Terbinaforce M
Terbinaforce M Uses, Dosage, Side Effects, Food Interaction and all others data.
Mometasone is a corticosteroid demonstrating anti-inflammatory properties. The precise mechanism of corticosteroids action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
Mometasone is a medium-potency synthetic corticosteroid with antiinflammatory, antipruritic, and vasoconstrictive properties. Studies in asthmatic patients have demonstrated that mometasone provides a favorable ratio of topical to systemic activity due to its primary local effect along with the extensive hepatic metabolism and the lack of active metabolites. Though effective for the treatment of asthma, glucocorticoids do not affect asthma symptoms immediately. Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When glucocorticoids are discontinued, asthma stability may persist for several days or longer. Mometasone has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone. The clinical significance of these findings is unknown.
Terbinafine is an allylamine with a range of antifungal activity. It is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Terbinafine is either fungicidal or fungistatic against yeasts, depending on the species. Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the fungal cell membrane at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine is highly effective in fungal infections of the skin, hair and nails caused by Trichophyton spp., Microsporum spp. and Epidermophyton floccosum. It is also effective against yeast infections of the skin, principally those caused by the genus candida. Topical terbinafine appears to be effective in pityriasis versicolor due to Pityrosporum arbiculare.
Terbinafine is an allylamine antifungal that inhibits squalene epoxidase (also known as squalene monooxygenase) to prevent the formation of ergosterol and cause an accumulation of squalene, weakening the cell wall of fungal cells. Terbinafine distributes into tissues and has a long terminal elimination half life, so the duration of action is long. Overdose with terbinafine is rare, even above the therapeutic dose, so the therapeutic index is wide. Patients taking oral terbinafine should have liver function tests performed prior to treatment to reduce the risk of liver injury.
| Trade Name | Terbinaforce M |
| Generic | Mometasone + Terbinafine |
| Weight | 1% |
| Type | Cream |
| Therapeutic Class | |
| Manufacturer | Mankind Pharmaceuticals Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Mometasone cream is used for the relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, such as psoriasis and atopic dermatitis.
Terbinafine cream is used for the treatment of the following dermatological infections: interdigital tinea pedis (Athlete’s foot), tinea cruris (jock itch) or tinea corporis (ring worm) due to susceptible organisms and planter tinea pedis (mocasin type) due to Trichophyton spp.
Terbinafine tablet is used for the treatment of onychomycosis of the toe nail or finger nail due to dermatophytes and also by non-dermatophyte fungi.
Terbinaforce M is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Bacterial Sinusitis, Dermatitis, Pruritus, SinusitisOnychomycosis, Pityriasis versicolor, Sporotrichosis, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Cutaneous candidiasis, Severe Tinea Corporis, Severe Tinea Cruris, Severe Tinea Pedis
How Terbinaforce M works
Unbound corticosteroids cross cell membranes and bind with high affinity to specific cytoplasmic receptors. Inflammation is decreased by diminishing the release of leukocytic acid hydrolases, prevention of macrophage accumulation at inflamed sites, interference with leukocyte adhesion to the capillary wall, reduction of capillary membrane permeability, reduction of complement components, inhibition of histamine and kinin release, and interference with the formation of scar tissue. The antiinflammatory actions of corticosteroids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Mometasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 12 times that of dexamethasone, 7 times that of triamcinolone acetonide, 5 times that of budesonide, and 1.5 times that of fluticasone.
Terbinafine inhibits the enzyme squalene monooxygenase (also called squalene epoxidase), preventing the conversion of squalene to 2,3-oxydosqualene, a step in the synthesis of ergosterol. This inhibition leads to decreased ergosterol, which would normally be incorporated into the cell wall, and accumulation of squalene.
Generation of a large number of squalene containing vesicles in the cytoplasm may leach other lipids away from, and further weaken, the cell wall.
Dosage
Terbinaforce M dosage
A thin film of Mometasone Furoate cream should be applied to the affected skin areas once daily.Safety and effectiveness in paediatric patients below 2 years of age have not been established.
Topical application:
Terbinafine cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Terbinafine tablet therapy.Usual duration of treatment of Terbinafine cream:
- In Tinea corporis and Tinea cruris: 1-2 weeks.
