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TARO-CLINDAMYCIN/BENZOYL PEROXIDE is a brand name for Clindamycin, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ............................................................................................... 3 WARNINGS AND PRECAUTIONS.............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations For external (dermatological) use only. Not for oral, ophthalmic or intravaginal use. Recommended Dose and Administration The skin should be thoroughly washed with a mild, non-irritating cleanser, rinsed with warm water and gently patted dry.
Once daily gently apply Taro-Clindamycin / Benzoyl Peroxide Gel (clindamycin and benzoyl peroxide gel, 1%/5%, w/w) to lightly cover the entire affected areas of the face with a thin layer of gel. , forehead, chin, each cheek). Hands should be washed with soap and water after application of Taro-Clindamycin / Benzoyl Peroxide Gel.
Patients with Renal Impairment No dosage adjustment is necessary. As percutaneous absorption is low following topical application, renal impairment is not expected to result in systemic exposure of clinical significance. Patients with Hepatic Impairment No dosage adjustment is necessary.
As percutaneous absorption is low following topical application, hepatic impairment is not expected to result in systemic exposure of clinical significance. Missed Dose If patients forget to apply Taro-Clindamycin / Benzoyl Peroxide Gel, they should be instructed to apply the next dose at the usual time.
Patients should be instructed not to apply a double dose to make up for forgotten doses. OVERDOSAGE Symptoms Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects. Excessive application of topically applied clindamycin phosphate formulations can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS AND PRECAUTIONS).
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. Page 11 of 31 Excessive topical application of Taro-Clindamycin / Benzoyl Peroxide Gel may cause severe skin irritation from the benzoyl peroxide and gastrointestinal side effects, including abdominal pain, nausea, vomiting and diarrhea, due to systemic absorption of clindamycin phosphate from Taro-Clindamycin / Benzoyl Peroxide Gel.
In the event of accidental ingestion of Taro-Clindamycin / Benzoyl Peroxide Gel, the same gastrointestinal side effects as those expected with oral clindamycin are expected (see WARNINGS AND PRECAUTIONS). Treatment In the case of symptoms resulting from excessive topical application of Taro- Clindamycin / Benzoyl Peroxide Gel (clindamycin and benzoyl peroxide gel, 1%/5%, w/w), Taro-Clindamycin / Benzoyl Peroxide Gel should be discontinued until the skin has recovered before resuming therapy (see WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clindamycin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, cold compresses) should be taken to provide relief from irritation due to excessive topical application. Further management of excessive topical application or accidental ingestion should be as clinically indicated or as recommended by the regional Poison Control Centre or healthcare professional, where available.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Clindamycin Phosphate:
Clindamycin phosphate is a semi-synthetic antibiotic which is derived from the parent antibiotic, lincomycin. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the active antibiotic clindamycin.
Like other macrolides, clindamycin inhibits bacterial protein synthesis by binding to the 50S subunit of ribosomes. Clindamycin in vitro inhibits Propionibacterium acnes, an organism that has been associated with acne vulgaris. Clindamycin also reduces inflammation by inhibiting leukocyte chemotaxis.
Benzoyl Peroxide:
The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its bactericidal activity, especially with respect to Propionibacterium acnes, the predominant organism in sebaceous follicles and comedones.
The antibacterial activity of this compound is presumably due to the release of active or free-radical oxygen capable of oxidizing bacterial proteins. This action, combined with a mild keratolytic effect, is believed to be responsible for its usefulness in acne.
P. acnes resistance has not been reported with benzoyl peroxide. In acne patients treated topically with benzoyl peroxide, resolution of the acne usually coincides with the reduction in the level of P. acnes and free fatty acids. Page 12 of 31 Pharmacodynamics Clinical studies in humans have demonstrated that clindamycin and benzoyl peroxide gel, 1%/5%, w/w did not have detectable phototoxic potential or photocontact allergenic potential in human skin.
Clindamycin and benzoyl peroxide gel, 1%/5%, w/w was found to possess an insignificant primary irritant potential. No instance of delayed contact sensitization was reported.
Pharmacokinetics 1% clindamycin / 3% benzoyl peroxide Gel:
In an open-label study (24 patients with moderate-to-severe acne vulgaris in each treatment arm), topical administration of approximately 4 grams of 1% clindamycin / 3% benzoyl peroxide Gel under maximal- use conditions once daily for 5 days, resulted in systemic clindamycin concentrations that were quantifiable in all 24 patients in each treatment arm starting from 1 hour post dose.
Clindamycin was slowly absorbed after topical application, reaching maximal observed plasma concentrations within 6 hours. 1 ng/mL on Day 5.
Benzoyl Peroxide:
Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 5% of the dose enters the systemic circulation as benzoic acid.
STORAGE AND STABILITY Prior to Dispensing:
Store between 2°C and 8°C. Do not freeze.
SPECIAL HANDLING INSTRUCTIONS To the Pharmacist:
Taro-Clindamycin / Benzoyl Peroxide Gel (clindamycin and benzoyl peroxide gel, 1%/5%, w/w): Dispense with a 60 day expiration date and specify “Store at room temperature (15°C - 25°C). Do not freeze. Keep tube tightly closed. Keep out of the reach of children”.
DOSAGE FORMS, […]