Zindaclin 1% Gel

/ Taro

Apply a thin film of gel once daily to the affected area. Patient response should be reviewed periodically.
Children: The drug is not indicated for use in children below the age of 12 years.

Treatment of mild to moderate acne vulgaris.

Patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that the drug  should not be used in patients who have demonstrated lincomycin sensitivity.

The product contains approximately 20% ethanol. Each gram contains approximately 0.2 gram alcohol. Do not light a cigarette or come in contact with an open flame until the product has been completely dried off. Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous colitis; however if diarrhea occurs the product should be discontinued immediately.
Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-associated colitis. Colitis is usually characterized by severe persistent diarrhea and abdominal cramps. Should antibiotic associated colitis occur, appropriate diagnostic and therapeutics measures (Such as vancomycin treatment) should be taken immediately. Responses may not be seen for 4-6 weeks.Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous colitis; however if diarrhea occurs the product should be discontinued immediately.
Although the risk of systemic absorption following the administration of this drug is low, the potential for the development of gastrointestinal adverse effects should be taken into account when considering treatment in patients with previous history of antibiotic-associated colitis, enteritis, ulcerative colitis or Crohn’s disease.
Cross resistance may occur with other antibiotics such as lincomycin and erythromycin.
Contact with the eyes or the mucous membranes of the nose and mouth should be avoided. In the event of accidental contact with the eyes or mucous membranes bathe the affected area with copious amounts of cool water.
Prolonged use of clindamycin may cause resistance and/or overgrowth of non susceptible bacteria or fungi although this is a rare occurrence.
This formulation contains propylene glycol. May cause skin irritation. The irritation potential of the drug may be increased if the product is used under occlusion.

Dry skin, erythema, skin burning, irritation around eyes, acne exacerbation pruritis.
See prescribing information for full details.

No interactions have been reported with topical clindamycin.

Pregnancy: For clindamycin applied cutaneously, no clinical data on exposed pregnancies are available. Data on the limited number of pregnancies exposed to clindamycin administered by other routes indicate no adverse effect on pregnancy or on the health of the fetus/newborn child.
Lactation: It is not known whether clindamycin is excreted in human milk following use of topical Gel.
See prescribing information for full details.

No cases of  overdose has been reported and It is not expected that overdose would occur in normal use.