Dalacin, gel 1%, 30g

Composition

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of 1 g of gel contains clindamycin (in the form of clindamycin phosphate) – 10 mg;

excipients:

allantoin;

methylparaben;

propylene glycol;

polyethylene glycol;

carbomer 934 P;

sodium hydroxide;

purified water

Pharmacological action

Dalacin is an antibiotic of the lincosamide group for topical use.

The mechanism of action is associated with the suppression of protein synthesis in the microbial cell due to interaction with the 50S subunit of ribosomes.

It has a bacteriostatic effect; in higher concentrations, it has a bactericidal effect against some microorganisms.

Indications

Vulgar blackheads.

Use during pregnancy and lactation

Adequate and controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted. The use of Dalacin in the first trimester of pregnancy is possible only if the intended benefit outweighs the potential risk to the fetus.

When using clindamycin preparations in the second and third trimesters of pregnancy in dosage forms for intravaginal use, there was no increase in the frequency of congenital fetal abnormalities. If Dalacin is used in the second and third trimesters of pregnancy (although official studies on the use of suppositories during pregnancy have not been conducted), then an adverse effect on the fetus is unlikely.

Currently, there are no data on the elimination of clindamycin in breast milk with intravaginal use of Dalacin. However, it has been established that when clindamycin is administered orally or parenterally, some of it is found in breast milk.

Therefore, when deciding whether to prescribe Dalacin during lactation (breastfeeding), it is necessary to compare the expected benefit for the mother and the possible risk for the child.

Contraindications

Hypersensitivity to clindamycin, lincomycin or any component of the drug Dalacin.

Side effects

The frequency of occurrence of the following side effects is less than 10%.

From the side of the reproductive system:  irritation of the vulvar and vaginal mucosa, vaginal pain, vaginal discharge, vaginal candidiasis, vulvovaginitis, trichomonas vaginitis, vaginal infections, menstrual disorders, uterine bleeding, abnormal labor, endometriosis.

From the urinary system: dysuria, urinary tract infections (including pyelonephritis), proteinuria.

From the digestive system:  generalized abdominal pain, localized abdominal pain, abdominal cramps, bloating, dyspepsia, nausea, vomiting, diarrhea, constipation, flatulence, bad breath, taste distortion.

From the central nervous system:  dizziness, headache.

Dermatological reactions:  rash, pruritus, maculopapular rash, erythema, candidiasis of the skin.

Allergic reactions:  urticaria.

From the endocrine system:  glucosuria, hyperthyroidism.

From the body as a whole:  fungal infections, fever, side pain, back pain, lower abdominal pain, generalized pain, bacterial infections, inflammatory edema, upper respiratory tract infections, nosebleeds, abnormal microbiological results.

Local reactions:  itching and pain at the injection site.

Interaction

An antagonistic interaction between clindamycin and erythromycin has been demonstrated in vitro.

Clindamycin has been shown to disrupt neuromuscular transmission with systemic use, so it is possible to enhance the effect of peripheral muscle relaxants. This fact should be taken into account when prescribing the latter with Dalacin.

No interactions have been observed in pharmacodynamic, pharmacokinetic, or clinical studies of these dosage forms.

How to take, course of use and dosage

A thin layer of gel is applied to the affected area of the skin, previously cleaned and dry 2 times a day.

Course of treatment:  to obtain satisfactory results, therapy should be continued for 6-8 weeks, and if necessary, it can be continued for up to 6 months.

Overdose

With intravaginal use, clindamycin may be absorbed in sufficient quantities to cause systemic reactions.

Accidental ingestion of the drug in the gastrointestinal tract can also cause systemic effects similar to those that occur after oral use of clindamycin in therapeutic doses. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.

Treatment:  if necessary, carry out symptomatic and supportive therapy.

Special instructions

With the systemic use of clindamycin, severe diarrhea and, in some cases, pseudomembranous colitis may develop.

In this regard, if severe or prolonged diarrhea occurs during Dalacin therapy, it is necessary to cancel the drug, conduct diagnostic procedures and, if necessary, prescribe appropriate treatment.

Form of production

Gel for external use

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Do not freeze it.

Shelf

life is 2 years.

Active ingredient

Clindamycin

Dosage form

gel for external use

Description

For adults, Children over 12 years of age

Indications

Acne