Itraconazole

The US label for itraconazole capsules lists several fungal infections.

Deep infections named are blastomycosis, histoplasmosis and aspergillosis. Aspergillosis is for people who cannot use or did not respond to amphotericin B.

The label also lists fungal infection of the toenails, with or without the fingernails, and of the fingernails alone.

The label asks for lab tests to confirm the fungus before nail treatment starts.

• Blastomycosis (lung and other sites)
• Histoplasmosis
• Aspergillosis, when amphotericin B is not suitable
• Toenail and fingernail fungal infection

The label says itraconazole blocks the fungus from making ergosterol.

Ergosterol is a vital part of the fungal cell membrane, so the fungus cannot keep its membrane healthy.

The US label says the capsules should be taken with a full meal so the body absorbs the medicine well. They must be swallowed whole.

For blastomycosis and histoplasmosis, the label gives 200 mg once daily as the usual starting level. It can be raised in 100 mg steps to a top of 400 mg a day, split into two doses above 200 mg.

For nail infection of the toenails, the label gives 200 mg once daily for 12 weeks. For fingernails only, it describes two one-week pulses with a gap between them.

The label warns that the capsules and the oral solution are not interchangeable.

Indian pack labels may differ from the US label, and your prescriber's instruction always comes first. Do not change the form or the length of treatment yourself.

The label gives a boxed warning for heart failure and for dangerous drug interactions.

It should not be used for nail infection in anyone with signs of heart failure or a history of heart failure.

Rare cases of serious liver harm have occurred, sometimes in the first week. The label suggests considering liver tests, and treatment stops if liver symptoms appear.

Pregnancy: the label says do not use it for nail infection in pregnancy or when planning pregnancy. Women who can become pregnant need effective contraception during treatment and for 2 months after.

Breastfeeding: the drug passes into breast milk, so benefit and risk are weighed.

Children: safety and effectiveness have not been established. The label notes bone effects seen in rats.

Older adults: the label advises care and notes reported hearing loss.

Immunocompromised patients may absorb less of the capsule, so the dose may need adjusting by the doctor.

• Do not combine with listed medicines such as simvastatin, lovastatin, quinidine, methadone or triazolam
• Acid reducers and antacids can reduce absorption
• Many other medicines need checking
• Itraconazole strongly blocks CYP3A4, an enzyme that clears many medicines.
• This can raise their levels and cause severe or life-threatening effects.
• The label lists many medicines that must not be combined with it.
• Examples include methadone, quinidine, dofetilide, simvastatin, lovastatin, triazolam, oral midazolam, pimozide, ergot medicines and cisapride.
• Some other medicines are not recommended during treatment, and for 2 weeks before and after.
• Carbamazepine is one example.
• Antacids and acid-reducing medicines can lower absorption of the capsule.
• Always show your doctor and pharmacist the full list of what you take, including herbal products.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says itraconazole is not removed by dialysis. Supportive care is used.

Effects seen with overdose match the known side effects. Contact a doctor or poison centre at once.

The US label says to store capsules at controlled room temperature, 15 to 25 degrees C.

It also says to protect them from light and moisture. Keep medicines out of children's reach.

We did not find Itraconazole in the Schedule H, H1, X or G lists we checked. Follow your doctor's prescription and the pharmacist's guidance for the pack you have.

Itraconazole is on the National List of Essential Medicines 2022 in these forms: Capsule 200 mg (page 75); Oral liquid 10 mg/mL (page 75).

We did not find an NPPA ceiling price row for itraconazole in the list we checked.

The Jan Aushadhi (PMBJP) list we checked has 7 product rows for itraconazole.

We found no entry for a banned fixed-dose combination that mentions itraconazole in the list we checked.

Jan Aushadhi lists the itraconazole products below. We did not capture a price for them, so check the store or the official list.

• Jan Aushadhi: Itraconazole Capsules 100 mg, pack 4's (row p13:sno292)
• Jan Aushadhi: Itraconazole Capsules 200 mg, pack 4's (row p36:sno813)
• Jan Aushadhi: Itraconazole (1% w/w) Gel, pack 15 g (row p75:sno1637)
• Jan Aushadhi: Itraconazole Dusting Powder 1% w/w, pack 30g (row p82:sno1789)
• Jan Aushadhi: Itraconazole Capsules 130mg, pack 10's (row p88:sno1906)
• Jan Aushadhi: Itraconazole Capsules 65mg, pack 10's (row p88:sno1907)
• Jan Aushadhi: Itraconazole Eye drops 1% w/v, pack 5ml Drops (row p88:sno1908)