Clindamycin Phosphate and Clotrimazole Soft Gelatin Capsule

This medication is used to treat certain type of vaginal infection (bacterial vaginosis). It comprises of Clindamycin Phosphate and Clotrimazole which are antibiotics that works by stopping the growth of bacteria. Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. The infection can cause a thin, grayish-white discharge with an unpleasant odor, but it often goes undetected. If it does produce symptoms, antibiotics can be used as an effective treatment, also during pregnancy. Treatment can help lower the slightly increased risk of miscarriage due to the infection, too.

• Treatment of vaginal infections
• Vaginal mycoses secondarily infected with bacteria
• Vaginal and vulvo-vaginal infections

PHARMACODYNAMIC PROPERTIES OF CLINDAMYCIN

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome similarly to macrolides such as erythromycin and inhibit the early stages of protein synthesis. The action of clindamycin is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains.

PHARMACOKINETIC PROPERTIES OF CLINDAMYCIN

ABSORPTION:
Rapidly absorbed after oral administration with peak serum concentrations observed after about 45 minutes. Absorption of an oral dose is virtually complete (90%) and the concomitant intake of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose. Clindamycin does not penetrate the blood brain barrier.
PROTEIN BINDING:
92-94%
METABOLISM:
Hepatic
ROUTE OF ELIMINATION:
Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites.

PHARMACODYNAMIC PROPERTIES OF CLOTRIMAZOLE

Clotrimazole, the broad spectrum antifungal acts by inhibiting ergosterol synthesis. Cell membranes of fungi and protozoa are made of ergosterol, inhibition of its synthesis leads to impairment of cytosplasmic membrane. Clotrimazole is known to have activity against dermatophytes, moulds and yeasts. In addition to its antifungal action, it also acts on gram-positive bacteria (Streptococci /Staphylococci / Gardnerella vaginalis), and gram-negative bacteria. Depending on the concentration of clotrimazole at the site of action, it exhibits fungi static and fungicidal activity.

PHARMACOKINETIC PROPERTIES OF CLOTRIMAZOLE

Pharmacokinetic studies after vaginal application of clotrimazole have shown that only a small amount of drug (3-10%) is absorbed. Clotrimazole undergoes rapid hepatic metabolism into inactive metabolites and the resulting peak plasma concentrations of Clotrimazole-500mg given via vaginal route were found to be less than 10ng/ml. From these findings it is inferred that Clotrimazole given via vaginal route is unlikely to show systemic side effects.

• Blood dyscrasias
• Decreased neutrophils
• Epileptic seizure
• First trimester of pregnancy
• Hypersensitivity

• Anorexia
• Bitter taste
• Nausea
• Vomiting
• Diarrhoea
• Fatigue
• Dry mouth
• Abdominal distress
• Headache