Agisten Paste

/ Perrigo

To ensure complete healing, treatment should be continued for about 2 weeks after the disappearance of the subjective symptoms. The following are the usual periods of treatment:
Dermatomycoses: 3-4 weeks
Erythrasma: 2-4 weeks
Pityriasis versicolor: 1-3 weeks
Candida vulvitis and balanitis: 1-2 weeks
A thin layer should be applied to the affected sites and gently rubbed in 2-3 times daily. A strip of paste ½ cm long is sufficient to treat an area about the size of a hand.

For treatment of abrasions and skin infections caused by species of fungi sensitive to clotrimazole.

Hypersensitivity to the active substance or to any of the excipients.
Do not use to treat nail or scalp infections.

Avoid contact with the eyes.

As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea,
urticaria).
Signs of an allergic reaction may include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, weakness, feeling dizzy or faint, nausea.
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.

Laboratory tests have suggested that, when Clotrimazole paste is used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

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 high oral doses. At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician.
Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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.