Wednesday, October 12, 2016

Fungoid Kit


Generic Name: miconazole topical (my CON a zole)

Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF


What is Fungoid Kit (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.


Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.


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


What is the most important information I should know about Fungoid Kit (miconazole topical)?


Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).


Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Fungoid Kit (miconazole topical)?


Do not use miconazole topical if you have had an allergic reaction to it in the past.


It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Fungoid Kit (miconazole topical)?


Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.


Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.


Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.


Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.


Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?


Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.


What happens if I overdose?


An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.


What should I avoid while using Fungoid Kit (miconazole topical)?


Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Fungoid Kit (miconazole topical) side effects


Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.


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. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Fungoid Kit (miconazole topical)?


Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.



More Fungoid Kit resources


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


  • Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Monistat 3 Prescribing Information (FDA)

  • Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Fungoid Kit with other medications


  • Cutaneous Candidiasis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor


Where can I get more information?


  • Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Fungoid side effects (in more detail)


Finacea Plus


Generic Name: azelaic acid topical (AZ eh LAY ik AS id)

Brand Names: Azelex, Finacea, Finacea Plus, Finevin


What is Finacea Plus (azelaic acid topical)?

Azelaic acid is a naturally occurring acid. It helps the skin to renew itself more quickly and therefore reduces pimple and blackhead formation. It also helps to kill the bacteria that cause acne and rosacea.


Azelaic acid topical (for the skin) is used to treat acne and rosacea.


Azelaic acid topical may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Finacea Plus (azelaic acid topical)?


You should not use this medication if you are allergic to azelaic acid or propylene glycol. Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin. Wait until these conditions have healed before using this medication. Do not cover the area after applying azelaic acid. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

It may take up 4 weeks or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of treatment.


If you have excessive burning, dryness, or irritation, ask your doctor about using azelaic acid once daily.


What should I discuss with my healthcare provider before using Finacea Plus (azelaic acid topical)?


You should not use this medication if you are allergic to azelaic acid or propylene glycol. FDA pregnancy category B. Azelaic acid topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether azelaic acid topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Finacea Plus (azelaic acid topical)?


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


Wash your hands before and after applying this medication.

Clean the affected area with a mild soap or a soapless cleansing lotion and pat dry with a soft towel. Apply the medication as directed.


Azelaic acid topical is usually applied twice daily, in the morning and at bedtime. Follow your doctor's instructions.


Do not cover the affected area after applying azelaic acid. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

It may take up 4 weeks or longer before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of treatment.


If you have excessive burning, dryness, or irritation, ask your doctor about using azelaic acid once daily.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while using Finacea Plus (azelaic acid topical)?


Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin. Wait until these conditions have healed before using this medication.

Avoid using other medications on the areas you treat with azelaic acid topical unless you doctor tells you to.


Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime.


Your doctor may recommend avoiding spicy foods, hot foods or drinks, alcoholic beverages and other foods or beverages that may cause flushing or redness of the skin during treatment with azelaic acid topical.


Do not cover the area after applying azelaic acid. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Finacea Plus (azelaic acid topical) 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. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or warmth;




  • severe itching or tingling;




  • severe redness, dryness, peeling, or other irritation; or




  • changes in skin color.



Less serious side effects are more likely, and you may have none at all.


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 Finacea Plus (azelaic acid topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied azelaic acid. But many drugs can interact with each other. 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 Finacea Plus resources


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


  • Finacea Plus Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Finacea Plus Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Azelex Prescribing Information (FDA)

  • Azelex Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Finacea Prescribing Information (FDA)

  • Finacea Consumer Overview

  • Finacea Gel MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Finacea Plus with other medications


  • Acne
  • Rosacea


Where can I get more information?


  • Your pharmacist can provide more information about azelaic acid topical.

See also: Finacea Plus side effects (in more detail)


Ferrex 150 Plus


Generic Name: ascorbic acid and iron polysaccharide (as KORE bik AS id and EYE urn SAK a ride)

Brand Names: Fe-Tinic 150, Ferrex 150 Plus, Niferex-150


What is Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?

