Each soft gelatin capsule contains,
Clindamycin ..................100 Mg
Clotrimazole .............................200 Mg
DOSAGE FORM: Soft Gelatin Capsule for vaginal use only
Clotrimazole: Is imidazoles and has broad spectrum anti-fungal action. It brings about its therapeutic effect by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis alters the permeability of the cell membrane of sensitive fungi and leads to structural and functional impairment of the cytoplasmic membrane. It has fungicidal action against Candida albicans, other species of Candida as well as Trichomonacidal action.
Clindamycin: Is a lincosamide antibiotic, which acts primarily against gram positive and a wide range of anaerobic bacteria. It is congener of lincomycin. Clindamycin inhibits bacterial protein synthesis by its action at the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and effects the process of protein synthesis. Clindamycin has antimicrobial activity against Bacteroides spp., Gardenerellavaginalis, Mobiluncus spp., Mycoplasma hominis, Peptostreptococcus spp., Haemophilus spp., and Corynebacterium.
In the treatment of Vulvo- vaginal infections (Bacterial & Fungal)
CLENOL-3D is contraindicated in women with a history of hypersensitivity to Clotrimazole, Clindamycin or Lincomycin. CLENOL-3D is also contraindicated in women with a history of regional enteritis, ulcerative colitis or lincomycin associated colitis (Pseudomembranous colitis)
WARNINGS AND PRECAUTIONS:
The patient should be instructed not to engage in vaginal intercourse or use of other vaginal products (such as tampons or douches) during treatment with Clindamycin. If there is lack of response to CLENOL-3D appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of therapy.
Clindamycin is found in very low levels in the serum (<5%) following multiple topical application. No systemic accumulation is seen.
Intravaginal administration of Clotrimazole in human has negligible systemic absorption.
Thus with CLENOL-3D no systemic effects are anticipated.
CLENOL-3D is to be administered intravaginally and is not to be taken orally.
PREGNANCY AND LACTATION:
Experimental and clinical investigations give no indication of harmful effects on the mother or child when Clotrimazole is used during pregnancy. However, there are no adequate and well-controlled studies of use of Clindamycin in pregnant women. Hence CLENOL-3D should be used during pregnancy only if it is a must (under the advice of Physician).
CLENOL-3D may be used in lactation with caution.
CLENOL-3D Vaginal Suppositories are well tolerated locally i.e. intravaginally. In isolated cases, vaginal irritation, and itching, burning, dysparaunia and in rare cases slight urinary frequency and burning or irritation in the sexual partner have been observed. Very rarely the patient may find this irritation intolerable and in such cases the treatment has to be stopped.
Hypersensitivity reactions may occur.
Only for vaginal insertion. Not for oral use.
Pregnant, lactating women should strictly abide by the instruction of their Physicians.