Clindamycin - a drug with antibacterial action.
Release form and composition
Clindamycin is available in the following forms:
- Vaginal cream 2% - from white with a creamy or yellowish tinge to white, with a slight specific odor (20 g and 40 g each in aluminum tubes, 1 tube complete with an applicator);
- Gelatin capsules - with a red lid and a purple case, size No. 1, the contents of the capsules are yellowish-white to white powder (8 pieces in blisters, 2 blisters in cardboard packs; 6 pieces in blisters, 2, 5 and 10 blisters in carton packs);
- Solution for injection (intravenous and intramuscular injection) - transparent, slightly yellowish or colorless (2 ml in ampoules, 5 ampoules in blisters, 2 packs in cartons).
The composition of 100 g of vaginal cream includes:
- Active ingredient: clindamycin (in the form of phosphate) - 2 g;
- Auxiliary components: sodium benzoate, macrogol-1500 (polyethylene oxide-1500), castor oil, emulsifier No. 1, propylene glycol.
The structure of 1 capsule includes:
- Active ingredient: clindamycin (in the form of hydrochloride) - 0.15 g;
- Auxiliary components: corn starch, talc, lactose monohydrate, magnesium stearate;
- The composition of the capsule cap: diamond black dye (E151), titanium dioxide (E171), azorubine dye (E122), quinoline yellow dye (E104), crimson dye Ponzo 4R (E124), gelatin;
- The composition of the capsule body: Brilliant Black dye (E151), Azorubine dye (E122), gelatin.
The composition of 1 ml solution for injection includes:
- Active ingredient: clindamycin (in the form of phosphate) - 0.15 g;
- Auxiliary components: edetate disodium, benzyl alcohol, water for injection.
Indications for use
Clindamycin in the form of a vaginal cream is prescribed for the treatment of bacterial vaginosis.
Inside and in the form of injections, the drug is used in the treatment of diseases:
- Infections of the upper respiratory tract, upper respiratory tract (tonsillitis, pharyngitis, otitis media, sinusitis), lower respiratory tract (pneumonia, including aspiration, pleural empyema, lung abscess, bronchitis), diphtheria, scarlet fever;
- Inflammatory infectious diseases caused by microorganisms sensitive to the active substance;
- Infections of the mouth, soft tissues and skin (abscesses, infected wounds, felon, boils), abdominal cavity (abscess, peritonitis);
- Infections of the urogenital tract (endometritis, chlamydia, tubo-ovarian inflammation, vaginal infections);
- Osteomyelitis (acute and chronic);
- Bacterial endocarditis.
Clindamycin is also prescribed simultaneously with aminoglycosides for the prevention of intra-abdominal abscesses and peritonitis after perforation of the intestine or due to traumatic infection.
Hypersensitivity to components of Clindamycin.
Contraindications to the use of the drug in the form of capsules and solution for injection are also:
- Bronchial asthma;
- Myasthenia gravis;
- Ulcerative colitis (in history);
- Rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for capsules);
- Pregnancy and lactation.
Children Clindamycin prescribed:
- Solution for intravenous and intramuscular administration - from 3 years;
- Capsules - from 8 years old with a weight of at least 25 kg.
The drug should be used with caution in patients with severe hepatic and / or renal insufficiency and in elderly patients.
Dosing and Administration
In case of diseases of moderate severity, adults and children from 15 years old (with a weight of 50 kg), inside Clindamycin is prescribed 1 capsule (150 mg) 4 times a day at equal intervals. In severe infections, a single dose can be increased by 2-3 times.
Younger children are usually prescribed:
- 8-12 years old (weight - 25-40 kg): severe degree of the disease - 4 times a day, 1 capsule; maximum per day - 600 mg;
- 12-15 years (weight - 40-50 kg): the average severity of the disease - 3 times a day, 1 capsule; severe disease - 3 times a day, 2 capsules; maximum per day - 900 mg.
The adult recommended dose for intramuscular and intravenous administration is 300 mg 2 times a day. In the treatment of severe infections, 1.2-2.7 g per day is prescribed, divided into 3-4 injections. Intramuscular administration of a single dose of more than 600 mg is not recommended. The maximum single dose for intravenous administration - 1.2 g for 1 hour.
For children from 3 years old, Clindamycin is prescribed at a dose of 15-25 mg / kg per day, divided into 3-4 equal doses. In the treatment of severe infections, the daily dose can be increased to 25-40 mg / kg with the same frequency of use.
Patients with severe renal and / or liver failure, in cases of use of the drug with an interval of at least 8 hours, correction of the dosing regimen is not required.
For intravenous administration, Clindamycin should be diluted to a concentration not higher than 6 mg / ml. The solution is administered for 10-60 minutes intravenously.
It is not recommended to inject the drug intravenously.
Solutions can be used as a solvent: 0.9% sodium chloride and 5% dextrose. Dilution and duration of infusion recommended under the scheme (dose / volume of solvent / duration of infusion):
- 300 mg / 50 ml / 10 minutes;
- 600 mg / 100 ml / 20 minutes;
- 900 mg / 150 ml / 30 minutes;
- 1200 mg / 200 ml / 45 minutes.