Ascorbic acid is found in citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for the skin and connective tissues, for normal chemical and hormonal production, and for the immune system.


Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.


Ascorbic acid is used to treat and prevent vitamin C deficiency.


Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.


Ascorbic acid and iron polysaccharide may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?


Do not take more ascorbic acid and iron polysaccharide than is prescribed for you or than is directed on the package. Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.


What should I discuss with my healthcare provider before taking Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?


If you do not have an iron deficiency, talk to your doctor about the use of ascorbic acid and iron polysaccharide. Generally, ascorbic acid and iron polysaccharide should not be taken chronically by individuals with a normal iron balance.


To make sure you can safely take ascorbic acid and iron polysaccharide, tell your doctor if you have any of these other conditions:



  • diabetes;




  • hemosiderosis;




  • hemolytic anemia;




  • hemochromatosis;




  • kidney disease or an increased risk of kidney stones;




  • if you are on a sodium restricted diet; or




  • if you are allergic to sulfites or tartrazine.




FDA pregnancy category C. It is not known whether ascorbic acid and iron polysaccharide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ascorbic acid and iron polysaccharide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?


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

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.


Take this medicine with a full glass of water.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.


This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using ascorbic acid and iron polysaccharide.


Store at room temperature, away from moisture and heat.

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.

Overdose can cause decreased energy, nausea, vomiting, abdominal pain, tarry stools, weak or rapid pulse, fever, or seizure (convulsions).


What should I avoid while taking Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?


Do not take ascorbic acid and iron polysaccharide within 2 hours before or after you take any of the following medicines

  • levodopa (Larodopa, Dopar, Sinemet);




  • levothyroxine (Synthroid, Levoxyl, others);




  • methyldopa (Aldomet);




  • penicillamine (Cuprimine);




  • antacids (Amphojel, Maalox, Mylanta, Rolaids, Rulox, Tums, and others);




  • a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or




  • an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others.



Ascorbic acid and iron polysaccharide may decrease the absorption of the drugs listed above.


Ferrex 150 Plus (ascorbic acid and iron polysaccharide) side effects


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

  • fever;




  • severe lower back pain;




  • painful or difficult urination;




  • blood in your urine; or




  • black or dark stools.



Less serious side effects may include:



  • stomach upset;




  • nausea or vomiting;




  • diarrhea;




  • constipation; or




  • temporary staining of the teeth.



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 Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?


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



  • a blood thinner such as warfarin (Coumadin).




  • an estrogen such as Premarin, Ogen, Estratest, Vivelle, Climara, Estring, Estrace, and others; or




  • an oral birth control pill such as Alesse, Levlen, Ovral, Triphasil, Tri-Levlen, Lo-Ovral, and others.



This list is not complete and other drugs may interact with ascorbic acid and iron polysaccharide. 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 Ferrex 150 Plus resources


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


Compare Ferrex 150 Plus with other medications


  • Dietary Supplementation


Where can I get more information?


  • Your pharmacist can provide more information about ascorbic acid and iron polysaccharide.

See also: Ferrex50 Plus side effects (in more detail)


Fluocinonide Cream




FLUOCINONIDE

CREAM USP, 0.05%

(Emollient Base)

Rx only


For Topical Use Only

Not for Ophthalmic Use



Fluocinonide Cream Description


Fluocinonide Cream USP, 0.05% (Emollient Base) is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name 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 the following chemical structure



Fluocinonide Cream USP, 0.05% (Emollient Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid, mineral oil, polysorbate 60, propylene glycol, sorbitan monostearate, stearyl alcohol and purified water.



Fluocinonide Cream - Clinical Pharmacology


Topical corticosteroids share anti-inflammatory, anti-pruritic 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 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


Fluocinonide Cream USP, 0.05% (Emollient Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.



CONTRAINDICATIONS


Topical corticosteroids are 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 anti-bacterial 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 Patient: 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 is 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, 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 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.


