Clindamycin STELLA 300 mg

Rx

Indications

• Clindamycin has been shown to be effective in the treatment of the infections caused by susceptible strains of gram positive aerobic bacteria, such as streptococci, staphylococci and pneumococci; and susceptible strains of Chlamydia trachomatis.
• Upper respiratory infections (tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever).
• Lower respiratory infections (bronchitis, pneumonia, empyema and lung abscess).
• Skin and soft tissue infections (acne, furuncles, cellulitis, impetigo, abscesses, and wound infections, erysipelas and paronychia).
• Bone and joint infections (osteomyelitis and septic arthritis).
• Gynecological infections (endometritis, cellulitis, vaginal cuff infection, tubo-ovarian abscess and salpingitis, cervicitis due to Chlamydia trachomatis).
• Intra-abdominal infections (peritonitis, abdominal abscess).
• Septicemia and endocarditis.
• Dental infections (periodontal abscess, periodontitis)
• Pneumocystis jirovecii pneumonia in patients with AIDS.
• Malaria: For this indication, please refer to latest guidelines of diagnostic and treatment for malaria issued by Ministry of Health.
• Prophylaxis of endocarditis in patients sensitive/allergic to penicillin(s).

Dosage

• Adults
  300 mg/time every 6, 8, 12 hours or 600 mg/time every 8, 12 hours.
• Children are able to swallow capsules.
  8 – 25 mg/kg/day divided into three or four equal doses.
  The use of capsules may not be suitable to provide the exact mg/kg doses required for the treatment of children; therefore, use of suitable dosage forms is recommended in the other cases.
• Children who are unable to swallow capsules: Shoud not use this drug.
• Elderly
  Dosage adjustments are not necessary.
• Renal impairment patients and hepatic impairment patients
  Dosage adjustments are not necessary .
• Specific indications
  Treatment of Beta-Hemolytic Streptococcal infections:
  Refer to the dosage recommendations above under Adults, Children: Treatment should be continued for at least 10 days.
  Treatment of Chlamydia trachomatis cervicitis:
  Clindamycin hydrochloride capsules orally 600 mg, 3 times daily for 10 – 14 days.
  Treatment of Pneumocystis jirovecii pneumonia in patients with AIDs:
  Clindamycin hydrochloride 300 mg every 6 hours or 600 mg every 8 hours orally for 21 days and primaquine 15 to 30 mg dose orally once daily for 21 days.
  Treatment of acute streptococcal tonsillitis/pharyngitis:
  Clindamycin hydrochloride capsules 300 mg orally twice daily for 10 days.
  Treatment of malaria:
  Please refer to latest guidelines of diagnostic and treatment for malaria issued by Ministry of Health.
  Prophylaxis of endocarditis in patients sensitive to penicillin:
  + Adults: 600 mg 1 hour before procedure.
  + Children: 20 mg/kg 1 hour before procedure.

Usage

• Clindamycin STELLA 300 mg capsules should be orally administered with a full glass of water.

• Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin, lincomycin or to any of the excipients listed.

Common

• Pseudomembranous colitis,
• Eosinophilia,
• Rash maculo-papular,
• Liver function test abnormal.

• Severe hypersensitivity reactions, including sever skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or sever skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated.
• Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, may range in severity from mild to life-threatening.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatmentwith antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.  These infection can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
• Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
• Laboratory tests for renal and hepatic function should be carried out during prolonged therapy. The use of clindamycin may result in overgrowth of non-susceptible organisms, particularly yeasts.
• Clindamycin STELLA 300 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine
• Clindamycin should be used in pregnancy only if clearly needed.
• Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.
• The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.