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HSA Approval

DALACIN C CAPSULE 150 mg

SIN02170P

DALACIN C CAPSULE 150 mg

DALACIN C CAPSULE 150 mg

June 28, 1988

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Regulatory Information

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

CAPSULE

**4.2. Posology and method of administration** Clindamycin phosphate IM administration should be used undiluted. Clindamycin phosphate IV administration should be diluted (See **DILUTION FOR IV USE AND IV INFUSION RATES** below). 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: DOSAGE OF CLINDAMYCIN PHOSPHATE (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 ONE MONTH OF AGE: DOSAGE OF CLINDAMYCIN PHOSPHATE (IM OR IV ADMINISTRATION)** 20–40 mg/kg/day in 3 or 4 equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. **NEONATES (UNDER 1 MONTH OF AGE): DOSAGE OF CLINDAMYCIN PHOSPHATE (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. **ADULTS: DOSAGE OF ORAL CLINDAMYCIN HYDROCHLORIDE CAPSULES** 600–1800 mg/day divided in 2, 3 or 4 equal doses. To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. **CHILDREN OVER 1 MONTH OF AGE: DOSAGE OF ORAL CLINDAMYCIN HYDROCHLORIDE CAPSULES** 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 the clindamycin palmitate oral solution in some cases. To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. **CHILDREN OVER 1 MONTH OF AGE: DOSAGE OF ORAL CLINDAMYCIN PALMITATE SOLUTION** 1. 8–25 mg/kg/day in 3 or 4 equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. 2. In children weighing 10 kg or less, 1/2 teaspoon (37.5 mg) of clindamycin palmitate solution three times a day should be considered the minimum recommended dose. BETA-HEMOLYTIC STREPTOCOCCAL INFECTIONS In cases of beta-hemolytic streptococcal infections, treatment should be continued 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 phosphate 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 phosphate 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. IMPORTANT No ampoule file is needed to open the ampoules. The neck of the ampoules is prescored at the point of constriction. A colored dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the colored dot. The ampoule opens easily by placing the thumb on the colored dot and gently pressing downwards as shown. ![Dalacin C Dosage Image 1](https://cdn.medpath.com/drug/dosage/20240520/ee84a1201a8d655be8844ce8c177bdcc.png) **DILUTION FOR IV USE AND IV INFUSION RATES** The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL and INFUSION RATES SHOULD NOT EXCEED 30 mg PER MINUTE. The usual infusion rates are as follows: ![Dalacin C Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/6ff3efbe156ba70a4fdec9c3973763ef.png) Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

ORAL

Medical Information

**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. 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. 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.

**4.3. Contraindications** Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or lincomycin or to any component of the formulation.

J01FF01

clindamycin

Manufacturer Information

PFIZER PRIVATE LIMITED

Fareva Amboise

Active Ingredients

CLINDAMYCIN HCl HYDRATE EQV CLINDAMYCIN

150 mg

Clindamycin

Documents

Package Inserts

Dalacin C PI.pdf

Approved: March 3, 2022

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