Summary of content

Clindamycine

Visa No.: 893110177924

Product: Clindamycin EG 300mg

API: Clindamycin

Product Category: Antibiotics

Version approved leaflet: 16363e/QLD-ĐK_22/04/2025

 

INDICATIONS

  • Clindamycin is indicated for the treatment of severe infections caused by susceptible anaerobic bacteria and susceptible Gram-positive aerobic organisms, including: Staphylococcus, Streptococcus, Pneumococcus and Chlamydia trachomatis.
  • Clindamycin is used in patients with penicillin allergy where penicillin is not appropriate. Indications include:
  • Upper respiratory tract infections: tonsillitis, pharyngitis, otitis media
  • Lower respiratory tract infections: pneumonia, pleural empyema, lung abscess
  • Skin and soft tissue infections, bone and joint infections, septicaemia
  • Intra-abdominal infections: peritonitis, intra-abdominal abscess
  • Gynaecological infections: severe pelvic infections, pelvic cellulitis, endometritis, tubo-ovarian abscess, non-gonococcal pelvic infections, post-operative vaginal cuff infections caused by anaerobic bacteria
  • Prophylaxis of endocarditis or infection related to surgical implants in patients allergic to penicillin
  • Acne vulgaris, infected pressure sores, chronic leg ulcers
     

DOSAGE AND ADMINISTRATION

Method of administration: Oral use

Dosage

Adults:
The dose may range from 150–300 mg or 300–450 mg every 6 hours, depending on the severity of the infection.

Children:
Severe infections: 8–16 mg/kg/day, pided into 3 or 4 doses
Very severe infections: 16–20 mg/kg/day, pided into 3 or 4 doses
In infections caused by Streptococcus group A beta-haemolytic strains, treatment should be continued for at least 10 days.
To reduce the risk of oesophageal irritation, clindamycin should be taken with a full glass of water.
Special populations

Elderly patients:
The elimination half-life of clindamycin is slightly prolonged after oral administration; however, pharmacokinetic data from clinical studies do not indicate any clinically relevant increase in toxicity. Therefore, dose adjustment is not required in elderly patients.

Patients with renal or hepatic impairment:
Dose reduction is recommended in patients with severe renal or hepatic impairment.
Dose adjustment is not necessary in patients with mild to moderate renal or hepatic impairment.
 

CONTRAINDICATIONS

Hypersensitivity to clindamycin, lincomycin, or any excipients of the product
Presence of diarrhoea
 

WARNINGS AND PRECAUTIONS

This medicine is for prescription use only.
Read the instructions for use carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.