2010/06/13

DALACIN C

CLINDAMYCINUM J01F F01
Pfizer Inc.

COMPOSITION AND FORM:

cps. 150 mg, № 16 46.85 grn.

Clindamycin 150 mg

Other ingredients: starch, lactose, talc, magnesium stearate.

Capsule: gelatin, sodium erythrosine, indigotindisulfonat sodium, titanium dioxide.

cps. 300 mg, № 16 60.45 grn.

Clindamycin 300 mg

Other ingredients: starch, lactose, talc, magnesium stearate.

Capsule: gelatin, sodium erythrosine, indigotindisulfonat sodium, titanium dioxide.

№ P.05.01/03065 from 20.03.2006 to 20.03.2010

Pharmacological properties: clindamycin - a semisynthetic antibiotic that is synthesized from lincomycin by replacing 7 - (R)-hydroxyl group of 7 - (S)-chloro.

Depending on the sensitivity of the microorganism and the concentration can act bactericidal or bacteriostatic.

In vitro active against these microorganisms:

- Aerobic Gram-positive cocci, including Staphylococcus aureus, Staphylococcus epidermidis (including strains producing and not producing penicillinase); in vitro saw a rapid development of resistance to the drug in some strains that are resistant to erythromycin; Streptococcus spp. (Except Streptococcus faecalis), Streptococcus pneumoniae;

- Anaerobic Gram-negative bacteria, including Bacteroides spp. (Including B. fragilis, B. melaninogenicus), Fusobacterium spp.;

- Anaerobic Gram-positive asporogenous bacteria, including Propionibacterium, Eubacterium, Actinomyces spp.;

- Anaerobic and microaerophilic Gram-positive cocci, including Peptococcus spp., Peptostreptococcus spp., Microaerophilic streptococci; Clostridium spp. Clostridium are more resistant to clindamycin than most other anaerobes. The majority of clostridia, particularly Clostridium perfringens, are susceptible to clindamycin, but some species (eg C. sporogenes and C. tertium) is often resistant to clindamycin. In connection with this test should be conducted on the sensitivity to antibiotics.

In in vitro studies found that the clindamycin susceptible strains of microorganisms such as Bacteroides melaninogenicus, B. disiens, B. bivius, Peptostreptococcus spp., Gardnerella vaginalis, Mobiluncus mulieris, M. curtisii, Mycoplasma hominis.

Once inside there is a rapid and almost complete (90%) absorption of clindamycin. Simultaneous food intake does not affect the concentration of clindamycin in serum krovi.U adults after oral administration of clindamycin at a dose of 150 mg maximum level of drug in serum (2.5 mg / ml) was achieved after 45 minutes, after 3 h drug concentration is 1.51 ug / ml, and after 6 h - 0,7 mg / ml. Cumulation of the drug in the body or changes its metabolism during prolonged (for 14 days) admission were noted.

The half-life of clindamycin is somewhat increased in patients with severely impaired renal function. Hemodialysis and peritoneal dialysis for removing clindamycin from the blood are not effective. The concentration of clindamycin in the serum increased linearly with the increase of the dose. Serum concentration of drug within 6 h after administration of the usual dose exceeds the minimum inhibitory concentration on most of the above mikroorganizmov.Klindamitsin broadly distributed in tissues and body fluids (including a bone). The average biological half-life of 2.4 h. Approximately 10% of the active drug is excreted in urine, 3,6% - with the feces, the remainder of the drug is released in the form of inactive metabolites. Acceptance of clindamycin at a dose of 2.0 g over 14 days was well tolerated; healthy volunteers, albeit at higher doses was observed an increase in the frequency of side effects from the digestive tract. In the CSF, even against the background of inflammatory process significant concentrations of clindamycin were not met. Ingestion of clindamycin hydrochloride in elderly patients showed an increase in the average half-life of up to 4 h (range 3,4-5,1 h), compared with a group of younger patients - 3.2 hours (range 2.1 - 4,2 h). However, the extent of absorption in different age groups did not differ significantly, so no need to adjust the dose of the drug in elderly patients with intact function of the liver and kidneys.

INDICATIONS: infectious-inflammatory diseases caused by microorganisms sensitive to clindamycin:

- Infection of lower respiratory tract, including bronchitis, pneumonia, lung abscess, empyema;

- Infections of skin and soft tissues, including acne, furunculosis, abscess, impetigo, abscesses, infected wounds, specific infectious processes of the skin and soft tissues (erysipelas, and paronychia / felon);

- Infections of bones and joints, including osteomyelitis and suppurative arthritis;

- Gynecological infections, including endometritis, abscess, coleitis, salpingoophoritis, pelviotsellyulit, pelvioperitonit;

- Infectious processes in the abdominal cavity, including peritonitis, abscesses of the abdominal cavity (in combination with antibiotics, acting on Gram-negative aerobes);

- Septicemia and endocarditis;

- Infection of oral cavity, including periodontal abscess and periodontitis;

- Toxoplasma encephalitis in AIDS patients (proof of efficacy of clindamycin in combination with pyrimethamine in patients with intolerance to standard therapy);

- Pneumocystis pneumonia in AIDS patients (patients who can not tolerate or are resistant to standard therapy, clindamycin may be used in combination with primaquine);

- Malaria, including cases caused by MDR Plasmodium falciparum (alone or in combination with quinine or chloroquine);

- Prevention of endocarditis in patients with hypersensitivity to penicillins.

