Buy Dalatsin vaginal cream 2% 40g No. 7 in pharmacies

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

Buy Dalatsin vaginal cream 2% 20g No. 3 in pharmacies

Instructions for use Dalatsin

Buy Dalatsin cream 2% 20g

Dosage forms vaginal cream 2% Manufacturers Pharmacy and Upjohn Company (United States of America) Group Antibiotics of the lincomycin group Composition Active ingredient - clindamycin. International nonproprietary name Clindamycin Synonyms Zerkalin, Clindamycin, Klindafer, Clindacin, Klindovit Pharmacological action Antibacterial. Binds to the 50S subunit of the ribosomal membrane and inhibits protein synthesis in microorganisms. It is quickly and completely absorbed into the gastrointestinal tract; simultaneous food intake slows down absorption without changing the completeness. Easily penetrates biological fluids and tissues; passes through the blood-brain barrier (BBB) ​​poorly. After intramuscular administration, the maximum concentration in the blood is reached after 2-2.5 hours, in a therapeutic concentration it circulates in the blood for 8-12 hours, the half-life is 2.4 hours; metabolized in the liver, most of the active and inactive metabolites are excreted within 4 days in the urine, a smaller part is excreted through the intestines. Refers to reserve antibiotics that suppress gram-positive cocci (staphylococci, streptococci, pneumococci), incl. producing penicillinase, as well as mycoplasmas, bacteroides, fusobacteria, actinomycetes, some strains of Haemophilus influenzae, causative agents of anthrax, gas gangrene and tetanus. According to the mechanism of action and antimicrobial spectrum, it is close to lincomycin. Indications for use Infections of the upper and lower respiratory tract (pharyngitis, tonsillitis, scarlet fever, diphtheria, sinusitis, otitis, pneumonia, including aspiration, lung abscess, bronchitis), abdominal cavity (peritonitis, abscess), oral cavity, urogenital area (chlamydia, endometritis, vaginal infections, tubo-ovarian inflammation), skin and soft tissues (infected wounds, abscesses), acute and chronic osteomyelitis, septicemia, bacterial endocarditis, acne (externally). Contraindications Hypersensitivity, myasthenia gravis, lactation. Restrictions on use: Severe liver and kidney dysfunction, infancy (up to 1 month), pregnancy. Side effects Dyspepsia (abdominal pain, nausea, vomiting, diarrhea), esophagitis, liver dysfunction, jaundice, dysbacteriosis (clostridial pseudomembranous colitis), allergic reactions (urticaria, erythema), leukopenia, neutropenia, eosinophilia, thrombocytopenia, hyperbilirubinemia. At the injection site there is irritation, pain, infiltrates and abscesses, thrombophlebitis. With rapid intravenous administration - cardiovascular failure (collapse, cardiac arrest), arterial hypotension. Interaction Incompatible with erythromycin, ampicillin, diphenylhydantoin, barbiturates, aminophylline, calcium gluconate and magnesium sulfate. Strengthens (mutually) the effect of rifampicin, aminoglycosides - streptomycin, gentamicin. Deepens muscle relaxation caused by n-cholinergic blockers. Co-administration with antidiarrheal drugs increases the risk of developing pseudomembranous colitis. Simultaneous use with solutions containing B complex vitamins is not recommended. Method of application and dosage Externally. A thin layer of gel is applied to the affected area of ​​clean, dry skin 2 times a day. To obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, can be continued for up to 6 months. Overdose No data available. Special instructions No data available. Storage conditions At a temperature of 20-25 °C. List B.

Dalacin C capsules 300 mg No. 8x2

Name

Dalacin C caps 300 mg in blister pack. in pack №8x2

Main active ingredient

Clindamycin

Release form

capsules

Compound

Active substance: clindamycin (in the form of clindamycin hydrochloride) 300 mg; Excipients: magnesium stearate (E470), corn starch, talc (E553), lactose monohydrate, titanium dioxide (E171), gelatin.

Description

This medicine is available in capsule form. 8 capsules in a PVC blister; 2 blisters with instructions for use in a cardboard box.

