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CLINDAMYCIN-M
Release form
Capsules
For children
From 6 years
For pregnant women
Not recommended
For nursing mothers
Contraindicated
For drivers
Not recommended
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: clindamycin; 1 capsule contains clindamycin hydrochloride in terms of clindamycin 0.15 g (150 mg); auxiliary substances: calcium stearate, lactose monohydrate, silicon dioxide colloidal anhydrous, sodium methylparaben (E 219), sodium propylparaben (E 217), gelatin, titanium dioxide (E 171), tartrazine (E 102), erythrosine (E 127), diamond blue, amaranth (E 123).
Medicinal form
Capsules. The main physical and chemical properties: hard gelatin capsules with a cap and body of pink color; the contents of the capsules are a white powder.
Pharmacotherapeutic group
Antibacterial agents for systemic use. Lincosamides. Clindamycin. ATX code J01F F01.
Pharmacological properties
Pharmacodynamics. Mechanism of action. The mechanism of action of clindamycin is based on inhibition of protein biosynthesis by binding to the 50S subunit of the bacterial ribosome, with the onset of a bacteriostatic effect in most cases. Pharmacokinetic/pharmacodynamic relationship. Effectiveness will depend significantly on the time during which the level of the substance exceeds the minimum inhibitory concentration (MIC) for the causative pathogen. Mechanism of development of resistance. The mechanisms listed below may underlie the development of resistance to clindamycin. Resistance in staphylococci and streptococci will mainly be the result of increased integration of methyl groups in 23S-rRNA (so-called constitutive MLSB-resistance), which significantly reduces the binding affinity of clindamycin to the ribosome. Most methicillin-resistant S. aureus (MRSA) strains have a constitutive MLSB phenotype and are therefore clindamycin-resistant. Therefore, infections caused by macrolide-resistant staphylococci should not be treated with clindamycin even when susceptibility has been demonstrated in vitro because of the risk of selection when treating mutant strains with constitutive MLSB resistance. Strains with constitutive MLSB resistance show complete cross-resistance between clindamycin and lincomycin, macrolides (eg, azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin), and streptogramin B. Pharmacokinetics. Absorption, distribution and binding to proteins. The difference between the used clindamycin derivatives is only in the time of absorption and cleavage of esters. After that, clindamycin is present in the body in the form of a free base (active form). Its ethers should be considered precursors of the medicinal product. Following oral administration, clindamycin hydrochloride and clindamycin 2-palmitate hydrochloride are rapidly and almost completely absorbed from the gastrointestinal tract. Simultaneous intake of food somewhat slows absorption. When administered on an empty stomach, maximum serum concentrations are reached in approximately 45–60 minutes, and when administered after a meal, approximately 2 hours later. Following oral administration of a single dose of 150 mg or 300 mg, concentrations range from 1.9 to 3.9 μg/ml and from 2.8 to 3.4 μg/ml, respectively (fasting administration). Binding of clindamycin to blood plasma proteins depends on its concentration and ranges from 60% to 94% within the therapeutic range. Clindamycin easily penetrates tissues, passes through the placental barrier and enters breast milk. Diffusion into the subarachnoid space is insufficient even with inflammation of the meninges. High concentrations are achieved in bone tissue. Biotransformation and elimination. The breakdown of clindamycin mainly occurs in the liver. Some metabolites are microbiologically active. Medicines that act as liver enzyme inducers reduce the average retention time of clindamycin in the body. Elimination of clindamycin occurs approximately 2/3 with feces and 1/3 with urine. The half-life of clindamycin from blood serum is about 3 hours in adults and about 2 hours in children. In case of impaired kidney function and moderate or severe liver failure, the half-life is prolonged. Clindamycin is not removed by dialysis.
Indication
Acute and chronic bacterial infections caused by pathogens sensitive to clindamycin, in particular: - infections of bones and joints; - ear, nose and throat infections; - infections of the teeth and jaws; - lower respiratory tract infections; - pelvic and abdominal infections; - infections of female genital organs; - skin and soft tissue infections; - scarlet fever With a severe clinical picture, treatment should first be carried out with drugs containing clindamycin and which are slowly injected into a blood vessel (through infusions).
