Audited Supplier
1mega, 5mega/10ml
for Injection
I.M./I.V.
Elderly, Children, Adult
Solid
Powder
Inorganic Chemicals
Chemical Synthesis
Design
69-57-8
Bulk
African
RYAN PHARMA
Carton
1mega, 5mega/10ml, 10vials or 50vials/box
China
Product Description
Benzylpenicillin Sodium for Injection 1mega, 5mega/10ml
PresentationPowder for injection using parenteral IM/IV of 1 MIU and 5 MIU
Composition
- Benzylpenicillin 1 MIU:
In the form of benzylpenicillin sodium 600mg/vial.
Sodium content: 38.7mg or 1.68 mmo1.
- Benzylpenicillin 5 MIU:
In the form of benzylpenicillin sodium 3 g/via1
Sodium content: 193.6mg or 8.4mmol
Therapeutic Class
Beta-lactams antibiotics
Indication
Infections due to susceptible organisms, causing following infections:
·Respiratory,
·Dental and ENT,
·Skin,
·Renal, urogenital,
·Gynecological,
·Digestive and bile,
·Meningitis,
·Sepsis (possibly in combination therapy)
·Gas gangrene.
Dosage and Administration
Adult: 3 to 6 MIU/day (I.M. or I.V. route)
Child and baby: 160 000 to 480 000 IU/kg/ day (l.M. or I.V. route)
New born: 80 000 to 240 000 IU/kg/day(Infusion I.V. route)
Higher doses may be taken by infusion, particularly in cases of endocarditis.
Do not exceed:
·Adult: 50 MIU/day
·Child and New born: 20MIU/day.
Contraindications
Known allergy to beta-lactam antibiotics (penicillins, cephalosporins).
Precaution of Use
Occurrence of any allergic reaction requires stopping treatment.
Severe and sometimes fatal hypersensitivity reactions (anaphylaxis) have been exceptionally observed in patients treated with beta-lactams
Lack of previous reactions to treatment with penicillins or cephalosporins must be informed and considered before any administration (risk of cross-allergy in 5 to 10% of cases).
Face with specific allergy to these products, contra-indication is strict.
In case of renal failure, dosage adjustments based on creatinine or creatinine clearance must be done (only at very high doses).
Consider sodium content per bottie: 46.6mg to 48.8 mg (from 2.03 to 2.12 mmol/mEq).
Drug Interactions
Particular problems of INR imbalance
Many cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics. Age and general condition of the patient appear as risk factors for infectious or inflammatory context. In these circumstances, it is difficult to distinguish between infectious disease and its treatment in the occurrence of INR imbalance.However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins
Side Effects
·Allergic reactions including fever, urticaria, eosinophilia, rarely angioedema, exceptionally anaphylactic shock
·Administration of high doses of beta-lactams, particularly in renalfailure, may cause metabolic encephalopathy (altered consciousness, abnormal movements, seizures).
·Epilepsy is possible when high doses are used (50 MIU), as well as intravenous injections over 5 MIUare made quickly.
·High doses can also cause sodium overload in heart or kidney failure
·It has been observed rare cases of increased transaminases( AST, ALT)
·Reversible hematologic reactions: rare cases of anemia, leukopenia or thrombocytopenia were observed at high I.V. doses.
Pregnancy and Breast feeding
Benzylpenillin may be prescribed if needed during pregnancy. It can be administered during breast feeding, nevertheless, breast feeding (or medicine) must be suspended in case of diarrhea, candidiasis and rash appear to the baby.
Storage
- Store in a cool (below 30C), dark and dry place. Protect from light.
- Do not use after expiry date printed on the box.
- Keep out of the reach of children
