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Dalatsin 300 mg No. 16 caps.

Instructions for medical use of the drug DALACIN® DALACIN® C PHOSPHATE Trade name DALACIN® DALACIN® C PHOSPHATE International nonproprietary name Clindamycin Dosage form Capsules of 150 mg and 300 mg Solution for injection 300 mg/2ml, 600 mg/4ml Composition Dalacin® capsules of 150 mg and 300mg: One capsule contains the active substance - clindamycin (in the form of clindamycin hydrochloride) 150 mg and 300 mg, excipients: lactose, magnesium stearate, corn starch, talc, gelatin, titanium dioxide. Dalatsin® C phosphate solution for injection: 1 ml of solution contains the active substance - clindamycin (in the form of clindamycin phosphate) 150 mg, excipients: benzyl alcohol, disodium edetate, water for injection. Description White hard gelatin capsules labeled “Clin 150” and “Pfizer” (for a dosage of 150 mg) or “Clin 300” and “Pfizer” (for a dosage of 300 mg) The contents of the capsules are homogeneous white powder. Dalacin® C phosphate solution for injection: clear, colorless solution. Pharmacotherapeutic group Antibacterial drugs of systemic action. Lincosamides. ATC code J01FF01 Pharmacological properties Pharmacokinetics Absorption After oral administration, almost complete (90%) absorption of clindamycin occurs. In adults, after oral administration of clindamycin at a dose of 150 mg, the maximum level of the drug in the blood serum (2.5 mcg/ml) is reached after 45 minutes. 3 hours after oral administration, the concentration of the drug in the blood serum is 1.5 mcg/ml, and after 6 hours it is 0.7 mcg/ml. After intramuscular administration of 600 mg of clindamycin phosphate, the maximum concentration of the drug in the blood serum (9 μg/ml) is achieved 1-3 hours from the moment of administration. After intravenous infusion of 300 mg of the drug over 10 minutes or 600 mg of the drug over 20 minutes, the maximum concentration of the drug, which is 7 μg/ml and 10 μg/ml, respectively, is achieved at the end of the drug administration. Clindamycin phosphate is prescribed to adults every 8-12 hours, to children - every 6-8 hours, or as a continuous intravenous infusion, which provides clindamycin serum concentrations that exceed the minimum in vitro concentration of the drug necessary to suppress the most sensitive to clindamycin microorganisms. A constant level of the drug in the body is achieved after the third dose. The distribution of 40-90% of the administered drug is bound in the body to blood proteins. After oral administration, accumulation of the drug in the body is not observed. Clindamycin easily penetrates into most tissues and body fluids. The concentration of clindamycin in bone tissue reaches approximately 40% (20-75%) of the drug concentration in the blood serum. In breast milk, the concentration of the drug is 50-100% of the concentration in blood serum, in synovial fluid 50%, in fetal blood 40%, in pus 30%, in pleural fluid 50-90% of the concentration in blood serum. Clindamycin does not cross the blood-brain barrier, even in cases of meningitis. Metabolism The half-life of clindamycin is + 1.5-3.5 hours. In patients with severely impaired liver and/or kidney function, this period may be prolonged. If you have mild or severe kidney or liver disease, the treatment regimen does not need to be changed. Clindamycin is almost completely metabolized. Excretion In the active form, 10-20% of the drug is excreted from the body by the kidneys, 4% - with feces. The remaining amount is excreted as inactive metabolites, mainly in bile and feces. Pharmacodynamics The active substance of the drug is clindamycin, a semi-synthetic substance with antimicrobial activity, which is formed from lincomycin by replacing the 7-(R)-hydroxyl group with 7-(S)-chloro. Depending on the sensitivity of the microorganism and the concentration of the drug, clindamycin can act bactericidal or bacteriostatic. In vitro, clindamycin has an effect on the following isolated forms of microorganisms: 1) Aerobic gram-positive cocci, including: · Staphylococcus aureus · Staphylococcus epidermidis (strains that produce and do not produce penicillinase). During in vitro studies, rapid development of resistance to clindamycin was observed in some staphylococcal strains resistant to erythromycin. · Streptococci (except fecal streptococcus) · Pneumococci 2) Anaerobic gram-negative bacilli, including: · Bacteroides species (including the B.fragilis group and the B.meleninogenicus group) · Fusobacterium species 3) Anaerobic gram-positive bacilli that do not form spores, including: · Propionibacterium · Eubacterium · Actinomyces species 4) Anaerobic and microaerophilic gram-positive cocci, including: · Peptococcus species · Peptostreptococcus species · Microaerophilic streptococci · Clostridia: Clostridia are more resistant to clindamycin than most other anaerobes. Most Clostridium perfringens are sensitive to clindamycin, but other species, such as C. sporogenes and C. tertium, are often resistant to clindamycin. Therefore, it is necessary to conduct sensitivity tests. 