Alopectyl

Alopectyl may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Alopectyl

Megestrol

Megestrol 17α-acetate (a derivative of Megestrol) is reported as an ingredient of Alopectyl in the following countries:

• Netherlands

International Drug Name Search

Fluoride Foam

Dosage Form: aerosol, foam
Fluoride Foam MINT Indications: For the topical application of fluoride to aid in the

protection against dental caries.

Contraindications: This product should not be used with

individuals with known sensitivities to fluoride.

Directions for Use:

1. Remove cap from can.

2. The first time you dispense from a new can, gently lift upward

on the nozzle to break the protective shipping tab (Fig. 1).

3. Shake can vigorously for at least 10 seconds before each use.

4. Hold can completely upside down to dispense (Fig. 2).

5. Point can towards applicator tray and slowly press the nozzle

to fill tray. Use one press per arch, as foam will expand

slightly to fill the tray.

6. For best results, dry teeth prior to application.

7. Insert the filled tray and have the patient bite down lightly,

with a chewing motion to ensure interproximal coverage.

8. Leave tray(s) in contact with teeth for 1 to 4 minutes.

9. Use a saliva ejector during treatment to minimize ingestion

of product.

10. Remove tray(s) and have patient expectorate.

11. Instruct patient not to eat, drink, or rinse for at least 30

minutes after application.
Contains:

1.23% Fluoride ion from sodium fluoride in a proprietary

acidulated phosphate flavored foam base. Does not contain

chlorofluorocarbon propellant.

Sweetened with Xylitol (sucralose). Does not contain Aspartame

or Saccharin. Gluten free.
Precautions:

Use only as directed.

For dental use only. U.S. Federal Law prohibits dispensing

without prescription.

Not for unsupervised home use. Safety and efficacy in patients

under the age of 3 has not been established. Repeated use of

APF formulations in patients with porcelain or composite

restorations should be avoided due to the possibility of etching

the restoration surface. Warning:

Do not swallow.

Keep out of reach of children.

Avoid spraying toward open flame.

Contents under pressure.

Do not puncture or incinerate. WATERPIK

Ultra Control

Fluoride Foam

MINT


Precise foaming action

Sweetened with Xylitol

Gluten free


*Acidulated Phosphate Fluoride

1.23% Fluoride Ion (pH 3.5)


For professional use only.

Store at room temperature

between 55°–80°F.

Shake well before each use.


To obtain a MSDS sheet, please

call Water Pik, Inc. customer

service at 1-800-525-2020.

Made in the U.S.A.

Distributed by:

Water Pik, Inc.

1730 E. Prospect Road

Fort Collins, CO 80553-0001

1-800-525-2020

www.waterpik.com

Waterpik® (stylized) is a

trademark of Water Pik, Inc.

registered Canada, EU, Japan,

Mexico, Switzerland, and the

United States.

©2011 Water Pik, Inc.

Water Pik Item Number:

20014143

FN 20014519-F AA

373485

FLUORIDE  MINT sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 75905-003 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.23 g  in 100 g

Inactive Ingredients Ingredient Name Strength WATER   SUCRALOSE   XYLITOL   SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE   BETAINE   POLOXAMER 407

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 75905-003-14 125 g In 1 CAN None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2011

Labeler - WATER PIK, INC. (001804074)

Registrant - WATER PIK, INC. (001804074)

Revised: 11/2011WATER PIK, INC.

Ibuprofeno Ilab

Ibuprofeno Ilab may be available in the countries listed below.

Ingredient matches for Ibuprofeno Ilab

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofeno Ilab in the following countries:

• Argentina

International Drug Name Search

Ferrex 150 Forte

Pronunciation: SYE-an-oh-koe-BAL-a-min/FOE-lik AS-id/EYE-urn
Generic Name: Cyanocobalamin/Folic Acid/Iron
Brand Name: Examples include BiferaRx and Ferrex 150 Forte

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.

Ferrex 150 Forte 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.

Ferrex 150 Forte is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.

