Clindamycin - instructions for use, dose, side effects, contraindications

Capsule shell: Capsule body: dye azorubin E122 0.036945 mg, colorant diamond black E151 0.013815 mg, gelatin up to 45 mg, capsule cap: titanium dioxide E171 0.24 mg, dye quinoline yellow E104 0.02529 mg, dye Azorubin E122 0.1344 mg, Crimson dye [Ponso 4R] E124 0.02184 mg, the diamond black dye E151 0.00231 mg, gelatin up to 30 mg.

Description:

Capsules: gelatin capsule number 1, the body of the capsule is purple, the lid is red.

Contents of the capsule: powder from white to yellowish white.

Pharmacotherapeutic group:Antibiotic-Lincosamide

ATX: & nbsp

J.01.F.F.01 Clindamycin

Pharmacodynamics:

Clindamycin is a drug from the group of antibiotics-lincosamides, has a wide spectrum of action, bacteriostatic, binds to the 50S subunit of the ribosome and inhibits protein synthesis in microorganisms. Active with respect to Staphylococcus spp. (incl. Staphylococcus epidermidis, producing penicillinase), Streptococcus spp. (excluding Enterococcus spp.), Streptococcuspneumoniae, anaerobic and microaerophilic Gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Corynebacterium diphtheriae, Clostridium perfringens, Clostridium tetani, Mycoplasma spp., Bacteroides spp. (including Bacteroides fragilis and Bacteroides melaninogenicus), anaerobic Gram-positive, non-spore, bacilli (including Propionibacterium spp., Eubacterium spp., Actinomyces spp.).

Most strains Clostridium perfringens sensitive to clindamycin, but other species of clostridia (Clostridium sporogenes, Clostridium tertium) are resistant to the action of the drug, therefore, for infections caused by Clostridium spp., the definition of antibioticogram is recommended.

According to the mechanism of action and the antimicrobial spectrum, it is close to lincomycin (for certain microorganisms, especially for bacteroides and non-spore forming anaerobes, is 2-10 times more active).

Pharmacokinetics:

Quickly and completely absorbed in the gastrointestinal tract, simultaneous ingestion slows down absorption, without changing the concentration of the drug in the plasma. Easily penetrates into biological fluids and tissues (tonsils, muscle and bone tissue, bronchi, lungs, pleura, bile ducts, appendix, fallopian tubes, prostate, synovial fluid, saliva, sputum, wound surfaces); through the blood-brain barrier passes badly (with inflammation of the meninges, the permeability of the blood-brain barrier is increased). The maximum concentration in the blood is achieved by oral intake through 0.75-1 hour, after intramuscular injection (in / m) - after 1 hour in children and 3 hours in adults, with intravenous administration (in / in) - at the end of infusion.

The therapeutic concentration circulates in the blood for 8-12 hours, the half-life is about 2.4 hours; is metabolized predominantly in the liver (70-80%) with the formation of active (N-dimethyl-clindamicin andclindamycin sulfoxide) and inactive metabolites; is excreted for 4 days by kidneys (10%) and through the intestine (3.6%) as an active drug, the rest - in the form of inactive metabolites.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to clindamycin:

- infections of the upper respiratory tract and infection of the ENT organs (pharyngitis, tonsillitis, sinusitis, otitis), lower respiratory tract (pneumonia, including aspiration, lung abscess, pleural empyema, bronchitis), scarlet fever, diphtheria;

- infection of the urogenital tract (chlamydia, endometritis, vaginal infections, tubo-ovarian inflammation);

- infections of the skin and soft tissues (infected wounds, abscesses, furuncles, panaritium), abdominal cavity (peritonitis, abscess),

- oral infection;

- Acute and chronic osteomyelitis;

- septicemia (primarily anaerobic);

bacterial endocarditis.

Prevention of peritonitis and intra-abdominal abscess after perforation of the intestine or as a result of traumatic infection (in combination with aminoglycosides).

Contraindications:

- Hypersensitivity;

- Myasthenia gravis;

- bronchial asthma;

- Ulcerative colitis (in the anamnesis);

- diarrhea;

- pregnancy, lactation period;

- rare hereditary diseases, such as: galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for capsules);

- Children under 8 years old for capsules (the average weight of the child is less than 25 kg).

Carefully:

Clindamycin is used with caution in patients with severe hepatic and / or renal insufficiency, in elderly patients.

Dosing and Administration:

Inside, adults and children over 15 years of age (the average weight of a child is 50 kg and above) with diseases medium gravity appoint 1 capsule (150 mg) 4 times a day (every 6 hours).

In severe infections adults and children over 15 years of age, a single dose can be increased to 2-3 capsules (300-450 mg).

For children from 8 years to 15 years the method of application of capsules is reflected in the table:

Age of child

The average severity of the disease

Severe disease

The maximum daily dose

From 8 to 12 years (average weight of a child from 25 to 40 kg)

1 capsule

4 times a day

Not more than 600 mg per day

(4 capsules)

From 12 to 15 years (average weight of a child from 40 to 50 kg)

1 capsule

3 times a day

2 capsules

3 times a day

Not more than 900 mg per day (6 capsules)

Side effects:

From the gastrointestinal tract: dyspepsia (abdominal pain, nausea, vomiting, diarrhea), esophagitis, jaundice, liver function abnormalities, hyperbilirubinemia, dysbacteriosis, pseudomembranous enterocolitis.

From the side of the musculoskeletal system: rarely - a violation of neuromuscular conduction.

On the part of the organs of hematopoiesis: leukopenia, neutropenia, agranulocytosis, thrombocytopenia.

Allergic reactions: rarely - maculopapular rash, hives, itching; in some cases, exfoliative and vesiculobullous dermatitis, eosinophilia, anaphylactoid reactions.

From the cardiovascular system: with rapid intravenous injection - lowering blood pressure, down to collapse; dizziness, weakness.

Other: development of superinfection.

Overdose:

Overdose may increase the side effects.

Treatment: symptomatic therapy, there is no specific antidote. Hemodialysis and peritoneal dialysis are ineffective.

Interaction:

Clindamycin increases (mutually) the effect of rifampicin, aminoglycosides streptomycin, gentamicin (especially in the treatment of osteomyelitis and the prevention of peritonitis after intestinal perforation).

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

Incompatible with ampicillin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.

It shows antagonism with erythromycin and chloramphenicol.

It is not recommended simultaneous use with solutions containing a complex of B vitamins, aminoglycosides, phenytoin.

Simultaneous administration with antidiarrheal drugs increases the risk of developing pseudomembranous colitis.

With simultaneous use with opioid (narcotic) analgesics, it is possible to intensify the respiratory depression caused by them (up to apnea).

Special instructions:

Pseudomembranous colitis can occur both with the use of clindamycin, and 2-3 weeks after discontinuation of treatment (3-15% of cases); is manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by discharge with mucous masses of blood and mucus).

If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein,the appointment of vancomycin inwards or metronidazole.

Do not use drugs that inhibit the intestinal motility.

The safety of the drug in children under 3 years is not established.

With prolonged therapy, children need periodic monitoring of the blood formula and the functional state of the liver.

When prescribing the drug in high doses, it is necessary to monitor the concentration of clindamycin in the plasma.

Patients with severe hepatic insufficiency need to monitor the function of the liver ("liver" enzymes).

Form release / dosage:

Capsules, 150 mg.

Packaging:For 8 capsules in a blister of PVC / Al.

2 blisters with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014781 / 02

Date of registration:04.06.2009 / 22.12.2015

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp28.01.2018

Illustrated instructions

Instructions

Clindamycin (Clindamycin)