- In Tinea pedis: 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.).
- In Cutaneous candidiasis: 1-2 weeks
- In Pityriasis (tinea) versicolor: 2 weeks.
To prevent relapses in fungal infection, treatment should be continued for a adequate length of time. To apply Terbinafine cream clean and dry the affected areas thoroughly and apply the cream once or twice a day to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections the application may be covered with a gauze strip, especially at night.
Oral administration:
Terbinafine tablet is essential for hair or nail infections:
- The usual oral dose: Terbinafine 250 mg daily for 2 to 12 weeks depending upon the infection.
- Finger nail onychomycosis: Terbinafine 250 mg once daily for 6 weeks.
- Toe nail onychomycosis: Terbinafine 250 mg once daily for 12 weeks.
Side Effects
Mometasone Furoate cream is generally well tolerated. Burning, Pruritus and skin atrophy may occur.
Terbinafine Tablet: Abdominal discomfort, anorexia, nausea, diarrhoea, headache, rash and urticaria occasionally with arthralgia or myalgia. Less frequently taste disturbance. Rarely liver toxicity, photosensitivity, serious skin reactions etc.
Terbinafine Cream: Redness, itching, or stinging; rarely allergic reactions.
Toxicity
The potential for acute toxic effects following overdose with the mometasone inhaler is low. However, habitual overuse of the product can cause symptoms of steroid overload, including menstrual irregularities, acne, obesity, and muscle weakness. Single oral doses up to 8000 µg have been studied on human volunteers with no adverse events reported.
The subcutaneous LD50 in rats and mice is >2g/kg. The TDLO for women is 210mg/kg/6W.
Overdose data with terbinafine is rare, however symptoms are expected to be nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache. Treat overdose with activated charcoal as well as symptomatic and supportive therapy.
Precaution
If irritation develops with the use of Mometasone Furoate cream, treatment should be discontinued.
Terbifine cream is for external use only. Contact with eyes should be avoided.Good general hygiene is necessary in conjunction with the use of Terbinafine in order to prevent reinfection (eg. from underwear, socks,shoes etc).
Terbinafine tablet is not recommended for patients with chronic or active liver disease. Before prescribing terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking terbinafine tablets.
Interaction
In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.
Volume of Distribution
A single 250mg oral dose of terbinafine has a volume of distribution at steady state of 947.5L or 16.6L/kg.
Elimination Route
Nasal spray is virtually undetectable in plasma
Oral terbinafine is >70% absorbed but only 40% bioavailable after first pass metabolism, reaching a Cmax of 1µg/mL with a Tmax of 2 hours an an AUC of 4.56µg*h/mL. Over the course of a week, 1% topical terbinafine's Cmax increases from 949-1049ng/cm2
Half Life
5.8 hours
Oral terbinafine has an effective half life of approximately 36 hours. However, the terminal half life ranges from 200-400 hours as it distributes into skin and adipose tissue. 1% topical terbinafine's half life increases over the first seven days from approximately 10-40 hours.
Clearance
A single 250mg oral dose of terbinafine has a clearance of 76L/h or 1.11L/h/kg.
Elimination Route
Terbinafine is approximately 80% eliminated in urine, while the remainder is eliminated in feces. The unmetabolized parent drug is not present in urine.
Pregnancy & Breastfeeding use
Pregnancy: There is no adequate and well-controlled studies in pregnant women.
Lactation: It is not known whether this drug passes into breast milk.
Terbinafine tablet: There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in breast milk of nursing mothers. Treatment with terbinafine in not recommended in nursing mothers.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Contraindication
The drug is contraindicated in individuals with a history of sensitivity reactions to Mometasone or any of the components of the preparation.
Hypersensitivity to Terbinafine or any of the excipients in thepreparation
Special Warning
Use in Children: Terbinafine cream appears to be an effective and well-tolerated treatmenr of tinea corposis and tinea cruris in children.
Use in Elderly: Terbinafine appears to be safe in the elderly. The dose should be reduced by half if significant hepatic or renal impairment is present.
Acute Overdose
Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
Storage Condition
Store in a cool and dry place, protected from light.
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