Dalatsin

Dalatsin – antibiotic drug from group of linkozamid.

Form of release and structure

Dalatsin release in the following dosage forms:

• Gel for external use of 1%: transparent, colourless, viscous (on 30 g in tubas, on 1 tuba in a cardboard pack);
• Cream of vaginal 2%: white color (on 20 or 40 g in tubas from polyethylene or aluminum foil complete with 3 or 7 applicators (respectively), on 1 set in a cardboard pack);
• Capsules: gelatinous, firm, with the case and a cover of white color, with a text of "P&U 225" (on 150 mg) or "P&U 395" (on 300 mg); contents of capsules – white powder (on 8 or 10 pieces in blisters, 2 or 10 blisters in a cardboard pack);
• Suppositories vaginal: a torpedo-shaped form, firm, with a smooth surface, almost white or white color (on 3 pieces in strips from the laminated foil with the applicator or without it, on 1 strip in a cardboard pack).

Structure of 1000 mg of gel for external use:

• Active agent: clindamycin (in the form of phosphate) – 10 mg;
• Auxiliary components: methylparaben – 3 mg; cordianine – 2 mg; polyethyleneglycol – 100 mg; propylene glycol – 50 mg; carbomer 934P - 7,5 of mg; solution of 40% of sodium hydroxide – in enough; the purified water – in quantity, sufficient to 1000 mg.

Structure of 1000 mg of cream vaginal:

• Active agent: clindamycin (in the form of phosphate) – 20 mg;
• Auxiliary components: cetyl palmitate – 32,1 mg; stearic acid – 21,4 mg; polysorbate of 60 - 50 mg; sorbitan monostearate – 20 mg; propylene glycol – 50 mg; benzyl alcohol – 10 mg; cetostearyl alcohol – 32,1 mg; mineral oil – 64,2 mg; the purified water – in enough.

Structure of 1 capsule:

• Active agent: clindamycin (in the form of a hydrochloride) – 150 or 300 mg;
• Auxiliary components: talc, lactose, corn starch, magnesium stearate, gelatin, titanium dioxide.

Composition of 1 suppository vaginal:

• Active agent: clindamycin (in the form of phosphate) – 100 mg;
• Auxiliary components: solid fat (Witepsol H-32, mix of monoglycerides, diglycerides and triglycerides) – about 2400 mg.

Indications to use

Dalatsin in the form of capsules appoint for treatment of the following infectious and inflammatory diseases caused by anaerobic bacteria or strains of gram-positive aerobic bacteria, sensitive to effect of active agent (Streptococcus spp., Pneumococcus spp. and Staphylococcus spp.), and also Chlamydia trachomatis serovars showing sensitivity to clindamycin:

• Scarlet fever, inflammation of a middle ear;
• Upper respiratory tract infections, including pharyngitis, tonsillitis, sinusitis;
• Infectious diseases of soft tissues and skin, including a furunculosis, impetigo, eels, infections of a hypodermic fatty tissue, contaminated wounds, abscesses, specific infectious processes in soft tissues and skin caused by activators, sensitive to Dalatsin's action (an ugly face and a felon (paronychia));
• Infections of lower parts of respiratory tracts, including pneumonia, bronchitis, abscess of a lung and an empyema of a pleura;
• Gynecologic infectious diseases, including an endometritis, infections of the fabrics surrounding a vagina (abscesses of fallopian ovaries and pipes, a hypodermic fatty tissue), inflammatory diseases of bodies of a small pelvis and a salpingitis (along with antibacterial drugs, active concerning gram-negative aerobic activators, for example, gentamycin);
• Infectious diseases of joints and bones, including septic arthritis and osteomyelitis;
• Infectious diseases of an abdominal cavity, including abscesses of an abdominal cavity and peritonitis (along with other antibacterial medicines influencing gram-negative aerobic bacteria);
• The infectious diseases of a neck of uterus caused by Chlamydia trachomatis (as monotherapy);
• Oral cavity infections (periodontitis and periodontal abscess);
• Endocarditis and septicaemia;
• Malaria, including caused by multiresistant Plasmodium falciparum (as monotherapy or along with chloroquine or quinine);
• Toksoplazmozny encephalitis at patients AIDS (along with Pyrimethaminum at intolerance of standard therapy);
• Pneumocystic pneumonia at patients AIDS (along with Primachinum at intolerance of standard therapy).

Also drug is used for prevention of an endocarditis at patients with hypersensitivity to penicillin.

Dalatsin in the form of vaginal cream and suppositories appoint at treatment of a bacterial vaginosis.

Dalatsin in the form of gel for external use appoint for treatment of vulgar eels.

Contraindications

Dalatsin it is contraindicated to apply with hypersensitivity to clindamycin, lincomycin or auxiliary components of drug.

Drug in the form of capsules should be taken with caution the patient with gastrointestinal diseases (in the anamnesis), especially with ulcer colitis, a myasthenia (disturbance of neuromuscular transfer is possible), a heavy liver failure.

