products-page-bottom-left-box

SivoClotrimazole

Adpharm Pharmaceuticals Limited
60, Ajao Road, Surulere, Lagos State, Nigeria
Email: adpharm2010@yahoo.com; info@adpharmltd.com
Tel: +234(0)818-839-0519, +234(0)807-408-4334. Mobile: 08033481022
Website: http://adpharmltd.com/

Brand Name

SivoClotrimazole

Manufacturer

GLOBELA PHARMA PVT. LTD. Plot No. 357, G.I.D.C., Sachin, Surat- 394 230, Gujarat State, INDIA. Mfg. Lic. No.: G/2511749

Therapeutic Class

Antifungals, Genital

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Vaginal tablet(NRN: A4-9076): Each uncoated tablet contains: Clotrimazole BP 100 mg. excipients q.s.

Pack size: 1 x 6's tablets packed in one strip. Such 1 strip packed in unit printed duplex board carton along with applicator and package insert. Such cartons packed in export worthy shipper. 

Sivoclotrimazole Tablet

Pharmacology

Indications

Fungal skin infections; vaginal candidiasis.

Contra-indications

Possible hypersensitivity to clotrimazole.

Hepatic impairment: No information available.

Pregnancy: Clotrimazole Vaginal Tablets should not be administered to pregnant women during the first trimester, since the safety in this regard has not been established. During pregnancy, the Clotrimazole Vaginal Tablets should be inserted without using an applicator. Clotrimazole Vaginal Tablets may only be used during pregnancy on the advice of a medical doctor.

Breast-feeding: No information available.

Precautions/Warnings

Acute porphyria.

Interactions

Adverse Effects

Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur. The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

In isolated cases there may be generalised hypersensitivity reactions of varying degrees of severity.

These reactions may affect the skin (e.g. itching, redness), breathing (shortness of breath), the circulation (e.g. a drop in blood pressure requiring treatment or even impaired consciousness) or the gastrointestinal tract (e.g. nausea, diarrhoea).

Dosage & Administration

First infections: In general, a 3-day treatment for Candida vaginitis will be sufficient. On three consecutive nights, 2 Clotrimazole Vaginal Tablets are inserted as deeply as possible into the vagina (see directions for use of applicator). This is best achieved when lying down with the knees slightly bent.

Re-infections: In general a 6-day treatment will be sufficient. On six consecutive nights, one Clotrimazole Vaginal Tablet is inserted as deeply as possible into the vagina even if symptoms disappear. If individual cases should require it, two vaginal tablets can be used daily, i.e. one in the morning and one in the evening for 6 - 12 days. Use even during menstruation, although it is recommended that the treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation. For prevention of re-infection, the partner should be treated locally with clotrimazole cream at the same time.

Clotrimazole Vaginal Tablets are odourless, colourless and do not stain the underwear. In individual cases where disintegration of the tablet does not occur, such as in dry vagina associated with menopause, it is recommended that clotrimazole vaginal cream be used.

Storage/Handling Recommendations

36 months from the date of manufacture.

Store in a cool and dry place.

Protect from light.

Review Date

2017-09-30 04:24:08