Do NOT use Ferrex 150 Forte if:

• you are allergic to any ingredient in Ferrex 150 Forte


• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) 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 Ferrex 150 Forte:

Some medical conditions may interact with Ferrex 150 Forte. 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 bowel problems (eg, colitis, Chron disease, diverticulitis), certain blood disorders (eg, hemolytic or pernicious anemia, porphyria cutanea tarda, thalassemia), or a peptic ulcer


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrex 150 Forte. 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 Ferrex 150 Forte


• Bisphosphonates (eg, alendronate), cephalosporins (eg, cefdinir), hydantoins (eg, phenytoin), levodopa, methyldopa, mycophenolate, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ferrex 150 Forte

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrex 150 Forte 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 Ferrex 150 Forte:

Use Ferrex 150 Forte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ferrex 150 Forte by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take an antacid within 1 hour before or 2 hours after you take Ferrex 150 Forte.


• Avoid taking Ferrex 150 Forte with dairy products; they may interfere with the absorption of the iron in Ferrex 150 Forte.


• If you also take a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), eltrombopag, levodopa, methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), ask your doctor or pharmacist how to take it with Ferrex 150 Forte.


• If you miss a dose of Ferrex 150 Forte, 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 Ferrex 150 Forte.

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 Ferrex 150 Forte unless your doctor tells you to.


• Ferrex 150 Forte 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.


• Ferrex 150 Forte may discolor the stools. This is normal and not a cause for concern.


• Ferrex 150 Forte 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.


• Ferrex 150 Forte 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 Ferrex 150 Forte.


• Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Ferrex 150 Forte. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Ferrex 150 Forte 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 Ferrex 150 Forte while you are pregnant. Ferrex 150 Forte is found in breast milk. If you are or will be breast-feeding while you use Ferrex 150 Forte, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ferrex 150 Forte:

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 nausea, vomiting, or 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: Ferrex50 Forte 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 Ferrex 150 Forte:

Store Ferrex 150 Forte 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 Ferrex 150 Forte out of the reach of children and away from pets.

General information:

• If you have any questions about Ferrex 150 Forte, please talk with your doctor, pharmacist, or other health care provider.


• Ferrex 150 Forte 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 Ferrex 150 Forte. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ferrex 150 Forte resources

• Ferrex 150 Forte Side Effects (in more detail)
• Ferrex 150 Forte Use in Pregnancy & Breastfeeding
• Ferrex 150 Forte Drug Interactions
• Ferrex 150 Forte Support Group
• 0 Reviews for Ferrex50 Forte - Add your own review/rating

• Ferrex 150 Forte 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)


• Ferralet 90 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)

Compare Ferrex 150 Forte with other medications

• Anemia
• Vitamin/Mineral Supplementation and Deficiency

Schistosoma japonicum Medications

Definition of Schistosoma japonicum: A species of trematode worm that parasitises humans and that

Drugs associated with Schistosoma japonicum

The following drugs and medications are in some way related to, or used in the treatment of Schistosoma japonicum. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Biltricide

Fluconazole Almus

Fluconazole Almus may be available in the countries listed below.

Ingredient matches for Fluconazole Almus

Fluconazole

Fluconazole is reported as an ingredient of Fluconazole Almus in the following countries:

• France

International Drug Name Search

Flagyl I.V.

Generic Name: metronidazole (Oral route)

met-roe-NYE-da-zole

Oral route(Tablet;Tablet, Extended Release;Capsule)

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved only for conditions for which it is approved .

Commonly used brand name(s)

In the U.S.

• Flagyl


• Flagyl ER

Available Dosage Forms:

• Tablet, Extended Release


• Capsule


• Tablet


• Suspension

Therapeutic Class: Antibiotic

Chemical Class: Nitroimidazole

Uses For Flagyl I.V.

Metronidazole is used to treat bacterial infections in different areas of the body. The extended-release tablets are used to treat women with vaginal infections (bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine 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 these uses are not included in product labeling, metronidazole is used in certain patients with the following medical conditions:

• Clostridium difficile diarrhea or colitis (antibiotic-associated colitis).


• Crohn's disease (inflammatory bowel disease).


• Gastritis or stomach ulcers due to Helicobacter pylori.


• Giardiasis (parasite infection in the intestines).

Before Using Flagyl I.V.

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 metronidazole to treat bacterial infections in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metronidazole in children with amebiasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving metronidazole.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir


• Disulfiram

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone


• Busulfan


• Fluorouracil


• Mycophenolate Mofetil


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Cholestyramine


• Cyclosporine


• Lithium


• Milk Thistle


• Tacrolimus

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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Leukopenia (low white blood cells), history of or


• Optic neuropathy (eye disease with vision changes), history of or


• Oral thrush (Candida infection) or


• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or


• Seizures, history of or


• Vaginal yeast infection (Candida infection)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of metronidazole

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

The regular tablet or capsule can be taken with or without food. If the medicine upsets your stomach, it is best to take it with a meal or snack.

