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Ketoconazole is an antimycotic or antifungal agent used to treat different types of mycoses. It can be used externally (topical use) in the form of a cream or shampoo, or internally in the form of a tablet (systemic use). This medicine is indicated mainly in cases of chronic candidiasis, topical dermatitis, seborrheic dermatitis, among others.
With regard to internal use in tablet form, this drug should be used only when other drugs cannot be used or have not worked, as their use carries a risk of hepatotoxicity.
About a molecule
Chemical name : ketoconazole
Nomes da molécula: 1-[4-(4-{[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one
Trade names
– tablet: Ketoconazole, Izonax, Nizoral.
– cream: Ketoconazole, Ketoderm, Cetonax Sham, Cetoneo, Izonax, Nizoral Sham.
– shampoo: Cleartop, Ketoconazole, Ketoderm, Ketoprox.
Dose
Internal use (systemic): 200 to 400mg
External use (topical)
– cream: apply 1 time a day
– shampoo: apply 1 to 2 times a week.
Posology
Internal (systemic) use: 200mg to 400mg/day, taken with a meal. The duration of treatment will depend on the fungus in question and the response to treatment, but should not exceed 4 weeks. Follow medical recommendations.
External use (topical)
– cream: should be applied to the affected areas once a day. The duration of treatment will depend on the fungus in question and the response to treatment. Treatment should be continued for a few days after the symptoms disappear, but should not exceed 4 weeks. Follow medical recommendations.
– shampoo: wash the affected area twice a week with ketoconazole shampoo, let it act for 3 to 5 minutes, use it for 2 to 4 weeks. In cases of prophylaxis, use once a week or once every 2 weeks.
Indications
Internal use:
– Superficial mycoses or dermatophytoses , especially those caused by Tinea capitis, such as athlete’s foot .
– Mucocutaneous mycoses, such as candidiasis .
– Malassezia folliculitis
– Advanced stage prostate cancer (some specialists use ketoconazole for this indication, although it is not approved by ANVISA – National Health Surveillance Agency).
Caution: this medicine should only be used on the recommendation of a specialized doctor, who will assess the risk and benefit of its use. There is a risk of severe hepatotoxicity.
External use:
– Skin infection caused by fungi (skin mycoses, pityriasis)
– Control of seborrheic dermatitis
– dandruff
Effects
Antifungal.
Adverse effects
All: allergy.
Tablet: hepatobiliary disorders, including risk of severe hepatotoxicity; gastrointestinal disorders, headache, among others. Decreased testosterone levels, which can lead to changes in sex life, breast enlargement, low sperm count. Testosterone levels return to normal once the drug is discontinued.
Cream or gel: intense skin irritation, redness, among others.
Shampoo: intense irritation of the scalp, folliculitis, eye irritation, among others.
Contraindications
This medication should not be used if you are allergic to ketoconazole or any substance contained in the medication.
Internal use : contraindicated in cases of acute or chronic liver disease, small children (<15 kg).
Drug interactions
Internal
use – The use of hormones to prevent pregnancy, such as birth control pills, may have their effectiveness altered. Use other contraceptive methods while you are taking ketoconazole, such as condoms.
– Medicines metabolized by CPY3A4, to find out if the medicine you are using belongs to this group, talk to your pharmacist or doctor.
– Medicines that reduce the acidity of the stomach (eg aluminum hydroxide, omeprazole, ranitidine, cimetidine,…).
– Antibacterials: isoniazid, rifabutin, rifampicin.
– Anticonvulsants: carbamazepine, phenytoin.
– Antivirals: efavirenz, nevirapine.
External use
Shampoo: None known.
Pregnancy
Internal use: Not to be used during pregnancy unless your doctor recommends it. There are no studies evaluating the potential risk in humans. In animal studies at high doses, this drug produced embryotoxic and teratogenic effects.
External use : There are no known risks of using ketoconazole in shampoo form in pregnant women. Do not use this medicine without medical knowledge.
Lactation
Internal use: Ketoconazole should not be used by women who are breastfeeding, as it is excreted in milk.
External use: Excretion of topical ketoconazole in milk is not known, use with caution.
pharmaceutical presentations
Internal use (systemic): tablet: 200mg
External use (topical): cream 20mg/g, shampoo 20mg/ml
overdose
Symptoms of intoxication or overdose: nausea, fatigue (including drowsiness and lethargy), vomiting, gastrointestinal pain (including abdominal discomfort, gastrointestinal upset, stomach discomfort), anorexia (including weight loss, decreased appetite), flushing (including hyperhidrosis) , edema (swelling), gynecomastia (enlargement of the breasts in men), rash (including eczema, purpura, dermatitis), diarrhoea, headache, dysgeusia (distortion or decrease in taste) and alopecia (hair loss).
Tips
For best effect :
General hygienic measures should be observed to control sources of infection and reinfection.
Internal (systemic) use:
– This medication should be used only when other medications cannot be used or have not worked. Talk to your doctor.
– It should be taken together with food or milk, to obtain a better effect and to decrease gastrointestinal adverse effects.
– Prior examinations and monitoring of liver function are recommended before and during treatment with ketoconazole. If there are symptoms of hepatitis such as: anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine; treatment should be stopped immediately and a liver function test performed.
– For people with reduced gastric acidity, either due to illness (eg achlorhydria) or use of medication, it is advisable to administer ketoconazole with an acidic drink (eg passion fruit juice) so that its absorption and effect are not affected.
External (topical) use:
– Wash and dry infected skin thoroughly before applying.
– Apply to and around the infected area.
– Wash your hands thoroughly after application to avoid contamination of other parts of the body.
– Keep clothing and towels separate from other people’s to avoid contaminating them.
– If you use this medicine too often, your skin problem may get worse.
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