FAQ
 
PAKHSH RAZI COMPANY  
 
   
 
 
 
     
   
KETOCONAZOLE
 
What is KETOCONAZOLE?
  Ketoconazole is usually used to treat serious fungal infections (specially when the infection is deepseated or resisant to other drugs and in patients with immune deficiency) of the nails, skin, mouth (thrush), lungs, vagina, and blood. This drug is also used in prostate cancer. Ketoconazole is produced as scored tablets, topical cream and shampoo.
 
How should I use KETOCONAZOLE?
  Ketoconazole tablet is usually prescribed once a day. Swallow the tablets whole, and do not crush or chew them. Oral treatment may be prescribed from 1-2 weeks to 6 months. The topical cream is usually taken 1-2 times a day for 2-4 weeks. Use enough amount of cream and wash your hands thoroughly after applying the drug. The shampoo is often used 2 times a week for at least 4 weeks. Do not wash the shampoo off your body quickly and let it be on your skin for at least 3-5 minutes. Read the directions on the drug leaflet carefully. Take ketoconazole exactly as directed by your doctor and do NOT change the dosage on your own. Do not stop taking ketoconazole without talking to your doctor, even if you feel better. If you stop taking the drug, your infection may regress even worse.
 
Contraindications
  Ketoconazole must not be used in patients with severe sensitivity to azole antifungals, liver failure and porphyria (a blood disorder).
 
If you miss a dose!
  Take the missed dose as soon as you remember it. But if it’s almost time for the next dose, skip the missed dose and continue your regular schedule. Do not take a double dose to make up for a missed one.
 
Dietary instructions
  Ketoconazole needs an acidic environment for good absorption (e.g. a glass of orange juice). You can take the drug with food, fruit juice, milk or water. This drug can cause nausea and upeset stomach, in that case take it with food.
 
Special Precautions & Warnings
  Tell your doctor if: • You are allergic to ketoconazole, other antifungal agents or any drugs. • You are taking any drugs, prescription or non-prescription, specially antacids, anticoagulants like warfarin, cyclosporine (sandimmune), cimetidine, hydrocortisone, isoniazid (INH), diabetes oral agents, drugs for asthma, phenytoin, rifampin or even vitamins. • You have or have had liver disease, porphyria, or stomach problems (e.g. lack of acid production). • You drink alcohol or you have a history of alcohol abuse.
 
Side Effects
  Ketoconazole may cause headache, drowsiness, light-headedness, photophobia, pins and needles in limbs, nausea, vomiting, diarrhea, constipation, upset stomach, bloating, itching and skin redness (specially with local drug forms). Consult your doctor if the mentioned symptoms become severe or persist. But in case you experience any of the following signs or symptoms, see your doctor immediately: Skin rash, severe itching, hives, unusual bruising or bleeding, joint swelling, convulsion, breast enlargement or tenderness in men, hair loss and symptoms of liver damage like severe fatigue, vomiting, dark urine, pale stool and yellowing of skin or eyes.
 
Storage
  Keep ketoconazole in its container, tightly closed, and out of reach of children. Store the drug at room temperature, away from direct light, excess heat or moisture. Throw away any medication that is outdated or no longer needed.
 
Emergency/Overdose
  In case of overdose, seek help at your nearest medical center.
 
Drug interactions
  Taking indigestion drugs like antacids (e.g. aluminium magnesium hydroxide), cimetidine or ranitidine decrease the absorption of ketoconazole. Take ketoconazole at least 1-2 hours before or after these medications. • Taking rifampin with this medicine can decearse blood level of ketoconazole and thus decrease its effects. • Taking ketoconazole with anticoagulants (e.g. warfarin) can increase the anticoagulation effect of such drugs. • Ketoconazole can increase blood concentration of cyclosporine and in result increase its effects. • Ketoconazole has interaction with phenytoin, isoniazide and cholestrol lowering drugs such as lovastatin or simvastatin. • Do not take ketocaonazole with astemizole, terfenadine or cisapride. This can lead to serious arrythmias (irregular heartbeats).
 
Children, pregnant women & nursing mothers
  ketoconazole must be used in children with a doctor’s prescription only. Ketoconazole is excreted in breast milk and there is possible harm to your infant, so do NOT breastfeed your baby during treatment and 48 hours after stopping the drug. If you are pregnant or planning to become pregnant, talk to your doctor.
 
More information
  • Avoid any contact of ketoconazole (shampoo or cream) with eyes. • Since ketoconazole may cause dizziness or drowsiness, do not drive a car until you come to know how it works on you. • Do not lose touch with your doctor. It’s essential for him to check your response to drug and check some of your blood markers such as liver enzymes. • Oral contraceptive pills may be less effective while taking ketoconazole. So in addition to taking the contraceptive pill, use a barrier method of contraception (e.g. condoms) when taking the drug. For further information consult your doctor.