Axcel Clindamycin

Axcel Clindamycin

clindamycin

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Clindamycin phosphate.
Description
Clindamycin Phosphate equivalent to Clindamycin 1% w/v.
Methylparaben 0.08% w/v and Propylparaben 0.02% w/v as preservatives. Isopropyl Alcohol 44% v/v as disinfectant.
Action
Pharmacology: Mechanism of Action: Clindamycin phosphate is the ester of clindamycin [7-(S)-chlorolincomycin], a semi-synthetic antibiotic. Clindamycin has been shown to have in vitro activity against isolates of Propionibacterium acnes. This may account for its usefulness in acne. Clindamycin has no fungicidal activity.
Pharmacokinetics: When applied topically, clindamycin has been shown to be absorbed from the skin in small amounts. Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin/mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and <0.2% of the dose is recovered in urine as clindamycin.
Indications/Uses
Treatment of acne vulgaris.
Dosage/Direction for Use
Apply a thin film of the solution twice daily to affected area.
Directions for use: Wash and dry the affected area.
Apply the medication sparingly to the affected area. Avoid contact with eyes and mucous membrane.
Use dabbing motion of the sponge of the applicator rather than rolling motion. If sponge dries out, invert the bottle and depress the sponge several times until it becomes moist.
Overdosage
This product is intended for topical use only. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), rinse affected area with copious amounts of water. Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects.
Contraindications
Hypersensitivity to clindamycin or lincomycin, history of regional enteritis, ulcerative colitis or antibiotic-associated colitis.
Special Precautions
Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. The physician should be alerted to the development of antibiotic-associated diarrhoea or colitis. If diarrhoea occurs, the product should be discontinued immediately. Patients with a history of the Crohn's disease and ulcerative colitis should be observed with caution. Prescribe with caution in atopic individuals. Prolonged use of this product for several months must be under the control of a physician.
Avoid contact with eyes.
Use in Pregnancy and Lactation: Safe use of topical clindamycin in pregnancy has not been established. Caution should be exercised when clindamycin is given during breast feeding.
Use In Pregnancy & Lactation
Safe use of topical clindamycin in pregnancy has not been established. Caution should be exercised when clindamycin is given during breast feeding.
Side Effects
Topical applications may be associated with local irritation and contact dermatitis. Sufficient clindamycin may be absorbed to produce systemic effects that have been associated with colitis. Other side effects have been reported with the use of topical clindamycin including gastrointestinal effects, oily skin and gram-negative folliculitis.
Drug Interactions
None.
Storage
Keep container well closed. Store below 30°C. Protect from light.
ATC Classification
D10AF01 - clindamycin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
Presentation/Packing
Topical soln (colourless) 1% w/w x 30 mL x 1's.
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