Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**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. **_Adults:_** 600–1800 mg/day divided in 2, 3 or 4 equal doses. **_Children over 1 month of age:_** Doses of 8–25 mg/kg/day in 3 or 4 equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use other clindamycin formulations in some cases. To avoid possibility of esophageal irritation, capsules should be taken with a full glass of water. BETA-HEMOLYTIC STREPTOCOCCAL INFECTIONS In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days. ACUTE STREPTOCOCCAL TONSILLITIS/PHARYNGITIS In the treatment of acute streptococcal tonsillitis/pharyngitis, clindamycin hydrochloride capsules 300 mg may be taken twice daily for 10 days. TOXOPLASMIC ENCEPHALITIS IN PATIENTS WITH AIDS 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 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. If significant diarrhea occurs during therapy, this antibiotic should be discontinued.
ORAL
Medical Information
**Therapeutic Indication** 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._ 01. Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever. 02. Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess. 03. 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). 04. Bone and joint infections including osteomyelitis and septic arthritis. 05. 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. 06. Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram-negative spectrum. 07. 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. 08. Dental infections such as periodontal abscess and periodontitis. 09. 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. 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.
**Contraindications** Hypersensitive to Clindamycin or lincomycin or to any component of the formulation.
J01FF01
clindamycin
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
PT. Novell Pharmaceutical Laboratories
Active Ingredients
Documents
Package Inserts
Novell-Clindamycin Capsule PI.pdf
Approved: December 11, 2023