CLINDAZAP-C Vaginal pessary

Indications:

Clindazap-C is used in the treatment of Bacterial vaginosis, Gardenella vaginalis, Mobilincus sp,

Trichomoniasis, Vaginal candidiasis, mixed vaginal infections, Vaginal mycoses, Infective Leucorrhea and Non specific vaginitis.

Dosage:

Insert one pessary intravaginally as high as possible at bed time for 3 consecutive nights.

Hypersensitivity to Clindamycin & Clotrimazole or any of the excipients of the vaginal pessary.

Adverse reactions may include skin irritation with symptoms of redness, itching, burning and urticaria or skin fissures.

• immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)

• reproductive system and breast disorders: Genital peeling, pruritus, rash oedema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

• Gastrointestinal disorders: abdominal pain.

Clindamycin

Respiratory depression with neuromuscular blockers-clindamycin has been shown to have neuromuscular blocking properties. Therefore, it should be used with caution in patients receiving such agents.

Clotrimazole:

Concomitant medication with vaginal clotrimazole and oral tacrolimus (immunosuppressant) might lead to increased tacrolimus plasma levels and similary with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage.

When used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

Pregnancy:

No adequate and well-controlled studies have been established in pregnant woment during 1st trimester of pregnancy. Patients should be advised to consult their physician to use during pregnancy.

Lactation:

It is not known whether the drug is excreted in breast milk. Caution should be exercised when administered during breast feeding.

• Treat male partner concurrently.

• Not to use during menstrual cycle.

• Hypersensitivity, perforated tympanic membrane.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Clindazap-C. Clindazap-C can be used again if the infection returns after 7 days. However, if the infection recurs more than twice within six months, patients should be advised to consult their physician.

NOTE: Vaginal pessaries should not be given to children under 16 years of age and geriatrics above 60 years of age.

Before using Clindazap-C, medical advice must be sought if any of the following are applicable:

- More than two infections of Bacterial vaginal infections, Vaginal candidiasis, mixed vaginal infections, Vaginal mycoses, infective Leucorrhea and non-specific vaginitis in the last six months.

- Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.

- Pregnancy or suspected pregnancy.

- known hypersensitivity to imidazole or lincosamide or other viginal antifungal and anti-bacterial products.

Clindazap-C is Indicated for vaginal infections. It contains Clindamycin and Clotrimazole which act as vaginal Microbicide by inhibiting bacterial protein synthesis and increasing fungal cell wall permeability.

Clindamycin is a semi synthetic lincosamide antibiotic that inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although Clindamycin

phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active Clindamycin.

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.