Medacin T Topical Solution is indicated in the treatment of acne vulgaris.

Apply a thin film of Medacin T Topical Solution twice daily to the affected area.
Shake well before use.

Products containing benzoyl peroxide should not be used concurrently with Medacin T
Topical Solution.
Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with
severe pseudomembranous colitis. Post-marketing studies, however, have indicated a very
low incidence of colitis with Clindamycin Topical Solution. The physician should,
nonetheless, be alert to the development of antibiotic associated diarrhoea or colitis.
If significant or prolonged diarrhoea occurs, the product should be discontinued
immediately.

Diarrhoea, colitis, and pseudomembranous colitis have been observed to begin up to several
weeks following cessation of oral and parenteral therapy with clindamycin.
Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic
associated colitis. Colitis is usually characterised by persistent, severe diarrhoea and
abdominal cramps. Endoscopic examination may reveal pseudomembranous colitis. Stool
culture for C. difficile and/or assay for C. difficile toxin may be helpful to diagnosis.
Vancomycin is effective in the treatment of antibiotic-associated colitis produced by C.
difficile. The usual dose is 125-500 mg orally every 6 hours for 7-10 days. Additional
supportive medical care may be necessary.
Mild cases of colitis may respond to discontinuance of clindamycin alone. Colestyramine
and colestipol resins have been shown to bind C. difficile toxin in vitro, and colestyramine
has been effective in the treatment of some mild cases of antibiotic-associated colitis.
Colestyramine resins have been shown to bind vancomycin; therefore, when both
colestyramine and vancomycin are used concurrently, their administration should be
separated by at least two hours.
Medacin T Topical Solution contains an alcohol base which can cause burning and irritation
of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin,
mucous membranes), bathe with copious amounts of cool tap water. The solution has an
unpleasant taste and caution should be exercised when applying medication around the
mouth.
Topical clindamycin should be prescribed with caution to atopic individuals.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance
the action of other neuromuscular blocking agents. Therefore, it should be used with caution
in patients receiving such agents.
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding have been reported in patients treated
with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol
and fluindione). Coagulation tests, therefore, should be frequently monitored in patients
treated with vitamin K antagonists.

Pregnancy:
There are no adequate and well-controlled studies in pregnant women during the first
trimester. A moderate amount of data from clinical trials in pregnant women (between 300-
1000 pregnancy outcomes) during the second and third trimesters indicates systemic
administration of clindamycin has not been associated with an increased frequency of
congenital abnormalities or feto/neonatal toxicity. Animal reproductive toxicity studies
revealed no evidence of impaired fertility or harm to the foetus due to clindamycin,except at
doses that caused maternal toxicity (see section 5.3). Animal reproduction studies are not
always predictive of human response.
Medacin T Topical Solution should be used during pregnancy only if clearly needed.
Breast-feeding
It is not known whether clindamycin is excreted in human milk following use of Medacin T
Topical Solution. However, orally and parenterally administered clindamycin has been
reported to appear in breast milk. As a general rule, breast-feeding should not be undertaken
while a patient is on a drug since many drugs are excreted in human milk.

The effect of clindamycin on the ability to drive or operate machinery has not been
systematically evaluated.

The table below lists the adverse reactions identified through clinical trial experience and
post-marketing surveillance by system organ class and frequency. The frequency grouping is
defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10);
Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000) and
Not known (frequency cannot be estimated from the available data). Within each frequency
grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions possibly or probably related to Clindamycin Phosphate Topical Solution
based on clinical trial experience and post-marketing surveillance:

Very Common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
≥1/1,000 to <1/100
Frequency Not
Known
Infections and
Infestations
Gram-negative
folliculitis,
Pseudomembranous
colitis
Eye Disorders Stinging of the eye
Gastrointestinal
Disorders
Gastrointestinal
disturbances
Abdominal pain
Skin and
Subcutaneous
Tissue Disorders
Skin dryness
Skin irritation
Urticaria
Skin oiliness Contact dermatitis

Reporting of suspected reactions:
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic
effects.
In the event of overdosage, general symptomatic and supportive measures are indicated as
required.

