KETOCONAZOLE- ketoconazole tablet 
Bryant Ranch Prepack

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SPL MEDGUIDE

MEDICATION GUIDE

KETOCONAZOLE (KEE-toe-KON-a-zole) TABLETS USP

What is the most important information I should know about ketoconazole tablets?

 

Ketoconazole tablets are not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if ketoconazole tablets are right for you.

 

Ketoconazole tablets can cause serious side effects, including:

Call your healthcare provider right away if you have any of the following symptoms:   

            •  loss of appetite or start losing weight (anorexia)

            •  nausea or vomiting

            •  feel tired

            •  stomach pain or tenderness

            •  dark urine or light colored stools

            •  yellowing of your skin or the whites of your eye

            •  fever or rash

 

What are ketoconazole tablets?

Who should not take ketoconazole tablets?

Before you take ketoconazole tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using ketoconazole tablets with certain other medicines may affect each other. Using ketoconazole tablets with other medicines can cause serious side effects.

 

How should I take ketoconazole tablets?

What should I avoid while taking ketoconazole tablets?

What are the possible side effects of ketoconazole tablets?

Ketoconazole tablets may cause serious side effects, including:

The most common side effects of ketoconazole tablets include nausea, headache, diarrhea, stomach pain, and abnormal liver function tests.

These are not all the possible side effects of ketoconazole tablets. For more information, ask your healthcare provider or pharmacist.

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

How should I store ketoconazole tablets?

General information about the safe and effective use of ketoconazole tablets.

 Medications are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ketoconazole tablets for a condition for which they were not prescribed. Do not give ketoconazole tablets to other people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about ketoconazole tablets.

If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ketoconazole tablets that is written for health professionals.

 

What are the ingredients in ketoconazole tablets, USP?

Active ingredient: ketoconazole, USP

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

 

Distributed by:

Strides Pharma Inc,

East Brunswick, NJ 08816

 

Manufactured by:

Strides Shasun Limited,

Puducherry-605 014, India

Rev. 03/2018

Revised: 9/2020
Bryant Ranch Prepack