indomethacin is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The structural formula is:

C19H16ClNO4 M.W. 357.8

Indomethacin Injection - Clinical Pharmacology

Mechanism of Action

Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis.

Pharmacodynamics

Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both in vitro and in vivo. In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction.

Studies in healthy young animals and in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow. Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established.

In double-blind, placebo-controlled studies of Indomethacin for Injection in 460 small pre-term infants, weighing 1750 g or less, the neonates treated with placebo had a ductus closure rate after 48 hours of 25 to 30 percent, whereas those treated with Indomethacin for Injection had a 75 to 80 percent closure rate. In one of these studies, a multicenter study, involving 405 pre-term infants, later reopening of the ductus arteriosus occurred in 26 percent of neonates treated with Indomethacin for Injection however, 70 percent of these closed subsequently without the need for surgery or additional indomethacin.

Pharmacokinetics

The disposition of indomethacin following intravenous administration (0.2 mg/kg) in pre-term neonates with patent ductus arteriosus has not been extensively evaluated. Even though the plasma half-life of indomethacin was variable among premature infants, it was shown to vary inversely with postnatal age and weight. In one study, of 28 neonates who could be evaluated, the plasma half-life in those less than 7 days old averaged 20 hours (range: 3 to 60 hours, n=18). In neonates older than 7 days, the mean plasma half-life of indomethacin was 12 hours (range: 4 to 38 hours, n=10). Grouping the neonates by weight, mean plasma half-life in those weighing less than 1000 g was 21 hours (range: 9 to 60 hours, n=10); in those neonates weighing more than 1000 g, the mean plasma half-life was 15 hours (range: 3 to 52 hours, n=18).

Following intravenous administration in adults, indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. The mean plasma half-life of indomethacin is 4.5 hours. In the absence of enterohepatic circulation, it is 90 minutes. Indomethacin has been found to cross the blood-brain barrier and the placenta.

In adults, about 99 percent of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentrations. The percent bound in neonates has not been studied. In controlled trials in premature infants, however, no evidence of bilirubin displacement has been observed as evidenced by increased incidence of bilirubin encephalopathy (kernicterus).

Nonclinical Toxicology

In rats and mice, oral indomethacin 4 mg/kg/day given during the last three days of gestation caused a decrease in maternal weight gain and some maternal and fetal deaths. An increased incidence of neuronal necrosis in the diencephalon in the live-born fetuses was observed. At 2 mg/kg/day, no increase in neuronal necrosis was observed as compared to the control groups. Administration of 0.5 or 4 mg/kg/day during the first three days of life did not cause an increase in neuronal necrosis at either dose level.

Pregnant rats, given 2 mg/kg/day and 4 mg/kg/day during the last trimester of gestation, delivered offspring whose pulmonary blood vessels were both reduced in number and excessively muscularized. These findings are similar to those observed in the syndrome of persistent pulmonary hypertension of the neonate.

How Supplied/Storage and Handling

How Supplied

Sterile Indomethacin for Injection is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin.

Product

No.

NDC

No.

605903

63323-659-03

Packaged individually.

Vial stoppers do not contain natural rubber latex.

Storage

Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Store container in carton until contents have been used.

451150

Issued: March 2010

PACKAGE LABEL - PRINCIPAL DISPLAY - Indomethacin for Injection 1 mg Carton Panel

NDC 63323-659-03

605903

INDOMETHACIN FOR INJECTION

1 mg/vial

For Intravenous Use Only

For The Preparation Of Intravenous Solutions

Rx only

One vial

Single Dose Vial - Discard any unused portion immediately.

PACKAGE LABEL - PRINCIPAL DISPLAY - Indomethacin for Injection 1 mg Vial Panel

NDC 63323-659-03

605903

INDOMETHACIN FOR INJECTION

1 mg/vial

For The Preparation Of Intravenous Solutions

Sterile

Rx Only

Single Dose Vial - Discard unused portion

INDOMETHACIN
indomethacin injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	63323-659
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
INDOMETHACIN (INDOMETHACIN)	INDOMETHACIN	1 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC	0.29 mg
SODIUM PHOSPHATE, DIBASIC	0.41 mg
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	63323-659-03	1 VIAL In 1 CARTON	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022536	03/19/2010

Labeler - APP Pharmaceuticals, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
APP Pharmaceuticals, LLC		091009530	MANUFACTURE

Revised: 03/2010APP Pharmaceuticals, LLC

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