Funbact A Triple Action Cream

FUNBACT-A

TRIPLE ACTION CREAM

(Antifungal, Antibacteria, Anti-inflammatory)

 

COMPOSITION

Each gm contains:

Clotrimazole USP 1.0%w/w

Betamethasone Diproprionate USP

Equivalent to Betamethasone 0.05%w/w

Neomycine Sulphate USP 0.5%w/w

Preservative: Chlorocresol USP NF 0.1%w/w

Cream Base q.s.

 

SPECTRUM OF ACTION

Funbact A is a triple action cream with three distinct pharmacological actions which makes it suitable for the treatment of various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin.

Betamethasone Diproprionate, being a corticosteroid has powerful anti-inflammatory, antipruritic and anti allergic properties, thereby rapidly controlling symptoms such as redness, itching and scaling.

Neomycin sulphate as a broad spectrum antibiotics has activity against gram negative skin pathogens and most gram positive including staphylococci and streptococci.

Clotrimazole offers broad spectrum anti fungal activity with fungicidal activitiy covering a wide range of fungal organism and dermatophytes.

 

INDICATIONS

Funbact A is indicated for topical use in the treatment of a wide range of eczemas and other inflammatory and allergic infections of the skin caused by various bacteria/fungi.

This conditions include contact dermatitis, follicular dermatitis, impetigo, intertrigo, eczematoid dermatitis, non specific pruritus etc.

 

CONTRA-INDICATIONS

Funbact A should not be used by patients with hypersensitivity to any of the components, tuberculosis of the skin, varicella, herpes simplex, any viral infection of the skin and measles.

 

DOSAGE AND ADMINISTRATION

After cleaning the affected area, a sufficient quantity of Funbact A should be applied to the affected area to form a thin even layer, two or three times daily. This treatment should be continued for several days after the disappearance of symptoms.

 

ADVERSE EFFECTS

Skin atrophy or striae may occur following long term treatment with preparation containing corticosteroids.

 

USE DURING PREGNANCY

This formulation should not be used in large amounts or for prolonged periods during pregnancy.

 

PRECAUTIONS

Prolonged use of topical antibiotics occasionally may result in overgrowth of non susceptible micro organism.

Caution should be taken in use for babies and pregnant women.

For external use only.

 

STORAGE

Keep in a cool, dry place.

Store below 25oC.

Do not freeze.

 

PRESENTATION

Tubes of 15g and 30g.

 

Manufactured by

Gopaldas Visram & Co. Ltd.

A-590/591, TTC Industrial Area,

M.I.D.C. Mahape, Navi Mumbai,

India.

 

Manufactured for

Bliss GVS Pharma Ltd.

10, Dewan Udyog Nagar, Aliyali,

Palghar, Maharashtra – 401 404,

India.

 

Marketed by

Greenlife Pharmaceuticals Ltd.

No. 2, Bank Lane, Ilupeju,

Lagos, Nigeria.

Ketoral 200 Ketoconazole Tablets

KETORAL-200

Ketoconazole Tablets USP 200 mg

 

DOSAGE FORM AND STRENGTH

Oral Solid Dosage Form: Tablets

Strength: 200 mg

 

HISTORY OF ACTIVE INGREDIENTS

Ketoconazole is a synthetic, imidazole-derived medication used primarily to treat fungal infections.

 

NET CONTENT

Each uncoated tablet contains:

Ketoconazole USP 200 mg

Excipients q.s.

 

CLINICAL PHARMACOLOGY

Ketoconazole is an imidazole-dioxolane anti-mycotic, which is effective after oral administration and has a broad spectrum of activity against dematophytes, yeast and other pathogen fungi.

In vitro studies have demonstrated that ketoconazole impairs the synthesis of ergosterol in fungai cells. Ergosterol is a vital cell membrane component in fungi. Impairment of its synthesis ultimately results in an antifungal effect.

 

PHARMACOKINETICS

Absorption

Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption. Mean peak plasma concentrations of approximately 3.5 µg/ml are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal.

Distribution

In vitro, the plasma protein binding is about 99%, mainly to the albumin fraction. Ketoconazole is widely distributed into tissues; however, only a negligible proportion of ketoconazole reaches the cerebral-spinal fluid.

Metabolism

Following absorption from the gastro-intestinal tract, ketoconazole is converted into several inactive metabolites. The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation.

Excretion

Plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged drug. The major route of excretion is through the bile into the intestinal tract.

 

INDICATION AND USAGE

Treatment of dermatophylosis and Malassezia (previously called Pityrosporum) folliculitis that cannot be treated topically because of the site, extent of the lesion or deep infection for the skin, in patients resistant to or intolerant of both fluconazole and itraconazole.

 

CONTRAINDICATION

In patients with a known hypersensitivity to ketoconazole, to any of the other excipients, or to any other imidazole antifugal.

 

INTERACTIONS

Oral anticoagulant, busulphan, docetaxel, erlotinib, ciclosporin, tacrolimus, budesonide, fluticasone, dexamethasone.

 

WARNINGS

Because of the risk for serious hepatic toxicity, Ketoral 200 mg tablets should be used only when the potential benefits are considered to outweigh the potential risks, taking into consideration the availability of other effective antifungal therapy.

