The active ingredient of the drug Dalacin C Phosphate is clindamycin - a semi-synthetic antibiotic that is synthesized from lincomycin by replacing the 7-(R) hydroxyl group with a 7-(S)-chloro group.
Indications for use
Clindamycin is indicated for the treatment of severe infections caused by susceptible strains of gram-positive aerobic microorganisms, such as streptococci, pneumococci, and staphylococci, or susceptible anaerobic bacteria.
Upper respiratory tract infections: Chronic sinusitis caused by anaerobic strains. Clindamycin may be used to treat some cases of chronic suppurative otitis media or as adjunctive therapy in combination with antibiotics active against aerobic gram-negative microorganisms. The indication does not apply to infections caused by H. influenzae. Clindamycin may be used to treat recurrent pharyngotonsillitis.
Lower respiratory tract infections, including infectious exacerbations of chronic bronchitis and pneumonia. Severe skin and soft tissue infections caused by susceptible organisms. Bone and joint infections, including osteomyelitis and septic arthritis. Severe gynecological infections, including pelvic inflammatory disease. Clindamycin monotherapy can also be used for cervicitis caused by Chlamydia trachomatis. Intra-abdominal infections, including peritonitis and abdominal abscesses. Septicemia and endocarditis. In isolated cases of septicemia and/or endocarditis caused by susceptible organisms, an adequate response to clindamycin has been obtained. However, bactericidal agents are preferred for the treatment of these infections. Dental infections, including periodontal abscess and periodontitis. Toxoplasmic encephalitis in patients with AIDS. In patients intolerant to standard treatment, clindamycin can be used in combination with pyrimethamine. Pneumocystis jirovecii pneumonia in AIDS patients. In patients intolerant to standard treatment, clindamycin can be used in combination with primaquine. Severe malaria. Prophylaxis of endocarditis in patients with penicillin allergy/hypersensitivity. Prophylaxis of wound infection in head and neck surgery. Clindamycin phosphate dissolved in saline can be used for intraoperative irrigation of the surgical site. Prevention of peritonitis and intra-abdominal abscesses after perforation and post-traumatic contamination when used concomitantly with aminoglycoside antibiotics (gentamicin or tobramycin).
As with all antibiotics, before prescribing clindamycin, it is necessary to familiarize yourself with information on the prevention of local resistance, as well as official recommendations for prescribing antibiotics.
Contraindication
Hypersensitivity to the active substance, lincomycin or to any of the excipients listed in the "Composition" section.
Infectious meningitis.
Method of administration and doses
Doses.
The method of administration and dosage should be determined by the severity of the infection, the patient's condition, and the sensitivity of the microorganism causing the disease.
Clindamycin phosphate should be administered undiluted.
Clindamycin phosphate must be diluted before administration.
Adults (intravenously or intramuscularly). For the treatment of intra-abdominal infections, pelvic infections in women, and other severe infections, the standard dose of clindamycin phosphate is 2400-2700 mg (in 2, 3, or 4 equally divided doses) and is usually used in combination with an appropriate antibiotic active against gram-negative aerobic organisms.
For less complicated infections caused by more susceptible organisms, a response to treatment may be observed with lower doses: 1200-1800 mg per day (3 or 4 equally divided doses).
Doses up to 4800 mg daily have been used successfully in adults.
The use of a single intramuscular dose of more than 600 mg is not recommended.
Treatment of pelvic inflammatory disease: clindamycin phosphate 900 mg every 8:00 a.m. in combination with an acceptable antibiotic active against gram-negative organisms (e.g. gentamicin, 2 mg/kg first dose followed by 1.5 mg/kg every 8:00 a.m.) in patients with normal renal function. This treatment should be continued for at least 4 days. If clinical signs of improvement appear, treatment should be continued for an additional 2 days. Then oral clindamycin hydrochloride 1800 mg per day (in divided doses) should be administered until the full course of treatment is completed, which is 10-14 days.
Children from 1 month of age (intravenously or intramuscularly). The drug is prescribed at a dose of 20-40 mg/kg per day in 3 or 4 equal doses).
The use of Dalacin C Phosphate in children under 3 years of age is indicated only if necessary (see the section "Peculiarities of use").
