DALACIN C CAPSULE 300 mg

Fareva Amboise (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Sep 12, 1997
Approval ID: 70f0308b4add6eac
Company: Fareva Amboise (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: 70f0308b4add6eac
Drug Name: DALACIN C CAPSULE 300 mg
Product Name: DALACIN C CAPSULE 300 mg
Approval Number: SIN09496P
Approval Date: 1997-09-12
Registrant: PFIZER PRIVATE LIMITED
Licence Holder: PFIZER PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: CAPSULE
Dosage: 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 1 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 and no less than 30 minutes before lying down. 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. To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water and no less than 30 minutes before lying down. 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. <img src="/TGIF/DalacinC-Image1.png" alt="Dalacin C Dosage Image 1" /> 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: <img src="/TGIF/DalacinC-Table1_030322.png" alt="Dalacin C Dosage Table 1" /> Administration of more than 1200 mg in a single 1-hour infusion is not recommended.
Route Of Administration: ORAL
Indication Info: 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. <ol> <li>Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.</li> <li>Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess.</li> <li>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).</li> <li>Bone and joint infections including osteomyelitis and septic arthritis.</li> <li>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.</li> <li>Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram-negative spectrum.</li> <li>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.</li> <li>Dental infections such as periodontal abscess and periodontitis.</li> <li>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.</li> <li>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.</li> </ol> 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.
Contraindications: 4.3. Contraindications Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or lincomycin or to any component of the formulation.
Atc Code: J01FF01
Atc Item Name: clindamycin
Pharma Manufacturer Name: PFIZER PRIVATE LIMITED

Active Ingredients

CLINDAMYCIN HCl EQV CLINDAMYCIN

300 mg

CLINDAMYCIN HCl EQV CLINDAMYCIN

300 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 12, 1997

Approval ID

70f0308b4add6eac

Type

Therapeutic

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