Dalacin C is intended for the treatment of acute and chronic bacterial infections caused by microorganisms sensitive to clindamycin, in particular:
In a severe clinical picture, first, treatment with preparations containing clindamycin should be carried out and slowly injected into the blood vessel (by injection).
Clindamycin belongs to the antibiotics of the lincosamide group. The mechanism of action of clindamycin is based on the inhibition of protein biosynthesis by binding to the 50S subunit and influencing both the collection of ribosomes and the translation process. Although clindamycin phosphate is inactive in vitro, rapid hydrolysis in vivo converts it to the antibacterially active clindamycin. At usual doses, clindamycin exhibits bacteriostatic activity.
Dalacin C should be taken with a sufficient amount of liquid (at least 1 large glass of water) to avoid possible irritation of the esophagus.
In case of suspicion of infection caused by β-hemolytic streptococcus, or in the case of signs of β-hemolytic streptococcus, treatment should be carried out for at least 10 days.
Depending on the location and severity of the infection, adults and children over 14 years of age should use 0.6-1.8 g of clindamycin per day. The daily dose is divided into 2, 3 or 4 separate doses.
Therefore, 2-6 capsules of the drug Dalacin C 300 mg (equivalent to 0.6-1.8 g of clindamycin) should be used per day.
For children under 14 years of age, there are medicines with a lower content of the active substance.
Children.
Dalacin C capsules are not suitable for use in children who cannot swallow them whole. Capsules allow you to accurately dose the drug in mg / kg, therefore, in some cases, it may be necessary to use the drug in a different, more convenient dosage form.
Application features
Application during pregnancy
The results of a large study involving pregnant women who received clindamycin during the first trimester of pregnancy (approximately 650 newborns received clindamycin exposure) did not demonstrate an increase in the incidence of malformations in newborns. However, the available data on the safety of clindamycin use during pregnancy are insufficient.
The results of experimental studies in animals do not suggest the presence of a direct or indirect harmful effect on the course of pregnancy, embryo / fetal development, the course of labor or postnatal development.
Clindamycin crosses the placenta. It is assumed that a therapeutic, effective concentration is achieved in the fetus. When using the preparation during pregnancy, the benefits and possible risks associated with treatment should be carefully weighed.
Application during breastfeeding
Clindamycin is excreted in breast milk. It has been reported that clindamycin is present in human breast milk at concentrations of <0.5 to 3.8 μg / ml with systemic use. Therefore, in breastfed newborns, it is impossible to exclude the appearance of such undesirable effects on the microflora of the gastrointestinal tract such as diarrhea or blood in the feces, sensitization, rashes and colonization of mucous membranes by yeast fungi. Clindamycin should not be used due to the risk of severe adverse reactions in breastfed or breastfeeding infants.
Reproductive function.
The results of animal studies showed no signs of reproductive dysfunction. There are no data on the effect of clindamycin on human reproductive function.
The ability to influence the reaction rate when driving or driving other mechanisms.
Clindamycin has a mild to moderate effect on the ability to drive vehicles or operate machinery. Some adverse reactions can affect the ability to concentrate and the speed of the reaction; therefore, they can affect the ability to drive vehicles or operate machinery.
Overdose
So far, no overdose symptoms have been observed. If necessary, gastric lavage is indicated. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from serum. The specific antidote is unknown.
Adverse Reactions
The adverse reactions below have been identified in clinical trials and post-market surveillance. In each category, adverse reactions are listed by frequency and by clinical significance.
In terms of frequency, adverse reactions are divided into the following categories: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from ≥ 1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from available data). Adverse reactions are listed in each category for decreasing severity.
Infections and infestations.
Often pseudomembranous colitis.
Frequency not known: Clostridium difficile colitis, vaginal infections.
On the part of the blood and lymphatic system.
Often agranulocytosis, neutropenia, thrombocytopenia, leukopenia, eosinophilia.
From the immune system.
Rarely preparation-induced fever.
Anaphylactic reactions are very rare.
Frequency unknown: anaphylactic shock, anaphylactoid reactions, hypersensitivity.
From the nervous system.
Infrequently a perversion of taste, blockade of neuromuscular transmission.
Frequency unknown: dizziness, drowsiness, headache.
From the gastrointestinal tract.
Very often, irritation of the esophagus, esophagitis, stomatitis, diarrhea, abdominal pain, nausea, vomiting.
Frequency unknown: esophageal ulcer.
Hepatobiliary system.
Very rarely, transient hepatitis with cholestatic jaundice.
Frequency not known: jaundice.
On the part of the skin and subcutaneous tissue.
Often maculopapular rash, measles-like rash, urticaria.
Rarely toxic epidermal necrolysis, Stevens-Johnson syndrome, Lyell's syndrome, Quincke's edema / angioedema, exfoliative dermatitis, bullous dermatitis, erythema multiforme, pruritus, vaginitis.
Very rare rashes and blistering, hypersensitivity reactions.
Frequency unknown: preparation reaction with eosinophilia and systemic manifestations (DRESS syndrome) acute generalized exanthematous pustulosis
On the part of the musculoskeletal system and connective tissue.
Very rarely, polyarthritis.
Interaction with other medicinal products and other types of interactions
Antagonism (induced resistance) was observed in vitro between clindamycin and erythromycin in a subgroup of macrolid-resistant bacterial isolates. Both preparations should not be used concurrently, given their potential clinical significance, unless appropriate sensitivity tests have been performed.
Pathogens show cross-resistance to clindamycin and lincomycin.
Due to the inherent properties of the preparation Dalacin C in blocking neuromuscular transmission, it can enhance the effect of muscle relaxants (for example, ether, tubocurarine, pancuronium halide). This can lead to unexpected life-threatening situations during operations. Thus, Dalacin C should be used with caution in patients receiving the above preparations.
With the simultaneous use of the preparation Dalacin C, the reliability of the contraceptive effect of oral contraceptives is doubtful. Therefore, during treatment with Dalacin C, other methods of contraception should be additionally used.
Vitamin K antagonists For patients taking clindamycin in combination with vitamin K antagonists (eg warfarin, acenocoumarol and fluindione), increased rates of coagulation studies (prothrombin time / international normalized ratio) and / or bleeding have been reported. Therefore, such patients should regularly monitor the results of coagulation studies.
Clindamycin is metabolized by CYP3A4 and, to a lesser extent, by CYP3A5 to form the main metabolite of clindamycin sulfoxide and a minor metabolite of N-desmethyl-clindamycin. Thus, inhibitors of CYP3A4 and CYP3A5 can reduce the clearance of clindamycin, and inducers of these isoenzymes can increase the clearance of clindamycin. When using potent inducers of CYP3A4, such as rifampicin, the loss of efficacy should be monitored.
In vitro studies show that clindamycin is not inhibited by CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Thus, clinically important interactions between clindamycin and preparations that are used concomitantly and are metabolized by these CYP enzymes are unlikely.
Storage conditions
Keep out of the reach of children at a temperature not exceeding 25 ° C.
The shelf life is 5 years.