Universal reference book for medicines
Product name: DALACIN ® (DALACIN ® )

Active substance: clindamycin

Type: Antibiotic for external use

Manufacturer: PHARMACIA & UPJOHN COMPANY (USA)
Composition, form of production and packaging
?
Gel for external use 1% in the form of a transparent, colorless, viscous mass.
1 g

clindamycin (in the form of phosphate) 10 mg

Auxiliary substances: allantoin - 2 mg, methylparaben - 3 mg, propylene glycol - 50 mg, polyethylene glycol - 100 mg, carbomer 934P - 7.5 mg, sodium hydroxide solution 40% - qs, purified water qs to 1 g.

30 g - tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antibiotic group lincosamides for topical use.

Clindamycin phosphate is not active in vitro, but after application on the skin it is rapidly hydrolyzed by phosphatases in the ducts of the sebaceous glands with the formation of clindamycin, which has antibacterial activity.
The sensitivity of all studied strains of Propionibacterium acnes to clindamycin in vitro (MPC 0.4 μg / ml) was shown.
After applying clindamycin to the skin, the amount of free fatty acids on the skin surface decreases from about 14% to 2%.

PHARMACOKINETICS

After external application of 1% clindamycin phosphate gel in blood serum and in urine, very low concentrations of clindamycin are detected.

The activity of clindamycin in comedones in patients with vulgar acne is shown.
The average concentration of antibiotic in the comedon content after application of a clindamycin solution in isopropyl alcohol and water (10 mg / ml) for 4 weeks averaged 597 mg / g comedon content (0-1490 mg / g).
Pharmacokinetics in specific patient groups

Clinical studies did not include a sufficient number of patients over the age of 65 to assess whether there were differences in pharmacokinetics in elderly patients compared to younger patients.

INDICATIONS

- Acne vulgaris.

DOSING MODE

Outwardly.
A thin layer of gel is applied to the affected area of ​​clean dry skin 2 times / day.
To obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, continue for up to 6 months.

If after the application of the drug for several months the effectiveness of therapy is reduced, you should take a break in treatment for 4 weeks.

SIDE EFFECT

Classification of the frequency of adverse reactions: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1 / 1000), very rarely (<1/10 000), the frequency is unknown (it is impossible to determine based on available data).

Infectious and parasitic diseases: frequency unknown - folliculitis.

From the side of the organ of vision: the frequency is unknown - the pain in the eyes.

From the side of the digestive system: often - a digestive disorder;
frequency unknown - abdominal pain, pseudomembranous colitis.
From the skin: very often - dry skin, skin irritation, urticaria;
often - seborrhea; frequency unknown - contact dermatitis.
If any of the side effects indicated in the manual are aggravated or any other side effects not indicated in the instructions are noted, the patient should immediately notify the physician about it.

CONTRAINDICATIONS

- an antibiotic-associated colitis in the anamnesis;

- age up to 12 years (data on safety and efficacy not available);

- Hypersensitivity to clindamycin or lincomycin in the anamnesis.

PREGNANCY AND LACTATION

In animal studies, clindamycin was not injected with or without any adverse effects on the fetus, with the exception of the use of the drug at doses toxic to the mother.The results of animal studies can not always be extrapolated to humans.
In clinical studies with systemic administration of the drug in women in the II and III trimesters of pregnancy, there were no increases in the frequency of congenital abnormalities of the fetus. Studies of the use of the drug in women in the first trimester of pregnancy have not been conducted. The drug should be prescribed during pregnancy only if the expected benefit for the mother exceeds the potential risk to the fetus.
It is not known whether clindamycin is excreted in breast milk after external application.
Clindamycin is found in breast milk after oral or parenteral administration, so during lactation, either stop the drug or stop breastfeeding, given the importance of the drug to the mother.
APPLICATION FOR CHILDREN

Contraindicated use of the drug in children under 12 years of age (safety and efficacy data are not available).

APPLICATION IN ELDERLY PATIENTS

Clinical studies did not include a sufficient number of patients over the age of 65 to assess whether there were differences in pharmacokinetics in elderly patients compared to younger patients.

SPECIAL INSTRUCTIONS

Avoid getting the drug on the mucous membrane of the eyes and mouth.

After applying the gel, wash hands thoroughly.
In case of accidental contact with sensitive surfaces (eyes, abrasions on the skin, mucous membranes), rinse this area with cool water.
The use of clindamycin (as well as other antibiotics) orally or parenterally in a number of cases is associated with the development of severe diarrhea and pseudomembranous colitis.
With external application of clindamycin, the occurrence of diarrhea and colitis is rare, nevertheless, caution should be exercised, and with the development of severe or prolonged diarrhea, the drug should be discontinued and, if necessary, carried out the appropriate diagnostic and therapeutic measures.Typically, the onset of diarrhea, colitis, and pseudomembranous colitis is observed within a few weeks after the oral and parenteral therapy with clindamycin is complete. In the case of severe diarrhea, the question of the advisability of conducting a colonoscopy should be decided. The use of drugs that reduce gastrointestinal motility, such as opioid analgesics and diphenoxylate with atropine, can prolong and / or worsen the course of this complication. It was found that vancomycin is effective against antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. The usual dose, divided into 3-4 injections for adults, is from 500 mg to 2 g of vancomycin / day inside for 7-10 days.
Influence on the ability to drive and drive machinery

There is no reason to believe that the use of Dalacin ® may affect the ability to drive and control machinery.

OVERDOSE

Symptoms: with topical application, clindamycin can be absorbed in amounts that cause systemic effects;
Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.
Treatment: symptomatic and maintenance therapy.

DRUG INTERACTION

There is a cross-resistance of microorganisms to clindamycin and lincomycin.

The antagonism between clindamycin and erythromycin was noted.

It has been established that clindamycin disrupts neuromuscular transmission and, consequently, can enhance the action of other peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Do not freeze. Shelf life - 2 years. Do not use after the expiration date printed on the package.
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