Candid V6 Clotrimazole USP Inserts

Candid™ – V6

CLOTRIMAZOLE VAGINAL INSERTS USP
BROAD SPECTRUM FUNGICIDE AND TRICHOMONACIDE

 

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory

CANDID-V6 offers efficient treatment for all vaginal infections caused by Candida species, Torulopsis species, Trichomonas vaginalis and certain Gram positive and Gram negative microorganisms.

 

COMPOSITION

Each uncoated Tablet contains:

Clotrimazole USP 100 mg

 

INDICATIONS

Vaginal Candidiasis, Vaginal Trichomoniasis, Mixed Vaginal Infections, Bacterial Vaginitis and Ineffective Leucorrhoea.

 

APPLICATION AND DOSAGE

One CANDID-V6 Vaginal Insert should be inserted daily, preferably on retiring to bed at night for 6 consecutive nights. It is to be inserted as deeply as possible into the vagina. This is best achieved with the applicator when lying on the back with legs pulled in a little towards the body (see special directions).

The treatment should not be carried out during menstruation but should be completed before this begins.

For complete relief, it is advisable to apply CANDID Cream to the area around the vagina.
For the prevention of reinfection, the partner should be treated locally with CANDID Cream.

CANDID-V6 Vaginal Inserts are colourless and do not stain the underwear.

 

TOLERANCE

There is virtually no absorption of the active ingredient through the vaginal mucosa. No systemic effects are therefore to be expected. CANDID-V6 Vaginal Inserts are well tolerated locally.

Administration of CANDID-V6 Vaginal Tablets during pregnancy, especially in the first trimester, is only under medical advice. This is in accordance with the general directions for the use of drugs.

 

PRESENTATION

Pack contains 6 Vaginal Inserts, each sealed in Aluminium foil, with an applicator.
Prior to application, cut out from the aluminium foil one Tablet.

 

SPECIAL DIRECTIONS

FOR USING THE APPLICATOR:

1. Pull out plunger A until it stops. Place one Vaginal Tablet into the applicator B.

2. Insert applicator containing the Tablet carefully as deep as possible into the vagina (this is done best by lying on the back).

3. Push plunger A until it stops, thereby depositing the Tablet into the vagina. Withdraw the applicator.

4. After use, remove plunger A completely by pulling it out of the applicator B1. Thereafter wash both in warm (not boiling) soapy water and dry completely.

 

IMPORTANT

Pregnant women should strictly abide by the instruction of their Physicians.

 

Storage

Store below 25°C. Protect from moisture & light. Keep all Medicines out of reach of children.

 

NAFDAC Reg. No: 04-6838

 

MANUFACTURED BY

Glenmark PHARMACEUTICALS LTD.

PLOT NO. E-37, 39, D-ROAD,

M.I.D.C. INDUSTRIAL AREA,

SATPUR, NASIK – 422 007, INDIA.

™Trade Mark

Fungkik Ketoconazole Tablets

FUNGKIK™

Ketoconazole Tablets USP 200 mg.

 

COMPOSITION

Each uncoated tablets contains:

Ketoconazole USP 200mg

Excipients q.s

 

PHARMACOLOGICAL CLASSIFICATION

Antifungal

 

PHARMACOLOGICAL ACTION

Ketoconazole is a synthetic imidazole dioxolane derivative active (in vitro) against dermatophytes yeasts and other pathogenic fungi. In vitro Ketoconazole is fungicidal and, therefore, suppresses the formation of mycelia, in vivo, at therapeutic level, however it is primarily fungi static. Ketoconazole acts in the case of C. albicans by inhibiting lanosterol demethylation in the biosynthesis of ergo sterol, resulting in cell membrane defects.

 

INDICATIONS

Treatment of superficial and deep mycoses:

• Systemic mycotic infections such as systemic candidiasis;

• Chronic and recurrent vaginal candidiasis not responding to topical treatment;

• Serious chronic infections of the skin, hair and nails caused by sensitive dermatophytes e.g. Trichophyton rubrum, Tmentagropytes and/or yeasts (dermatomycoses, paronychia, serious mucocutaneous candidiasis etc);

• When topical treatment is ineffective owing to the involvement of large areas of the skin, or lesion penetrating the deeper dermal layer nails and hair;

• Serious mycoses of the gastro-intestinal tract not responsive to other therapy or when the organism is resistant to other therapy;

• Serious chronic mucocutaneous candidiasis not responsive to other therapy or when the organism is resistant to other therapy;

• Paracoccidioidomycosis;

• Pulmonary, oral and/or disseminated histoplasmosis; and

• Coccidiodomycosis.