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:


















BurningPerioral dermatitis
ItchingAllergic contact dermatitis
IrritationMaceration of the skin
DrynessSecondary infection
FolliculitisSkin atrophy
HypertrichosisStriae
Acneiform eruptionsMiliaria
Hypopigmentation

Overdosage


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



Fluocinonide Cream Dosage and Administration


Fluocinonide Cream USP, 0.05% (Emollient Base) is generally applied to the affected area as a thin film from 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 Cream Supplied


Fluocinonide Cream USP, 0.05% (Emollient Base) is supplied as follows:








NDC 0168-0246-1515 gram tubes
NDC 0168-0246-3030 gram tubes
NDC 0168-0246-6060 gram tubes

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]


Avoid excessive heat, above 40°C (104°F).


E. FOUGERA & CO.


A division of


Fougera

PHARMACEUTICALS INC.

Melville, New York 11747


I246C

R10/11

#191



PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER


NDC 0168-0246-15


FOUGERA®


FLUOCINONIDE


CREAM USP, 0.05%


(Emollient Base)


Rx only


Each gram contains fluocinonide


0.5 mg in a water-washable


aqueous emollient base of cetyl


alcohol, citric acid (anhydrous),


mineral oil, polysorbate 60,


propylene glycol, sorbitan


monostearate, stearyl alcohol


and purified water.


NET WT 15 grams




PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON


NDC 0168-0246-15


Rx only


FOUGERA®


FLUOCINONIDE


CREAM USP, 0.05%


(Emollient Base)


FOR TOPICAL USE ONLY


NOT FOR OPHTHALMIC USE


Store at 20° - 25°C (68° - 77°F) [see


USP Controlled Room Temperature]


AVOID EXCESSIVE HEAT,


ABOVE 40°C (104°F).


NET WT 15 grams










FLUOCINONIDE 
fluocinonide  cream










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0168-0246
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
fluocinonide (fluocinonide)fluocinonide0.5 mg  in 1 g




















Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
anhydrous citric acid 
mineral oil 
polysorbate 60 
propylene glycol 
sorbitan monostearate 
stearyl alcohol 
water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
10168-0246-151 TUBE In 1 CARTONcontains a TUBE
115 g In 1 TUBEThis package is contained within the CARTON (0168-0246-15)
20168-0246-301 TUBE In 1 CARTONcontains a TUBE
230 g In 1 TUBEThis package is contained within the CARTON (0168-0246-30)
30168-0246-601 TUBE In 1 CARTONcontains a TUBE
360 g In 1 TUBEThis package is contained within the CARTON (0168-0246-60)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07658606/23/2004


Labeler - E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. (043838424)









Establishment
NameAddressID/FEIOperations
Fougera Pharmaceuticals Inc.043838424ANALYSIS









Establishment
NameAddressID/FEIOperations
Fougera Pharmaceuticals Inc.174491316MANUFACTURE
Revised: 01/2012E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

Flebogamma IGIV


Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)

Brand Names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin


What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.


Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.


Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.


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


What is the most important information I should know about immune globulin?


Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.


Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.


To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.


Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.


What should I discuss with my health care provider before using immune globulin?


You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:



  • kidney disease;




  • diabetes (especially if you use insulin);




  • a history of stroke or blood clot;




  • heart disease or high blood pressure;




  • a condition called paraproteinemia; or




  • if you are over 65 years old.




FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known if immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.


How is immune globulin intravenous given?


Immune globulin intravenous is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.


IVIG should not be injected into a muscle or under the skin.


Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.


Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.


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


To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.


Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

What happens if I miss a dose?


Call your doctor for instructions if you miss a dose of this medication.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using immune globulin?


Do not receive a "live" vaccine while using IVIG. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Immune globulin side effects


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

  • urinating less than usual or not at all;




  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;




  • swelling, weight gain, feeling short of breath;




  • wheezing, chest tightness;




  • feeling like you might pass out;




  • fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or




  • pale or yellowed skin, dark colored urine, fever, confusion or weakness.