The extended–release tablet must be taken without food, one hour before or two hours after a meal.

Swallow the extended-release tablet whole. Do not break, crush, or chew it.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your infection may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help planning the best times to take your medicine, check with your doctor.

If you have taken a medicine called disulfiram (Antabuse®) within the last 2 weeks, do not take metronidazole until you talk to your doctor. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage forms (capsules or tablets):
  
  • For amebiasis infections:
    
    • Adults and teenagers—500 or 750 milligrams (mg) 3 times per day for 5 to 10 days.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 35 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given in 3 doses, for 10 days.
    
    
  
  
  • For bacterial infections:
    
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to a maximum dose of 1 gram, every 6 hours for 7 to 10 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For trichomoniasis infections:
    
    • Adults and teenagers—The tablet can be given 3 different ways: as a single dose of 2 grams; or as 1 gram 2 times per day for 1 day; or as 250 milligrams (mg) 3 times per day for 7 days. The capsule dose is 375 mg 2 times per day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For bacterial vaginosis:
    
    • Adults and teenagers—750 milligrams (mg) once a day for 7 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Flagyl I.V.

It is important that your doctor check your progress after you finish taking this medicine. This is to make sure that the infection is cleared up. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least one day after you stop using metronidazole. This medicine may also cause alcoholic beverages to taste different. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are using this medicine and for at least 3 days after stopping it.

Using this medicine while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are using this medicine for trichomoniasis (an infection of the sex organs in men or women), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (rubber) during sexual intercourse. These measures will help to keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Metronidazole may cause dry mouth, an unpleasant or sharp metallic taste, and a change in taste sensation. For temporary relief of dry mouth, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Flagyl I.V. 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 immediately if any of the following side effects occur:

More common

• Agitation


• back pain


• blindness


• blurred vision


• burning, numbness, tingling, or painful sensations in the hands or feet


• changes in speech patterns


• confusion


• convulsions


• decreased vision


• depression


• dizziness


• drowsiness


• eye pain


• fever


• hallucinations


• headache


• irritability


• lack of coordination


• mood or mental changes


• nausea


• seizures


• shakiness and unsteady walk


• slurred speech


• stiff neck or back


• trouble with speaking


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• vomiting


• weakness in the arms, hands, legs, or feet

Less common

• Black, tarry stools


• blood in the urine or stools


• body aches or pain


• chills


• clumsiness or unsteadiness


• difficulty with breathing


• ear congestion


• feeling of pelvic pressure


• frequent or painful urination


• loss of voice


• nasal congestion


• pinpoint red spots on the skin


• runny nose


• skin rash, hives, redness, or itching


• sneezing


• stomach and back pain (severe)


• unusual bleeding or bruising


• vaginal irritation, discharge, or dryness not present before taking the medicine

Rare

• Bleeding gums


• bloating


• chest pain


• constipation


• cough


• dark-colored urine


• fast heartbeat


• indigestion


• loss of appetite


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• burning while urinating


• continuing diarrhea


• continuing stomach pain


• diarrhea


• feeling of warmth


• increased volume of pale, dilute urine


• joint or muscle pain


• loss of bladder control


• red irritated eyes


• red skin lesions, often with a purple center


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin

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

• Abdominal or stomach cramps


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• heartburn


• sensation of spinning


• sleeplessness


• trouble sleeping


• unable to sleep


• weight loss

Less common or rare

• Change in taste sensation


• congestion


• dry mouth


• pain or tenderness around the eyes and cheekbones


• stuffy nose


• tender, swollen glands in the neck


• trouble with swallowing


• unpleasant or sharp metallic taste


• voice changes

Incidence not known

• Decreased interest in sexual intercourse


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• painful sexual intercourse

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: Flagyl I.V. 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.

