Stieprox Liquid: Indications, Dosage, Precautions, Adverse Effects
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Stieprox Liquid - Product Information

Manufacture: GlaxoSmithKline
Country: Australia
Condition: Ichthyosis, Psoriasis, Seborrheic Dermatitis
Class: Antifungals
Form: Liquid solution
Ingredients: ciclopirox olamine, sodium laureth sulfate 70%, cocamidopropyl betaine, sodium phosphate – dibasic dodecahydrate, citric acid monohydrate, cocamide DEA, hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium-10, Timotei Fragrance AF17050, sodium hydroxide and purified water.

Name of the Medicine

STIEPROX Liquid contains 1.5% w/w ciclopirox olamine.

Ciclopirox olamine is white or cream white crystalline powder; very soluble in ethanol and chloroform, slightly soluble in water and practically insoluble in ether.

Chemical name: 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone compound with 2-aminoethanol (1:1)

Chemical formula: C12H17NO2.C2H7NO MW: 268.36

CAS: 41621-49-2.


Description

STIEPROX Liquid is a clear, straw to light orange coloured, viscous liquid with a characteristic odour.

STIEPROX Liquid contains the active ingredient ciclopirox olamine. It also contains the following ingredients: sodium laureth sulfate, cocamidopropyl betaine, sodium phosphate – dibasic dodecahydrate, citric acid monohydrate, cocamide DEA, hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium-10, Timotei Fragrance AF17050, sodium hydroxide and purified water.

Pharmacology

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.

Pharmacokinetic properties

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.

Clinical Trials

The pivotal study compared the efficacy and safety of 1.5% ciclopirox olamine shampoo against placebo shampoo in subjects with either mild to severe dandruff and/or seborrhoeic dermatitis. Treatment groups were balanced for age, sex, presence/absence of seborrhoeic dermatitis and the baseline dandruff score. Fifty-four patients were enrolled in the ciclopirox olamine arm and 55 patients in the placebo arm. Shampoos were used twice weekly (total contact time 3-5 minutes) for 4 weeks.

The results of this study indicate a significantly greater reduction in dandruff (with respect to area of quadrant involved and severity within quadrant) from baseline with ciclopirox olamine than placebo.

Global evaluation of clinical change was significantly better for ciclopirox olamine than placebo.

There were no significant differences between ciclopirox olamine and placebo with respect to clinical and subjects’ assessment for seborrhoeic dermatitis. On day 29 subjects were asked to rate their overall opinion of the treatment in respect of seborrhoeic dermatitis and/or dandruff, the treatment was rated good to excellent in 69% of the ciclopirox olamine shampoo group, compared with 45% in the placebo group.

There was no serious adverse event attributable to 1.5% ciclopirox olamine or placebo shampoos and no subject on either treatment withdrew as a result of an adverse event.

During the pivotal study, treatment with 1.5% ciclopirox olamine tended to make the subjects’ hair slightly drier; however in subsequent clinical trials the acceptability of 1.5% ciclopirox olamine was good with there being no significant tendency for subjects’ hair to become drier or more greasy.

Indications

STIEPROX Liquid is indicated for the treatment of dandruff and mild to moderate seborrhoeic dermatitis of the scalp.

Contraindications

Patients with known hypersensitivity to ciclopirox, ciclopirox olamine or any of the other ingredients (refer to DESCRIPTION above).

Precautions

STIEPROX Liquid is for external use only.

Avoid contact with eyes. 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

No teratogenic effect has been observed during studies done on animals. The safety of STIEPROX Liquid in pregnant women has not been established.

Use in Lactation

STIEPROX liquid is not recommended for use for breastfeeding mothers unless under medical advice. The safety of STIEPROX Liquid in lactating women has not been established.

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast feeding.

Paediatric Use

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

Effects on Ability to Drive and Use Machines

Very unlikely to produce any effect.

Interactions with Other Medicines

None known.

Adverse Effects

Clinical Trial Data

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

Skin and subcutaneous tissue disorders

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

Postmarketing data

Immune system disorders

Rare: Application site hypersensitivity

Skin and subcutaneous tissue disorders

Rare: Skin exfoliation*, eczema, alopecia*, hair colour changes, 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.

Dosage and Administration

Adults and children 12 years and over:

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 rinse thoroughly and repeat the 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.

Children under 12 years:

The safety and efficacy of STIEPROX Liquid have not been established in children less than 12 years of age.

Overdosage

Management should be as clinically indicated.

In case of accidental ingestion, contact the Poisons Information Centre on 13 11 26 for advice.

Presentation and Storage Conditions

STIEPROX Liquid contains 1.5% w/w ciclopirox olamine in a shampoo formulation for topical application. The product is presented in 60 ml or 150 ml high-density polyethylene bottles fitted with flip-top screw caps.

Store below 30°C.

Name and Address of the Sponsor

GlaxoSmithKline Australia Pty Ltd

Level 4, 436 Johnston Street

Abbotsford Victoria 3067

Poison Schedule of the Medicine

Pharmacy Medicine

Date of First Inclusion in the Australian Register of Therapeutic Goods

30 July 2003

Date of the Most Recent Amendment

15 November 2013

STIEPROX is a registered trade mark of Stiefel Laboratories, Inc.