Klindamiцin (When ATH D10AF01)

When ATH:
D10AF01

Characteristic.

Clindamycin - a semisynthetic antibiotic group of lincosamides, resulting from the substitution of lincomycin 7(R)-a hydroxyl group at 7(S)-chlorine.

In medical practicing as hydrochloride, palmitate hydrochloride and phosphate.

Clindamycin hydrochloride is soluble in water, pyridine, ethanol, dimethylformamide.

Clindamycin palmitate hydrochloride is soluble in water.

Clindamycin phosphate is soluble in water.

Pharmacological action.
Antibacterial.

Application.

For systemic use: bacterial infection, caused by susceptible microorganisms: infection of upper respiratory tract (incl. pharyngitis, tonsillitis, sinusitis, otitis media), Respiratory infections (bronchitis, pneumonia, incl. Aspiration, lung abscess, empyema, fibrosing alveolitis), bone and joint infections (osteomyelitis, septicheskiy arthritis), purulent infections of the skin and soft tissues (incl. acne, boils, flegmona, impetigo, panaris, infected wounds, abscesses, mug), septicemia (first of all, anaerobic), pelvic infections and intra-abdominal infections (incl. peritonitis, abscesses of the abdominal cavity provided simultaneous use drugs, active against gram-negative aerobic microorganisms), gynecological diseases (incl. endometritis, adnexitis, abscesses fallopian tubes and ovaries, salpingitis, pelvioperitonit), oral infections (incl. periodontal abscess), Toxoplasma encephalitis, tropical malaria (caused Plasmodium falciparum), resistant to chloroquine (in combination with quinine); Pneumonia (called Pneumocystis carinii), sepsis, bacterial endocarditis, scarlet fever, Diphtheria.

For intravaginal use: vaginosis, caused by organisms susceptible to clindamycin.

For outdoor use (gel): acne.

Contraindications.

Hypersensitivity (incl. to lincomycin), indications of a history of regional enteritis, yazvennыy colitis or antibiotic-assotsiirovannыy colitis.

Restrictions apply.

Myasthenia (possible violation of neuromuscular transmission), expressed human liver and / or kidney, infancy (to 1 Months), Gel - up to age 12 years (Safety and efficacy have not been determined).

Pregnancy and breast-feeding.

When pregnancy is possible, if the effect of therapy outweighs the potential risk to the fetus (adequate and well-controlled studies in pregnant women have not performed, Clindamycin crosses the placenta and can concentrate in the fetal liver, however, complications in humans has not been registered). As a result, studies have found, whether the treatment reduces the risk of bacterial vaginosis such adverse pregnancy outcomes, as the premature rupture of membranes, premature onset of labor or premature delivery is.

Caution should be exercised when used during breastfeeding (unknown, Is Clindamycin penetrates into breast milk after topical and vaginal use, but it is found in breast milk after oral or parenteral administration).

Side effects.

Systemic effects:

From the nervous system and sensory organs: rarely - a violation of neuromuscular conduction.

Cardio-vascular system and blood (hematopoiesis, hemostasis): transient neutropenia (leukopenia) and eosinophilia, agranulocytosis, thrombocytopenia; with the rapid on / in the introduction - heart failure (collapse, cardiac arrest), hypotension.

From the digestive tract: abdominal pain, psevdomembranoznыy colitis, esophagitis, nausea, vomiting, diarrhea, dysbiosis, jaundice, abnormal liver function, giperʙiliruʙinemija; at / in large doses - an unpleasant or metallic taste in the mouth.

Allergic reactions: generalized morbilliform rashes of mild to moderate severity, maculopapular rash, hives, itch; a rare - and эksfoliativnыy vesicle bulleznыy dermatitis, erythema multiforme, toxic epidermal necrolysis; in some cases - anaphylactoid reactions.

Other: rarely - azotemia, oliguria and / or proteinemiya, polyarthritis, development of superinfection; reactions at the injection is soreness, packing, abscess (when i / m administration), tromboflebit (at / in the introduction).

In intravaginal application,:

Cream

In clinical studies, approximately 4% patients discontinued treatment cream on the occurrence of adverse reactions.

With the genitourinary system: cervicitis / vaginitis (symptomatic, 16%; Candida albicans, 11%; Trichomonas vaginalis, 1%), irritation of the vulva (6%), vulvovaginitis, menstrual irregularities, colpodynia, vaginal discharge, uterine bleeding, dizurija, urinary tract infection, abnormal births, endometriosis, glycosuria, proteinuria.

From the nervous system and sensory organs: dizziness, headache, vertigo.

System General: fungal infections, bacterial infection, inflammatory edema, upper respiratory tract infection, generalized pain, backache.

From the digestive tract: heartburn, nausea, vomiting, diarrhea / constipation, dyspepsia, flatulence, bad breath, abdominal pain, lower abdominal pain, stomach cramps.

Other: deviation of the results of microbiological tests from the norm, candidiasis, dysgeusia, nose bleed, hyperthyroidism, rash, hives.

Vaginal Suppositories

With the genitourinary system: irritation of the vulva and vagina, colpodynia, vaginal candidiasis, vaginal infections, menstrual irregularities, vaginal discharge, dizurija, pyelonephritis.

