INTRODUCTION

KZL 200MG TABLET contains Ketoconazole which belongs to the group of medicines called Antifungals. It is used in adults to treat systemic fungal infections, chronic mucocutaneous and vaginal candidiasis, oral rush candiduric (fungal infection of mouth), etc.

Avoid drinking alcohol while receiving KZL 200MG TABLET treatment. Before taking KZL 200MG TABLET, inform your doctor if you have any liver, heart, or adrenal problems.

KZL 200MG TABLET should be used during pregnancy only if the potential benefit justifies the potential risk to the baby. KZL 200MG TABLET is not recommended for use by breastfeeding women. KZL 200MG TABLET is not for use in children (especially under 2 years of age), so consult your doctor for advice.

The most common side effects of taking KZL 200MG TABLET are nausea, headache, diarrhoea, stomach pain, etc. If any of the symptoms worsen, contact your doctor.

USES OF KZL 200MG TABLET

Treats

• systemic fungal infections
• candidiasis (chronic mucocutaneous and vaginal)
• oral rush candiduric

HOW KZL 200MG TABLET WORKS

KZL 200MG TABLET works by blocking the synthesis of ergosterol (a key component of the fungal cell membrane) thus weakening the structure and function of the fungal cell membrane.

DIRECTIONS FOR USE

Take KZL 200MG TABLET as advised by your physician. Do not crush or chew it. Swallow KZL 200MG TABLET as whole with a glass of water. Your doctor will decide the right dose and duration of therapy for you according to your age, body weight and disease condition. Do not stop taking KZL 200MG TABLET unless your doctor advises you to stop.

SIDE EFFECTS OF KZL 200MG TABLET

HOW TO MANAGE SIDE EFFECTS

Loss Of Appetite

Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a protein-rich snack or other healthy snack, such as dried fruit and nuts. If your appetite does not improve, consult your doctor.

Diarrhea

Drink lots of liquids like water or fruit juice to maintain hydration. Call your doctor before taking any medicine for diarrhoea. If diarrhoea persists, contact your doctor.

Dizziness Or Drowsiness

Lie down until the dizziness gets better, then get up slowly. Don’t hurry, and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. If dizziness persists, consult your doctor.

Nausea And Vomiting

Take KZL 200MG TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If nausea persists, contact your doctor.Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it; you don't have to eat or avoid any specific foods. Do not take any medicine for vomiting without your doctor's consultation. If vomiting persists, contact your doctor.

Headache

Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Call your doctor before taking any medicine for a headache. If the headache persists, consult your doctor.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

KZL 200MG TABLET should be used during pregnancy only if the potential benefit justifies the potential risk to the baby. Consult your doctor before taking it.

BREASTFEEDING

Contraindicated

KZL 200MG TABLET is not recommended for use in breastfeeding women as it can pass into the breastmilk. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate any machines if you feel dizzy or sleepy after taking KZL 200MG TABLET.

ALCOHOL

Contraindicated

Do not consume alcohol while taking KZL 200MG TABLET as it can lead to disulfiram-like reaction (a very uncomfortable reaction characterized by severe flushing). Consult your doctor for advice.

LIVER

Contraindicated

KZL 200MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take KZL 200MG TABLET if you are allergic to Ketoconazole or any of the other ingredients of this medicine.

HEART DISEASE

Use with Caution

KZL 200MG TABLET should be used with caution if you or any of your family members had an abnormal heart rhythm tracing (ECG) or a heart problem called “congenital long QT syndrome”. Consult your doctor before taking it.

USE IN PEDIATRICS

Contraindicated

KZL 200MG TABLET is not recommended for use in children (especially under 2 years of age). Consult your child’s doctor for advice.

