Fluconazole (Page 8 of 9)

HOW SUPPLIED

Fluconazole Tablets USP are available containing 50 mg, 100 mg, 150 mg or 200 mg of fluconazole USP and are supplied as:

50 mg – Pink to light pink, round, biconvex tablets are debossed with ‘H’ above ‘01’ on one side and plain on the other. They are supplied in bottles of 30 tablets (NDC 62559-990-30).

100 mg – Pink to light pink, round, biconvex tablets are debossed with ‘H’ above ‘602’ on one side and plain on the other. They are supplied in bottles of 30 tablets (NDC 62559-991-30).

150 mg – Pink to light pink, round, biconvex tablets are debossed with ‘H’ above ‘603’ on one side and plain on the other. They are supplied in cartons of 12 blister cards of 1 tablet (NDC 62559-992-12).

200 mg – Pink to light pink, round, biconvex tablets are debossed with ‘H’ above ‘604’ on one side and plain on the other. They are supplied in bottles of 30 tablets (NDC 62559-993-30).

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc.

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
ani_logo

Issued: 03/2024LB4577-02

PATIENT INFORMATIONFluconazole (floo-KOE-na-zole) Tablets USP

This leaflet contains important information about fluconazole tablets. It is not meant to take the place of your healthcare provider’s instructions. Read this information carefully before you take fluconazole tablets. Ask your healthcare provider if you do not understand any of this information or if you want to know more about fluconazole tablets.

What are Fluconazole Tablets?

Fluconazole tablets are a prescription medicine used to treat vaginal yeast infections caused by a yeast called Candida. Fluconazole tablets help stop too much yeast from growing in the vagina so the yeast infection goes away.

Fluconazole tablets are different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole tablets are also used for other conditions. However, this leaflet is only about using fluconazole for vaginal yeast infections. For information about using fluconazole tablets for other reasons, ask your healthcare provider. See the section of this leaflet for information about vaginal yeast infections.

What is a vaginal yeast infection?

It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life.

Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your healthcare provider for tips on what you can do to help prevent vaginal yeast infections.

If you get a vaginal yeast infection, you may have any of the following symptoms:

itching
a burning feeling when you urinate
redness
soreness
a thick white vaginal discharge that looks like cottage cheese

Do not take Fluconazole Tablets if you

take the following medicines:
o
quinidine
o
erythromycin
o
pimozide
o
are allergic to fluconazole, the active ingredient in fluconazole tablets, or any of the ingredients in fluconazole tablets. See the end of this Patient Information leaflet for a complete list of ingredients in fluconazole tablets.

Before you take Fluconazole Tablets, tell your healthcare provider about all of your medical conditions, if you:

have liver problems
have kidney problems
have heart problems including heart arrythmias
have hypokalemia (low potassium)
are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking fluconazole tablets. You and your healthcare provider will decide if fluconazole tablets are right for you. If you may become pregnant you should use a birth-control (contraceptive) method while taking fluconazole tablets and for 1 week after your final dose.
are breastfeeding or plan to breastfeed. Fluconazole can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while you are taking fluconazole tablets.

Before you start taking Fluconazole Tablets, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

diabetes medicines such as glyburide, tolbutamide, glipizide
blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, verapamil, nifedipine or felodipine
blood thinners such as warfarin
cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants)
rifampin or rifabutin for tuberculosis
phenytoin or carbamazepine to control seizures
theophylline to control asthma
quinidine (used to correct disturbances in heart rhythm)
amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
amitriptyline or nortriptyline for depression
pimozide for psychiatric illness
amphotericin B or voriconazole for fungal infections
erythromycin for bacterial infections
olaparib, cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer
fentanyl, alfentanil or methadone for chronic pain
ibrutinib used for treating blood cancer
ivacaftor or ivacaftor combinations, such as tezacaftor/ivacaftor and ivacaftor/tezacaftor/elexacaftor, used to treat cystic fibrosis
lurasidone used to treat schizophrenia or depression
lemborexant, used for the treatment of insomnia
lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin
non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen
prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders
antiviral medications used to treat HIV like saquinavir or zidovudine
tofacitinib for rheumatoid arthritis
abrocitinib (used to treat atopic dermatitis, also known as eczema)
vitamin A nutritional supplement
tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline

Since there are many brand names for these medicines, check with your healthcare provider or pharmacist if you have any questions.

How should I take Fluconazole Tablets?

Take fluconazole tablets exactly as your healthcare provider tells you to.
Take fluconazole tablets by mouth with or without food.
If you take too much fluconazole, call your healthcare provider or go to the nearest emergency room right away.

What should I avoid while taking Fluconazole Tablets?

Fluconazole tablets can cause dizziness and seizures. Do not drive or operate machinery until you know how fluconazole tablets affect you.

What are the possible side effects of Fluconazole Tablets?

Fluconazole Tablets may cause serious side effects including:

serious liver problems. Some people with serious medical problems have developed serious liver problems that became life-threatening or caused death while taking fluconazole tablets. Sometimes these liver problems can be reversed when you stop taking fluconazole tablets. Tell your healthcare provider right away if you have symptoms of serious liver problems including:
o
dark colored urine
o
severe skin itching
o
yellowing of the skin and eyes (jaundice)
o
light-colored stools
o
tiredness
o
vomiting
o
loss of appetite
serious allergic reactions: Serious allergic reactions (anaphylaxis) have happened while taking fluconazole tablets. Stop taking fluconazole tablets, call your healthcare provider or go to the nearest hospital emergency room right away if you get any signs or symptoms of an allergic reaction including:
o
shortness of breath
o
fever
o
swelling of the eyelids, face, mouth, neck, or any other part of the body
o
coughing
o
skin rash, hives, blisters or skin peeling
o
wheezing
o
throbbing of the heart or ears
o
chills
serious skin problems. Some people with serious medical problems have developed serious skin problems that have caused death while taking fluconazole tablets. Tell your healthcare provider right away if you develop a rash while taking fluconazole tablets.

The most common side effects of Fluconazole Tablets include:

headache
dizziness
diarrhea
stomach pain
nausea or upset stomach
changes in the way food tastes

Other side effects include:

adrenal insufficiency: Some people who have taken fluconazole tablets developed adrenal insufficiency that was reversible. Tell your healthcare provider right away if you have symptoms of adrenal insufficiency including:
o
long lasting fatigue
o
weight loss
o
nausea
o
muscle weakness
o
stomach pain
o
vomiting
o
loss of appetite
o
dizziness
dizziness or seizures.

These are not all the possible side effects of fluconazole tablets.

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

How should I store Fluconazole Tablets?

Store fluconazole tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep fluconazole tablets and all medicines out of the reach of children.

General information about the safe and effective use of Fluconazole Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use fluconazole tablets for a condition for which it was not prescribed. Do not give fluconazole tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider for information about fluconazole tablets that is written for health professionals.

What are the ingredients in Fluconazole Tablets?

Active ingredient: fluconazole

Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake, magnesium stearate, microcrystalline cellulose and povidone.

Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623logo

This Patient Information has been approved by the U.S. Food and Drug Administration
Issued: 03/2024
LB4577-02

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