5) Various organisms, including Chlamidia trachomatis, Toxoplasma gondii, Plasmodium falciparum and Pneumocystis carinii (in combination with primaquine), Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Mycoplasma hominis. The following organisms are commonly resistant to clindamycin: Aerobic gram-negative bacilli Streptococcus faecalis Nocardia species Neisseria meningitidis Methicillin-resistant Staphylococcus aureus strains and Haemophilus influenzae strains Cross-resistance exists between lincomycin and clindamycin. There is antagonism between clindamycin and erythromycin. Although clindamycin hydrochloride is active both in vitro and in vivo, clindamycin phosphate and clindamycin palmitate are inactive in vitro. However, both compounds are rapidly hydrolyzed to the active base in vivo. Indications for use Dalatsin® is effective in the treatment of the following infections if they are caused by susceptible anaerobic bacteria or strains of gram-positive aerobic bacteria such as streptococci, staphylococci and pneumococci, as well as clindamycin-sensitive species of Chlamidia trachomatis: - upper respiratory tract infections, including: tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever - infections of the lower respiratory tract, including: bronchitis, pneumonia, pleural empyema and lung abscess - infectious diseases of the skin and soft tissues, including: acne, boils , cellulite, 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 (felon) - infectious diseases of bones and joints, including: osteomyelitis and septic arthritis - gynecological infections, including endometritis, tubal and ovarian abscesses, salpingitis and pelvic inflammatory disease, when prescribed in combination with a suitable antibacterial drug active against gram-negative aerobic pathogens. In the case of cervical infections caused by Chlamidia trachomatis, drug therapy exclusively with Dalatsin® has been shown to be effective for complete cure - infectious diseases of the abdominal cavity, including: peritonitis and abdominal abscesses (in combination with other antibacterial drugs that act on gram-negative aerobic bacteria) - septicemia and endocarditis. The effectiveness of the drug Dalacin® has been proven in certain cases of endocarditis: the drug has a bactericidal effect on the infectious agent in vitro when using such concentrations of the drug that are achieved in human blood serum. - oral infections such as periodontal abscess and periodontitis - toxoplasma encephalitis in patients with AIDS. The effectiveness of the drug in combination with pyrimethamine has been proven in patients with intolerance to standard therapy - Pneumocystis pneumonia in patients with AIDS. In patients intolerant or resistant to standard therapy, Dalatsin® can be used in combination with primaquine - malaria, including that caused by multidrug-resistant Plasmodium falciparum, both as monotherapy and in combination with quinine or chloroquine - prevention of endocarditis in patients with hypersensitivity to penicillins - prevention of infections during operations in the head and neck area. Dalacin® C phosphate, diluted in saline solution, is used in surgery to irrigate the surgical wound - early administration of the drug Dalacin® C phosphate in combination with an antibacterial drug from the aminoglycoside group, for example gentamicin or tobramycin, successfully prevents the development of peritonitis or abdominal abscess after perforation intestines or as a result of traumatic infection In vitro studies have shown that the following strains of microorganisms are sensitive to clindamycin: B.melaninogenicus, B.disiens, B.bivius, Peptostreptococcus spp., G.vaginalis, M.mulieris, M.curtisii, Mycoplasma hominis To avoid complications, use strictly as prescribed by your doctor. Method of administration and dosage Adults and children over 12 years of age Dalatsin® C phosphate (intravenously or intramuscularly): For the treatment of infectious diseases of the abdominal cavity, inflammatory diseases of the pelvic organs in women, as well as for other complicated