USE IN GERIATRICS

Use with Caution

KZL 200MG TABLET should be used with caution in elderly patients to avoid the risk of fracture. Consult your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

Before taking KZL 200MG TABLET, inform your doctor if you are taking any of the following medicines:

• medicines used to treat acidity or heartburn (Ex. aluminum hydroxide, ranitidine, omeprazole, cisapride)
• medicines used to treat bacterial infections (Ex. rifampicin, rifabutin, isoniazid, telithromycin)
• medicines used to treat fits (Ex. carbamazepine, phenytoin)
• tamsulosin (used in benign prostate enlargement)
• medicines used to reduce severe pain (Ex. methadone, alfentanil, buprenorphine, fentanyl, oxycodone, sufentanil)
• medicines used to treat irregular heartbeat (Ex. disopyramide, dofetilide, dronedarone, quinidine, digoxin)
• medicines used to treat blood clots (Ex. rivaroxaban, cilostazol, warfarin, dabigatran)
• medicines used to reduce blood sugar levels (Ex. repaglinide, saxagliptin)
• praziquantel (used to treat protozoal infections)
• medicines used to treat migraine headaches (Ex. dihydroergotamine, ergometrine, ergotamine, methylergometrine, eletriptan)
• medicines used in cancer treatment (Ex. irinotecan, dasatinib, lapatinib, nilotinib)
• medicines used to treat certain psychiatric conditions (Ex. alprazolam, lurasidone, midazolam, pimozide, triazolam, risperidone)
• medicines used to treat viral infections (Ex. indinavir, maraviroc, saquinavir)
• medicines used to reduce blood pressure (Ex. felodipine, nisoldipine)
• ranolazine (used to treat angina)
• eplerenone (used to treat fluid retention)
• medicines used to suppress your immunity (Ex. everolimus, rapamycin, sirolimus, temsirolimus)
• medicines used to reduce high cholesterol (Ex. lovastatin, simvastatin)
• salmeterol (used in respiratory conditions like COPD)
• colchicine (used to treat gout)
• tolvaptan (used to control low blood sodium levels)

Overdosage:

If you or anyone else accidentally take too much of KZL 200MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep KZL 200MG TABLET out of reach of children
• Store between 20-25°C

FAQs ABOUT KZL 200MG TABLET

Q: Can KZL 200MG TABLET be used to treat fungal infections of the nails?

A: No, KZL 200MG TABLET is not recommended to treat fungal infections of the nails. It should not be used for any other condition than the one for which it was prescribed.Consult your doctor for further doubts.

Q: What if I forget to take a dose of KZL 200MG TABLET?

A: If you forget to take a dose of KZL 200MG TABLET, take it as soon as you remember. However, leave out the missed dose if it's almost time for the next one. Do not take KZL 200MG TABLET twice to make up for the missed dose.

Q: Can KZL 200MG TABLET be taken with acidic beverages?

A: KZL 200MG TABLET should be taken with an acidic beverage (ex., non-diet cola) only upon co-treatment with medicines reducing stomach acidity. Acid-neutralising medicines should be taken at least 1 hour before or 2 hours after taking KZL 200MG TABLET. Consult your doctor for further doubts.

Q: Can KZL 200MG TABLET lead to an excessive reduction in my cortisol levels?

A: Yes. Adrenal insufficiency (an excessive drop in cortisol levels) can occur during KZL 200MG TABLET treatment, and so your adrenal function will be monitored regularly. Consult your doctor immediately if you have symptoms such as tiredness, weakness, dizziness, nausea, or vomiting.

Q: Can I stop taking KZL 200MG TABLET?

A: Do not stop taking KZL 200MG TABLET until your doctor tells you to do so, as it may cause your cortisol levels to increase again and your symptoms may come back. Consult your doctor for further doubts.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Adrenal Gland Disorders. Pharmacotherapy Handbook. Ninth edition. Page- 155.

2. Sharquie, Khalifa E., Adil A. Noaimi, Wasnaa S. Al-Salam. The safety of oral ketoconazole in the treatment of skin diseases (single blinded, therapeutic, comparative study). Scientific Research- An Academic Publisher. December 2018. [Accessed 17th May 2022] https://www.scirp.org/journal/paperinformation.aspx?paperid=89299

3. Sinawe H, Casadesus D. Ketoconazole. NIH National Library of Medicine, National center for biotechnology information. StatPearls [Internet]. June 2022. [Accessed 17th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2888552/

4. Janssen Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in July 2013] [Accessed on 17th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf

5. A-S Medication Solutions. Ketoconazole tablet. Dailymed. [Revised in October 2022] [Accessed on 17th October 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=517c29fc-2a2a-4bd5-a8bb-b464a65d2be0#ID316

6. Taj Life Sciences. Ketoconazole 200mg tablet. [Accessed on 17th October 2022] https://tajlifesciences.com/portfolio/ketoconazole-tablets-200mg/

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count (CBC)