APPLICATION: dose depends on the severity of the disease, the patient's condition and the sensitivity of a pathogen to the antibiotic.

Adults appoint a dose of 600-1800 mg / day, divided into 2, 3 or 4 equal doses. To avoid irritation of the mucous membrane of the esophagus capsules should be taken with a full glass of water.

The dose of clindamycin hydrochloride for children over 6 years of age is 8-25 mg / kg / day in 3-4 reception within 7-10 days.

Corrections of dose in the elderly, as well as in patients with hepatic or renal insufficiency is not required.

For infections caused by β-hemolytic streptococcus, treatment should continue for at least 10 days. In acute streptococcal tonsillitis / pharyngitis dose of clindamycin hydrochloride for oral administration of 300 mg 2 times a day for 10 days.

In the treatment of pelvic inflammatory disease after parenteral reference drug for 6 days should continue receiving clindamycin hydrochloride oral dose of 450-600 mg every 6 h until the completion of 10-14 day cycle of therapy.

With cervical infection caused by Chlamydia trachomatis, is prescribed in doses of 450-600 mg by mouth 4 times a day for 10-14 days.

In Toxoplasma encephalitis in AIDS patients clindamycin hydrochloride prescribe oral dose of 600-1200 mg every 6 h for 2 weeks, then 300-600 mg orally every 6 hours Usually therapy is 8-10 weeks. The dose of pyrimethamine 25-75 mg orally every day for 8-10 weeks. In the application of pyrimethamine in higher doses should be administered folinievuyu acid in a dose of 10-20 mg / day.

When pneumocystis pneumonia in AIDS patients clindamycin hydrochloride administered in a dose of 300-450 mg orally every 6 hours for 21 days and primaquine at a dose of 15-30 mg orally 1 time a day for 21 days.

When malaria in adults prescribed a dose of 10-20 mg / kg per day, the children - 10 mg / kg / day in equal doses every 12 hours for 7 days as monotherapy or in combination with quinine (12 mg / kg every 12 h) or hlorohininom (15-25 mg every 24 h) for 3-5 days.

In order to prevent endocarditis in patients with hypersensitivity to penicillin adults prescribe 600 mg 1 hour prior to surgical or medical diagnostic procedures (eg tonsillectomy, adenoidektomii, bronchoscopy, rigid bronchoscopy, dilatation of the stricture of the esophagus, retrograde cholangiopancreatography, cystoscopy, etc.) ; children - 20 mg / kg for 1 h before the procedure.

CONTRAINDICATIONS: Hypersensitivity to clindamycin, lincomycin, or other components of the drug, myasthenia gravis, the age of 6 years.

SIDE EFFECTS: transient neutropenia / leukopenia, eosinophilia, agranulocytosis, thrombocytopenia (a distinct causal connection with the use Dalatsina C is not installed); anaphylactoid reaction, dysgeusia, abdominal pain, nausea, vomiting, diarrhea, esophagitis, esophageal ulcers, jaundice, changes indicators of hepatic functional tests (including hyperbilirubinemia), maculopapular rash, urticaria, small or moderate generalized rash, erythema polymorphous syndrome, Stevens - Johnson, itching, vaginitis, exfoliative, and vesicle-bullous dermatitis, toxic epidermal necrolysis.

Cautions: The treatment of clindamycin, as well as other antibiotics, may be complicated by the development of pseudomembranous colitis. It is therefore important to diagnose this pathology in patients with diarrhea during treatment with antibacterial drugs and repeal the drug.

Clindamycin should not be appointed for the treatment of meningitis because the drug enters the CSF poorly.

If the treatment is done for a long time, in this case it is necessary to control the function of liver and kidneys. Because clindamycin therapy may occur activation microflora, insensitive to the drug, especially yeast flora.

Clindamycin crosses the placenta. Prolonged use of drug concentration in the amniotic fluid is 30% of its concentration in maternal blood. Dalatsin C can be used for treatment of pregnant women only when absolutely necessary. Reported the detection of clindamycin in human breast milk in concentrations of 0,7-3,8 mg / ml. Dalatsin C can be used for women who are breastfeeding, unless absolutely necessary.

INTERACTION: in vitro found that clindamycin and erythromycin are the antagonists in this connection is not recommended to co-administration of these drugs. Between clindamycin and lincomycin there is cross-resistance.

The drug is incompatible with ampicillin, barbiturates, aminophylline, calcium gluconate, magnesium sulfate. The simultaneous use of antidiarrheal drugs increases the risk of pseudomembranous colitis.

Dalatsin C has the ability to block neuromuscular transmission and may enhance the action of other neuromuscular blockers, and the drug should be used with caution in patients who are prescribed muscle relaxants.

OVERDOSE: Overdose of the drug has no specific clinical manifestations. No specific antidote. Hemodialysis or peritoneal dialysis are ineffective.

STORAGE: at room temperature (15-25 ° C).