Dosage

300 mg

Indications for use

This medicine is indicated for the treatment of certain severe bacterial infections caused by organisms sensitive to this antibiotic. This drug is also indicated for the prevention of infective endocarditis during dental and upper respiratory tract procedures performed on an outpatient basis in patients allergic to beta-lactam antibiotics (penicillins, cephalosporins). Take this medicine only if your doctor has prescribed it (see Counseling/Medical Information section). What you should know before using Dalatsin C 300 mg, capsules If you know that you have an intolerance to some sugars, consult your doctor before starting to use this medicine. Do not take the drug if you are allergic to clindamycin, lincomycin or any other component of this drug (listed in the section “Full list of active and auxiliary substances”); in children under 6 years of age as they may choke on the capsule if swallowed. The use of this medicine is contraindicated during breastfeeding (see section "Pregnancy, breastfeeding and fertility"). If you are unsure, consult your doctor or pharmacist. Special instructions and precautions Before taking this medicine, tell your doctor if you have: allergies, especially to antibiotics, or a history of bronchial asthma; liver failure (liver disease); intolerance to certain sugars. Tell your doctor immediately if you develop any of the following disorders during treatment with Dalatsin 300 mg, capsules: Sudden or severe allergic reaction (anaphylactic reaction, Quincke's edema). Severe skin reaction (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis). There is a small risk of a severe allergic reaction, which may include chest tightness, dizziness, sudden swelling of the face and neck, severe skin rash. If these symptoms develop, stop taking Dalacin C 300 mg, capsules, as they are potentially life-threatening, and contact your doctor immediately. The appearance at the beginning of treatment of redness spreading throughout the body, combined with fever and pustular rashes, may indicate the development of a serious reaction - acute generalized exanthematous pustulosis (see section "Possible adverse reactions"). In this case, you should immediately inform your doctor, as this means that treatment should be stopped immediately; After this type of reaction develops, any future use of clindamycin is contraindicated. Taking antibiotics, including clindamycin, may be accompanied by the development of diarrhea even several weeks after the end of treatment. If you develop severe or persistent diarrhea, or if you notice blood or mucus in your stool, tell your doctor right away. Treatment with clindamycin should be stopped immediately as this reaction may be life-threatening. Do not take any medications to stop or slow the passage of contents through the intestines. When prescribing this treatment for a long period, laboratory tests are carried out. Dalacin C 300 mg, capsules contain lactose. Patients with rare hereditary diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug. Before taking Dalacin C 300 mg, capsules, consult your doctor or pharmacist.

Contraindications

if you are allergic to clindamycin, lincomycin or any other component of this medicinal product (listed in the section “Full list of active and auxiliary substances”); in children under 6 years of age as they may choke on the capsule if swallowed. The use of this medicine is contraindicated during breastfeeding (see section "Pregnancy, breastfeeding and fertility"). If you are unsure, consult your doctor or pharmacist.

Use during pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your healthcare professional before taking this medicine. Pregnancy It is recommended that you do not use this drug during the first trimester of pregnancy as a precaution. In the second and third trimester of pregnancy, clindamycin can be used as prescribed by your doctor. If you become pregnant while taking this drug, contact your doctor immediately as only your doctor is qualified to decide whether to continue or stop treatment. Breastfeeding Breastfeeding should be avoided during treatment with Dalacin C 300 mg, capsules. Before using any medicine, consult your doctor or pharmacist.

