Clindastad 150

Rx

Indications

• Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.
• Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess.
• Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses, and wound infections, specific skin and soft tissue infections like erysipelas and paronychia (panaritium).
• Bone and joint infections including osteomyelitis and septic arthritis.
• Gynecological infections including endometritis, cellulitis, vaginal cuff infection, tubo-ovarian abscess and salpingitis when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. In cases of cervicitis due to Chlamydia trachomatis, single drug therapy with clindamycin has been shown to be effective in eradicating the organism.
• Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum.
• 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.
• Dental infections, such as periodontal abscess and periodontitis.
• 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.
• 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.
• Clindastad 150 capsules should not be used for children who are unable to swallow capsules.
• Elderly
  Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration. Therefore, dosage adjustments are not necessary in the elderly with normal hepatic function and normal (age-adjusted) renal function.
• Clindamycin dosage modification is not necessary in patients with renal and hepatic insufficiency.

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:
  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 to penicillin:
  Adults: 600 mg 1 hour before procedure; children: 20 mg/kg 1 hour before procedure.

Usage

• Clindastad 150 is administered orally.
• To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.

Patients previously found to be sensitive to clindamycin, lincomycin or to any of the ingredients.

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

• Severe hypersensitivity reactions, including severe 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 severe 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. Therefore, it is important to consider the diagnosis in patients who present with diarrhea subsequent to be administration of antibacterial agents.
• Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of the clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic associated colitis”. After the primary diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.
• Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
• 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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections 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 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.
• Patients should be aware of how they react to drug before driving or operating machinery.