Contraindication
Clindamycin-M should not be used in patients with sensitivity to clindamycin, lincomycin, or any other component of the drug. Clindamycin-M is not suitable for the treatment of meningitis because the concentration of the antibiotic achieved in the cerebrospinal fluid is too low. Usually, such a dosage form as capsules is not suitable for use by children under 6 years of age.
Interaction with other medicinal products and other forms of interaction
If possible, Clindamycin-M should not be combined with erythromycin, as an antagonistic effect on antibacterial activity in vitro was observed. Pathogenic microorganisms show cross-resistance to clindamycin and lincomycin. Since the drug Clindamycin-M has the property of blocking neuromuscular transmission, it can enhance the effect of muscle relaxants (for example, ether, tubocurarine, pancuronium halide). This can lead to unexpected life-threatening situations during operations. Thus, Clindamycin-M should be used with caution in patients receiving the above drugs. With simultaneous use of the drug Clindamycin-M, the reliability of the contraceptive effect of oral contraceptives is questionable. Therefore, during treatment with Clindamycin-M, other methods of contraception should be additionally used. Vitamin K antagonists Increased coagulation parameters (prothrombin time/international normalized ratio) and/or bleeding have been observed in patients receiving clindamycin in combination with vitamin K antagonists (eg, warfarin, acenocoumarol, and fluindione). Therefore, coagulation parameters should be monitored in such patients.
Features of use
Clindamycin-M should be used with caution in the following categories of patients: - with impaired liver function; - with disorders of neuromuscular transmission (myasthenia gravis, Parkinson's disease); - with a history of gastrointestinal diseases (for example, inflammation of the colon); - with atopy; - with allergies and asthma. Note: Clindamycin-M should not be used in patients with acute respiratory infections if they are caused by viruses. Clindamycin-M is not suitable for the treatment of meningitis because the concentrations of the antibiotic achieved in the cerebrospinal fluid are too low. Severe hypersensitivity reactions have been reported in patients treated with clindamycin, including serious skin reactions such as drug reaction with eosinophilia and systemic manifestations (DRESS syndrome), Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. . In the event of a hypersensitivity reaction or serious skin reactions, treatment with clindamycin should be discontinued and appropriate treatment should be prescribed (see the section "Contraindications" and "Adverse reactions"). With long-term treatment (for more than 10 days), indicators of clinical blood analysis and liver and kidney function should be checked regularly. Long-term and repeated use of the drug Clindamycin-M can lead to the development of superinfection or colonization of the skin and mucous membranes with resistant microorganisms or yeast fungi. Clostridium difficile diarrhea (CDAD) has been reported with almost all antibacterial drugs, including clindamycin, ranging in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs disrupts the normal flora of the colon, leading to overgrowth of C. difficile. C. difficile produces toxins A and B, which contributes to the development of CDAD and is the root cause of the development of "antibiotic-associated colitis." Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections may be refractory to antimicrobial therapy and require colectomy. CDAD should be considered in all patients with antibiotic-induced diarrhea. A careful history should be taken, as cases of CDAD have been reported up to two months after the use of antibacterial drugs. Progression to colitis is possible, including pseudomembranous colitis, the severity of which can vary from mild to fatal. Antibiotics, including clindamycin, should be discontinued and appropriate therapeutic measures initiated if antibiotic-associated diarrhea or antibiotic-associated colitis is diagnosed or suspected. Medicines that inhibit peristalsis are contraindicated in this situation. In cases of moderate-to-severe pseudomembranous colitis, consideration should be given to fluids and electrolytes, protein supplementation, and antibacterial agents clinically effective in the treatment of Clostridium difficile colitis. If the therapy is continued, functional tests of the liver and kidneys should be performed. Acute kidney injury, including acute renal failure, has been reported infrequently. Therefore, monitoring of renal function should be considered in patients receiving long-term therapy, who already have impaired renal function or are taking concomitant nephrotoxic drugs (see Section "Adverse reactions"). Clindamycin treatment is sometimes an alternative in case of penicillin allergy (hypersensitivity to penicillin). Cross-allergy between clindamycin and penicillin is unknown, and its development is also not expected due to the presence of structural differences between these substances. However, in some cases, anaphylactic reactions (hypersensitivity) to clindamycin have been reported in individuals who already had an allergy to penicillin. This should be taken into account when clindamycin is used to treat patients with penicillin allergy. If you have an intolerance to some sugars, consult your doctor before taking this medicine. Clindamycin-M contains 121 mg of lactose monohydrate per 1 capsule. When using the medicine according to the instructions, the patient receives up to 484 mg of lactose monohydrate. This corresponds to the total amount of lactose contained in 4 capsules of the drug Clindamycin-M. Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use Clindamycin-M. Excipients: tartrazine (E 102), amaranth (E 123), sodium methylparaben (E 219), sodium propylparaben (E 217), included in the capsule shell can cause allergic reactions (possibly delayed). Use during pregnancy or breastfeeding. Use during pregnancy. The results of a large study involving pregnant women who used clindamycin during the first trimester of pregnancy (approximately 650 newborns were exposed to clindamycin) did not demonstrate an increase in the incidence of malformations in newborns. However, available data on the safety of clindamycin use during pregnancy are insufficient. The results of experimental studies on animals do not suggest the presence of direct or indirect harmful effects on the course of pregnancy, development of the embryo/fetus, the course of labor or postnatal development. Clindamycin crosses the placenta. It is assumed that a therapeutic, effective concentration is achieved in the body of the fetus. When using the drug during pregnancy, the benefits and possible risks associated with the treatment should be carefully weighed. Use during breastfeeding. Clindamycin passes into breast milk. Therefore, in newborns, who are breastfeeding, the development of sensitization, diarrhea and colonization of mucous membranes by yeast fungi cannot be excluded. Because of the risk of severe adverse reactions in the breastfed newborn, clindamycin should not be used by women who are breast-feeding. Reproductive function. The results of animal studies did not show any signs of impaired reproductive function. There are no data on the effect of clindamycin on human reproductive function. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Clindamycin has a mild to moderate effect on the ability to drive vehicles or operate machinery. Some side effects (in particular, dizziness, drowsiness, see the section "Side effects") can affect the ability to concentrate attention and the speed of reaction; therefore, they may affect the ability to drive or operate machinery.
Methods of application
Clindamycin-M should be taken with a sufficient amount of liquid (at least 1 large glass of water) to avoid possible irritation of the esophagus. If an infection caused by β-haemolytic streptococcus is suspected or if there are signs of β-haemolytic streptococcus, treatment should be carried out for at least 10 days. Adults Depending on the location and severity of the infection, adults and children over 14 years of age should use 4–12 capsules per day (equivalent to 0.6–1.8 g of clindamycin). The daily dose is divided into 4 doses. To ensure higher doses, there are also medicines with a higher content of the active substance. Liver disease. The half-life of clindamycin is prolonged in patients with moderate to severe liver disease. Usually, if Clindamycin-M is used every 8 hours, it is not necessary to reduce the dose. However, patients with severe hepatic impairment should be monitored for clindamycin plasma levels. Depending on the results obtained, it may be necessary to reduce the dose or lengthen the intervals between doses. Kidney disease. With kidney disease, the half-life of clindamycin is prolonged; but in case of mild or moderate renal impairment, it is not necessary to reduce the dose. However, plasma clindamycin levels should be monitored in patients with severe renal insufficiency or anuria. Depending on the results of these measurements, it may be necessary to reduce the dose or, alternatively, to extend the intervals between doses to 8 or even 12 hours. Hemodialysis. Clindamycin is not removed by hemodialysis. Therefore, before or after hemodialysis, the use of an additional dose is not necessary. Children. This medicinal form should be used by children aged 6 and over. Depending on the location and severity of the infection, children under 14 years of age should be given 8–25 mg of clindamycin per kilogram of body weight per day, see table Body weight Number of capsules per day (150 mg capsules) Clindamycin, mg 20 kg 3 capsules 450 mg 30 kg 4–5 capsules 600–750 mg 40 kg 4–6 capsules 600–900 mg 50 kg 4–8 capsules 600–1200 mg The daily dose is divided into 3–4 separate doses. As a rule, preference is given to use in the form of 4 doses.