In addition Dalatsin in other dosage forms it is contraindicated to apply at the following diseases / states:

• The antibiotic-associated colitis in the anamnesis;
• Age: up to 18 years – for vaginal cream and suppositories; up to 12 years – for gel for external use (data on efficiency and safety of use of Dalatsin for this group of patients are absent);
• Hypersensitivity to lincomycin or clindamycin in the anamnesis (for gel for external use).

Route of administration and dosage

Dalatsin in the form of capsules accept inside. In order to avoid complications it is recommended to be applied strictly on doctor's orders.

To avoid irritation mucous a gullet, capsules need to be accepted, washing down with a full glass of water.

Drug is usually accepted:

• Adults: 600-1800 mg a day, frequency rate of reception – 2-4 times (in equal doses);
• Children: 8-25 mg/kg of body weight a day, frequency rate of reception – 3-4 times (in equal doses).

At treatment of the infections caused by a beta and hemolitic streptococcus, Dalatsin apply in the doses described above. Duration of a therapeutic course – not less than 10 days.

Treatment of infectious and inflammatory diseases of bodies of a small pelvis there begin with intravenous administration of clindamycin, in a dose of 900 mg each 8 hours, along with suitable antibacterial agent within not less than 4 days. After improvement of a condition of the patient therapy is continued within not less than 2 more days then appoint Dalatsin in the form of capsules in a single dose 450-600 mg. Drug is accepted daily by each 6 hours. A full course of treatment – 10-14 days.

Depending on indications Dalatsin appoint:

• Toksoplazmozny encephalitis at patients AIDS: at intolerance of standard therapy drug is accepted along with Pyrimethaminum according to the following scheme: Dalatsin – to 600-1200 mg is each 6 hours within 14 days, then on 300-600 mg with the same frequency rate of use; Pyrimethaminum – daily on 25-75 mg. As a rule, the medical course makes 8-10 weeks. At use of Pyrimethaminum in higher doses it is necessary to appoint 10-20 mg of folic acid a day;
• The caused Chlamydia trachomatis of an infection of a neck of uterus: daily on 450-600 mg, frequency rate of reception – 4 times a day, therapy duration – 10-14 days;
• Acute streptococcal pharyngitis / tonsillitis: within 10 days on 300 mg 2 times a day;
• Pneumocystic pneumonia at patients AIDS: within 21 days on 300-450 mg each 6 hours along with Primachinum on 15-30 mg once a day;
• Malaria: adults – on 10-20 mg/kg a day; children – on 10 mg/kg a day. Drug is accepted equal doses by each 12 hours, course duration – 7 days. Dalatsin's use along with quinine (each 12 hours on 12 mg/kg) or chloroquine (each 24 hours on 15-25 mg), course duration – 3-5 days is also possible.

For prevention of an endocarditis at patients with hypersensitivity to penicillin Dalatsin appoint: the adult – on 600 mg; to children – on 20 mg/kg. Drug should be accepted in 1 hour prior to small dental or surgical intervention, or any other procedure at which there is a risk of development of an endocarditis.

To elderly patients with function of kidneys, normal for this age, and a liver, and also patients with functional disturbances of a liver and kidneys it is not necessary to adjust a dose.

At treatment of a bacterial vaginosis usually appoint:

• Cream vaginal: 5000 mg of cream (1 full applicator, about 100 mg of clindamycin) should be entered into a vagina. It is better to carry out the procedure before going to bed. Course duration – 3 or 7 days;
• Suppositories vaginal: 1 suppository is entered intravaginalno once a day, preferably before going to bed. Course duration – 3 days.

Dalatsin in the form of gel apply outwardly at treatment of vulgar eels. Drug is applied with a thin layer on the struck area (dry clean skin). Frequency rate of use – 2 times a day. The recommended course duration – 6-8 weeks. According to indications Dalatsin's use within 6 months is possible. If after use of gel within several months efficiency of treatment goes down, for 4 weeks it is necessary to take a break.

Side effects

At Dalatsin's use development of the following side effects is inside possible:

• Alimentary system: nausea, an abdominal pain, an esophagitis, diarrhea and vomiting, pseudomembranous colitis, a gullet ulcer, jaundice, dysbacteriosis, abnormal liver functions, including a hyperbilirubinemia;
• Hemogenesis (hemopoietic system): cases of an eosinophilia of the passing character and a leukopenia (neutropenia), and also cases of thrombocytopenia and an agranulocytosis were noted, however communication between Dalatsin's reception and these phenomena is not established;
• Allergic reactions: itch, urticaria, makulopapulezny rash; most often – korepodobny generalized rash of average and easy degree of manifestation; seldom – vezikulobullezny and exfoliative dermatitis, a toxic epidermal necrolysis, a multiformny erythema, anaphylactoid reactions;
• Others: vaginitis.

Also during therapy there can be following by-effects: development of superinfection, disturbance of neuromuscular transfer.