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More Flagyl I.V. resources

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

• Flagyl Prescribing Information (FDA)


• Flagyl Consumer Overview


• Flagyl Monograph (AHFS DI)


• Flagyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Flagyl ER Prescribing Information (FDA)


• Metronidazole Prescribing Information (FDA)


• Metronidazole Professional Patient Advice (Wolters Kluwer)


• Metronidazole MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Flagyl I.V. with other medications

• Amebiasis
• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Clostridial Infection
• Crohn's Disease, Acute
• Crohn's Disease, Maintenance
• Deep Neck Infection
• Dental Abscess
• Diverticulitis
• Dracunculiasis
• Endocarditis
• Giardiasis
• Helicobacter Pylori Infection
• Intraabdominal Infection
• Joint Infection
• Meningitis
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pseudomembranous Colitis
• Skin Infection
• Surgical Prophylaxis
• Trichomoniasis

Flaxseed

Pronunciation: Not applicable.
Generic Name: Flaxseed
Brand Name: Generics only. No brands available.

Flaxseed is used for:

Constipation and stomach irritation. It has also been used for pain and inflammation due to arthritis and as a supplement to decrease total cholesterol and low-density lipoprotein (LDL) cholesterol. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Flaxseed is an herbal product. It works by providing an essential fatty acid that benefits the digestive tract and heart.

Do NOT use Flaxseed if:

• you are allergic to any ingredient in Flaxseed


• you have ileus or a history of intestinal blockage of any type


• you have swelling or closure of the esophagus


• you are pregnant

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

Before using Flaxseed:

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

• if you are 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 inflammation of the bowel (eg, Crohn disease), heart disease or other heart problems, or high blood pressure, or you are taking medicines for any of these conditions

Some MEDICINES MAY INTERACT with Flaxseed. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flaxseed 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 Flaxseed:

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• Drinking extra fluids while you are taking flaxseed is recommended.


• Do not take flaxseed at the same time you take any other medicines prescribed by your doctor. Do not take this product if it has a bad smell or bitter taste.


• If you miss taking a dose of Flaxseed for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

• The immature seeds of flax are poisonous. To avoid taking immature seeds, never use a flax product unless it is designed for human consumption.


• If you take any prescription medicines and you notice a decreased effect, report this to your doctor as soon as possible.


• If you are taking flaxseed to reduce cholesterol or LDL, talk with your doctor or pharmacist about other cholesterol-lowering therapies that are proven to reduce the risk of heart disease and improve survival.


• Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter, including laxatives, stool softeners, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs; eg, ibuprofen).


• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Flaxseed may cause harm to the human fetus. Do not take flaxseed if you are pregnant. Do not breast-feed while you are taking flaxseed.

Possible side effects of Flaxseed:

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:

Gas; mild diarrhea; nausea.

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); slightly bluish, grayish, slate-like, or dark purple discoloration of the skin.

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.

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 fast heartbeat; paralysis; seizures; shortness of breath; unsteadiness when walking; weakness.

Proper storage of Flaxseed:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Flaxseed out of the reach of children and away from pets.

General information:

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


• Flaxseed 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 Flaxseed. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

Aspoxicillin

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0063358-49-6

Chemical Formula

C21-H27-N5-O7-S

Molecular Weight

493

Therapeutic Category

Antibacterial: Penicillin, penicillinase-sensitive

Chemical Name

(2S,5R,6R)-6-[(2R)-2-[(2R)-2-Amino-3-(methylcarbamoyl)propionamidol]-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid

Foreign Names

• Aspoxicillinum (Latin)
• Aspoxicillin (German)
• Aspoxicilline (French)
• Aspoxicillina (Spanish)

Generic Names

• TA 058 (IS: Tanabe)
• Aspoxicillin (PH: JP XIV)

Brand Name

• Doyle
  Sawai Seiyaku, Japan

International Drug Name Search

Glossary

IS	Inofficial Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Flagyl Capsules

Pronunciation: MET-roe-NYE-da-zole
Generic Name: Metronidazole
Brand Name: Flagyl

Long-term use of Flagyl Capsules has caused cancer in mice and rats. Discuss any questions or concerns with your doctor. Do not use Flagyl Capsules for a condition other than the one for which it was prescribed.

Flagyl Capsules is used for:

Treating certain infections caused by bacteria or amoebas. It may also be used for other conditions as determined by your doctor.

Flagyl Capsules is an oral antiprotozoal and antibacterial. It is thought to work by entering the bacterial cell, acting on some components of the cell, and destroying the bacteria.

