Instructions for DALACIN (Clindamycin) acne gel
Pharmacological properties:
Pharmacodynamics
The active ingredient of the drug is clindamycin, a semi-synthetic synthesized from lincomycin by replacing the 7- (R) -hydroxyl group with 7- (S) -chlorine.
Depending on the sensitivity of the microorganism and the concentration of clindamycin, it can act bactericidal or bacteriostatic.
In vitro active against microorganisms.
Aerobic gram-positive cocci , including Staphylococcus aureus; epidermal staphylococcus (including strains producing and not producing penicillinase). During in vitro studies, the rapid development of drug resistance in some strains resistant to erythromycin was noted; streptococci (with the exception of fecal streptococcus), pneumococci;
anaerobic gram-negative bacteria including Bacteroides spp. (including groups B. fragilis, B. melaninogenicus ), Fusobacterium spp. ;
anaerobic gram-positive non-spore-forming bacteria, including Propionibacterium, Eubacterium, Actinomyces spp. ;
anaerobic and microaerophilic gram-positive cocci, including Peptococcus spp., Peptostreptococcus spp. , Microaerophylis streptococci ; Clostridium spp. Clostridia are more resistant to clindamycin than many other anaerobes. Most clostridia, especially Clostridium perfringens, are sensitive to clindamycin , but some species (eg C. sporogenes and C. tertium ) are often resistant to clindamycin . In this regard, it is necessary to test for sensitivity.
In vitro studies have shown that strains of microorganisms such as Bacteroides melaninogenicus, B. disiens, B. bivius, Peptostreptococcus spp., Gardnerella vaginalis, Mobiluncus mulieris, M. curtisii, Mycoplasma hominis are susceptible to clindamycin .
DALACIN Pharmacokinetics:
After oral administration in a dose of 150 mg of clindamycin hydrochloride, there is a rapid and almost complete (90%) absorption of clindamycin . The maximum level of the drug in the blood serum (2.5 μg / ml) is reached after 45 minutes, after 3 hours the concentration of the drug is 1.51 μg / ml and after 6 hours - 0.7 μg / ml. After oral administration, almost complete (90%) absorption of clindamycin occurs ; simultaneous food intake does not affect the concentration of clindamycin in the blood serum. The study of serum concentrations of the drug with prolonged use of clindamycin hydrochloride (within 14 days) did not reveal the accumulation of the drug or changes in its metabolism.
The half-life of clindamycin is slightly increased in patients with significantly impaired renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the blood. The concentration of clindamycin in the blood serum increases linearly in accordance with the increase in dose. The serum concentration of the drug already 6 hours after administration in the usual dose exceeds the minimum inhibitory concentration relative to most of the above microorganisms.
Clindamycin is widely distributed in tissues and body fluids (including bone tissue). The average biological half-life is 2.4 hours. About 10% of the active drug is excreted in the urine, 3.6% in the feces, the rest of the drug in the form of inactive metabolites. The intake of clindamycin at a dose of 2.0 g for 14 days was well tolerated by healthy volunteers, although an increase in the frequency of side effects from the digestive tract was noted with increasing doses. Significant concentrations of clindamycin are not reached in the CSF, even against the background of an inflammatory process . With oral clindamycinhydrochloride in elderly patients, an increase in the half-life was noted on average up to 4 hours (range 3.4-5.1 hours) compared with the indicator in the group of younger patients - 3.2 hours (range 2.1-4.2 hours ). However, the degree of absorption in different age groups did not differ significantly, so there is no need to adjust the dose of the drug in elderly patients with normal (corresponding to age-related changes) liver and kidney function.
