Regulatory Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION
**Dosage and Administration:** Single I.M. injection should not exceed 600mg; for I.V. infusion, do not administer more than 1200mg in a single 1 hour infusion. Adult dose: I.M. or I.V. Ordinary infections: 600–1200mg/day in 2,3 or 4 equal doses. Serious infections: 1200–1800mg/day in 3 or 4 equal doses. Very serious infections: 2400–2700mg/day in 2,3 or 4 equal doses. In life threatening situations, a maximum of 4800mg/day may be given I.V. May be administered as a single rapid infusion on the first dose and followed by continuous I.V. infusion, as follows: To maintain serum  To prepare initial dilution for I.V. dose, each dose must be diluted as follows (it must not be administered undiluted as a bolus):  Children dose: I.M. or I.V. Infants up to 1 month of age: 15–20mg/kg/day in 3 or 4 equal doses. Over 1 month of age: 20–40mg/kg/day in 3 or 4 equal doses. May be given based on body surface area: Serious infections: 350mg/m2/day More serious infections: 450mg/m2/day In _β_-hemolytic streptococcal infection, treatment should be continued for at least 10 days. To be administered only by a physician.
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**Indications:** For the treatment of serious infections due to susceptible strains of Staphylococci, Streptococci, Pneumococci, and anaerobic bacteria.
**Contraindications:** 1. History of gastrointestinal disease, especially ulcerative colitis, regional enteritis, and antibiotic-associated colitis. Clindamycin may cause pseudomembranous colitis. 2. Severe hepatic function impairment. Half-life of Clindamycin is prolonged in this condition, therefore may require dosage adjustment. 3. Hypersensitivity to Lincomycins and doxorubicin. 4. Severe renal function impairment may require reduction of dosage.
J01FF01
clindamycin
Manufacturer Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
YUNG SHIN PHARMACEUTICAL IND CO LTD
Active Ingredients
Documents
Package Inserts
Attachment 3 TDI- Proposed Clean PI.pdf
Approved: September 6, 2022