 

PREGNANCY AND LACTATION

Pregnancy

Not recommended.

Lactation

Ketoconazole is excreted in the milk, mothers who are under treatment should not breast-feed whilst being treated with Ketoral 200 mg tablets.

 

PRECAUTIONS

Liver function must be monitored in all patients receiving treatment with Ketoral 200 mg tablets.

Monitor liver function prior to treatment to rule out acute or chronic liver disease.

 

ADVERSE REACTION

Headache, dizziness, somnolence, nausea, vomiting, abdominal pain, diarrhea, pruritus, rash.

 

DRUG ABUSE AND DEPENDENCE

Not applicable.

 

SYMPTOMS OF OVERDOSE AND ANTIDOTE

No specific data are available.

 

DOSAGE AND ADMINISTRATION

There is no known antidote to ketoconazole.

In the event of accidental overdose, treatment consists of supportive measures. Within the first hour after ingestion gastric lavage may be performed. Activated charcoal may be given if considered appropriate.

 

THE PREPARATION FOR USE

Not applicable.

 

PRESENTATION

1 x 10 tablets packed in a carton along with Patient information leaflet.

 

STORAGE CONDITION

Keep in a cool, dry and dark place at a temperature not exceeding 30oC.

Keep medicines out of reach of children

 

NAFDAC REG. NO.: 04-9538

 

Manufactured by

Saga Laboratories

Survey No. 198/2 & 198/3

Chachrawadi Vasna, Taluka Sanand

District Ahmedabad-382 210, Gujarat, India.

 

Sole Agent

Embassy Pharmaceutical & Chemicals Ltd.

41 Ademola Street South West Ikoyi,

Lagos Nigeria

Clarion Crivicin Griseofulvin Tablets

CRIVICIN GRISEOFULVIN TABLET B.P. 500 mg

 

COMPOSITION

Each uncoated tablet contains

Griseofulvin B.P. 500mg

 

PROPERTIES

CRIVICIN-500 is an fungistatic antibiotic derived from a specie of penicillium and used for the treatment of superficial mycosis.

CRIVICIN-500 is active in vitro against various species of microsporum, Epiderniophyton and Trichophyton. It has no effect on bacteria or another genera of fungi, such as candida albicans (‘thrush fungus’); Aspergillas and Malassezia furfur (pityriasis Versicolor).

CRIVICIN-500 is deposited in the keratin precursor cells and has a greater affinity for diseased tissues. It enables newly-formed keratin of the skin, hair and nails to resist attack by fungi.

 

INDICATIONS

CRIVICIN-500 is effective against the dermatophytes causing ringworm (tinea) infection of the skin, hair and nails including microsporum canis, Trichophyton rubrum and T. Verucosum. It is generally given for such infections that involve the scalp, hair, nails and skin and which do not respond to topical treatment.

 

DOSAGE AND ADMINISTRATION

Dosage should be taken after meals, otherwise absorption is likely to be inadequate.

Adults

Normally 500-1000 mg (1-2 tablets) daily, but not less than 10 mg/kg body weight daily. A single dose daily is often satisfactory but divided doses may be more effective in patients who respond poorly.

Children

Usually 10mg/kg body weight daily in divided doses.

The duration of treatment depends upon the thickness of keratin at the site of infection. 2-6 weeks for infection of hair and skin, 6-9 months for infections of the finger nails and 12-18 months for the infection of the toe nails.

 

CONTRA INDICATIONS

CRIVICIN-500 is contraindicated in patients with porphyria, liver failure, and in individuals with history of hypersensitivity to Griseofulvin.

 

PRECAUTIONS

Concurrent treatment with CRIVICIN-500 may reduce the effectiveness of oral contraceptives, so additional contraceptive precautions should be taken during CRIVICIN-500 treatment and for a month after stopping it. As there is no evidence of its safety in human pregnancy (Griseofulvin is teratogenic in animals and some case reports suggest that it produces human foetal abnormalities). CRIVICIN-500 should not be used during pregnancy.

Griseofulvin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after CRIVICIN-500 therapy.

Barbiturates usually depress Griseofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent.

Potentiates alcohol, effect producing effect like trachycardia and flush.

 

ADVERSE REACTIONS

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely angioneurotic edema.

Other side effects, reported occasionally, are gastric discomfort, headache, dizziness and insomnia, dryness of the mouth, an altered sensation of taste. Proteinuria and leucopenia have been reported rarely. Administration of the drug should be discontinued if granulocy topenia occurs.

 

STORAGE

STORE IN COOL DRY PLACE.

PROTECT FROM DIRECT LIGHT.

KEEP ALL MEDICINE OUT OF REACH OF CHILDREN.

 

PRESENTATION

CRIVICIN-500 tabs are supplied in Blister pack of 20 Tablets.

 

NAFDAC Reg. No.: A4-6246

 

Manufactured in China by

Nantong Jinghua Pharmaceutical Co, Ltd.

9 Xingtai Road, Gangzha Zone Nantong Jiangsu China 226005

 

Marketed by

CLARION MEDICALS LTD.

23, Afolabi Lesi Street, llupeju,

Lagos, Nigeria.