Less serious side effects may include:



  • mild headache;




  • dizziness;




  • tired feeling;




  • back pain, muscle cramps;




  • minor chest pain; or




  • flushing (warmth, redness, or tingly feeling).



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 immune globulin?


Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:



  • lithium (Lithobid);




  • methotrexate (Rheumatrex, Trexall);




  • pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;




  • medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);




  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);




  • IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);




  • antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or




  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).



This list is not complete and other drugs may interact with immune globulin. 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 Flebogamma resources


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


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  • Autoimmune Neutropenia
  • Bone Marrow Transplantation
  • Chronic Lymphocytic Leukemia
  • Evan's Syndrome
  • HIV Infection
  • Idiopathic Thrombocytopenic Purpura
  • Kawasaki Disease
  • Polymyositis/Dermatomyositis
  • Primary Immunodeficiency Syndrome


Where can I get more information?


  • Your pharmacist can provide more information about immune globulin intravenous.

See also: Flebogamma side effects (in more detail)


Ferrous Fumarate/Vitamin C/Vitamin B12


Pronunciation: FER-us FUE-ma-rate/VYE-ta-min B
Generic Name: Ferrous Fumarate/Vitamin C/Vitamin B12
Brand Name: Fumatinic

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years. 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.





Ferrous Fumarate/Vitamin C/Vitamin B12 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.


Ferrous Fumarate/Vitamin C/Vitamin B12 is a vitamin and iron combination. It works by providing vitamins and iron to the body.


Do NOT use Ferrous Fumarate/Vitamin C/Vitamin B12 if:


  • you are allergic to any ingredient in Ferrous Fumarate/Vitamin C/Vitamin B12

  • you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or 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 Ferrous Fumarate/Vitamin C/Vitamin B12:


Some medical conditions may interact with Ferrous Fumarate/Vitamin C/Vitamin B12. 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, hemolytic anemia, porphyria, thalassemia)

  • if you have a peptic ulcer or bowel problems (eg, colitis, Crohn disease, diverticulitis)

  • if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrous Fumarate/Vitamin C/Vitamin B12. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Chloramphenicol because it may decrease Ferrous Fumarate/Vitamin C/Vitamin B12's effectiveness

  • Fluorouracil because the risk of its side effects may be increased by Ferrous Fumarate/Vitamin C/Vitamin B12

  • Doxycycline, hydantoins (eg, phenytoin), penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ferrous Fumarate/Vitamin C/Vitamin B12

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrous Fumarate/Vitamin C/Vitamin B12 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 Ferrous Fumarate/Vitamin C/Vitamin B12:


Use Ferrous Fumarate/Vitamin C/Vitamin B12 as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Ferrous Fumarate/Vitamin C/Vitamin B12 by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • If you also take an antacid, a bisphosphonate (eg, alendronate), cefdinir, eltrombopag, methyldopa, penicillamine, a quinolone antibiotic (eg, ciprofloxacin), or a tetracycline (eg, doxycycline, minocycline), ask your doctor or pharmacist how to take it with Ferrous Fumarate/Vitamin C/Vitamin B12.

  • If you miss a dose of Ferrous Fumarate/Vitamin C/Vitamin B12, 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 Ferrous Fumarate/Vitamin C/Vitamin B12.



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 Ferrous Fumarate/Vitamin C/Vitamin B12 unless your doctor tells you to.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 has iron, vitamin C, and vitamin B12 in it. Before you start any new medicine, check the label to see if it also has iron, vitamin C, or vitamin B12 in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years. In case of an overdose, call a doctor or poison control center right away.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 may darken the stools. This is normal and not a cause for concern.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 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 Ferrous Fumarate/Vitamin C/Vitamin B12.

  • Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Ferrous Fumarate/Vitamin C/Vitamin B12. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 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 Ferrous Fumarate/Vitamin C/Vitamin B12 while you are pregnant. Ferrous Fumarate/Vitamin C/Vitamin B12 is found in breast milk. If you are or will be breast-feeding while you use Ferrous Fumarate/Vitamin C/Vitamin B12, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Ferrous Fumarate/Vitamin C/Vitamin B12:


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; diarrhea; flushing of the arms, face, or legs; 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); black, tarry, or bloody stools; severe or persistent stomach pain or cramping; vomit that looks like coffee grounds.



