Dalacin, gel 1% 30 g

Dalacin is an antibiotic of lincosamide group for topical use.

The mechanism of action is associated with inhibition of protein synthesis in the microbial cell through interaction with the 50S-subunit of ribosomes.

It has bacteriostatic action; in higher concentrations against some microorganisms it is bactericidal.

Indications

Acne vulgaris.

Pharmacological effect

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 ribosomal subunit.

Has a bacteriostatic effect; in higher concentrations against some microorganisms – bactericidal.

Special instructions

With 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 discontinue the drug, carry out diagnostic procedures and, if necessary, prescribe appropriate treatment.

Active ingredient

Clindamycin

Composition

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

excipients:

allantoin;

methylparaben;

propylene glycol;

polyethylene glycol;

carbomer 934P;

sodium hydroxide;

purified water

Pregnancy

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 expected benefit outweighs the potential risk to the fetus.

When using clindamycin drugs in the second and third trimesters of pregnancy in dosage forms for intravaginal administration, there was no increase in the incidence of congenital anomalies of the fetus. If Dalatsin is used in the second and third trimesters of pregnancy (although no official studies have been conducted on the use of suppositories during pregnancy), then an adverse effect on the fetus seems unlikely.

Currently, there is no data on the excretion of clindamycin into breast milk during intravaginal use of Dalatsin. However, it has been found that when clindamycin is administered orally or parenterally, some of it is found in breast milk.

Therefore, when deciding on the possibility of prescribing Dalacin during lactation (breastfeeding), the expected benefit for the mother should be compared with the possible risk for the child.

Contraindications

Hypersensitivity to clindamycin, lincomycin or any component of Dalatsin.

Side Effects

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

From the reproductive system: irritation of the mucous membrane of the vulva and vagina, pain in the vagina, vaginal discharge, vaginal candidiasis, vulvovaginitis, trichomonas vaginitis, vaginal infections, menstrual irregularities, uterine bleeding, abnormal birth, 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, perversion of taste.

From the side of the central nervous system: dizziness, headache.

Dermatological reactions: rash, itching, maculopapular rash, erythema, skin candidiasis.

Allergic reactions: urticaria.

From the endocrine system: glucosuria, hyperthyroidism.

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

Local reactions: itching and pain at the injection site.

Interaction

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

It has been established that when used systemically, clindamycin disrupts neuromuscular transmission, so it is possible to enhance the effect of peripherally acting muscle relaxants. This fact should be taken into account if it is necessary to prescribe the latter with Dalatsin.

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

Overdose

When used intravaginally, absorption of clindamycin is possible in quantities sufficient to cause systemic reactions.

Accidental exposure of the drug to the gastrointestinal tract can also cause systemic effects similar to those that occur after oral administration 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.

Storage conditions

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

Shelf life

2 years.

Manufacturer

Pharmacy and Upjohn Company LLC, USA