Klindatsil

General characteristics. Structure:

Active ingredient: 150 mg or 300 mg of clindamycin (in the form of a hydrochloride) in 1 capsule.

Excipients: starch corn, magnesium stearate, talc, lactoses monohydrate.

Structure of the capsule (white color): gelatin, methylparahydroxybenzoate, пропилпарагидроксибензоат, titanium E 171 dioxide.

Structure of the capsule (yellow color): gelatin, methylparahydroxybenzoate, пропилпарагидроксибензоат, yellow quinolinic E 104, yellow sunset E 110, titanium E 171 dioxide.

Pharmacological properties:

Pharmacodynamics. Antibiotic of group of linkozamid. Possesses a broad spectrum of activity, бактериостатик, communicates with 50S in subunit of a ribosomalny membrane and suppresses synthesis of protein in a microbic cell. Concerning a number of gram-positive cocci perhaps bactericidal action.

It is active concerning Staphylococcus spp. (including Staphylococcus epidermidis producing a penicillinase), Streptococcus spp. (excepting Enterococcus spp), Streptococcus pneumoniae, Corynebacterium diphtheriae, sporo-and asporous anaerobe bacterias and mikroaerofilny gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Clostridium perfringens, Clostridium tetani, Mycoplasma spp., Bacteroides spp. (including Bacteroides fragilis and Prevotella melaninogenica), Fusobacterium spp., Propionibacterium spp., Eubacter spp., Actinomyces spp. The majority of strains of Clostridium perfringens are sensitive to clindamycin, however, as other types of clostridiums (Clostridium sporogenes, Clostridium tertium) are steady against effect of clindamycin, at the infections caused by Clostridium spp., definition of an antibiotikogramma is recommended.

Haemophilus influenzae, Helibacter pylori, Neisseria meningitidis, Neisseria gonorrhoeae, Ureaplasma urealyticum is clinically inefficient against Mycoplasma pneumoniae. Between clindamycin and lincomycin there is a cross stability. It is effective at therapy of an asymptomatic diphtheritic carriage (a week course of therapy, orally).

Pharmacokinetics. After intake it is quickly soaked up from digestive tract; does not lose activity under the influence of a gastric juice. It is quickly distributed in the majority of liquids and body tissues, except for cerebrospinal fluid; high concentration are reached in a bone tissue, bile and urine. Quickly passes through a placenta, gets into breast milk.

Very high linkng with proteins – 92-94%. It Biotransformirutsya in a liver, some metabolites have antibacterial activity. Elimination half-life: adults are 2,4-3 h, children are 2,5-3,4 h, premature newborns are 6,3-6,8 h. About 10% of the general dose are removed with urine and 3,6% with excrements in the form of active drug. The rest is removed in the form of inactive metabolites. By a hemodialysis it is not removed.

Indications to use:

Before appointment it is necessary to carry out an inspection of sensitivity of microflora.

The bacterial infections caused by sensitive microorganisms:

- infections of ENT organs (including tonsillitis, pharyngitis, sinusitis, average otitis);

- infections of a respiratory organs (bronchitis, pneumonia, abscess of lungs, pleura empyema, fibroziruyushchy alveolitis);

- infections of bones and joints (osteomyelitis, septic arthritis);

- purulent infections of skin and soft tissues (including acne, furuncles, phlegmon, impetigo, felon, contaminated wounds, abscesses, ugly face);

- sepsis (first of all anaerobic);

- infections of pelvic bodies and intra belly infections (including peritonitis, abscesses of abdominal organs on condition of simultaneous use of HP, active concerning gram-negative aerobic microbes);

- gynecologic diseases (endometritis, adnexitis, colpitis, abscesses of fallopian pipes and ovaries, salpingitis, pelviperitonitis);

- oral cavity infections (including periodontal abscess);

- toksoplazmenny encephalitis;

- the malaria (caused by Plasmodium falciparum), the pneumonia (caused by Pneumocystis carinii), sepsis;

- endocarditis,

- clamidiosis;

- scarlet fever;

- diphtheria.

Route of administration and doses:

Before use of medicine it is necessary to consult surely with the attending physician.

To adults and children 12 years are more senior appoint inside irrespective of meal.

Depending on severity of a disease accept from 600 to 1800 mg/day in 2, 3 or 4 receptions (equal doses). In order to avoid irritation of the mucous capsule of a gullet it is necessary to accept, washing down with a full glass of water.

Children are more senior than 6 years: 8-25 mg/kg/day divided into 3 or 4 equal doses.

Separate indications. The infections caused by a beta and hemolitic streptococcus: doses are stated above, it is necessary to continue treatment not less than 10 days.

Urogenital infections: After a course of parenteral administration to accept inside on 450-600 mg each 6 hours before end 10-14 day courses of a tarapiya.