Patients with renal and/or hepatic impairment. No dose adjustment is necessary for patients with renal impairment. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from the blood.
In patients with moderate to severe hepatic impairment, a prolonged half-life of clindamycin has been observed. When clindamycin is administered every 8 hours, accumulation occurs in isolated cases. Therefore, a dose reduction is not considered necessary.
Dosage for specific indications.
Dalacin C Phosphate should be administered at a dose of 600-1200 mg every 6 hours for 2 weeks, then 300-600 mg orally as capsules every 6 hours. The full course of treatment usually lasts from 8 to 10 weeks. Pyrimethamine should be administered orally at a dose of 25-75 mg per day for 8-10 weeks. Folic acid should be administered at a dose of 10-20 mg per day in conjunction with high doses of pyrimethamine.
Pneumonia caused by Pneumocystis jirovecii in patients with AIDS.
The drug is administered by intravenous infusion at a dose of 600-900 mg every 6:00 or 900 mg every 8:00 for 21 days in combination with primaquine at a dose of 15-30 mg per day for 21 days.
Severe malaria.
Adults. Quinidine gluconate: loading dose of 10 mg/kg over 1-2 hours, then 0.02 mg/kg/min, continuous infusion for at least 24 hours (alternative dosing regimens are given in the quinidine instructions for use). When the parasite density reaches <1% and the patient is able to take oral medication, treatment should be supplemented with oral quinine at the dose indicated above and oral clindamycin at a dose of 20 mg active substance/kg/day (divided into 3 doses per day for 7 days).
If the patient is unable to take oral medications, a loading dose of clindamycin of 10 mg active substance/kg should be administered, followed by 5 mg active substance/kg every 8 hours. Rapid administration should be avoided. Oral clindamycin should be switched to (oral dosage given above) as soon as the patient is able to take oral medications. The course of treatment is 7 days.
Children. Quinidine gluconate: same mg/kg dose and recommendations as for adults, and oral clindamycin 20 mg active substance/kg/day (dose divided into 3 doses per day for 7 days). If the patient cannot take oral medication, administer a loading dose of clindamycin 10 mg active substance/kg, followed by 5 mg active substance/kg every 8 hours. Avoid rapid administration. Switch to the appropriate dosage form of clindamycin (oral dose as above) as soon as the patient is able to take oral medication. The course of treatment is 7 days.
Prophylaxis of endocarditis in patients sensitive to penicillin.
As an alternative treatment, if parenteral administration is necessary, 600 mg of clindamycin phosphate should be administered 1 hour before the procedure.
Prevention of infections during surgical interventions in the head and neck area.
900 mg of clindamycin phosphate dissolved in 1000 ml of saline should be used to flush the affected area during head and neck surgery prior to wound closure.
Method of application.
Dilution and infusion rate for intravenous administration.
The concentration of clindamycin in the diluted state should not exceed 18 mg/ml, and the infusion rate should not exceed 30 mg/min (see section "Adverse reactions"). The values of the infusion rate are given below:
| dose | amount of solvent | time of entry |
| 300 mg | 50 ml | 10 min |
| 600 mg | 50 ml | 20 min |
| 900 mg | 100 ml | 30 minutes |
| 1200 mg | 100 ml | 40 min |
Intravenous infusions at doses exceeding 1200 mg per hour are not recommended.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Overdose
Clindamycin toxicity is not dose-related. Overdose does not cause specific symptoms. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from serum.
Composition
active ingredient: clindamycin;
1 ml of clindamycin phosphate 150 mg (corresponds to clindamycin base)
Excipients: benzyl alcohol, sodium edetate, water for injections.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Shelf life - 2 years.
Incompatibility
The following drugs are physically incompatible with clindamycin phosphate solution for injection: ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, ceftriaxone sodium, and ciprofloxacin.
Compatibility.
Solutions of clindamycin phosphate in 5% glucose in water and in sodium chloride solution to which the following antibiotics have been added at standard concentrations remain stable for at least 24 hours: amikacin sulfate, aztreonam, cefamandole naphtha, cefazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulfate, netromycin sulfate, piperacillin, and tobramycin.
The compatibility and stability of these mixtures may vary depending on concentration and other conditions.