Directions for use and doses

Dosage regimen In all cases, you should strictly adhere to the doctor's instructions. If in doubt, consult your healthcare professional. The dosage regimens typically used are as follows: Treatment of infections Adults: 600 to 2400 mg/day in 2, 3, or 4 divided doses. Children over 6 years of age: from 8 to 25 mg/kg/day in 3–4 divided doses. Prevention of infective endocarditis Adults: 600 mg orally one hour before surgery. Children over 6 years of age: 15 mg/kg orally one hour before the intervention. Method and method(s) of application Internally. The capsules are swallowed whole with a large glass of water. Dalacin capsules are not intended for the treatment of children who are unable to swallow the capsule whole. Frequency of taking the drug Treatment of infections: 2, 3 or 4 times a day. Preventive treatment: once an hour before the intervention. Duration of treatment For effective treatment, this antibiotic should be taken regularly at the prescribed dose and for as long as recommended by the doctor. Normalization of temperature or disappearance of any other symptom does not mean a complete cure. Increased fatigue, which may occur during treatment, is not due to the antibiotic taken, but to the infection itself. Lowering the dose of the drug or stopping it will not relieve this symptom, but may slow down your recovery. If you take more of the drug than you should, tell your doctor. If you forget to take Dalacin 300 mg capsules: Continue treatment as usual, do not take a double dose to make up for the missed capsule. If you have additional questions, consult your healthcare provider. Possible adverse reactions Like other medicines, Dalacin 300 mg capsules may cause adverse reactions, although these do not occur in all patients receiving Dalacin. The frequency of possible adverse reactions listed below was determined based on the following generally accepted categories: Very common (occurs in more than 1 in 10 patients) Common (occurs in 1-10 in 100 patients) Uncommon (occurs in 1-10 in 1000 patients) Rare (occurs in 1–10 in 10,000 patients) Very rare (occurs in less than 1 in 10,000 patients) Frequency unknown (frequency cannot be determined based on available data). Frequent adverse reactions: inflammation of the intestine caused by taking antibiotics (pseudomembranous colitis); diarrhea, stomach pain; changes in laboratory parameters reflecting liver function. Uncommon adverse reactions: nausea, vomiting; skin rash, which may be in the form of papules and macules; hives. Adverse reactions of unknown frequency: drug-related allergic reactions (severe, acute allergic reactions caused by the drug), including angioedema (acute swelling of the face and neck), have been observed in patients allergic to penicillin; severe skin reactions that can be fatal, such as: blisters and blisters on the body, mainly around the mouth, nose, eyes and genital area (Lyell's syndrome and Stevens-Johnson syndrome); a skin rash, which may be accompanied by fever, occurs acutely on the face or on skin folds, and then a generalized reaction may develop (acute generalized exanthematous pustulosis); or a severe allergic reaction (drug hypersensitivity syndrome, called DRESS syndrome), which may be accompanied by severe symptoms such as fever, skin rash, enlarged lymph nodes, severe fatigue, liver or kidney damage, and abnormal laboratory results (eg, an increase in the number of a certain type of leukocyte (eosinophilia)); redness of the skin (erythema), itching, other skin lesions (exfoliative dermatitis, bullous dermatitis, erythema multiforme); a decrease in the level of some blood cells (leukocytes, platelets), which can cause an unexplained increase in body temperature or the appearance of small red-bluish spots on the surface of the skin (thrombocytopenic purpura); increased levels of certain types of white blood cells (eosinophilia); change in taste (dysgeusia); inflammation of the mucous membrane of the esophagus (esophagitis and esophageal ulcers); yellow discoloration of the skin, mucous membranes and white of the eye (jaundice); vaginal infection; colitis associated with Clostridium difficile infection. Providing information about adverse reactions If you notice any adverse reactions, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report adverse reactions through the National Adverse Event Reporting System.

Interaction with other drugs

When used in combination with certain other drugs, your doctor may need to order blood tests more often to monitor blood clotting. Local medications used for diseases of the gastrointestinal tract, activated carbon and antacids (aluminium, calcium and magnesium salts), reduce the absorption of clindamycin and other concomitantly taken drugs in the gastrointestinal tract. As a precaution, it is recommended to use topical medications or antacids 2 hours after taking other medications. Tell your doctor or pharmacist if you are currently taking, have recently taken, or may take any other medicines, including over-the-counter medicines.

