KOMAZOLE-Topical-Solution-Clotrimazole-1%w/v

Warning and precautions:

If irritation or sensitivity develops with the use of KOMAZOLE, treatment should be discontinued and appropriate therapy instituted.

Pregnancy & Lactation
Pregnancy: There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at higher oral doses. At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. KOMAZOLE can be used during pregnancy, but only under the supervision of a physician.

Lactation: There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. KOMAZOLE may be used during lactation. If used topically on the nipple area, wash breasts before feeding child.

Adverse Effects / Undesirable Effects
As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders: Anaphylaxis, angioedema, hypersensitivity.
Vascular disorders: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.
General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.

Overdose
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote. However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.