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 benzathine benzylpénicilline (500mg poudre pour injection)  
 

Indications

– Early syphilis, late syphilis or syphilis of unknown duration
– Congenital syphilis (absence of clinical signs in the neonate and adequate treatment in the mother)
– Endemic treponematoses (yaws, bejel, pinta)
– Streptococcal tonsillitis 
– Prophylaxis of diphtheria in the event of direct contact
– Primary and secondary prophylaxis of rheumatic fever

Forms and strengths, route of administration

– Powder for injection in vials of:
• 1.2 MIU (900 mg), to be dissolved in 4 ml of water for injection, for IM injection
• 2.4 MIU (1.8 g), to be dissolved in 8 ml of water for injection, for IM injection
NEVER FOR IV INJECTION NOR INFUSION

Dosage

– Syphilis
Child: 50 000 IU (37.5 mg)/kg per injection (max. 2.4 MIU or 1.8 g per injection)
Adult: 2.4 MIU (1.8 g) per injection

– Yaws, bejel, pinta
Child under 10 years: 1.2 MIU (900 mg) per injection

Child 10 years and over and adult: 2.4 MIU (1.8 g) per injection

– Streptococcal tonsillitis, prophylaxis of diphtheria, prophylaxis of rheumatic fever
Child under 30 kg: 600 000 IU (450 mg) per injection
Child 30 kg and over and adult: 1.2 IU (900 mg) per injection

Duration

 Congenital syphilis, early syphilis, tonsillitis, yaws, bejel, pinta, prophylaxis of diphtheria, primary prophylaxis of rheumatic fever: single dose; late syphilis or syphilis of unknown duration: one injection/week for 3 weeks; secondary prophylaxis of rheumatic fever: one injection every 4 weeks for several years

Contra-indications, adverse effects, precautions

– Do not administer to penicillin-allergic patients.
– Administer with caution to patients allergic to cephalosporins (cross-sensitivity may occur) and renal impairment (reduce dosage).
– May cause:
• gastroinstestinal disturbances, pain at injection site, allergic reactions sometimes severe;
• Jarisch-Herxheimer reaction (fever, chills, myalgia, tachycardia) in patients with syphilis;
• convulsions in the event of high dosages or renal impairment;
• symptoms of shock with neuropsychiatric disorders if accidentally injected intravascularly.
– Ensure that the IM injection does not enter a blood vessel.
– Do not combine with methotrexate.
– Pregnancy: no contra-indication
– Breast-feeding: no contra-indication

© 2010 Noro Bio-Pharmaceutical Co., Ltd. all rights reservedExport Company