Precautionary measures

Before taking this medicine, tell your doctor if you have: allergies, especially to antibiotics, or a history of bronchial asthma; liver failure (liver disease); intolerance to certain sugars. Tell your doctor immediately if you develop any of the following disorders during treatment with Dalatsin 300 mg, capsules: Sudden or severe allergic reaction (anaphylactic reaction, Quincke's edema). Severe skin reaction (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis). There is a small risk of a severe allergic reaction, which may include chest tightness, dizziness, sudden swelling of the face and neck, severe skin rash. If these symptoms develop, stop taking Dalacin C 300 mg, capsules, as they are potentially life-threatening, and contact your doctor immediately. The appearance at the beginning of treatment of redness spreading throughout the body, combined with fever and pustular rashes, may indicate the development of a serious reaction - acute generalized exanthematous pustulosis (see section "Possible adverse reactions"). In this case, you should immediately inform your doctor, as this means that treatment should be stopped immediately; After this type of reaction develops, any future use of clindamycin is contraindicated. Taking antibiotics, including clindamycin, may be accompanied by the development of diarrhea even several weeks after the end of treatment. If you develop severe or persistent diarrhea, or if you notice blood or mucus in your stool, tell your doctor right away. Treatment with clindamycin should be stopped immediately as this reaction may be life-threatening. Do not take any medications to stop or slow the passage of contents through the intestines. When prescribing this treatment for a long period, laboratory tests are carried out. Dalacin C 300 mg, capsules contain lactose. Patients with rare hereditary diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug. Before taking Dalacin C 300 mg, capsules, consult your doctor or pharmacist.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Dalacin® C phosphate

To avoid complications, use strictly as prescribed by your doctor!

There have been case reports of severe hypersensitivity reactions, including severe skin reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis in patients receiving clindamycin therapy. If a hypersensitivity reaction or severe skin reaction occurs, treatment with clindamycin should be discontinued and appropriate therapy for these complications should be initiated (see sections "Contraindications" and "Side Effects").

The drug contains benzyl alcohol. There are reports that benzyl alcohol causes Gasping Syndrome

- disorders of the respiratory system, manifested in the form of suffocation) with a fatal outcome in children. Although therapeutic doses of the drug usually contain a dose of benzyl alcohol significantly lower than the dose at which the development of this complication was observed, the minimum amount of benzyl alcohol that has a toxic effect is unknown. The degree of toxicity of benzyl alcohol depends on the amount of drug administered and the ability of the liver and kidneys to detoxify chemical compounds. Premature and low birth weight infants are at higher risk of toxicity.

The amount of benzyl alcohol per 1 ml of drug solution is 9 mg.

Clostridium difficile

associated diarrhea is observed with the use of almost all antibacterial drugs, including clindamycin, and manifests itself from mild forms of diarrhea to severe colitis with a fatal outcome.
Antibacterial drugs suppress the normal intestinal flora, which can contribute to increased proliferation of clostridia. Clostridium difficile
produces toxins A and B, leading to the development of
Clostridium difficile
associated diarrhea.
Hypertoxin-producing strains of Clostridium difficile
lead to increased morbidity and mortality because they may be resistant to antibiotic therapy and may require colonectomy for treatment.
All cases of diarrhea in patients during antibiotic therapy should be considered suspicious for the development of Clostridium difficile
associated diarrhea.
A thorough medical history is required if Clostridium difficile
associated diarrhea develops within 2 months after the prescription of antibacterial drugs.
Pseudomembranous colitis can appear both while taking clindamycin and 2-3 weeks after stopping treatment; manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by the release of blood and mucus in the stool). After a diagnosis of pseudomembranous colitis is made, in mild cases it is sufficient to discontinue treatment and use ion exchange resins (colestyramine, colestipol); in moderate and severe cases, replacement of the loss of fluid, electrolytes and protein, and the prescription of an antibacterial drug effective against Clostridium difficile
, for example, vancomycin at a dose of 125-500 mg, or bacitracin at a dose of 25,000 units orally 4 times a day for 7-10 days, or metronidazole at a dose of 250-500 mg 3 times a day.

Drugs that reduce gastrointestinal motility should not be coadministered with clindamycin.

