Clindax-B Gel
Clindamycin + Benzoyl Peroxide
1% + 5%
Opsonin Pharma Limited
| Pack size | 10gm, 20gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 150.00,350.00 AED |
Indications
Clindax-B Gel is used for:
Acne vulgaris
Adult Dose
Topical/Cutaneous
Acne vulgaris
Adult: Apply to the affected areas once or twice daily (morning and evening) after the skin is gently washed and patted dry.
Child Dose
Topical/Cutaneous
Acne vulgaris
<12 years: Safety and efficacy not established
>12 years: Apply to the affected areas once daily after the skin is gently washed and patted dry.
Renal Dose
Administration
Apply to the affected areas after the skin is gently washed and patted dry.
Contra Indications
History of regional enteritis or ulcerative colitis or history of antibiotic-associated colitis.
Precautions
Should be used with caution in atopic individuals
For external use only; avoid contact with eyes and mucous membranes
Minimize sun expsoure following application
May have bleaching effects on hair or colored fabric
Bacterial of fungal superinfection may result from prolonged use
Concomitant topical acne therapy may result in cumulative irritancy, especially with use of peeling, desquamating, or abrasive agents; if irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once irritation subsides; discontinue treatment if irritation persists
Systemic absorption of clindamycin has been demonstrated following topical use; diarrhea, and colitis (including pseudomembranous colitis) reported with topical use; discontinue immediately if significant diarrhea occurs and consider large bowel endoscopy
Pregnancy-Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; limited published data on use of clindamycin in pregnant women with exposure during first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes; in limited published clinical trials with pregnant women, systemic administration of clindamycin during second and third trimesters has not been associated with an increased frequency of major birth defects
Animal data
In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times maximum recommended human dose (MRHD) of 2.5 g, based on body surface area (BSA) comparisons
Lactation
There are no data on presence of clindamycin or benzoyl peroxide in human milk, effects on breastfed child, or on milk production following topical administration; however, clindamycin has been reported to be present in breast milk in small amounts following oral and parenteral administration
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 child from 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).
PABA sunscreens may transiently discolour fabric.
Contraindicated (0)
Serious (2)
aminolevulinic acid oral
aminolevulinic acid topical
Adverse Effects
Side effects of Clindamycin + Benzoyl Peroxide :
Frequency Not Defined
Application site pain
Application site exfoliation
Application site irritation
Erythema
Burning
Pruritus
Sunburn
Scaling
Dryness
Diarrhea
Colitis
Peeling
Mechanism of Action
Clindamycin is a semi-synthetic derivative of lincomycin. It inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms.
Benzoyl peroxide has mild keratolytic effect and antimicrobial activity which is attributed to its potent oxidizing activity.
Clindamycin and Benzoyl peroxide are both active against Propionibacterium acnes, an organism associated with acne vulgaris.
Note
Clindax-B 1% + 5% Gel manufactured by Opsonin Pharma Limited. Its generic name is Clindamycin + Benzoyl Peroxide. Clindax-B is availble in Bangladesh.
Farmaco BD drug index information on Clindax-B Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.