KLOVINAL

For the use of registered medical practitioner or hospital or laboratory only.

Composition:

Metronidazole BP        500 mg
Clotrimazole BP          100mg

Lactobacillus Spores 150 million

Pharmacodynamics:

Clotrimazole is a broad-spectrum antifungal agent available for topical or intravaginal use. It is active against yeast and dermatophytes and also some action against Gram bacteria, especially Staphylococci and against Trichomonas. Clotrimazole acts by altering the permeability of fungal cell walls by interfering with cell wall lipids.

Metronidazole is active against several protozoa including Trichomonas vaginalis. It is bactericidal. Metronidazole is used in the treatment of susceptible protozoal infections and in the treatment and prophylaxis of anaerobic infections. Specific bacterial infections treated with Metronidazole include bacterial vaginosis (nonspecific vaginitis).

The vagina is a dynamic ecosystem that normally contains approximately 10° bacterial colony forming units per gram of vaginal fluid. The normal bacterial flora is dominated by Lactobacilli. Lactic acids and other organic acids are metabolized from glycogen by the lactobacilli, maintaining the vaginal pH between 3.8 and 4.2. 

The acidic environment inhibits the overgrowth of bacteria and other organisms with pathogenic potential. Because of vaginal infections like bacterial vaginosis, trichomoniasis and vulvovaginal candidiasis, the Lactobacilli flora goes down and vaginal pH increases to more than 4.5. Because of anaerobic bacteria, musty or fishy odor starts.

Lactobacillus sporogeneses is used to maintain normal bacterial flora in vaginal fluid.
Lactobacillus is in spore form. It is used to recolonize the vaginal flora and to maintain the vaginal pH between 3.8 to 4.2.

Pharmacokinetics

When applied topically Clotrimazole penetrates the epidermis but there is little if any systemic absorption has been reported following vaginal administration. Absorption of Metronidazole from vaginal Pessaries has been reported to be poor. Lactobacillus sporogeneses recolonize the vaginal flora.

Indications

KLOVINAL Pessary is indicated for vaginal infections like trichomoniasis, bacterial vaginosis and vulvovaginal candidiasis.

Dosage

One KLOVINAL Pessary should be inserted into the vagina as deeply as possible once daily. It should be used for 6 days, preferably on retiring to bed at night.
The treatment should not be carried out during menstruation.

Contraindications

KLOVINAL Pessary is contraindicated in patients known to be hypersensitive to topical imidazole.

Adverse Reactions

Few patients have reported local pruritis and burning sensation after vaginal administration. 

Warnings and Precautions

If irritation or sensitivity develops with the use of KLOVINAL Pessary, treatment should be discontinued, and appropriate therapy instituted. If there is lack of response to KLOVINAL Pessary treatment, microbiological studies should be done to confirm the diagnosis and rule out other pathogens before instituting other courses of antimycotic therapy. 

Pregnancy and lactation

Not recommended.

Interaction

Antibiotics with activity against lactobacilli should be avoided.

Metronidazole

Inhibits metabolism of warfarin and potentiates the anticoagulant effect.
Causes an intolerance to alcohol similar to disulfiram (therefore, avoid alcohol for 24 h after administration) abdominal cramps, nausea, vomiting, headaches and flushing occur when co-ingested with alcohol.
Cimetidine prolongs the plasma clearance by inhibiting metabolic enzymes; conversely, drugs that induce liver enzymes (e.g., Phenobarbital) may increase the elimination of
metronidazole.

Clotrimazole

May impair barrier contraceptives.
Concomitant medication with vaginal clotrimazole and oral tacrolimus might lead to increased tacrolimus plasma levels. Patients should thus be closely monitored for signs and symptoms of tacrolimus overdosage, if necessary, by determination of the respective plasma levels.

Overdoses

• No data for KLOVINAL overdose has been reported.
• No major concerns about toxicity are observed if used as recommended.

Storage

• Keep in a dry place, below 30°C. Protect from light.
• Keep out of reach and sight of children.

How to use Pessaries

• Wash your hands.
• Do not open the pessary if it seems soft, hold the foil wrapper under cold water or place it in refrigerator for few minutes to harden it before removing the wrapper.
• Remove one pessary from the strip and hold it in fingertips.
• Remove any foil or plastic wrapping stuck to the pessary.
• Sit or lie down with your knees bent and legs apart.
• Gently insert the pessary into the vagina as far as comfortably
• possible using your fingers.
• Wash your hands again.

Manufactured by:
BLISS GVS PHARMA LTD.
Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra - 401 404, INDIA. Regd. Off. 102, Hyde Park, Saki Vihar Road, Andheri (E),
Mumbai-400 072, INDIA.