or severe infections, 2400-2700 mg of the drug is usually prescribed per dose. day, divided into 2, 3 or 4 equal doses. In milder forms of infection and in the presence of a pathogen more sensitive to therapy, the therapeutic effect is achieved by prescribing smaller doses of the drug - 1200-1800 mg/day, divided into 3 or 4 equal doses. Doses of the drug reaching 4800 mg/day have been used with success. It is not recommended to administer intramuscularly a single dose exceeding 600 mg. Dalatsin® capsules (orally): 600-1800 mg/day in 2, 3 or 4 divided doses (equal doses). To avoid irritation of the esophageal mucosa, capsules should be taken with a full glass of water. Children over 1 month Dalatsin® C phosphate (intravenous or intramuscular): 20-40 mg/kg body weight/day, divided into 3 or 4 equal doses. It is administered as an infusion, the solvent is saline solution. Newborns (under 1 month) Dalacin® C phosphate (intravenous or intramuscular): 15-20 mg/kg body weight/day, divided into 3 or 4 equal doses. It is administered as an infusion, the solvent is saline solution. For premature babies, a lower dose of the drug may be sufficient. Selected indications Infections caused by beta-hemolytic streptococcus: doses are indicated above, treatment should be continued for at least 10 days. Pelvic inflammatory diseases: 900 mg of Dalacin® C phosphate IV every 8 hours + IV a suitable antibacterial agent active against gram-negative aerobic pathogens (for example, gentamicin at a dose of 2.0 mg/kg followed by 1.5 mg /kg every 8 hours for patients with normal renal function). Continue IV medications for at least 4 days and then for at least 48 hours after the patient's condition improves. Then take 450-600 mg of Dalacin® orally every 6 hours until the 10-14 day course of therapy is completed. Cervical infections caused by Chlamidia trachomatis: 450-600 mg of Dalatsin® orally 4 times a day for 10-14 days. Toxoplasma encephalitis in patients with AIDS: in patients with intolerance to standard therapy, Dalacin® C phosphate or Dalacin® is used in combination with pyrimethamine according to the following regimen: Dalacin® C phosphate IV or Dalacin® orally at a dose of 600-1200 mg every 6 hours for 2 weeks, and pyrimethamine at a dose of 25-75 mg orally every day. Typically the course of therapy is 8-10 weeks. When using higher doses of pyrimethamine, folinic acid should be prescribed at a dose of 10-20 mg/day. Pneumocystis pneumonia in patients with AIDS: Dalacin® C phosphate IV 600-900 mg every 6 hours or 900 mg IV every 8 hours, or Dalacin® 300-450 mg orally every 6 hours for 21 days and primaquine 15- 30 mg orally once daily for 21 days. Acute streptococcal tonsillitis/pharyngitis: Dalatsin® 300 mg orally 2 times a day for 10 days. Malaria: Dalatsin® capsules 10-20 mg/kg/day for adults and 10 mg/kg/day for children every 12 hours in equal doses for 7 days as monotherapy, or in combination with quinine (12 mg/kg every 12 hours ) or chloroquine (15-25 mg every 24 hours) for 3-5 days. Prevention of endocarditis in patients with hypersensitivity to penicillin: 600 mg capsules orally for adults and 20 mg/kg for children 1 hour before taking penicillin; or Dalacin® C phosphate IV at a dose of 600 mg 1 hour before penicillin administration. Prevention of infections during operations in the neck and head: Dalatsin® C phosphate (900 mg in 1 liter of saline) is used during surgery to irrigate contaminated wounds of the head and neck before closing the wound. Dilution and infusion rate The concentration of clindamycin in the solution for infusion should not exceed 18 mg/ml and the infusion rate should not exceed 30 mg/min. The following infusion rates are typically used: Clindamycin dose Volume of saline Time 300 mg 600 mg 900 mg 1200 mg 50 ml 50 ml 50-100 ml 100 ml 10 min 20 min 30 min 40 min Administration of more than 1200 mg in a single 1-hour infusion is not recommended . Side effects - abdominal pain, nausea, vomiting and diarrhea, and with oral use - esophagitis (in addition to the above reactions) - hypersensitivity reactions. In some cases, maculopapular rash and urticaria are noted. A generalized morbilliform rash of mild to moderate severity is the most common adverse reaction. Rare cases of erythema multiforme resembling Stevens-Johnson syndrome, as well as cases of anaphylactoid reactions. - phenomena of jaundice and liver dysfunction - itching, vaginitis, as well as rare cases of exfoliative and vesicular-bulous dermatitis - neutropenia (leukopenia) and eosinophilia of a passing nature, as well as cases of agranulocytosis and