Clindamycin should be used with caution in patients with a history of gastrointestinal diseases, especially colitis. Antibiotic-associated colitis and diarrhea occur more frequently and more severely in debilitated and/or elderly patients.

When using all antibacterial agents, including clindamycin, excessive growth of microorganisms that are insensitive to this drug, especially yeast-like fungi, is possible. If superinfection develops, appropriate measures should be taken depending on the clinical situation.

Clindamycin should not be used to treat meningitis because it does not penetrate the blood-brain barrier well.

When using the drug in high doses, monitoring the concentration of clindamycin in the blood plasma is necessary. If treatment is carried out over a long period of time, liver and kidney function tests should be carried out regularly. In patients with impaired liver and kidney function, no dose adjustment of the drug is required, since clindamycin practically does not accumulate in the body if the drug is administered at intervals of 8 hours. Patients with severe hepatic and/or liver failure should use the drug with caution and monitor liver function (“ liver" enzymes) and kidneys.

The drug should not be administered intravenously undiluted or simultaneously. The infusion must be carried out for at least 10-60 minutes (see section “Method of administration and dosage”).

Dalatsin 100 mg 3 pcs. vaginal suppositories

pharmachologic effect

Antibiotic of the lincosamide group for topical use.
Clindamycin phosphate is not active in vitro, but is rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity. Clindamycin inhibits protein synthesis in microbial cells due to interaction with the 50S ribosomal subunit.

In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.

Composition and release form Dalatsin 100 mg 3 pcs. vaginal suppositories

Vaginal suppositories are solid, torpedo-shaped, with a smooth surface, white or almost white.

1 sup.:

• Active substance: clindamycin (in phosphate form) - 100 mg;
• Excipients: solid fat (Witepsol H-32, a mixture of triglycerides, diglycerides and monoglycerides) - about 2.4 g.

3 pcs. — strips made of laminated foil — cardboard packs.

3 pcs. — strips made of laminated foil complete with an applicator — cardboard packs.

Directions for use and doses

The recommended dose is 1 suppository intravaginally, preferably at bedtime, for 3 consecutive days.

Pharmacokinetics

Suction

After using clindamycin intravaginally at a dose of 100 mg 1 time / day (in the form of suppositories) for 3 days, approximately 30% (6-70%) of the administered dose of clindamycin is absorbed into the systemic circulation, with an AUC of 3.2 mcg / h / ml (0.42 -11 mcg/h/ml). Cmax in the blood serum is achieved approximately 5 hours (1-10 hours) after administration of the vaginal suppository and averages 0.27 mcg/ml (0.03-0.67 mcg/ml) on the 3rd day of therapy.

The systemic effect of clindamycin when administered intravaginally is significantly weaker than when administered in therapeutic doses orally or intravenously.

Removal

On average, T1/2 is 11 hours (4-35 hours).

Pharmacokinetics in special groups of patients

Clinical studies of clindamycin vaginal suppositories included insufficient numbers of patients aged 65 years and older to evaluate the difference in clinical response to therapy between this age group and younger patients.

Indications for use Dalatsin 100 mg 3 pcs. vaginal suppositories

Bacterial vaginosis.

Contraindications

• hypersensitivity to clindamycin, lincomycin or any component of the drug;
• history of antibiotic-associated colitis;
• age under 18 years (data on safety and effectiveness are not available).

Application of Dalacin 100 mg 3 pcs. vaginal suppositories during pregnancy and breastfeeding

When clindamycin was used intravaginally in the second or third trimester of pregnancy, no increase in the incidence of congenital anomalies of the fetus was observed. If Dalatsin® vaginal suppositories are used during the second or third trimesters of pregnancy (although no official studies have been conducted on the use of suppositories in pregnant women), then an adverse effect on the fetus seems unlikely. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus.

There have been no adequate controlled studies on the use of the drug in the first trimester of pregnancy, therefore Dalatsin® vaginal suppositories can be prescribed to women in the first trimester of pregnancy only for absolute indications, i.e. when the potential benefit of drug therapy outweighs the potential risk to the fetus.

