CLINDAMYCIN-HAMELN SOLUTION FOR INJECTION 150MG/ML [SIN14599P]

Product Info

CLINDAMYCIN-HAMELN SOLUTION FOR INJECTION 150MG/ML

[SIN14599P]

Indication

4.1 Therapeutic indications

Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram-positive aerobic bacteria such as streptococci, staphylococci and pneumococci.

1. Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.

2. Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess.

3. Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses and wound infections, specific skin and soft tissue infections caused by susceptible organisms like erysipelas and paronychia (panaritium).

4. Bone and joint infections including osteomyelitis and septic arthritis.

5. Gynecological infections including endometritis, cellulitis, vaginal cuff infection, tubo-ovarian abscess, salpingitis, and pelvic inflammatory disease when given in conjunction with an antibiotic of appropriate gram-negative spectrum.

6. Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram-negative spectrum.

7. Septicemia and endocarditis. The effectiveness of clindamycin in the treatment of selected cases of endocarditis has been documented when clindamycin is determined to be bactericidal to the infecting organism by in vitro testing of appropriate achievable serum concentrations.

8. Dental infections such as periodontal abscess and periodontitis.

9. Toxoplasmic encephalitis in patients with AIDS. In patients who are intolerant to conventional treatment, clindamycin in combination with pyrimethamine has been shown to be efficacious.

10. Pneumocystis jirovecii (previously classified as Pneumocystis carinii) pneumonia in patients with AIDS. In patients who are intolerant to, or do not respond adequately to conventional treatment, clindamycin may be used in combination with primaquine.

Clindamycin phosphate, when used concurrently with an aminoglycoside antibiotic such as gentamicin or tobramycin, has been shown to be effective in preventing peritonitis or intra-abdominal abscess after bowel perforation and bacterial contamination secondary to trauma.

Limited data from uncontrolled studies using a variety of doses suggest that clindamycin, either orally or parenterally at a dose of 20 mg/kg/day for a minimum of 5 days is useful alternative therapy when used alone or in combination with quinine or amodiaquine, for the treatment of multi-drug resistant Plasmodium falciparum infection.

Dosing

4.2 Posology and method of administration

Dosage and route of administration should be determined by the severity of the infection, the condition of the patient, and the susceptibility of the causative micro-organisms.

Posology

Adults: dosage of Clindamycin-hameln (IM or IV administration)
The usual daily adult dosage of clindamycin phosphate for infections of the intra-abdominal area, female pelvis, and other complicated or serious infections is 2400–2700 mg given in 2, 3, or 4 equal doses. Less complicated infections due to more susceptible micro-organisms may respond to lower doses such as 1200–1800 mg/day administered in 3 or 4 equal doses. Doses of up to 4800 mg daily have been used successfully.

Single IM doses of greater than 600 mg are not recommended.

Children over 1 months of age: dosage of Clindamycin-hameln (IM or IV administration)
20–40 mg/kg/day in 3 or 4 equal doses.

Neonates (under 1 month of age) : dosage of Clindamycin-hameln (IM or IV administration)
15–20 mg/kg/day in 3 or 4 equal doses. The lower dosage may be adequate for small premature infants.

Clindamycin-hameln must be dosed based on total body weight regardless of obesity (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly
The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone. See section 4.4 for other factors which should be taken into consideration – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

BETA-HEMOLYTIC STREPTOCOCCAL INFECTIONS
In cases of beta-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

TOXOPLASMIC ENCEPHALITIS IN PATIENTS WITH AIDS
Clindamycin-hameln IV or clindamycin hydrochloride by mouth 600–1200 mg every 6 hours for two weeks followed by 300–600 mg by mouth every 6 hours. The usual total duration of therapy is 8 to 10 weeks. The dose of pyrimethamine is 25 to 75 mg by mouth daily for 8 to 10 weeks. Folinic acid 10 to 20 mg/day should be given with higher doses of pyrimethamine.

PNEUMOCYSTIS CARINII PNEUMONIA IN PATIENTS WITH AIDS
Clindamycin-hameln IV 600 to 900 mg every 6 hours or 900 mg IV every 8 hours or clindamycin hydrochloride 300 to 450 mg by mouth every 6 hours for 21 days and primaquine 15 to 30 mg dose by mouth once daily for 21 days.

Hepatic impairment
In patients with liver disease of moderate to severe degree, the elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if Clindamycin-hameln is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic insufficiency.

Renal impairment
In the presence of kidney disease, elimination half-life is prolonged; however, a dosage reduction is not necessary in the event of mild to moderate impairment of renal function. Nevertheless, the plasma concentration should be monitored in patients with severe renal insufficiency or anuria.

Dosage in the event of haemodialysis
Clindamycin cannot be removed by haemodialysis. Therefore, no additional dose is necessary before or after haemodialysis.

Method of administration
For intramuscular injection or intravenous infusion after dilution.

This medicinal product MUST NOT be administered as an intravenous bolus injection as rapid intravenous injection of undiluted clindamycin may lead to cardiac arrest (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The medicinal product should be visually inspected prior to use and also after dilution. The product should not be used if it contains any particles or in case of strong coloration of the solution.
Only clear solutions practically free from visible particles should be used.

Intravenous infusion
For use via intravenous infusion, this medicinal product must be diluted. For instructions on dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. For a single infusion, no more than 1200 mg of clindamycin should be infused per hour. The concentration of clindamycin should not exceed 18 mg/ml and the rate of infusion should not exceed 30 mg/min.

Intramuscular injection
For use via the intramuscular injection, this medicinal product should be used undiluted. Individual intramuscular doses greater than 600 mg of clindamycin are not recommended.

Contraindications

4.3 Contraindications

Hypersensitivity to clindamycin or to lincomycin or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.