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Terbinaforce Cream 15G

Terbinaforce Cream 15G - (008787) -
Terbinaforce Cream 15G
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  • Stock: 7
  • Model: Terbinaforce Cream 15G
  • SKU: 008787
  • Pack size: 1
  • Generic name: Terbinafine
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Therapeutic Indications Terbinafine is an allylamine antifungal-indicated for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis, cutaneous candidiasis and pityriasis versicolor. 

Contraindications: Hypersensitivity to Terbinafine or any of the excipients contained in the cream. 

Special Warning and Precautions for use: Terbinaforce Contains Cetostearyl Alcohol which may cause local irritation (e.g. contact dermatitis) and Propylene Glycol which may cause skin irritation. Terbinaforce Contains Butylated Hydroxytoluene & Butylated Hydroxy anisole which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes Terbinafine cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water. 

Interaction with other medicinal products and other forms of interaction: There are no known drug interactions with Terbinafine 1 % Cream. 

Pregnancy and Lactation: Use in Pregnancy: Pregnancy Category B. Should be used during pregnancy only if clearly needed. Use in Lactation: Terbinafine is excreted in breast milk and therefore mothers should not receive Terbinafine while breast-feeding. 

Effect on ability to drive and use machines: Not Applicable.

Undesirable Effects: Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptoms must be distinguished from allergic reactions such as pruritis, rash, bullous eruptions and hives, which are rare but require discontinuation.

Overdose: No adverse events in relation to ingestion accidental ingestion of Terbinafine 1% cream have been reported. However, if accidental ingestion of terbinafine 1% cream occurs, an appropriate method of gastric emptying may be used if considered appropriate. 

Pharmacodynamic Properties: Pharmacotherapeutic group: Antifungal for topical use. ATC Code: DOIAE15. Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations Terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. 

Pharmacokinetic Properties: Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is therefore very slight. 

Pre-Clinical Safety Data: No relevant additional information is available. 

List of Excipients: Benzyl Alcohol, Phenoxyethanol, Copolymer Vinyl Pyrrolidone, Cetostearyl Alcohol, Silicone Elastomer Blend, White Soft Paraffin, Isopropyl Myristate, Light Liquid Paraffin, Propylene Glycol, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dihydrate, Butylated Hydroxytoluene, Butylated Hydroxyanisole. 

Manufactured for: MANKIND PHARMA LTD  

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