DALACIN Indications:
Dalacin C and Dalacin C Phosphate is an effective agent in the treatment of infections caused by pathogens sensitive to it: • infections of the ENT organs, including pharyngitis, sinusitis, otitis media, scarlet fever;
infections of the lower respiratory tract, including bronchitis, pneumonia, lung abscess, pleural empyema;
infections of the skin and soft tissues, including acne, furunculosis, phlegmon, impetigo, abscesses, infected wounds, specific infectious processes of the skin and soft tissues caused by pathogens sensitive to this drug, such as erysipelas and paronychia / panaritium;
infections of bones and joints, including osteomyelitis and purulent arthritis;
gynecological infections, including endometritis, phlegmon, colpitis, tubo-ovarian abscesses, salpingitis and pelvic inflammatory disease, if the drug is prescribed in combination with an appropriate active against gram-negative pathogens. In the case of infections of the cervix caused by Chlamydia trachomatis , monotherapy with clindamycin is an effective means of eradication of this microorganism;
intra-abdominal infections, including peritonitis and abscesses of the abdominal organs (in combination with acting on gram-negative aerobes);
septicemia and endocarditis. The effectiveness of clindamycin in certain cases of endocarditis has been proven: the drug has a bactericidal effect on the infectious agent in vitro when using such concentrations of the drug that are achieved in human serum;
infections of the oral cavity, including periodontal abscess and periodontitis;
toxoplasmotic encephalitis in AIDS patients (the effectiveness of clindamycin in combination with pyrimethamine in patients with intolerance to standard therapy has been proven );
Pneumocystis pneumonia in AIDS patients (in patients who cannot tolerate or are resistant to standard therapy, clindamycin can be used in combination with primaquine);
malaria, including cases caused by multidrug-resistant Plasmodium falciparum (as monotherapy or in combination with quinine or chloroquine);prevention of endocarditis in patients with hypersensitivity to penicillins;
prevention of wound infection during surgery in the head and neck area;
prevention of peritonitis and intra-abdominal abscesses after perforation and post-traumatic contamination with simultaneous use with aminoglycoside (gentamicin or tobramycin).
Application:
The dose and method of administration of the drug DALACIN depend on the severity of the disease, the patient's condition and the sensitivity of the pathogen to the The course of treatment lasts on average 7-10 days.
Adults
Dose of Dalacin C in capsule form for oral administration: 600–1800 mg per day, divided into 2, 3 or 4 equal doses. In order to prevent possible irritation of the esophagus, Dalacin C capsules should be taken with a full glass of water. Capsules should not be opened.
Children over the age of 6
The dose of Dalacin C is 8-25 mg / kg per day in 3-4 divided doses. To avoid irritation of the esophageal mucosa, capsules should be taken with a full glass of water.
Elderly patients
Correction of the dose of the drug in the elderly with normal liver and kidney function is not required.
Patients with renal impairment
No dose adjustment is required for patients with renal insufficiency.
Patients with hepatic impairment
No dose adjustment is required for patients with hepatic impairment.
Features of the use of Dalacin C for individual indications
Treatment of infections caused by β-hemolytic streptococcus. For infections caused by β-hemolytic streptococcus, treatment must be continued for at least 10 days.
Treatment of acute streptococcal tonsillitis a / f aryngitis. The dose of Dalacin C in capsules for oral administration is 300 mg 2 times a day for 10 days.
Treatment of inflammatory diseases of the pelvic organs.
After parenteral administration of the drug for 6 days, you should continue taking clindamycin hydrochloride orally at a dose of 450-600 mg every 6 hours until the end of the 10-14 day cycle of therapy.
Cervical infections caused by Chlamydia trachomatis 450-600 mg Dalacin C orally 4 times a day for 10-14 days.
Toxoplasmotic encephalitis in AIDS patients. Dalacin C orally at a dose of 600–1200 mg every 6 hours for 2 weeks, then 300–600 mg orally every 6 hours. Typically, the course of therapy is 8–10 weeks. The dose of pyrimethamine is 25–75 mg orally daily for 8–10 weeks. When using pyrimethamine in higher doses, folinic acid should be prescribed at a dose of 10–20 mg / day.
Pneumocystis pneumonia in AIDS patients. Dalacin C 300-450 mg orally every 6 hours for 21 days and primaquine at a dose of 15-30 mg orally once a day for 21 days.