In animal studies, when clindamycin was administered subcutaneously or orally, no negative effects on the fetus were found, except when the drug was taken in doses toxic to the mother.

It is unknown whether clindamycin is excreted in breast milk after intravaginal use. Clindamycin is found in breast milk after oral or parenteral administration, therefore, during breastfeeding, the drug should either be discontinued or breastfeeding should be discontinued, taking into account the importance of the drug for the mother.

The use of the drug is contraindicated in people under 18 years of age (data on safety and effectiveness are lacking).

special instructions

Before prescribing the drug, vulvovaginitis caused by Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and the Herpes simplex virus should be excluded using appropriate laboratory methods.

Intravaginal use of clindamycin may lead to increased growth of nonsusceptible microorganisms, especially yeast-like fungi.

The use of clindamycin (like almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and, in some cases, pseudomembranous colitis. If severe or prolonged diarrhea develops, the drug should be discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken.

Patients should be warned that during drug therapy they should avoid sexual intercourse, as well as the use of other means for intravaginal administration (tampons, douching).

The drug contains components that can reduce the strength of latex or rubber products (condoms, contraceptive vaginal diaphragms). Therefore, the use of such products during treatment with Dalatsin and within 72 hours after use is not recommended.

The use of Dalatsin® vaginal suppositories during menstruation is not recommended. The initiation of therapy should be delayed until after menstruation.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles or engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

With intravaginal use of Dalacin® suppositories, absorption of clindamycin is possible in quantities sufficient to cause systemic reactions.

Accidental exposure of the drug to the gastrointestinal tract may cause systemic effects similar to those that occur after oral administration of clindamycin in therapeutic doses. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.

Treatment: symptomatic and supportive therapy.

Side effects Dalacin 100 mg 3 pcs. vaginal suppositories

The safety of clindamycin in the form of vaginal suppositories was assessed in non-pregnant women.

Table. Adverse drug reactions

Drug interactions

There is cross-resistance between clindamycin and lincomycin.

Antagonism between clindamycin and erythromycin has been demonstrated in vitro.

It has been established that clindamycin disrupts neuromuscular transmission and, therefore, can enhance the effect of peripherally acting muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.

Since there is no information on use with other drugs for intravaginal administration, combined use of the drug with other intravaginal drugs is not recommended.

Dalacin®

Clindamycin phosphate is inactive in vitro, but is rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity.

Clindamycin belongs to the group of lincosamide antibiotics, which inhibits protein synthesis in microbial cells through interaction with the 50S ribosomal subunit and affects the translation process.

Clindamycin, like most protein synthesis inhibitors, is primarily a bacteriostatic, the effectiveness of which is associated with the duration of maintaining the concentration of the active substance at a level higher than the MIC (Minimum Inhibitory Concentration) of the infecting organism.

Resistance to clindamycin in most cases occurs due to modification of ribosomal target sites, usually through chemical modification of RNA nitrogenous bases or point mutations in RNA or sometimes protein mutations. Cross-resistance between lincosamides, macrolides and streptogramins B has been demonstrated in some organisms in vitro. Cross-resistance exists between clindamycin and lincomycin.

Bacterial culture and sensitivity studies are not routinely performed to establish the diagnosis and guide treatment of bacterial vaginosis. There is no standard methodology for assessing the susceptibility of potential bacterial vaginosis pathogens (Gardnerella vaginalis, Mobiluncus spp.). Methods for determining the sensitivity of Bacteroides spp and gram-positive anaerobic cocci, also Mycoplasma spp. are described by the Clinical and Laboratory Standards Institute (CLSI), and clindamycin susceptibility breakpoints for gram-negative and gram-positive anaerobic bacteria are published by the European Committee on Antimicrobial Susceptibility Testing (EUCAST). For clinical isolates that are tested to be susceptible to clindamycin but resistant to erythromycin, testing should also be performed to determine clindamycin resistance using the D test. However, breakpoints are intended to guide systemic antibiotic treatment rather than topical treatment.

In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.