STRAFOS Cream (Amorolfine 0.25% w/w)

Table of Content

Fungal diseases are a global public health problem affecting over a billion people. Superficial mycoses are common worldwide, affecting 20–25% of the world's population and the incidence continues to increase.

Indian Burden

As per the Expert Consensus on The Management of Dermatophytosis in India (ECTODERM India), prevalence of dermatophytosis in India ranges from 36.6 to 78.4%. The current face of dermatophytosis in India has possibly been an outcome of a complex and intriguing interplay between host, fungus, drug and environment, influenced by multiple factors, including more humid and warmer climate, the absurd use of topical corticosteroid-based combinations, the increased use of broad-spectrum antibiotics, the increasing burden of an immune-compromised population, the widespread use of antifungals in the agricultural industry, and the questionable role of antifungal drug resistance. Thus, the management of dermatophytosis in India needs an evidence-based, experience-driven, practical approach from the experts in the field

STRAFOS (Amorolfine) Cream is indicated in the treatment of dermatomycoses caused by dermatophytes, i.e. tinea pedis, tinea cruris, tinea corporis, tinea manuum. It is also indicated in cutaneous candidiasis and pityriasis versicolor. Amorolfine is a morpholine derivative that is chemically distinct from other currently available antifungal agents. It acts primarily by inhibiting ergosterol biosynthesis, a component of fungal cell membrane, and possesses both fungistatic and fungicidal activity.

Available as 15gm tube in Cream form

1. Composition

STRAFOS Cream

Amorolfine Hydrochloride IP

Equivalent to Amorolfine ... 0.25% w/w

Phenoxyethanol IP ............ 1.00% w/w

(As Preservative)

In a cream base ….......................... q.s.

2.Dosage Form and Strength

Cream 15g

3. Clinical Particulars

3.1 Therapeutic Indications

STRAFOS Cream is indicated in the treatment of dermatomycoses caused by dermatophytes, i.e. tinea pedis, tinea cruris, tinea corporis and tinea manuum. It is also indicated in cutaneous candidiasis and pityriasis versicolor.

3.2 Posology and Method of Administration

STRAFOS Cream should be applied to the affected areas once daily (in the evening). The treatment should be continued without interruption until clinical cure, and for several days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least 2–3 weeks. In foot mycoses, up to 6 weeks of therapy may be necessary. Based on the results of reported clinical trials, cure can be expected in 80–90% of skin mycoses.

3.3 Contraindications

STRAFOS Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

3.4 Special Warnings and Precautions for Use

  • If hypersensitivity to amorolfine occurs, discontinue use and seek immediate medical advice.
  • STRAFOS Cream should not be applied to the mucous membranes(e.g. mouth and nostrils), ears or eyes.
  • A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by cleaning the skin. The product should not be reapplied.

3.5 Drug Interactions

  • There are no specific studies involving concomitant treatment with other topical medicines.
  • Use of nail varnish or artificial nails should be avoided during treatment.
  • An interaction with acenocoumarol has been reported with increase in International Normalised Ratio (INR) values.

3.6 Use in Special Populations

Pregnancy

There are no reported adequate data on the use of amorolfine in pregnant women. The potential risk in humans is unknown; hence, STRAFOS Cream should not be used unless clearly necessary.

Lactation

There are no reported adequate data of the use of amorolfine in nursing mothers. The potential risk in humans is unknown; hence, STRAFOS Cream should not be used unless clearly necessary. Nursing mothers must not use the cream in the breast area.

Paediatric Use

Due to lack of safety data, STRAFOS Cream is not advised for use in the paediatric population.

Geriatric Use

Due to lack of safety data, STRAFOS Cream is not advised for use in the elderly population.

3.7 Effects on Ability to Drive and Use Machines

Not relevant.

3.8 Undesirable Effects

Amorolfine cream is reportedly well tolerated. Treatment-related adverse events are reportedly limited to burning, itching, erythema, skin dryness and scaling. Case reports of allergic contact dermatitis have been reported.

Adverse drug reactions are rare and mostly mild in nature.

System Organ Class

Frequency

Adverse Drug Reaction

Immune system disorders

Unknown frequency*

Hypersensitivity (systemic

allergic reaction) *

Skin and subcutaneous tissue disorders

Rare (≥1/10,000, <1/1,000)

Skin irritation, erythema,

pruritus, skin burning

sensation

Unknown frequency*

Dermatitis contact*

* Postmarketing experience

If you experience any side effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the National Pharmacovigilance Programme of India by calling on 18002677779 (Cipla number) or you can report to PvPI on 1800 180 3024.

By reporting side effects, you can help provide more information on the safety of this product.

3.9 Overdosage

Accidental Oral Ingestion

STRAFOS Cream is for topical use only. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used

4. Pharmacological Properties

4.1 Mechanism of Action

The fungicidal effect of amorolfine is based on an alteration of the fungal cell membrane targeted primarily on sterol-ergosterol biosynthesis. The ergosterol content is reduced and, at the same time, unusual, sterically nonplanar steroids accumulateinducing lysis of the fungal cell.

4.2 Pharmacodynamic Properties

Amorolfine hydrochloride cream, 0.25%, is a topical anti-mycotic. The active substance, amorolfine, belongs to the morpholine class of anti-mycotic substances.

Amorolfine has a broad antifungal spectrum. It is highly effective against the following:

Yeasts: Candida, Malassezia or Pityrosporum, Cryptococcus

Dermatophytes:Trichophyton, Microsporum, Epidermophyton

Moulds: Alternaria, Scytalidium, Hendersonula, Scopulariopsis, Aspergillus

Dermatiacea: Cladosporium, Fonsacaea, Wangiella

Dimorphic fungi: Coccidioides, Histoplasma, Sporothrix

With the exception of Actinomyces, bacteria are not sensitive to amorolfine.