thrombocytopenia, but it was not possible to establish an etiological connection between these phenomena and the therapy with the drug Dalacin® - with too rapid intravenous administration of the drug, cases of respiratory and cardiac arrest, as well as the development of hypotension have been observed - with intramuscular administration of the drug, phenomena such as local irritation, pain and the formation of abscesses in the area of injection may be observed. When administered intravenously, thrombophlebitis sometimes occurred. The incidence of such phenomena decreases when the drug is administered deeply intramuscularly and with the rarest possible use of permanent intravenous catheters. Contraindications - hypersensitivity to clindamycin, lincomycin or any component of the drug Drug interactions The following drugs are physically incompatible with Dalatsin® C phosphate in solution for infusion: ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, ceftriaxone sodium, ciprofloxacin. It was found that in vitro antagonism occurs between clindamycin and erythromycin. Because this antagonism may be clinically significant, the two drugs should not be administered simultaneously. Clindamycin has been found to interfere with neuromuscular transmission, so it may enhance the effect of other peripherally acting muscle relaxants. Therefore, it should be used with caution in patients receiving drugs in this group. Special instructions Dalatsin® C phosphate injection solution contains benzyl alcohol. There are reports that benzyl alcohol can cause the development of fatal Gasping Syndrome (respiratory problems manifested by suffocation) in premature newborns. Cases of pseudomembranous colitis of varying severity, even life-threatening, have been observed with the use of almost all antibacterial agents, including Dalatsin®. Therefore, in all cases of diarrhea after taking antibacterial drugs, this diagnosis should be considered. Antibacterial drugs suppress the normal intestinal flora, which can contribute to increased proliferation of clostridia. Toxins produced by Clostridium difficile have been shown to be a major cause of antibiotic-associated colitis. After making a diagnosis of pseudomembranous colitis, the following measures must be taken: in mild cases, it is usually sufficient to discontinue the antibacterial agent; In moderate to severe cases, consideration should be given to fluid, electrolyte, protein, and an antibacterial drug effective against Clostridium difficile. Dalacin® should not be prescribed for the treatment of meningitis, since clindamycin does not penetrate the blood-brain barrier well. If treatment is carried out over a long period of time, liver and kidney function tests should be carried out regularly. When using antibacterial agents, including Dalatsin®, excessive growth of microorganisms that are insensitive to this drug, especially yeast-like fungi, is possible. Dalacin® C phosphate should not be administered intravenously and at the same time. Infusion must be carried out for at least 10-60 minutes. There are no recommendations for reducing the dose of Dalacin® in patients with impaired liver and kidney function. Pregnancy and breastfeeding clindamycin penetrates through the placenta. After the introduction of several doses of the drug, the concentration in amniotic fluid was approximately 30% of the concentration in the blood of the mother. Dalacin® should be used in pregnant women only according to absolute indications, i.e. When the potential benefits of therapy with the drug surpasses potential risk. It was reported that clindamycin is found in breast milk at a concentration of 0.7-3.8 μg/ml. Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms were not studied. Overdose symptoms: strengthening side effects. Treatment: symptomatic and supportive. The form of release and packaging Dalacin® Capsules: · Blisters of 8 capsules · 2 blisters and instructions for use are packed in a cardboard pack. Dalacin® C phosphate injection solution: · ampoules made of transparent glass of 2 ml, 4 ml; · 1 ampoule and instructions for use are packed in a cardboard pack. Storage conditions are stored at a temperature of not higher than +25 ° C. Keep out of the reach of children! The shelf life of the capsule is 5 years in injection - 2 years cannot be used after expiration of the shelf life. Conditions of pharmacies according to the recipe manufacturer capsule: Pfizer PGM Zone Industrielle-29 Route des Industries 37530 POCE-SUR-CISSE FRANCE A solution for injections: PFIZER MFG Belgium N.V. Rijksweg 12, 2870 Puurs Belgium