Clindax Vaginal Cream
Clindamycin Vaginal prep
20 mg/gm
Opsonin Pharma Limited
| Pack size | 20gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 70.00 AED |
Indications
Clindax Vaginal Cream is used for:
Bacterial vaginosis
Adult Dose
Bacterial Vaginosis
Vaginal cream: 1 full applicator inserted (approximately 5 gram) intravaginally at bedtime for 3 days in nonpregnant patients and for 7 days in pregnant patients
Child Dose
<12 years old
Safety and efficacy not established
Renal Dose
Administration
For vaginal use only
Administration at bedtime decreases leakage
Vaginal cream
While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort
Slowly push the plunger until it stops
Carefully withdraw applicator from vagina, and discard applicator
Contra Indications
Hypersensitivity.Clindamycin cream is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of \"antibiotic-associated\" colitis.
Precautions
Clostridioides difficile-associated diarrhea: Discontinue and evaluate if diarrhea occurs
Rubber or latex products: Do not use barrier contraceptives (condoms or vaginal contraceptive diaphragms) concurrently or for 5 days following treatment. Condoms may not be reliable for preventing pregnancy or for protecting against the transmission of HIV and other sexually transmitted diseases during this time
Pregnancy-Lactation
Pregnancy
This medication has not been studied in pregnant women; the systemic exposure (based on AUC and C max ) of this medication administered intravaginally is substantially lower than clindamycin administered intravenously; therefore, maternal use is not likely to result in significant fetal exposure to the drug
Available data from published observational studies and randomized controlled trials over decades of use with other clindamycin products during pregnancy have not identified an increased risk of major birth defects, miscarriage, or other adverse maternal and fetal outcomes
Animal data
In animal reproduction studies, no adverse developmental outcomes were observed in pregnant rats and mice administered oral doses of clindamycin at up to 600 mg/kg/day (58 and 29 times, respectively, the recommended human dose based on a body surface area comparison)
Females and males of reproductive potential
This medication contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment
During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases
Lactation
The systemic exposure (based on AUC and C max ) of this medication is substantially lower than intravenous administration of clindamycin; therefore, adverse effects on breastfed infant are not expected from transfer of clindamycin into breastmilk
There are no data on effect of clindamycin on milk production; developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed infant from this drug or from underlying maternal condition
Interactions
May enhance the action of neuromuscular blocking agents (e.g. atracurium).
May antagonise the effects of parasympathomimetics.
May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. Increased coagulation tests (prothrombin time/INR) and/or bleeding w/ vit K antagonists (e.g. warfarin, acenocoumarol, fluindione).
Adverse Effects
Side effects of Clindamycin Vaginal prep :
1-10%
Vulvovaginitis (4.4-6%)
Vulvovaginal disorder (3.2-7.1%)
Trichomonal vaginitis (1.3%)
Moniliasis, body (0.2-1.3%)
Pruritus, nonapplication site (1.1%)
<1%
Body as a whole: Upper respiratory infection
Dermatologic: Pruritic rash, pruritus, erythema
Gastrointestinal: Diarrhea, vomiting
General: Fatigue
Immune System: Hypersensitivity
Nervous System: Dizziness
Reproductive System: Dysfunctional uterine bleeding, dysuria, dysmenorrhea, intermenstrual bleeding, menorrhagia, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema, vulvitis, vulvovaginal discomfort/pain, vulvovaginal dryness, vulvovaginitis
Mechanism of Action
Clindamycin inhibits protein synthesis by reversibly binding to the 50S subunit of the ribosomal thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting to stunted cell growth.
Note
Clindax 20 mg/gm Vaginal Cream manufactured by Opsonin Pharma Limited. Its generic name is Clindamycin Vaginal prep. Clindax is availble in Bangladesh.
Farmaco BD drug index information on Clindax Vaginal Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.