Propionibacterium acnes is only slightly sensitive.

4.3 Pharmacokinetic Properties

Following topical application, an active concentration of amorolfine is retained in the skin for several days. The bioavailability of topical amorolfine is 4–10% and the drug is excreted in the urine and faeces. Nevertheless, the plasma concentration of active ingredient was reportedly below the sensitivity limit even after long-term treatment.

5.Non-Clinical Properties

5.1Animal Toxicology or Pharmacology

Oral 13-week studies have been performed with up to 60 mg/kg body weight (bw)/day or 26-week studies with a dosage of up to 40 mg/kg bw/day in rats and dogs. Keratodermia and dermatitis such aslesions of the skin, hyperkeratosis of the mucous membranes and the transition skin/mucous membranes have been observed.

Reproductive toxicology studies showed evidence of teratogenicity, embryotoxicity and foetotoxicity in laboratory animals but these effects were observed at exposure far exceeding human exposure, indicating no anticipated risk for pregnant women.

Amorolfine potential genotoxicity has been tested in vitro and in vivo. No genotoxic potential has been observed. No carcinogenicity studies have been conducted.

6. Pharmaceutical Particulars

6.1 Incompatibilities

Not applicable.

6.2 Shelf-Life

See on the pack.

6.3 Packaging Information

STRAFOS Cream: Available in a 15g tube

6.4 Storage and Handling Instructions

Store at a temperature not exceeding 25°C. Do not freeze. Protect from light.

Keep out of reach of children

7.Patient Counselling Information

7.1 What is STRAFOS Cream and What is It Used For?

STRAFOS Cream contains the active substance amorolfine (as amorolfine hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause fungal infections.

It is used to treat superficial fungal infections of the skin and nails caused by dermatophytes and Candida species.

7.2 What Do You Need to Know Before You Apply STRAFOS Cream?

Do not use STRAFOS Cream if you are allergic to amorolfine or any of the other ingredients of this medicine.

Warnings and precautions

STRAFOS Cream can cause a systemic or local allergic reaction that could possibly occur after use of this product in some patients. If this happens, the product usage should be stopped immediately, and medical advice should be sought. Remove the product carefully by cleaning the skin. The product should not be reapplied.

STRAFOS Cream should not be applied to the mucous membranes (e.g. mouth and nostrils), ears or eyes.

If STRAFOS Cream accidentally gets into your eyes or ears, wash out with water immediately and contact your doctor or the nearest hospital without delay.

STRAFOS Cream is for topical use only. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used

Please get urgent medical help if you have any of the following symptoms:

• You have difficulty breathing

• Your face, lips, tongue or throat swell

• Your skin develops a severe rash

Use in children

Children should not be treated with STRAFOS Cream, owing to the lack of clinical experience available to date.

7.3 Before You Use STRAFOS Cream, Tell Your Doctor About the Following:

Other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast feeding

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will then decide whether you should use amorolfine.

7.4 How Should You Use STRAFOS Cream?

Always use this medicine exactly as advised by your doctor. Check with your doctor if you are not sure.

STRAFOS Cream should be applied to the affected areas once daily (in the evening). The treatment should be continued without interruption until clinical cure, and for several days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least 2–3 weeks.

In foot mycoses, up to 6 weeks of therapy may be necessary. Based on the results of reported clinical trials, cure can be expected in 80–90% of skin mycoses.

Regarding the duration of treatment, your physician will determine the type of infection you are suffering from and will determine for how long you should take STRAFOS Cream depending upon the severity

Use in children

There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

If you forget to apply STRAFOS Cream

Do not apply extra quantity of cream to make up in case you forgot to apply it when required. If you forget to apply the cream when required, apply it as soon as possible, and then go back to your regular application schedule. If you have any further questions on the use of this medicine, ask your doctor.

7.5 What Are the Possible Side Effects?

Like all medicines, this medicine can cause side effects, although not everybody experiences them. In addition to the beneficial effects of amorolfine, it is possible that unwanted effects will occur during treatment, even when it is used as directed. However, amorolfine cream is reportedly well tolerated.

Adverse drug reactions are rare and mostly mild in nature.

System Organ Class

Frequency

Adverse Drug Reaction

Immune system disorders

Unknown frequency*

Hypersensitivity (systemic allergic reaction)*

Skin and subcutaneous tissue disorders

Rare (≥1/10,000, <1/1,000)

Skin irritation, erythema,

pruritus, skin burning

sensation

Unknown frequency*

Dermatitis contact*

*Postmarketing experience

7.6 How Should You Store STRAFOS Cream?

Store at a temperature not exceeding 25°C. Do not freeze. Protect from light.

Keep out of reach of children

Do not use this medicine after the expiry date that is stated on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via waste water or house hold waste. Ask your doctor how to throw away medicines you no longer use. These measures will help protect the environment.

8. Details of The Manufacturer

Marketed by:

CIPLA LTD.

Cipla House, Peninsula Business Park,

Ganpatrao Kadam Marg, Lower Parel

Mumbai-400 013 INDIA

Manufactured by:

Mepromax Lifesciences Pvt. Ltd.

16, Pharmacity, Selaqui, Dehradun-248011,

Uttarakhand (India)

Details of Permission Number with Date: 

Mfg. Lic. No.: 23/UA/2007

Last Updated: May 2019

Last Reviewed: May 2019