Clindamycin

General characteristics. Structure:

Active agent: clindamycin (in the form of a hydrochloride) 150 mg

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

Structure of the case of the capsule: dye azoruby (E122), dye diamond black (E151), gelatin.
Structure of a lid of the capsule: titanium dioxide (E171), dye hinolinvy yellow (E104), dye azoruby (E122), dye crimson Ponso 4R (E124), dye diamond black (E151), gelatin.

Pharmacological properties:

Clindamycin - drug from group of antibiotics - linkozamid, possesses a broad spectrum of activity, бактериостатик, communicates with 50S in subunit of a ribosome and inhibits synthesis of protein in microorganisms. It is active concerning Staphylococcus spp. (including Staphylococcus epidermidis producing a penicillinase), Streptococcus spp. (excepting Enterococcus spp.), Streptococcus pneumoniae, anaerobic and mikroaerofilny gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani, Mycoplasma spp., Bacteroidesspp. (including Bacteroides fragilis and Bacteroides melaningenicus), anaerobic gramiolozhitelny, not forming a dispute, bacilli (including Propionibacterium spp., Eubacterium spp., Actinomyces spp.).
The majority of strains of Clostridium perfringens are sensitive to clindamycin, however other types of clostridiums (Clostridium sporogenes, Clostridium tertium) are steady against effect of drug therefore at the infections caused by Clostridium spp., definition of an antibiotikogramma is recommended.
On the mechanism of action and an antimicrobic range it is close to lincomycin (concerning some species of microorganisms, especially concerning bacteroids and asporous anaerobe bacterias, at 2-10 times is more active).

Pharmacokinetics. It is quickly and fully soaked up in a GIT, the concomitant use of food slows down absorption, without changing concentration of drug in plasma. Easily gets into biological liquids and fabrics (almonds, a muscular and bone tissue, bronchial tubes, lungs, a pleura, bilious channels, an appendix, fallopian pipes, a prostate, synovial fluid, saliva, a phlegm, wound surfaces); passes through GEB badly (at an inflammation of a meninx permeability of GEB increases). Cmax in blood is reached at oral administration in 0.75-1 h, after introduction in oil - in 1 h at children and 3 h is at adults, at in introduction - by the end of infusion.

In therapeutic concentration circulates in blood during 8-12 h, T1/2 makes about 2.4 h; it is metabolized preferential in a liver (70-80%) with education active (N-dimetilklindamitsin and клиндамицинсульфоксид) and inactive metabolites; the rest is removed during 4 days by kidneys (10%) and through intestines (3.6%) in the form of active drug, - in the form of inactive metabolites.

Indications to use:

— the infectious and inflammatory diseases caused by microorganisms, sensitive to clindamycin;
— upper respiratory tract infections and infections of ENT organs (pharyngitis, tonsillitis, sinusitis, otitis), lower respiratory tracts (pneumonia, including aspiration, lung abscess, pleura empyema, bronchitis), scarlet fever, diphtheria;
— infections of an urogenital path (clamidiosis, endometritis, vaginal infections, tubo-ovarian inflammation);
— infections of skin and soft tissues (contaminated wounds, abscesses, furuncles, felon), abdominal cavity (peritonitis, abscess), oral cavity;
— acute and chronic osteomyelitis;
— septicaemia (first of all anaerobic);
— bacterial endocarditis;
— prevention of peritonitis and intra belly abscesses after a perforation of intestines or as a result of traumatic infection (in a combination with aminoglycosides).

Route of administration and doses:

Inside, to adults and children 15 years are more senior (the average weight of the child of 50 kg and above) at moderately severe diseases appoint on 1 capsule (150 mg) of 4 times/days (each 6 h).
At heavy infections to adults and children the single dose can be more senior than 15 years is increased to 2-3 capsules (300-450 mg).
For children from 8 to 15 years the route of administration of capsules is reflected in the table.

