ClindaTech Topical Solution is a clear hydroalcoholic solution containing clindamycin hydrochloride 1%. Diocytl malate, a noncomodegenic humectant is incorporated to prevent skin dryness.
CLINDATECH
TOPICAL SOLUTION
ClindaTech Topical Solution is a clear hydroalcoholic solution
containing clindamycin hydrochloride 1%. Diocytl malate, a noncomodegenic
humectant is incorporated to prevent skin dryness.
ACTION
Clindamycin is a lincosamide antibiotic obtained as a semi-synthetic
derivative from cultures of Streptomyces
lincolnensis. It is active in
vitro and in vivo
against aerobic gram-positive cocci and several anaerobic and
micro-aerophilic gram-negative and gram-positive organisms including
Propionibacterium acnes,
a resident anaerobe found in acne-susceptible follicles.
ClindaTech Topical Solution is for the topical treatment of
acne vulgaris, particularly forms in which comedones, papules
and pustules predominate.
ClindaTech Topical Solution is contraindicated in patients
with a known history of
hypersensitivity reactions to preparations containing clindamycin,
lincomycin or other ingredients in the formulation.
PREGNANCY
Category A. Reproductive studies have been performed in rats
and mice using oral and parenteral doses up to 300mg/kg/day and
have revealed no evidence of harm to the foetus due to clindamycin.
There exist, however, no adequate and well controlled studies
to demonstrate safety of use in pregnant women.
LACTATION
It is not known if clindamycin is excreted in human milk following
use of topically administered clindamycin. However, after oral
and parenteral administration clindamycin has been detected in
human milk. In the absence of any adequate and well controlled
studies, topical clindamycin should not be used in lactating women.
PRECAUTIONS
FOR EXTERNAL USE ONLY. Clindamycin Topical Solution
has an unpleasant taste. Caution should be exercised when applying
the solution around the mouth to avoid any possible ingestion.
Avoid any contact with eyes, eyelids, abraded skin, nasal folds,
lips or mucous membranes because of the irritating dryness caused
by the alcoholic solvent. In the event of any accidental contact,
bathe with copious amounts of cool water.
Use
with caution in the following circumstances
The topical solution contains alcohol and may cause a burning
sensation especially in those patients with sensitive skins. Sensitivity
reactions including contact dermatitis and rash are rare but may
occur in individuals who are hypersensitive to clindamycin, lincomycin
or any ingredient in the formulation.
Clindamycin should be prescribed with caution in atopic individuals
or patients with impaired hepatic or renal functions. Safety has
not been established when applied to areas affected concurrently
with other dermatoses or to severely inflamed skin.
The use of clindamycin may cause overgrowth of non-susceptible
organisms. Although rare, gram-negative folliculitis has been
reported following topical application of clindamycin. If superinfection
occurs, discontinue treatment.
Use of topical clindamycin has been associated with the development
of strains of P.acnes resistant to clindamycin in some
patients. If there is evidence of the development of clinical
resistance during treatment, consideration should be given to
discontinuation of treatment with topical clindamycin (ClindaTech
Solution).
ClindaTech Solution is not indicated in severe and deep nodulo-cystic
acne.
The drug should not be used for patients with a history of
ulcerative colitis, regional enteritis or antibiotic-associated
colitis.
Oral and parenteral clindamycin have been associated with severe
diarrhoea and
DOSAGE
ClindaTech Solution is for external use only and is applied
directly on the skin.
Wash the entire face with mild, non-alkaline soap and warm
water prior to any application. Using the Dab-O-Matic applicator
provided, apply a thin film directly to the to each acne lesion
or to areas having potential of eruption.
The solution is usually applied to affected areas twice daily,
once every morning and once at bedtime. The frequency of treatment
will depend on the severity of acne condition as well as skin
tolerance, but should not be used more than twice daily.
Application to the entire face of an average adult is equivalent
to approximately 2ml of solution or clindamycin 20mg.
Generally, a decrease in the number of inflammatory lesions
should be noticed after two or six weeks, but more than eight
weeks of therapy may be required before any definite beneficial
effects are observed. Therapy is usually continued until a satisfactory
response is obtained. If condition does not seem to improve or
worsens, modification of treatment or alternative therapy should
be considered.
STORAGE
Store below 30°C.
PACK
50ml and 100ml
ALL
STATES
Schedule 4