 

CONTRA- INDICATIONS

Ketoconazole is contra- indicated in patients who have shown hypersensitivity to it or any of its ingredients. Ketoconazole should not be given to patients with pre-existing liver disease. Ketoconazole is not recommended during pregnancy, as Ketoconazole has been shown to be teratogenic in animals. Ketoconazole should not be used by breastfeeding mothers. Ketoconazole is not intended for use in children, as safety has not been proven. The concomitant administration of terfenadine and astemizole with Ketoconazole is contra-indicated.

 

WARNINGS

Patients taking Ketoconazole should avoid alcohol. Cases have been reported of a disulfiram – like reaction to alcohol, characterised by flushing peripheral oedema, nausea and headache. Hepatitis has been reported during treatment with Ketoconazole. If symptoms or signs suggestive of hepatic dysfunction are detected medication should be stopped at once. Patients on Ketoconazole should be instructed to report any of the prodromal symptoms of hepatitis such as fatigue associated with nausea or vomiting, jaundice, dark urine or pale stools, immediately and stop treatment.

 

DOSAGE AND DIRECTIONS FOR USE

As directed by the physician.

Note: Ketoconazole should be taken with meats for maximal absorption. Effective absorption depends upon intact gastric activity; hence concomitant administration with drugs that reduce gastric secretion (ant cholinergic drugs antacids and H2 blockers) should be avoided. When indicated, these drugs should not be taken within two hours after Ketoconazole.

 

SIDE – EFFECT AND SPECIAL PRECAUTIONS

Side-effects: Nausea, vomiting, gastro- intestinal complaints, constipation, headache, dizziness, somnolence or drowsiness, photophobia, paraesthesia, thrombocytopenia, exanthema or itching have been reported. Increases in serum liver enzymes may occur. Anaphylactoid reactions, alopecia, urticaria, rash, transient decreased libido, reversible gynaecomastia and oligospermia may occur.

 

SPECIAL PRECAUTIONS

Serum cortisol levels may decrease and response of cortisol on ACTH may be blunted. The adrenal function should therefore be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress (major surgery intensive care etc)

Interactions: The concomitant administration of rifampicin or isoniazid with Ketoconazole reduces the blood level of the latter. Both drugs should not be administered concomitantly.

Since Ketoconazole inhibits certain hepatic oxidase enzymes, it may decrease the elimination of co-administered drugs whose metabolism depends on such enzymes. Increased levels of such drugs, when used together with Ketoconazole have been associated with an increase in side – effects.

Known examples of serious interactions include those with cyclosporine, terfenadine astemizole, cisapride oral midazolam, triazole anticoagulants (e.g. warfarin) methylprednisolone, phenytoin and possibly busulphane and tacrolimus. Terfenadine astemizole cisapride, oral midazolam and triazotam, should not be used by patients using Ketoconazole. Ketoconazole interacts with certain anti – retroviral agents, namely didanosine saquinavir, ritonavir and indinavir.

 

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See Side – effects and Special Precautions. In the event of accidental over dosage, supportive and symptomatic measures including gastric lavage with sodium bicarbonate should be employed.

 

STORAGE

Store below 30°C. Protect from light and moisture.

Keep all medicines away from children.

 

PRESENTATION

Pack of 10’ Tablets

 

NAFDAC Reg. No.: A4-6804

 

Marketed by

Maydon Pharmaceutical Ltd

15, Wilmer Street, Off Town Planning way,

Ilupeju, Lagos-Nigeria.

 

Manufactured in India by

Maxheal Laboratories Pvt. Ltd.

H.O.: 401, Maxheal House, Bangur Nagar, Goregaon-W,

Mumbai-400090

Factory: 2-7/80-85, SURSEZ, Sachin, Dist.

Dist. Surat, Gujarat-394230.