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 black, tarry, or bloody stools; drowsiness or dizziness; fainting; fast heartbeat; irritability; rapid breathing; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomit that looks like coffee grounds; weakness.


Proper storage of Ferrous Fumarate/Vitamin C/Vitamin B12:

Store Ferrous Fumarate/Vitamin C/Vitamin B12 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 Ferrous Fumarate/Vitamin C/Vitamin B12 out of the reach of children and away from pets.


General information:


  • If you have any questions about Ferrous Fumarate/Vitamin C/Vitamin B12, please talk with your doctor, pharmacist, or other health care provider.

  • Ferrous Fumarate/Vitamin C/Vitamin B12 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 Ferrous Fumarate/Vitamin C/Vitamin B12. 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 Ferrous Fumarate/Vitamin C/Vitamin B12 resources


  • Ferrous Fumarate/Vitamin C/Vitamin B12 Use in Pregnancy & Breastfeeding
  • Drug Images
  • Ferrous Fumarate/Vitamin C/Vitamin B12 Drug Interactions
  • Ferrous Fumarate/Vitamin C/Vitamin B12 Support Group
  • 11 Reviews for Ferrous Fumarate/Vitamin C/Vitamin B12 - Add your own review/rating


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  • Anemia
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Tuesday, October 11, 2016

Flagyl ER Extended-Release Tablets


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

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





Flagyl ER Extended-Release Tablets are used for:

Treating certain bacterial infections of the vagina (bacterial vaginosis). It may also be used for other conditions as determined by your doctor.


Flagyl ER Extended-Release Tablets are 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 ER Extended-Release Tablets if:


  • you are allergic to any ingredient in Flagyl ER Extended-Release Tablets 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 the 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 ER Extended-Release Tablets:


Some medical conditions may interact with Flagyl ER Extended-Release Tablets. 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 ER Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


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

  • Amiodarone because the risk of irregular heartbeat may be increased

  • Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Flagyl ER Extended-Release Tablets's effectiveness

  • Anticoagulants (eg, warfarin), busulfan, cyclosporine, ergot alkaloids (eg, ergotamine), HIV protease inhibitors containing alcohol (eg, amprenavir solution), lithium, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Flagyl ER Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flagyl ER Extended-Release Tablets 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 ER Extended-Release Tablets:


Use Flagyl ER Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Flagyl ER Extended-Release Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.

  • Swallow Flagyl ER Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

  • To clear up your infection completely, take Flagyl ER Extended-Release Tablets 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 ER Extended-Release Tablets, 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 ER Extended-Release Tablets.



Important safety information:


  • Flagyl ER Extended-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Flagyl ER Extended-Release Tablets 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 ER Extended-Release Tablets 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 ER Extended-Release Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Be sure to use Flagyl ER Extended-Release Tablets 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 ER Extended-Release Tablets 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 ER Extended-Release Tablets 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 ER Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Flagyl ER Extended-Release Tablets.

  • Lab tests, including liver function and white blood cell counts, may be performed while you use Flagyl ER Extended-Release Tablets. 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 ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

  • Flagyl ER Extended-Release Tablets 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 ER Extended-Release Tablets while you are pregnant. Do not use Flagyl ER Extended-Release Tablets in the first 3 months of pregnancy. Flagyl ER Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Flagyl ER Extended-Release Tablets.


Possible side effects of Flagyl ER Extended-Release Tablets:


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 ER 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 ER Extended-Release Tablets:

Store Flagyl ER Extended-Release Tablets 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 Flagyl ER Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Flagyl ER Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Flagyl ER Extended-Release Tablets 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 Flagyl ER Extended-Release Tablets. 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 ER resources


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


Compare Flagyl ER with other medications


  • Bacterial Vaginitis