The infections of a neck of uterus caused by Chlamidia trachomatis: on 450-600 mg in 4 times a day within 10-14 days.

Toksoplazmenny encephalitis at HIV-positive patients: inside in a dose of 600-1200 mg each 6 hours within 2 weeks, and Pyrimethaminum in a dose of 25-75 mg inside every day. Usually the course of therapy makes 8-10 weeks. At use of higher doses of Pyrimethaminum it is necessary to appoint folic acid in a dose of 10-20 mg/day.

Pneumocystic pneumonia at HIV-positive patients: on 300 – 450 mg inside each 6 hours within 21 days and Primachinum of 15 - 30 mg inside once a day within 21 days.

Acute streptococcal tonsillitis / pharyngitis: 300 mg in 2 times a day within 10 days.

Malaria: 10 – 20 mg/kg/day for adults and 10 mg/kg/day for children each 12 hours equal doses within 7 days in the form of monotherapy, or in combination with quinine (to 12 mg/kg there are each 12 hours) or chloroquine (to 15-25 mg there are each 24 hours) within 3 - 5 days.

Prevention of an endocarditis at patients with hypersensitivity to penicillin: 600 mg for adults and 20 mg/kg for children in 1 hour prior to penicillin reception.

Features of use:

Pseudomembranous colitis can develop both against the background of clindamycin reception, and in 2 - 3 weeks after the treatment termination (3-15% of cases); it is shown by diarrhea, a leukocytosis, fever, abdominal pains (sometimes followed by allocation with a fecal mass of blood and slime).

At emergence of these phenomena in mild cases there is enough cancellation of treatment and use of ion-exchange resins (Colestyraminum, колестипол), in hard cases compensation of loss of liquid, electrolytes and protein, purpose of Vancomycinum in a dose of 125 - 500 mg of 4 times/days, or bacitracin in a dose of 25 thousand is shown. Piece of 4 times/days within 7 - 10 days, or metronidazole on 500 mg of 3 times/days.

It is impossible to apply the HP braking an intestines peristaltics. Safety of use of drug for newborns is not established. At long therapy of children periodic control of a blood count and functional condition of a liver is necessary. At purpose of drug in high doses control of concentration of clindamycin in plasma is necessary. It is not necessary to appoint for treatment of meningitis.

Pregnancy and period of a lactation. Clindamycin gets through a placenta. After introduction of several doses of drug concentration in amniotic liquid made about 30% of concentration in mother's blood. Clindamycin should be applied at pregnant women only according to absolute indications i.e. when the potential advantage of therapy surpasses by drug potential risk. It was reported that Klindamitsin is found in maternal milk in concentration of 0,7 - 3,8 mkg/ml.

Side effects:

From a nervous system: seldom - disturbance of neuromuscular conductivity.

From the alimentary system: abdominal pain, nausea, diarrhea, vomiting, esophagitis, pseudomembranous coloenteritis, hepatotoxic, hyperbilirubinemia, jaundice, dysbacteriosis.

From bodies of a hemopoiesis: leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

From integuments: allergic reactions: seldom - makulopapulezny rash, a small tortoiseshell, an itch; in some cases - exfoliative and vezikulobullezny dermatitis, an eosinophilia.

Others: development of superinfection, anaphylactoid reactions.

Interaction with other medicines:

Shows antagonism with erythromycin and chloramphenicol. Strengthens action of competitive muscle relaxants.

At simultaneous use with opioid (narcotic) analgetics strengthening of the respiratory depression caused by them (is possible up to an apnoea).

Co-administration with the antidiarrheal medicines reducing motility of digestive tract increases risk of development of pseudomembranous colitis.

Aminoglycosides expand a range of antimicrobic action; strengthens (mutually) effect of rifampicin.

Contraindications:

- hypersensitivity;

- children's age (up to 6 years);

- gastrointestinal diseases, especially nonspecific ulcer colitis, regional enteritis or colitis connected with reception of antibiotics;

- heavy disturbance of functions of a liver;

- heavy disturbance of functions of kidneys.

With care

- myasthenia,

- bronchial asthma,

- ulcer colitis (in the anamnesis),

- heavy renal and/or liver failure,

- pregnancy, period of a lactation (breastfeeding).

Overdose:

Owing to a short elimination half-life (2,4 hours) there is no need for special measures.

Symptoms: allergic reactions.

Treatment: corticosteroids (hydrocortisone, Prednisolonum, dexamethasone), adrenaline and antihistaminic drugs.

Storage conditions:

In the place protected from light and moisture, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 2 years. Not to use medicine after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in a blister strip packaging; in packaging No. 10 × 2 or in packaging 10 × 3.