Clotrimazole

The US label for the lozenge lists local treatment of oropharyngeal candidiasis, a fungal infection (thrush) of the mouth and throat. The label says the diagnosis should be confirmed with a smear or culture first.

The label also lists use to reduce the chance of this infection in people whose immunity is lowered by chemotherapy, radiotherapy or steroid treatment for leukaemia, solid tumours or kidney transplant.

The label says the lozenge is not meant for fungal infections that spread through the body (systemic candidiasis).

In the National List of Essential Medicines 2022, clotrimazole appears as tablets, pessaries, ointment, cream and lotion. The label we reviewed does not cover those forms, so your doctor decides what applies.

• Thrush of the mouth and throat (lozenge)
• Prevention in some people with weak immunity (lozenge)
• Not for infections spread through the body

The label describes clotrimazole as a synthetic antifungal agent for local use in the mouth.

The label section we reviewed does not explain in detail how it acts on fungi.

The US label for adults and children says the lozenge must dissolve slowly in the mouth. It is not to be swallowed whole or chewed.

For treatment, the label says one lozenge five times a day for 14 days in a row. It says use should be short term where possible.

To reduce the risk in people on chemotherapy, radiotherapy or steroids, the label says one lozenge three times a day while the therapy continues, or until steroids reach a maintenance level.

The label says patients must be able to understand and follow the instruction to let the lozenge dissolve slowly.

This is label information for the lozenge only, not a prescription. Indian pack labels may differ from the US label, and your prescriber's instruction always comes first.

Allergy: the label says do not use it if you are allergic to any component.

Liver: abnormal liver tests were reported, so the label advises periodic liver checks, especially if you already have liver impairment.

Pregnancy: the label says clotrimazole harmed offspring in animals at doses far above the human dose. There are no adequate studies in pregnant women, so use only if the benefit justifies the risk.

Children: use below 3 years is not recommended, and prevention use in children is not established. Older adults: no differences were found.

Long use: only limited data exist, so the label says to keep treatment short where possible.

Breastfeeding, alcohol and driving: the label text we reviewed does not describe these.

• The label text we reviewed does not list drug interactions for the lozenge.
• Tell your doctor or pharmacist about all medicines you take, especially liver-affecting ones.

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

The label says no overdose data are available.

The label says to store the lozenges at 20 to 25 degrees C and not to freeze them.

The product described is a 10 mg lozenge supplied in bottles with child-resistant closures.

In the Drugs Rules schedules we checked, clotrimazole is listed under the prescription-only schedule (Schedule H) (Schedule H, serial 130). Schedule H medicines are sold only on a doctor's prescription.

Clotrimazole appears in the National List of Essential Medicines 2022 on pages 74 and 78 and 90. Forms in the list include tablets of 50 mg, 100 mg, 150 mg and 200 mg, a 100 mg pessary, 1 percent cream, 1 percent lotion and 1 percent ointment.

NPPA lists ceiling prices for several clotrimazole formulations. The table shows the rows we found. Check NPPA directly for the current list.

Banned combinations: the banned-combination list we checked has 16 mentions of clotrimazole, mostly fixed-dose combinations. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. Check the pack and the seller.

Jan Aushadhi (PMBJP) lists clotrimazole 1 percent cream, vaginal tablets, powder, mouth paint, vaginal gel and several clotrimazole combination products. We have not shown a brand price here.

• Clotrimazole Cream IP 1% w/w (pack 15 g tubes)
• Clotrimazole Vaginal Tablets IP 100mg (pack 10's)
• Clotrimazole Mouth Paint 1% w/v (pack 25 ml)