Overdose
So far, no symptoms of overdose have been observed. If necessary, gastric lavage is indicated. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from serum. The specific antidote is unknown.
Side effects
The side effects listed below have been identified during clinical trials and during post-marketing surveillance. In each category, adverse reactions are listed by frequency and clinical significance. By frequency, adverse reactions are divided into the following categories: very often (≥ 1/10), often (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data). Adverse reactions are listed in each category in order of decreasing severity. Infections and infestations. Common: pseudomembranous colitis*. Frequency unknown: colitis caused by Clostridium difficile*, vaginal infections. From the side of the blood system and the lymphatic system. Often: agranulocytosis*, neutropenia*, thrombocytopenia*, leukopenia*, eosinophilia. From the side of the immune system. Rarely: medicinal fever. Very rare: anaphylactic reaction*. Frequency unknown: anaphylactic shock*, anaphylactoid reaction*, hypersensitivity*. From the side of the nervous system. Infrequent: distortion of taste, blockade of neuromuscular transmission. The frequency is unknown: dizziness, drowsiness, headache. From the gastrointestinal tract. Very often: irritation of the esophagus, esophagitis*, stomatitis, soft stool masses, diarrhea, abdominal pain, vomiting, nausea. Frequency not known: esophageal ulcer*. Hepatobiliary disorders. Very rare: transient hepatitis with cholestatic jaundice. Frequency unknown: Jaundice*. From the side of the skin and subcutaneous tissue. Often: maculopapular exanthema, caroboid exanthema*, urticaria. Rare: toxic epidermal necrolysis, Stevens-Johnson syndrome*, Lyell's syndrome, Quincke's edema/angioedema*, exfoliative dermatitis*, bullous dermatitis*, erythema multiforme, pruritus, vaginitis. Very rarely: rash, blistering, hypersensitivity reactions. Frequency unknown: drug reaction with eosinophilia and systemic manifestations (DRESS syndrome)*, acute generalized exanthematous pustulosis*. From the musculoskeletal system and connective tissue. Very rare: polyarthritis. From the side of the kidneys and urinary tract. Renal dysfunction in the form of azotemia, oliguria and/or proteinuria. The frequency is unknown: acute kidney damage: (see the section "Particulars of use"). Results of laboratory studies. Often: abnormal biochemical parameters of liver function. * Adverse reactions detected during the use of the medicinal product after registration (see the section "Features of use"). Side effects of antibiotics (class effect). Pseudomembranous enterocolitis can often develop when using Clindamycin-M. Immediately after the determination (diagnosis) of pseudomembranous enterocolitis, the doctor should consider the possibility of stopping the use of Clindamycin-M and starting appropriate treatment (use of special antibiotics/chemotherapy agents with clinically proven effectiveness). Medicines, that inhibit peristalsis, are contraindicated. The use of clindamycin can lead to overgrowth of other intestinal microorganisms, including fungi. Sometimes allergic reactions occur even after the first use. Severe acute allergic reactions, such as anaphylactic shock, occur very rarely. In this case, the use of Clindamycin-M medicinal product should be stopped immediately and appropriate emergency measures should be taken (for example, use antihistamines, corticosteroids, sympathomimetics and, if necessary, artificial ventilation). Reporting of suspected adverse reactions. After registration of the medicinal product, it is very important to report suspected side effects. This makes it possible to monitor the ratio between benefits and risks associated with the use of this medicinal product. Physicians should report any suspected adverse reactions as required by law.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
10 capsules in a blister; 1 blister in a cardboard pack.
Leave category
By prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.
Incompatibility
Incompatibility. Due to the existence of antagonism between clindamycin and erythromycin, their simultaneous use is not recommended. Do not use together with ampicillin, diphenylhydantoin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.