Vaginal cream is used intravaginally. Single dose - one full cream applicator (5 g), preferably at bedtime. Duration of use - 3-7 days daily.
When used orally or as an injection, side effects may develop:
- Cardiovascular system: with rapid intravenous administration - a decrease in blood pressure, up to collapse; weakness, dizziness;
- Digestive system: dyspepsia (nausea, abdominal pain, diarrhea, vomiting), esophagitis, abnormal liver function, jaundice, dysbiosis, hyperbilirubinemia, pseudomembranous enterocolitis;
- Organs of blood formation: neutropenia, leukopenia, thrombocytopenia, agranulocytosis;
- Musculoskeletal system: rarely - a violation of neuromuscular conduction;
- Local reactions: in the place of intramuscular injection - pain, irritation, in the place of intravenous injection - thrombophlebitis;
- Allergic reactions: rarely - urticaria, pruritus, maculopapular rash; in some cases - vesiculobullous and exfoliative dermatitis, anaphylactoid reactions, eosinophilia;
- Other: development of superinfection.
When using Clindamycin as a vaginal cream, the following side effects may occur (with a frequency of less than 10%):
- Urinary system: abnormal births, Trichomonas vaginitis, vulvovaginitis, vaginal candidiasis, mucous membrane irritation of the vulva and vagina, menstrual disorders, vaginal infections, pain in the vagina, uterine bleeding, urinary tract infection, dysuria, vaginal discharge, glycosuria, endometriosis, proteinuria ;
- Central nervous system: dizziness;
- Skin: urticaria, maculopapular rash, pruritus, rash, itching at the injection site, erythema, candidiasis (skin);
- Respiratory system: nosebleeds;
- Endocrine system: hyperthyroidism;
- Digestive system: flatulence, dyspepsia, diarrhea, vomiting, constipation, nausea, gastrointestinal disorders;
- General: abdominal distension, fungal and bacterial infections, headache, generalized and localized abdominal pain, backache, bad breath, inflammatory edema, allergic reactions, deviation of microbiological results from the norm;
- Other: a perversion of taste.
Before the appointment of a vaginal cream, with the help of appropriate laboratory methods, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, Herpes simplex and Candida albicans, which often cause vulvovaginitis, should be excluded.
Intravaginal use of the drug can cause enhanced growth of insensitive microorganisms, especially yeast-like fungi.
Women who use Clindamycin should be warned that during treatment they should not have sexual intercourse, and other means for intravaginal administration (douching, tampons) are not recommended.
The composition of the vaginal cream includes components that can reduce the strength of products made of rubber or latex, therefore, condoms, vaginal contraceptive diaphragms and other latex products are not recommended for intravaginal use during treatment.
The safety of Clindamycin in children under 3 years of age has not been established. With long-term treatment, children need to periodically monitor the functional state of the liver and blood counts.
While taking Clindamycin and 2–3 weeks after stopping therapy, pseudomembranous colitis may develop, manifested by diarrhea, fever, leukocytosis, and abdominal pain (sometimes accompanied by discharge of mucus and blood in the stool). In mild cases, it is enough to cancel the treatment and use of ion exchange resins (Colestipol, Kolestiramine), in severe cases, it is shown to replace the loss of electrolytes, protein and fluid and the appointment of metronidazole or vancomycin inside.
During the use of Clindamycin, it is not recommended to use drugs that slow down intestinal motility.
At use of drug in high doses it is necessary to control concentration of Clindamycin in plasma.
Patients with severe liver failure should monitor liver function (liver enzymes).
In pharmacodynamic, clinical, or pharmacokinetic studies of Clindamycin in the form of a vaginal cream, no interactions were observed.
Data on the simultaneous use of the drug with other drugs are not available. The combined use of vaginal cream with other drugs for intravaginal administration is not recommended.
Clindamycin mutually enhances the effect of aminoglycosides: streptomycin, rifampicin, gentamicin (especially in the prevention of peritonitis after bowel perforation and the treatment of osteomyelitis).
The drug in the form of capsules and solution for injection:
- Incompatible with barbiturates, ampicillin, aminophylline, magnesium sulfate and calcium gluconate;
- Increases the risk of developing pseudomembranous colitis while prescribing with antidiarrheal drugs;
- Shows antagonism with chloramphenicol and erythromycin.
The simultaneous use of Clindamycin with aminoglycosides, solutions containing the complex of vitamins of group B, phenytoin is not recommended.
With simultaneous use with narcotic (opioid) analgesics, it is possible to increase the respiratory depression they cause (up to apnea).
Terms and conditions of storage
Store in a dark, dry, out of reach of children.
- Vaginal cream - 2 years at temperatures up to 20 ° C;
- Solution for injection - 2 years, capsules - 3 years at a temperature of 15-25 ° C.