Malaria treatment . Adults are prescribed at a dose of 10-20 mg / kg per day, children - 10 mg / kg per day in equal doses 2 times a day for 7 days as monotherapy or in combination with quinine (12 mg / kg 2 times a day) or chloroquine (15-25 mg once a day) for 3-5 days.
Prevention of endocarditis in patients with hypersensitivity to penicillin. Adults are prescribed 600 mg 1 hour before surgery or diagnostic and treatment procedures (for example, tonsillectomy, adenoidectomy, bronchoscopy with a rigid bronchoscope, dilatation of the esophageal stricture, retrograde cholangiopancreatography, cystoscopy, etc.); children - 20 mg / kg 1 hour before surgery or diagnostic and treatment procedure.
Contraindications:
Hypersensitivity to clindamycin , lincomycin or any component of the drug, myasthenia gravis, children under 6 years of age.
DALACIN Side effects:
Blood and lymphatic system: transient neutropenia / leukopenia, eosinophilia, agranulocytosis, thrombocytopenia (while a clear causal relationship with the use of Dalacin C has not been established);
immune system: anaphylactoid reactions;
nervous system: dysgeusia;
astrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, esophagitis, esophageal ulcer;
hepatobiliary disorders: jaundice, changes in liver function indicators (including hyperbilirubinemia);
skin, subcutaneous tissue and mucous membranes: maculopapular rash, urticaria, mild to moderate generalized rash, polymorphic erythema, Stevens-Johnson syndrome, pruritus, vaginitis, exfoliative and vesicular-bullous dermatitis, toxic epidermal necrolysis.
special instructions DALACIN:
Treatment with clindamycin , like other, can be complicated by the development of pseudomembranous colitis. Therefore, it is important to diagnose this pathology in a timely manner in patients with diarrhea while using antibacterial agents and to cancel the drug.
Antibacterial drugs inhibit the vital activity of the normal flora of the large intestine, which can cause the rapid multiplication of Clostridia. The results of the studies carried out indicate that the toxins produced by Clostridia, especially Clostridium difficile, are the most important and direct cause of the development of colitis. If pseudomembranous colitis develops, appropriate treatment should be prescribed. With a mild form of pseudomembranous colitis, discontinuation of clindamycin may be sufficient . With the development of a moderate and severe form, it is necessary to carry out appropriate therapy, which includes the use of fluids, solutions of electrolytes and protein preparations and the use of drugs that are effective against the pathogen - Clostridium difficile...
Clindamycin should not be used to treat meningitis because the drug does not penetrate well into the CSF.
With long-term treatment with antibacterial drugs, it is necessary to monitor the function of the liver and kidneys.
As a result of clindamycin therapy , microflora that is insensitive to this drug, especially yeast microflora, can be activated.
Cases of Clostridium difficile- associated diarrhea have been reported with almost all antibacterial agents, including clindamycin . Diarrhea can range in severity from moderate to severe fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, resulting in an increase in Clostridium difficile .
C. difficile produces exotoxins A and B, which cause Clostridium difficile- associated diarrhea. Toxin- producing strains of C. difficile cause increased morbidity and mortality, since these infections may be refractory to therapy; sometimes a colectomy may be necessary. In patients with developed diarrhea syndrome against the background of use, it is necessary to exclude the possibility of developing Clostridium difficile- associated diarrhea. It is necessary to carefully monitor and maintain the patient's medical records from the moment of reporting the occurrence of Clostridium difficile- associated diarrhea and up to 2 months after the use of antibacterial agents.
During pregnancy and breastfeeding. Clindamycin is able to cross the placenta. With long-term use, the level of clindamycin in the amniotic fluid is about 30% of the concentration level of the drug in the mother's blood. Dalacin C can be prescribed during pregnancy only in case of urgent need.
The penetration of clindamycin into breast milk at a concentration of 0.7–3.8 μg / ml has been reported . It is recommended to stop breastfeeding while using Dalacin C.
Impact on the ability to drive vehicles and work with potentially dangerous machinery. There are no data indicating the effect of Dalacin C on the ability to drive vehicles and work with mechanisms.