Age of the child	Average disease severity	Heavy degree of a disease	Maximum daily dose
From 8 to 12 years (the average weight of the child is from 25 to 40 kg)		1 capsule 4	No more than 600 mg / (4 capsules)
From 12 to 15 years (the average weight of the child is from 40 to 50 kg)	1 capsule 3	2 capsules 3	No more than 900 mg / (6 capsules)

To children is more senior than 3 years - 15-25 mg/kg/days divided into 3-4 equal doses. At heavy infections it is possible to increase a daily dose to 25-40 mg/kg of body weight, divided into 3-4 identical introductions.

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 inside or metronidazole is shown.

It is impossible to apply the medicines braking an intestines peristaltics.

Safety of use of drug for children up to 3 years is not established. At long therapy periodic control of a blood count and functional condition of a liver is necessary for children.

At purpose of drug in high doses control of concentration of clindamycin in plasma is necessary.

Patients with a heavy liver failure need to control function of a liver (liver enzymes).

Side effects:

From the alimentary system: dyspepsia (abdominal pains, nausea, vomiting, diarrhea), esophagitis, jaundice, abnormal liver functions, hyperbilirubinemia, dysbacteriosis, pseudomembranous coloenteritis.
From a musculoskeletal system: seldom - disturbance of neuromuscular conductivity.
From bodies of a hemopoiesis: leukopenia, neutropenia, agranulocytosis, thrombocytopenia.
Allergic reactions: seldom - makulopapulezny rash, a small tortoiseshell, an itch; in some cases exfoliative and vezikulobullezny dermatitis, eosinophilia, anaphylactoid reactions.
From cardiovascular system: at bystry in introduction - decrease in the ABP, up to a collapse; dizziness, weakness.
Local reactions: irritation, morbidity (in the place in oil of an injection), thrombophlebitis (in the place in/in an injection).
Others: development of superinfection.

Interaction with other medicines:

Clindamycin strengthens (mutually) effect of rifampicin, aminoglycosides of streptomycin, gentamycin (especially at treatment of osteomyelitis and prevention of peritonitis after perforation of intestines).

Strengthens action of competitive muscle relaxants, and also strengthens the muscle relaxation caused by n-holinoblokatorami.

It is incompatible with ampicillin, barbiturates, Aminophyllinum, calcium a gluconate and magnesium sulfate.

Shows antagonism with erythromycin and chloramphenicol.

Simultaneous use with the solutions containing a complex of vitamins of group B, aminoglycosides, Phenytoinum is not recommended.

Co-administration with antidiarrheal drugs increases risk of development of pseudomembranous colitis.

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

Contraindications:

— myasthenia;
— bronchial asthma;
— ulcer colitis (in the anamnesis);
— rare hereditary diseases, such, as: intolerance of a galactose, deficit of lactase or glyukozo-galaktozny malabsorption (for capsules);
— pregnancy;
— lactation period;
— children's age up to 3 years - for solution for in/in and introductions in oil (due to the lack of data on safety of use of benzyl alcohol);
— children's age up to 8 years for capsules (the average weight of the child is less than 25 kg);
— hypersensitivity.
Clindamycin with care is applied at patients with a heavy liver and/or renal failure, at patients of advanced age.

Use of the drug CLINDAMYCIN at pregnancy and feeding by a breast
It is contraindicated.

Use at abnormal liver functions
Clindamycin with care is applied at patients with a heavy liver failure.

Use at renal failures
Clindamycin with care is applied at patients with a heavy renal failure.

Use for elderly patients
Clindamycin with care is applied at patients of advanced age.

Use for children
It is contraindicated:
— children's age up to 3 years - for solution for in/in and introductions in oil (due to the lack of data on safety of use of benzyl alcohol);
— children's age up to 8 years for capsules (the average weight of the child is less than 25 kg).

Overdose:

At overdose strengthening of side effects is possible.

Treatment: symptomatic therapy, is not present a specific antidote. The hemodialysis and peritoneal dialysis are inefficient.

Storage conditions:

To store capsules at a temperature from 15 °C to 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Капс. 150 mg: 16 pieces.