Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion

1. Name Of The Medicinal Product

Dalacin T Topical Lotion

Clindamycin Phosphate Topical Lotion

2. Qualitative And Quantitative Composition

.

One ml of Dalacin T Topical Lotion contains the equivalent of 10mg clindamycin.

For excipients see Section 6.1 ('List of excipients').

3. Pharmaceutical Form

Topical Emulsion.

White to off-white aqueous emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

Dalacin T Topical is indicated for the treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Apply a thin film of Dalacin T Topical Lotion twice daily to the affected area.

4.3 Contraindications

Topical clindamycin is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clindamycin topical is contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.

4.4 Special Warnings And Precautions For Use

Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. However, post-marketing studies have indicated a very low incidence of colitis with Dalacin T Solution. The physician should, nonetheless, be alert to the development of antibiotic-associated diarrhoea or colitis. If diarrhoea occurs, the product should be discontinued immediately.

Diarrhea, 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 characterized 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 cholestyramine 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.

The lotion 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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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 agents15,16.

4.6 Pregnancy And Lactation

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the foetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

It is not known whether clindamycin is excreted in human milk following use of Dalacin T Topical Lotion. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. As a general rule, breastfeeding should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Skin dryness is the most common adverse reaction seen with the solution. In addition, the following adverse effects have been reported with the use of topical clindamycin.

Eye disorders: stinging of the eye

Gastrointestinal disorders: abdominal pain, gastrointestinal disturbances

Infections and infestations: gram-negative folliculitis

Skin and subcutaneous skin disorders: skin irritation, contact dermatitis, skin oiliness, urticaria

4.9 Overdose

Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects.

5. Pharmacological Properties

Anti-infectives for treatment of acne.                D10A F

5.1 Pharmacodynamic Properties

The active constituent, clindamycin, is a known antibiotic. When applied topically it is found in comedone samples at sufficient levels to be active against most strains of P. acnes.

5.2 Pharmacokinetic Properties

When applied topically in an alcoholic solution, clindamycin has been shown to be absorbed from the skin in small amounts. Very low levels, more than 1,000 times lower than those from normal systemic doses of clindamycin, have been found in the plasma. Using a sensitive RIA method, clindamycin has been detected in the urine at levels of < 1 to 53 ng/ml, 0.15-0.25% of the cumulative dose being recovered from the urine. No clindamycin has been detected in the serum following topical application.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol,

sodium lauroyl sarcosinate,

stearic acid,

tegin,

cetostearyl alcohol,

isostearyl alcohol,

methylparaben,

purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

LDPE bottles and polypropylene dispensing cap containing 60 ml of Dalacin T Topical lotion

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich Kent

CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00032/0156

9. Date Of First Authorisation/Renewal Of The Authorisation

18th September 1990/21^st May 2001/ 7^th August 2009

10. Date Of Revision Of The Text

February 2011

11. LEGAL CATEGORY

POM

Ref: DA6_0