Fluconazole (Page 9 of 9)

Who Should Not Take Fluconazole?

To avoid a possible serious reaction, do NOT take fluconazole if you are taking cisapride (Propulsid®†) since it can cause changes in heartbeat in some people if taken with fluconazole.

How Should I Take Fluconazole

Take fluconazole by mouth with or without food. You can take fluconazole at any time of the day.

Fluconazole keeps working for several days to treat the infection. Generally the symptoms start to go away after 24 hours. However, it may take several days for your symptoms to go away completely. If there is no change in your symptoms after a few days, call your doctor.

Graphic

Directions: Push tablet through foil and take by mouth

Just swallow 1 Fluconazole tablet to treat your vaginal yeast infection.

What Should I Avoid While Taking Fluconazole?

Some medicines can affect how well fluconazole works. Check with your doctor before starting any new medicines within seven days of taking fluconazole.

What Are The Possible Side Effects of Fluconazole?

Like all medicines, fluconazole may cause some side effects that are usually mild to moderate.

The most common side effects of fluconazole are:

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

Allergic reactions to fluconazole are rare, but they can be very serious if not treated right away by a doctor. If you cannot reach your doctor, go to the nearest hospital emergency room. Signs of an allergic reaction can include shortness of breath; coughing; wheezing; fever; chills; throbbing of the heart or ears; swelling of the eyelids, face, mouth, neck, or any other part of the body; or skin rash, hives, blisters or skin peeling.

Fluconazole has been linked to rare cases of serious liver damage, including deaths, mostly in patients with serious medical problems. Call your doctor if your skin or eyes become yellow, your urine turns a darker color, your stools (bowel movements) are light-colored, or if you vomit or feel like vomiting or if you have severe skin itching.

In patients with serious conditions such as AIDS or cancer, rare cases of severe rashes with skin peeling have been reported. Tell your doctor right away if you get a rash while taking fluconazole.

Fluconazole may cause other less common side effects besides those listed here. If you develop any side effects that concern you, call your doctor. For a list of all side effects, ask your doctor or pharmacist.

What To Do For An Overdose

In case of an accidental overdose, call your doctor right away or go to the nearest emergency room.

How To Store Fluconazole

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

General Advice About Prescription Medicines

Medicines are sometimes prescribed for conditions that are mentioned in patient information leaflets. Do not use fluconazole for a condition for which it was not prescribed. Do not give fluconazole to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about fluconazole. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about fluconazole that is written for health professionals.

Propulsid is a registered trademark of Janssen Pharmaceutica

Seldane is registered trademark of Hoechst Marion Roussel Inc. (now Aventis Pharmaceuticals)

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115www.glenmarkgenerics.com

May 2010

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel — 100 mg

Fluconazole 100mg
(click image for full-size original)

Principal Display Panel — 150 mg

Fluconazole 150mg
(click image for full-size original)

FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-131(NDC:68462-102)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE (FLUCONAZOLE) FLUCONAZOLE 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
Product Characteristics
Color PINK Score no score
Shape TRAPEZOID Size 10mm
Flavor Imprint Code 100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-131-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077253 01/25/2006
FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-193(NDC:68462-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE (FLUCONAZOLE) FLUCONAZOLE 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-193-01 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (21695-193-01)
2 NDC:21695-193-02 2 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (21695-193-02)
3 NDC:21695-193-12 12 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
3 1 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (21695-193-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077253 01/25/2006
FLUCONAZOLE fluconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-560(NDC:68462-104)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUCONAZOLE (FLUCONAZOLE) FLUCONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
Product Characteristics
Color PINK Score no score
Shape TRAPEZOID Size 12mm
Flavor Imprint Code 200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-560-07 7 TABLET (TABLET) in 1 BOTTLE None
2 NDC:21695-560-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077253 01/25/2006
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 09/2010 Rebel Distributors Corp

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