Do NOT use Flagyl Capsules if:

• you are allergic to any ingredient in Flagyl Capsules or to another nitroimidazole (eg, tinidazole)


• you are in the first 3 months of pregnancy


• you are taking busulfan, an ergot alkaloid (eg, ergotamine), or you have taken disulfiram within the past 2 weeks


• you are taking an HIV protease inhibitor that contains alcohol (eg, amprenavir solution); check with your pharmacist if you are unsure if your medicine contains alcohol


• you drink alcohol

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

Before using Flagyl Capsules:

Some medical conditions may interact with Flagyl Capsules. 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 nerve, brain, or blood problems; Crohn disease; or a history of liver problems or seizures

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

• Amiodarone because the risk of irregular heartbeat may be increased


• Disulfiram because side effects, such as mental or mood changes, may occur


• Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Flagyl Capsules's effectiveness


• Anticoagulants (eg, warfarin), busulfan, cyclosporine, ergot alkaloids (eg, ergotamine), HIV protease inhibitors that contain alcohol (eg, amprenavir solution), lithium, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Flagyl Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flagyl Capsules 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 Flagyl Capsules:

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

• Take Flagyl Capsules by mouth with or without food.


• To clear up your infection completely, take Flagyl Capsules for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Flagyl Capsules, 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 Flagyl Capsules.

Important safety information:

• Flagyl Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Flagyl Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are taking Flagyl Capsules and for at least 3 days after the last dose.


• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Flagyl Capsules only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Flagyl Capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Flagyl Capsules may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Flagyl Capsules for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Flagyl Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Flagyl Capsules.


• Lab tests, including liver function and white blood cell counts, may be performed while you use Flagyl Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Flagyl Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Flagyl Capsules 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 Flagyl Capsules while you are pregnant. Do not use Flagyl Capsules in the first 3 months of pregnancy. Flagyl Capsules is found in breast milk. Do not breast-feed while taking Flagyl Capsules.

Possible side effects of Flagyl Capsules:

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:

Appetite loss; constipation; diarrhea; dizziness; headache; metallic taste; nausea; stomach upset; 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); bloody stools; decreased coordination; increased or decreased urination; numbness, tingling, or burning of the arms, hands, legs, or feet; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe or persistent dizziness or headache; sore throat, chills, or fever; speech problems; stiff neck; stomach pain or cramps; vaginal itching, odor, or discharge; vision loss or other vision changes; white patches in the mouth.

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: Flagyl 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 nausea; seizures; vomiting.

Proper storage of Flagyl Capsules:

Store Flagyl Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Flagyl Capsules out of the reach of children and away from pets.

General information:

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


• Flagyl Capsules 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 Flagyl Capsules. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Flagyl resources

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

Compare Flagyl with other medications

• Amebiasis
• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Clostridial Infection
• Crohn's Disease, Acute
• Crohn's Disease, Maintenance
• Deep Neck Infection
• Dental Abscess
• Diverticulitis
• Dracunculiasis
• Endocarditis
• Giardiasis
• Helicobacter Pylori Infection
• Intraabdominal Infection
• Joint Infection
• Meningitis
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pseudomembranous Colitis
• Skin Infection
• Surgical Prophylaxis
• Trichomoniasis

Novina

Novina may be available in the countries listed below.

Ingredient matches for Novina

Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Novina in the following countries:

• Mexico

International Drug Name Search

Fer-Gen-Sol Drops

Pronunciation: FER-us SUL-fate
Generic Name: Ferrous Sulfate
Brand Name: Examples include Fer-Gen-Sol and Fer-In-Sol

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years old. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Fer-Gen-Sol Drops are used for:

Preventing or treating low levels of iron in the blood. It also may be used for other conditions as determined by your doctor.

Fer-Gen-Sol Drops are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Fer-Gen-Sol Drops if:

• you are allergic to any ingredient in Fer-Gen-Sol Drops


• you have high levels of iron in your blood


• you are taking disulfiram

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

Before using Fer-Gen-Sol Drops:

Some medical conditions may interact with Fer-Gen-Sol Drops. 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 inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)


• if you have had multiple blood transfusions

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

• Cephalosporins (eg, cefotetan), disulfiram, fluorouracil, furazolidone, metronidazole, or sulfonylureas (eg, glipizide) because the risk of side effects, such as flushing, headache, fast or irregular heartbeat, nausea, or vomiting, may be increased


• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Fer-Gen-Sol Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fer-Gen-Sol Drops 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 Fer-Gen-Sol Drops:

Use Fer-Gen-Sol Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Fer-Gen-Sol Drops by mouth immediately after a meal.