Pharmacotherapeutic group: Anti-infectives for treatment of acne,
ATC Code: DA10AF01.

Microbiology
Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to
the 50S ribosomal subunit and affects both ribosome assembly and the translation process.
Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this
compound to the antibacterially active clindamycin.
Clindamycin has been shown to have in vitro activity against isolates of the following
organisms:
Anaerobic gram positive nonsporeforming bacilli, including:
• Propionibacterium acnes.
EUCAST has established susceptibility interpretive criteria for gram-negative and grampositive
anaerobes (with the exception of C. difficile): susceptible, ≤4 mg/L; resistant, >4
mg/L.
In a U.S. surveillance study, clindamycin MICs were ≤4 mg/L for 97% of P. acnes isolates
tested.
In some bacterial species, cross resistance has been demonstrated in vitro among
lincosamides, macrolides, and streptogramins B.
Clinical efficacy and safety
P. acnes produces an extracellular lipase that hydrolyses sebum triglycerides to glycerol,
used by the organism as a growth substrate, and free fatty acids, which have proinflammatory
and comedogenic properties. A double-blind study had been conducted to
examine the effect of topical 1% clindamycin hydrochloride hydrate in a hydroalcoholic
vehicle as compared to the effect of the vehicle alone. Fourteen patients applied clindamycin
or vehicle alone twice daily for eight weeks. Free fatty acid surface lipid percentages,
quantitative bacterial counts, and clinical response were assessed every two weeks. A
significant reduction (88%) in the percentage of free fatty acids in the surface lipids was
seen in the clindamycin-treated group and not in the vehicle-treated group. Free fatty acids

on the skin surface have been decreased from approximately 14% to 2% following
application of clindamycin solution in a hydroalcoholic base to 9 patients (average age 22.3
years) with acne vulgaris. There was no significant change in the surface microflora. Despite
the short duration of treatment, objective clinical improvement was seen in three of nine
treated patients, while none was observed in the placebo-treated patients.

Following multiple topical applications of clindamycin phosphate at a concentration
equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very
low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the
dose is recovered in urine as clindamycin.
Clindamycin concentrations have been demonstrated in comedones from acne patients. The
mean (±SD) concentration of clindamycin in extracted comedones after application of
clindamycin topical solution for 4 weeks was 0.60 ± 0.11 mcg/mg.
Older people
Clinical studies for topical clindamycin did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger subjects.

Impairment of fertility;
Fertility studies in rats treated orally with up to 300 mg/kg/day (72-fold the human exposure
based on mg/m2 ) revealed no effects on fertility or mating ability.
Pregnancy:
In oral embryo foetal development studies in rats and subcutaneous embryo fetal
development studies in rats and rabbits, embryo-fetal toxicity was observed at doses that
produced maternal toxicity. In rats, maternal death occurred with an exposure ratio of
approximately 3000 relative to patient exposure. In rabbits, maternal toxicity, including
abortions, occurred at exposure ratio of approximately 400.
Embryo-fetal toxicity, including post-implantation loss and decreased viability, occurred in
rabbits at an exposure ratio of 1000.

Carcinogenesis
Long term studies in animals have not been performed with clindamycin to evaluate
carcinogenic potential.
Mutagenesis
Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests
were negative.

6.1.List of Exipients
Propylene Glycol
Ethanol 99.9% or Ethanol 96%
Sodium Hydroxide Pellets
Purified Water

None Known.

Do not store above 30° C.
Do not refrigerate
Keep out of the reach of children.
Do not use after the expiry date stated on the label.
Do not use if there is any physical change on the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

MEDACIN T Solution is clear colourless solution available in 30ml applicator bottle designed for
the direct application of the solution to the affected skin, packed in a carton box along with a
leaflet.

No special instructions.