CLINDO (Vaginal cream)
-
Chemical Name:
Clindamycin -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibacterial -
Pharmaceutical Form:
Vaginal cream -
Composition:
Clindamycin 2%
CLINDO
Vaginal Cream
Clindamycin (Phosphate)
1. PHARMACOLOGY:
Clindamycin 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.
Clindamycin is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:
Bacteroides spp.
Gardnerella vaginalis
Mobiluncus spp.
Mycoplasma hominis
Peptostreptococcus spp.
2. PHARMACOKINETICS:
- Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2% administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11% ) of the administered dose was absorbed systemically.
The peak serum clindamycin concentration observed on the first day averaged 18ng/ml (rang 4 to 47ng/ml) and on a day 7 it averaged 25 ng/ml (range 6 to 61 ng/ml). These peak concentrations were attained approximately 10 hours post-dosing (range 4-24 hours).
- Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2% administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and less variable than that observed in healthy females. Approximately 5% (range 2% to 8%) of the dose was absorbed systemically. The peak serum clindamycin concentration observed on the first day averaged 13 ng/ml (range 6 to 34 ng/ml) and on day 7 it averaged 16 ng/ml (range 7 to 26 ng/ml). These peak concentrations were attained approximately 14 hours post-dosing (range 4 - 24hours).
There was little or no systemic accumulation of clindamycin after repeated vaginal dosing of clindamycin phosphate vaginal cream 2%. The systemic half-life was 1.5 to 2.6 hours.
3. INDICATIONS:
CLINDO Vaginal Cream 2% is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebbacterium vaginitis, or anaerobic vaginosis).
CLINDO Vaginal Cream 2% can be used to treat non-pregnant women and pregnant women during the second and third trimester.
4. CONTRAINDICATIONS:
- CLINDO Vaginal Cream 2% is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream.
- CLINDO Vaginal Cream 2% is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of “antibiotic-associated” colitis.
5. PRECAUTIONS:
CLINDO Vaginal Cream 2% contains ingredients that will cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.
6. SIDE EFFECTS:
- Urogenital system: vaginal pain, cervicitis/vaginitis secondary to C. albicans or trichomonal vaginitis.
- Sometimes itching burning, nausea, and vomiting.
7. DRUG INTERACTIONS:
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
8. DOSAGE & ADMINISTRATION:
One dose of clindamaycin phosphate vaginal cream 2% intravaginally preferably at bedtime for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients.
9. PACKAGING & COMPOSITION:
CLINDO – Vaginal Cream: A pack of aluminium tube of 20 g vaginal cream with vaginal dosing applicator of 5g. Each cream tube contains 2% Clindamycin Phosphate equivalent to 20 mg Clindamycin base per 1g cream.
10. STORAGE CONDITIONS:
Store CLINDO – Vaginal Cream at temperature between (15-30)°C
.
Instructions for Preparing and Applying CLINDO Vaginal Cream
The applicator provides a dose of 5gr of CLINDO Vaginal Cream
I. CLINDO applicator is prepared as follows:
1. Pull the plunger till the final quarter of the applicator.
2. Remove the cap of the tube and screw the applicator on the tube.
3. Squeeze the tube gently from the bottom till the applicator is filled.
4. Unscrew the applicator from the tube and replace the cap of the tube.
5. The applicator is ready is ready now for vaginal administration.
II. Vaginal Application:
1. While lying on your back, insert the applicator into vagina as far
as possible without causing discomfort.
2. Slowly push the plunger and empty the applicator content.
3. Carefully withdraw the applicator.
III. Applicator Cleaning:
1. Wash the applicator after finishing the administration with hot water
and rinse to remove traces of the cream.
2. Keep the applicator dry in a clean place.
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