• Take Fer-Gen-Sol Drops with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Fer-Gen-Sol Drops.


• Use the dropper that comes with Fer-Gen-Sol Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Fer-Gen-Sol Drops may be squeezed directly from the dropper into the mouth, or may be mixed in water or fruit juice. Be sure to drink the entire dose.


• If you are also taking antacids, a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), methyldopa, penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline) along with Fer-Gen-Sol Drops, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Fer-Gen-Sol Drops and your other medicines.


• Certain foods and drinks may decrease the amount of Fer-Gen-Sol Drops that works in your body. Ask your doctor or pharmacist how you should take Fer-Gen-Sol Drops if you consume whole grain breads or cereal, dairy products, coffee, or tea.


• If you miss a dose of Fer-Gen-Sol Drops, 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 Fer-Gen-Sol Drops.

Important safety information:

• Do not take large doses of vitamins while you use Fer-Gen-Sol Drops unless your doctor tells you to.


• Do NOT take more than the recommended dose or take for longer than 6 months without checking with your doctor.


• Fer-Gen-Sol Drops has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Fer-Gen-Sol Drops may discolor the stool. This is normal and not a cause for concern.


• Fer-Gen-Sol Drops may temporarily stain the teeth. Mixing Fer-Gen-Sol Drops with water or fruit juice or drinking it through a straw may help to decrease this effect. If staining occurs, it may be removed by rubbing teeth once a week with a little baking soda on a small cloth.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Lab tests, including complete blood cell counts and blood iron levels, may be performed while you use Fer-Gen-Sol Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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

Possible side effects of Fer-Gen-Sol Drops:

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; darkened or green stools; diarrhea; nausea; stomach upset.

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 stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp 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: Fer-Gen-Sol 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 difficulty breathing; loss of consciousness; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Fer-Gen-Sol Drops:

Store Fer-Gen-Sol Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fer-Gen-Sol Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Fer-Gen-Sol Drops, please talk with your doctor, pharmacist, or other health care provider.


• Fer-Gen-Sol Drops are 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 Fer-Gen-Sol Drops. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fer-Gen-Sol resources

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

Compare Fer-Gen-Sol with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia
• Vitamin/Mineral Supplementation and Deficiency
• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Fluocinonide Gel

Dosage Form: gel
Fluocinonide Gel USP, 0.05%

Rx only

For External Use Only - Not for Ophthalmic Use

Fluocinonide Gel Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Fluocinonide Gel contains fluocinonide USP (Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula:

Each gram contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and Carbopol 940 with sodium hydroxide and/or hydrochloric acid added to adjust the pH. This clear, colorless vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.

Fluocinonide Gel - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase the percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Fluocinonide Gel

Fluocinonide Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Fluocinonide Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.


4. Patients should report any signs of local adverse reactions especially under occlusive dressing.


5. Parents of pediatric patients should be advised not to use tight fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test; ACTH stimulation test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy:Teratogenic Effects: Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, anceiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Fluocinonide Gel Dosage and Administration

Apply a thin film to the affected area two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Fluocinonide Gel Supplied

Fluocinonide Gel USP, 0.05% in

15 gram tubes, NDC 0168-0135-15

60 gram tubes, NDC 0168-0135-60

Store at controlled room temperature 15°-30°C (59°-86°F).

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

I213515B

R2/08

#60

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

NDC 0168-0135 - 15

FOUGERA®

FLUOCINONIDE

GEL USP, 0.05%

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx only

Each gram contains: Fluocinonide 0.5

mg solubilized in a gel consisting of

propylene glycol, propyl gallate, edetate

disodium and Carbopol 940. Sodium

hydroxide and/or hydrochloric acid is

added to adjust the pH.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0168-0135 - 15

FOUGERA® Rx only

FLUOCINONIDE

GEL USP, 0.05%

WARNING: Keep out of

reach of children.

FOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams

FLUOCINONIDE  fluocinonide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0168-0135 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluocinonide (fluocinonide) fluocinonide 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   propyl gallate   edetate disodium   carbomer homopolymer type c   sodium hydroxide   hydrochloric acid   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0168-0135-15 15 g In 1 TUBE None 2 0168-0135-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072933	12/30/1994

Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Revised: 11/2009E. FOUGERA & CO., A division of Nycomed US Inc.

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

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