System General: fungal infections, fever, generalized pain, headache, pain in the side.

From the digestive tract: diarrhea, nausea, vomiting, abdominal pain, stomach cramps.

For the skin: itching, rash, pain and itching at the injection site.

When applied topically (gel)

Dryness and irritation of the skin (the site of application), contact dermatitis, burning sensation in the eyes; folliculitis, caused by gram-negative flora; increased production of the sebaceous glands. If there is potential for systemic absorption of systemic side effects, incl. dysfunction of the gastrointestinal tract (abdominal pain, mild diarrhea); in rare cases - pseudomembranous colitis.

Cooperation.

Incompatible with solutions, containing a complex of B vitamins, aminoglikozidami, Ampicillin, phenytoin, ʙarʙituratami, aminofillinom, calcium gluconate and magnesium sulphate.

In vitro shows antagonism of clindamycin with erythromycin, and chloramphenicol; because this effect can be clinically significant, These drugs should not be taken simultaneously.

Since clindamycin violates neuromuscular transmission and may exacerbate the effects of muscle relaxants peripherally acting, while the application should use caution and lead the patient carefully monitored. While the use of opioid (Drug) analgesics may increase respiratory depression, until apnea. Simultaneous with the appointment antidiarrheal drugs, reducing the motility of the gastrointestinal tract, It increases the risk of pseudomembranous colitis.

Overdose.

Symptoms: increased severity of side effects.

Treatment: symptomatic and supportive. Not reported by hemodialysis and peritoneal dialysis.

Dosing and Administration.

The dosage regimen and duration of treatment are determined individually taking into account the indications, severity of infection, susceptibility. Inside, adults - 150-450 mg every 6-8 hours, children - 8-25 mg / kg / day for 3-4 hours.

/ M or / drip 300 mg 2 once a day, in severe infections - up to 1,2-4,8 g / day (2-4 Administration), Children - 10-40 mg / kg / day (3-4 Administration).

Outwardly, a thin layer of gel is applied to clean, dry skin of the affected area 2 once a day.

Intravaginal, 100 mg at night for 3-7 days.

Precautions.

With the development of the treatment of hypersensitivity reactions should be discontinued and clindamycin (if necessary) conduct appropriate therapy.

Antibacterial drugs inhibit the normal intestinal flora, which can contribute to enhanced proliferation of clostridia. Cases of pseudomembranous colitis of varying severity, up to life-threatening, We observed with virtually all antibacterials, including clindamycin.

Proved, toxins, produced Clostridium difficile, They are the main cause of colitis, associated with antibiotic therapy. Diarrhea, colitis, Symptoms of pseudomembranous colitis can appear in patients receiving clindamycin, and 2-3 weeks after cessation of treatment. Pseudomembranous colitis manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by the release of a stool blood and mucus). Therefore, in all cases of diarrhea after taking antibacterial drugs should consider this diagnosis. After the diagnosis of pseudomembranous colitis in mild cases enough to discontinuation of treatment and the use of ion exchange resins (cholestyramine, colestipol), in cases of moderate and severe cases shown in compensation of fluid loss, electrolytes and protein, appointment of antibacterial drugs, Efficacy against Clostridium difficile (naprimer vankomiцin Gospel metronidazol).

It should be remembered, that the use of local dosage forms may be a manifestation of systemic effects. When topical clindamycin in rare cases develop pseudomembranous colitis, in intravaginal application, but it is not marked.

Patients older 60 years of antibiotic-associated diarrhea and colitis (caused Clostridium difficile) They occur more often, and may be more severe (should carefully monitor the condition of patients and the frequency of stools, so as not developed diarrhea).

When clindamycin is possible overgrowth of non-susceptible organisms it, particularly yeasts. With the development of superinfection should take appropriate measures depending on the clinical situation.

When administered in high doses necessary to monitor the concentration of clindamycin in the plasma. If the treatment is carried out for a long period of time, you should regularly conduct studies of liver and kidney.

Before prescribing vaginal suppositories or vaginal creams with appropriate laboratory methods should be excluded Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, Virus Herpes simplex, often causing vulvovaginitis.

The combined use of vaginal suppositories and vaginal creams with other preparations for intravaginal administration is not recommended. During therapy, patients should not engage in sexual relationships. Do not use products for intravaginal administration (eg tampons). During treatment is not recommended to use condoms or vaginal contraceptive diaphragms, tk. components, included in the cream or suppository, may reduce the strength of latex and rubber products.

When applied topically as a gel to avoid getting gel on the mucous membrane of the eyes and mouth. After applying the gel on your skin, wash your hands. In case of accidental contact with sensitive surfaces (eyes, skin abrasion, mucosa) this should be rinsed with plenty of cool water.

Gel for external use is not recommended to be used simultaneously with the means, causing flaking and peeling of the skin (incl. resorcinol, salicylic acid, an alcohol), with soaps or disinfectants, containing abrasives - possible cumulative irritant or a drying effect and excessive skin irritation.

During treatment should use caution during the drivers of vehicles and people, skills relate to the high concentration of attention (dizziness).

Cooperation