1. Name Of The Medicinal Product
Dalacin Cream 2%.
2. Qualitative And Quantitative Composition
Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.
For Excipients, see section 6.1
3. Pharmaceutical Form
Cream
White, semi-solid.
4. Clinical Particulars
4.1 Therapeutic Indications
Antibiotic for the treatment of bacterial vaginosis.
4.2 Posology And Method Of Administration
One applicator full intravaginally at bedtime for 7 consecutive days.
In patients in whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.
Paediatric population:
Safety and efficacy in paediatric patients have not been established (see Section 4.4).
Elderly:
No clinical studies have been conducted in populations older than 60.
4.3 Contraindications
Dalacin Cream is contra-indicated in patients previously found to be hypersensitive to preparations containing clindamycin or any of the components of the cream base (see "Presentation"). Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Dalacin Cream should not be used in patients who have demonstrated lincomycin sensitivity. Dalacin Cream 2% is also contraindicated individuals with a history of inflammatory bowl disease or a history of antibiotic-associated colitis.
4.4 Special Warnings And Precautions For Use
As there are no data available on the use of Dalacin Cream in patients younger than 12 years of age, it should not be used in this population.
The use of clindamycin may result in the overgrowth of non-susceptible organisms, particularly yeasts.
Virtually all antibiotics have been associated with diarrhoea and in some cases pseudomembranous colitis. Therefore, even though only a minimal amount of drug is absorbed, if significant diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.
Dalacin Cream contains oil-based components. Some of these have been shown to weaken the rubber of condoms and diaphragms and make them less effective as a barrier method of contraception or as protection from sexually transmitted disease, including AIDS. Do not rely on condoms and diaphragms when using Dalacin Cream.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Cross resistance has been demonstrated between clindamycin and lincomycin, and erythromycin and clindamycin. Antagonism has been demonstrated between clindamycin and erythromycin in vitro.
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.
No information is available on concomitant use with other intravaginal products, which is not recommended.
4.6 Pregnancy And Lactation
Pregnancy
Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 20 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the foetus due to clindamycin. In one mouse strain, cleft palates were observed in treated foetuses; this response was not produced in other mouse strains or in other species, and is therefore considered to be a strain specific effect.
There are no adequate and well-controlled studies in pregnant women during their first trimester, and because animal reproduction studies are not always predictive of human response, this drug should be used during the first trimester of pregnancy only if clearly needed. In a clinical trial in pregnant women during the second trimester, Dalacin Cream was effective in treating bacterial vaginosis, and no drug-related medical events were reported in the neonates. However, as with any drug used during pregnancy, a careful risk-benefit assessment should take place beforehand.
Lactation
It is not known if clindamycin is excreted in breast milk following the use of vaginally administered clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Therefore, a full assessment of benefit-risk should be made when consideration is given to using vaginal clindamycin phosphate in a nursing mother.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Thefollowing treatment-related adverse events were reported by less than 10% of patients.
In clinical trials medical events judged to be related, probably related, or possibly related to vaginally administered clindamycin phosphate cream were reported for (24%) of patients as indicated below:
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(Events without percentages were reported by less than 1% of the patients.)
4.9 Overdose
Vaginally applied clindamycin phosphate vaginal cream 2% can be absorbed in sufficient amounts to produce systemic effects.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Clindamycin is an antimicrobial agent which has been shown to be effective in the treatment of infection caused by susceptible anaerobic bacteria or susceptible strains of Gram positive aerobic bacteria. It has been shown to have in-vitro activity against the following organisms which are associated with bacterial vaginosis.:
Gardnerella vaginalis;
Mobiluncus spp;
Bacteroides spp;
Mycoplasma hominis;
Peptostreptococcus spp.
5.2 Pharmacokinetic Properties
Following once a day dosing of 100 mg of vaginally administered clindamycin phosphate, at a concentration equivalent to 20 mg of clindamycin per gram of cream, peak serum clindamycin levels average 20 nanograms/ml (range 3-93 nanograms/ml in normal volunteers. Approximately 3% (range 0.1-7%) of the administered dose is absorbed systematically.
In women with bacterial vaginosis, the amount of clindamycin absorbed following vaginal administration of 100 mg of Dalacin Cream (20 mg/g) is 4% (range 0.8-8%), which is approximately the same as in normal women.
Characteristics in patients
No special characteristics. See section 4.4 "Special warnings and special precautions for use" for further information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sorbitan stearate
polysorbate 60
propylene glycol
stearic acid
cetostearyl alcohol
cetyl palmitate
liquid paraffin
benzyl alcohol
water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
2 years
6.4 Special Precautions For Storage
Do not store above 25°C. Do not freeze.
6.5 Nature And Contents Of Container
Laminate tube (consisting of LMDPE and aluminium foil) with polypropylene cap containing 7.8 g, 20 g or 40 g cream, packed in cardboard carton, together with a leaflet.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
None.
Administrative Data
7. Marketing Authorisation Holder
Pharmacia Limited
Ramsgate Road
Sandwich Kent
CT13 9NJ
United Kingdom
8. Marketing Authorisation Number(S)
PL 0032/0176
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 27 April 1993 / Renewal 21st May 2001/ 7th August 2009
10. Date Of Revision Of The Text
07/2011
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