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CLOTRIPIN CREAM (Clotrimazole Cream BP 1 % w/w)

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivatives ATC code: D01A C01

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

CLOTRIPIN CREAM Therapeutic indication

For the treatment of:

  • All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species)
  • All dermatomycoses due to yeasts (Candida species). These include ringworm (tinea) infections (e.g. athlete’s foot), paronychia, pityriasis versicolor, erythrasma and intertrigo.
  • Skin diseases showing secondary infection with these fungi.
  • Candidal nappy rash, vulvitis and balanitis.

CLOTRIPIN CREAM Posology and Method of Administration:

There is no separate dosage schedule for the young or elderly.

CLOTRIPIN CREAM Method of administration

The cream should be applied thinly and evenly to the affected area 2 – 3 times daily and rubbed gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand.

If the feet are infected, they should be thoroughly washed and dried, especially between the toes, before applying the cream.

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Treatment should be continued for at least one month for dermatophyte infections, or for at least two weeks for candidal infections.

CLOTRIPIN CREAM Contraindications:

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

CLOTRIPIN CREAM Special warnings and precautions for use

To be used only if candidal vulvitis has previously been confirmed by a doctor.

The patient should be referred for medical advice if:

  • Previous history of STD or exposure to partner with STD.
  • More than two previous attacks in the last 6 months.
  • Known hypersensitivity to imidazoles or other vaginal antifungal products.
  • Pregnancy or suspected pregnancy.
  • Patients aged less than 16 or over 60.
  • Any abnormal or irregular vaginal bleeding.
  • Any blood staining of a vaginal or penile discharge.
  • Any vulval, vaginal or penile sores, ulcers or blisters.
  • Any associated lower abdominal pain or dysuria
  • No improvement in 7 days.
  • Any adverse effects such as redness, irritation or swelling associated with the treatment

This product contains Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

CLOTRIPIN CREAM Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that, when 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.

CLOTRIPIN CREAM Fertility, pregnancy and 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 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 or midwife.

Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion ofClotrimazole/metabolites in milk after intravenous administration. A risk to the sucklingchild cannot be excluded. A decision must be made whether to discontinue breast-feeding orto discontinue/abstain from Clotrimazole therapy taking into account the benefit of breastfeedingfor the child and the benefit of therapy for the woman.

Fertility: No human studies of the effects of Clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.

CLOTRIPIN CREAM Effects on ability to drive and use machines

Clotrimazole cream has no or negligible influence on the ability to drive or use machines.

CLOTRIPIN CREAM Undesirable effects

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, dyspnoea, urticaria)

Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.

CLOTRIPIN CREAM 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.

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