STIEPROX Liquid contains 1.5% w/w ciclopirox olamine in a shampoo base for topical application.

Presentations

Dosage and Administration

STIEPROX Liquid is for topical application to the scalp and adjacent areas. The hair should be wetted and sufficient STIEPROX Liquid applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. Leave in hair then thoroughly rinse and repeat procedure. Over the two applications, the shampoo should be left in the hair for a total time of 3 to 5 minutes. STIEPROX Liquid should be used two to three times weekly. STIEPROX Liquid will provide temporary relief during the period of use and dandruff and/or seborrhoeic dermatitis may recur if treatment is discontinued. The recommended treatment period is 4 weeks. A mild shampoo may be used in between applications of STIEPROX Liquid.

The safety and efficacy of STIEPROX Liquid have not been established in children less than 12 years of age. Do not use STIEPROX Liquid in children under 12 years of age, unless under the advice of a Healthcare Professional.

Contraindications

Patients with known hypersensitivity to ciclopirox, ciclopirox olamine or any of the other ingredients (see Further Information).

Warnings and Precautions

STIEPROX Liquid is for external use only. Ciclopirox olamine may cause eye irritation. In case of accidental contact with the eyes, rinse with water. Ciclopirox olamine may cause skin irritation. If irritation occurs and persists, treatment should be discontinued. In rare instances, mainly in patients with chemically damaged (for example, due to hair dye), grey or white hair, a discolouration of the hair has been observed.

Use in Pregnancy

The safety of ciclopirox olamine during human pregnancy has not been established. Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any developmental toxicity. No effects during pregnancy are anticipated since systemic exposure is low.

Use in Lactation

It is not known if ciclopirox olamine is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast feeding.

Effects on ability to drive and use machines

Use for Children

Safety and effectiveness in children under 12 years of age have not been established.

Adverse Effects

The following convention has been used for the classification of adverse reactions: Very common >= 1/10 Common >= 1/100 to < 1/10 Uncommon >= 1/1000 to < 1/100 Rare >= 1/10,000 to < 1/1000 Very rare < 1/10,000

Clinical Trial Data.

Skin and subcutaneous tissue disorders

Common:Application site irritation including pruritus, burning sensation, application site rash * and erythema.

Post-Marketing Experience

Immune system disorders

Rare:Application site hypersensitivity

Skin and subcutaneous tissue disorders

Rare:Skin exfoliation *, eczema, alopecia *, hair colour changes and hair texture changes *Since these effects are also symptoms of the underlying disease, it is expected that these adverse reactions would manifest as worsening of symptoms.

Interactions

Overdose

Management should be as clinically indicated. In case of accidental ingestion, contact the National Poisons Information Centre on 0800 POISON or 0800 764 766 for advice.

Further Information

Actions

Ciclopirox olamine is an antifungal agent (pyridones family), which is active in-vitro inhibiting the growth of various fungal species including the yeast Malassezia furfur (formerly known as Pityrosporum ovale or Pityrosporum orbiculare). The latter has been implicated as a causative organism in dandruff and seborrhoeic dermatitis. Ciclopirox olamine also exhibits some anti-inflammatory activity.

Pharmacokinetics

Topical application of ciclopirox olamine as a 1% cream to human skin showed that the percutaneous absorption is very low:1.1% to 1.7% of the applied dose was detected in urine. The potential for systemic absorption of ciclopirox olamine from a wash-off shampoo containing 1.5% ciclopirox olamine is low.

Other

STIEPROX Liquid also contains sodium laureth sulfate, cocamidopropyl betaine, sodium phosphate-dibasic dodecahydrate, citric acid monohydrate, sodium hydroxide, cocamide DEA, hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium-10, Fragrance AF17050 and purified water.

Pharmaceutical Precautions

Instructions for Handling Incompatibilities

Shelf Life

Special Precautions for Storage

Package Quantities

STIEPROX Liquid is presented in 60 ml and 150 ml high-density polyethylene bottles fitted with flip-top screw caps. Not all pack sizes may be distributed in New Zealand.

STIEPROX(r) Liquid