Rolfin

Rolfin Uses, Dosage, Side Effects, Food Interaction and all others data.

Amorolfine is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

Phenoxyethanol is a colorless liquid with a pleasant odor. It is a glycol ether used as a perfume fixative, insect repellent, antiseptic, solvent, preservative, and also as an anesthetic in fish aquaculture. Phenoxyethanol is an ether alcohol with aromatic properties. It is both naturally found and manufactured synthetically. Demonstrating antimicrobial ability, phenoxyethanol acts as an effective preservative in pharmaceuticals, cosmetics and lubricants .

Phenoxyethanol (EU), or PE, is the most commonly used globally-approved preservative in personal care formulations. It is very easy to use in various types of formulations and is chemically stable. Phenoxyethanol is a colorless, clear, oily liquid with a faint aromatic odor at room temperature and a low water solubility and evaporation rate. It is produced by reacting phenol (EU) and ethylene oxide (EU) at a high temperature and pressure. This substance occurs naturally in green tea (EU) .

According to the European Union Cosmetics Regulation (EC) n.1223/2009, phenoxyethanol is authorized as a preservative in cosmetic formulations at a maximum concentration of 1.0% .

Rolfin
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Rolfin
Generic	Amorolfine + Phenoxyethanol
Type	Cream
Therapeutic Class
Manufacturer	Curetech Skincare
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Amorolfine Hydrochloride is used for Dermatomycoses caused by dermatophytes: tinea pedis (athlete's foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.

Phenoxyethanol is an antiseptic used as a hand disinfectant or preservative in medications.

Antimicrobial agent used as a preservative in cosmetics , , .

Rolfin is also used to associated treatment for these conditions: Dermatomycoses, Fungus, Nail, Pityriasis versicolor, Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea inguinalis, Tinea manuum, Cutaneous candidiasisSkin disinfection

How Rolfin works

Phenoxyethanol has antibacterial properties and is effective against strains of Pseudomonas aeruginosa even in the presence of 20% serum. It not as effective against Proteus vulgaris, other gram-negative organisms, and gram-positive organisms. Phenoxyethanol has been used as a preservative at a concentration of 1%. A wider spectrum of antimicrobial activity is achieved with preservative mixtures of phenoxyethanol and hydroxybenzoates. Phenoxyethanol may be used as a 2.2% solution or a 2% cream for the treatment of superficial wounds, burns, or abscesses infected by Pseudomonas aeruginosa. In skin infection, derivatives of phenoxyethanol are used in combination with either cyclic acid or zinc undecenoate .

Dosage

Rolfin dosage

Adult: To be applied to affected skin areas once daily following cleansing (in the evening). The treatment should be continued without interruption until clinical cure, and for 3-5 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 two to three weeks. With foot mycoses, up to six weeks of therapy may be necessary.

Elderly: There are no specific dosage recommendations for use in elderly patients.

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

Side Effects

Side effects are Skin Irritation, erythema, pruritus, skin burning sensation, Hypersensitivity (systemic allergic reaction).

Toxicity

LC50 oral, rat; 1980 mg/kg . LD50 Rabbit dermal 2250 mg/kg .

2-Phenoxyethanol (PhE) has been shown to induce hepatotoxicity, renal toxicity, and hemolysis at dosages ≥ 400 mg/kg/day in subchronic and chronic studies in multiple species .

The major hazards encountered in the use and handling of 2-phenoxyethanol stem from its toxicologic properties. Toxic by all routes (inhalation, ingestion, and dermal contact), exposure to this very faintly aromatic, colorless, oily liquid may occur from its use as a fixative for cosmetics, perfumes, and soaps; as a bactericide and insect repellant; as a solvent for cellulose acetate,dyes, stamp pad, ball point, and specialty inks; as a chemical intermediate for carboxylic acid esters (eg, acrylate, maleate) and polymers (eg, formaldehyde, melamine); and as a preservative for human specimens used for dissection and demonstrations in anatomical studies. Effects resulting from exposure to this substance can include eye irritation, headache, tremors, and central nervous system depression. If contact with the eyes occurs, irrigate exposed eyes with copious amounts of tepid water for at least 15 minutes, and wash exposed skin thoroughly with soap and water. 2-Phenoxyethanol must be preheated before ignition can occur .

Precaution

Avoid contact of Amorolfine cream with eyes, ears and mucous membranes. This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis) Owing to the lack of clinical experience available to date, the use of Amorolfine 0.25% cream in children is not recommended. 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.

Interaction

There are no specific studies involving concomitant treatment with other topical medicines. Use of nail varnish or artificial nails should be avoided during treatment.

Volume of Distribution

A pharmacokinetic study of phenoxyethanol was performed using a mass spectrometry model for simultaneous analysis of phenoxyethanol (PE) and its major metabolite, phenoxyacetic acid (PAA), in rat plasma, urine, and 7 different tissues .

The absolute topical bioavailability of PE was 75.4% and 76.0% for emulsion and lotion, respectively. Conversion of PE to PAA was extensive, with the average AUCPAA-to-AUCPE ratio being 4.4 and 5.3 for emulsion and lotion, respectively. The steady-state tissue-to-plasma PE concentration ratio (Kp) was higher than unity for kidney, spleen, heart, brain, and testis and was lower (0.6) for lung and liver, while the metabolite Kp ratio was higher than unity for kidney, liver, lung, and testis and was lower (0.3) for other tissues .

Elimination Route

The fate of phenoxyethanol in rats and humans has been investigated. More than 90% of an oral dose of 16, 27 or 160 mg/kg body weight of (2-(14)C)phenoxyethanol administered to male Colworth rats by was excreted in the urine within 24 hours of administration. A female rat also excreted about 90% of a dose of 27 mg/kg body weight in the urine within 24 hours. About 2% and 1.3% of the ingested dose was recovered from the exhaled air of female and male rats, respectively .

Pregnancy & Breastfeeding use

No experience exists of use during pregnancy and nursing, therefore, the use of Amorolfine should be avoided during pregnancy and lactation. Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human foetus appears to be negligible. Amorolfine Cream should not be used during pregnancy and/or lactation unless clearly necessary. Breast-feeding women must not use the cream in the breast area.