At treatment of a bacterial vaginosis by Dalatsin in the form of vaginal cream and suppositories development of disturbances from some systems of an organism is possible:

• Reproductive system: a vulvovaginitis, vaginal candidiasis, uterine bleeding, irritation of a mucous membrane of a vagina and vulva, vaginal infections, a mecotic vaginitis, a colpodynia, abnormal childbirth, disturbances of a menstrual cycle, allocation from a vagina, endometriosis;
• Urinary system: infections of urinary tract, dysuria, proteinuria;
• Alimentary system: a food faddism, a meteorism, nausea, diarrhea, vomiting, dyspepsia, a lock, an unpleasant smell from a mouth, gastrointestinal frustration;
• Integuments: erythema, itch, rash, skin candidiasis, makulo-papular rash, small tortoiseshell;
• Central nervous system: dizziness, headache, вертиго;
• Endocrine system: hyperthyroidism, glucosuria;
• Respiratory system: upper respiratory tract infections, nasal bleeding;
• Organism in general: fungal infections, bacterial infections, abdominal distention, the localized and/or generalized abdominal pain, pain in the bottom of a stomach, spasms in a stomach, a deviation of results of microbiological analyses from norm, a dorsodynia, allergic reactions;
• Local reactions: inflammatory hypostasis and an itch in a drug injection site.

At use of gel for external use there can be following side effects:

• Alimentary system: colitis, abdominal pain, pseudomembranous colitis, dispepsichesky frustration (nausea, diarrhea, vomiting);
• Organ of sight: burning sensation in eyes;
• Integuments: most often – a xeroderma; increase in products of sebaceous glands, irritation of skin, urticaria, contact dermatitis;
• Others: the folliculitis caused by gram-negative flora.

Special instructions

At development of diarrhea after Dalatsin's use inside or it is intravaginalno necessary to consider the possibility of development of pseudomembranous colitis. The disease can develop also in 2-3 weeks after the therapy termination. Treat its main symptoms: diarrhea, a leukocytosis, fever, abdominal pains (sometimes followed by mucifying and blood with a fecal masses). If necessary it is necessary to hold diagnostic and medical events. At external use of drug cases of developing of colitis are rare, nevertheless, it is necessary to show care and, in case of developing of the long or expressed diarrhea, use of gel should be cancelled.

At the infections of a neck of uterus caused by Chlamydia trachomatis, monotherapy by Dalatsin in the form of capsules is effective for full treatment.

At Dalatsin's reception the excess growth of microorganisms, insensitive to drug, in particular drozhzhepodobny mushrooms is inside possible. In case of development of superinfection depending on a clinical situation it is necessary to take the appropriate measures.

It is not necessary to appoint clindamycin for treatment of meningitis.

At Dalatsin's appointment in high doses it is necessary to control concentration of clindamycin in plasma. At long therapy it is regularly necessary to conduct researches of function of kidneys and a liver.

Before Dalatsin's appointment for treatment of a vulvovaginitis it is necessary to exclude its following possible activators: Chlamydia trachomatis, Trichomonas vaginalis, Candida albicans, Neisseria gonorrhoeae and Herpes simplex virus.

It is necessary to consider that intravaginalny use of drug can cause the strengthened growth of microorganisms, insensitive to its action, especially drozhzhepodobny mushrooms.

At intravaginalny use of drug it is necessary to avoid sexual contacts, and also use of other types of the products entered intravaginalno (for example, syringes, tampons).

Dalatsin's use in the form of cream or suppositories in the period of periods is not recommended. The beginning of therapy in this case needs to be postponed until the termination of periods.

Dalatsin contains the components influencing durability of products from rubber or latex (contraceptive vaginal diaphragms, condoms). Use of similar products during therapy and within 3 days after use of drug is not recommended.

It is necessary to avoid hit of gel for external use on mucous membranes of an oral cavity and eyes. After putting drug it is necessary to wash up hands carefully. At emergence of accidental contact with sensitive surfaces (grazes on skin, eyes, mucous membranes) it is necessary to wash out plentifully them cool water.

Medicinal interaction

It is not necessary to accept clindamycin inside along with erythromycin and chloramphenicol.

There is a cross lincomycin and clindamycin resistance of microorganisms.

The patients receiving other muscle relaxants of peripheral action need to apply clindamycin with care.

At simultaneous use of Dalatsin inside with the opioid (narcotic) analgetics possessing the central oppressing action on breath function development of more expressed respiratory depression up to an apnoea is possible.

The risk of development of pseudomembranous colitis increases at simultaneous use of Dalatsin with the antidiarrheal drugs reducing motility of digestive tract.

The range of antimicrobic effect of clindamycin is expanded by aminoglycosides.

Simultaneous use of vaginal cream and suppositories with other medicines for intravaginalny introduction is not recommended.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C. Not to freeze.

Period of validity:

• Capsules – 5 years;
• Cream vaginal, gel for external use – 2 years;
• Suppositories vaginal – 3 years.