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1000mg AMOXICILLIN SODIUM and 200mg CLAVULANATE POTASSIUM Powder For Injection
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1000mg AMOXICILLIN SODIUM and 200mg CLAVULANATE POTASSIUM Powder For Injection AMOXICILLIN SODIUM & CLAVULANATE POTASSIUM
FOR I.V. INJECTION
COMPOSITION:
Each vial contains 1000mg amoxicillin (as the sodium salt) and 200mg clavulanic acid (as the potassium salt).
INDICATIONS:
Upper respiratory tract infections, e.g. otitis media, sinusitis.
Lower respiratory tract infections, e.g. bronchitis.
Genito-urinary tract infections, e.g. cystitis, urethritis.
Skin and soft tissues infections, e.g. severe dental abscess, wound infections, cellulitis.
DOSAGE AND ADMINISTRATION:
Dissolve one vial of Amoxicil in Sodium & Clavulanate Potassium in 20ml Water for Injection BP. Inject slowly.
The constituted solution must be used up within 20 minutes below 25oC.
Dissolve one vial of Amoxicil in Sodium & Clavulanate Potassium in 20ml Water for Injection BP and then add the reconstituted solution to 100ml Sodium
Chloride intravenous injection BP 0.9% w/v. Infuse over 30 minutes.
The diluted solution must be used up within 1 hour below 25ºC.
Adult and children over 12 years: 1.2g of Amoxicil in Sodium & Clavulanate Potassium every 8 hours. In severe infections, increase frequency to six-hourly
Children 3 months to 12 years: 30mg/kg* of Amoxicil in Sodium & Clavulanate Potassium every 8 hours. In severe infections, increase frequency to six-hourly
Children 0 - 3months: 30mg/kg* of Amoxicil in Sodium & Clavulanate Potassium every 12 hours in premature infants and in full-term infants during the perinatal
period, increasing to eight hours thereafter.
* each 30mg Amoxicil in Sodium & Clavulanate Potassium provides 25mg amoxicillin and 5mg clavulanic acid.
CONTRAINDICATIONS:
Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other ß-lactam antibiotics, e.g. cephalosporins.
Previous history of amoxicillin or penicillin-associated jaundice/hepatic dysfunction.
PRECAUTIONS:
1. Before starting therapy with Amoxicil in Sodium & Clavulanate Potassium, previous hypersensitivity reactions (e.g. penicillin hypersensitivity) should be
2. Use Amoxicil in Sodium & Clavulanate Potassium with caution in patients with hepatic dysfunction and dosage adjustment should be made in patients with
3. Amoxicil in Sodium & Clavulanate Potassium cannot be used for intramuscular administration.
4. Amoxicil in Sodium & Clavulanate Potassium is less stable in infusions containing glucose, dextran or bicarbonate.
DRUG INTERACTION:
1. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
2. Amoxicil in Sodium & Clavulanate Potassium should be used with care in patients on anti-coagulation therapy e.g. warfarin, as prolongation of bleeding time
and prothrombin time have been reported in some patients.
Amoxicil in Sodium & Clavulanate Potassium may reduce the efficacy of oral contraceptives.
PREGNANCY AND LACTATION:
Use in pregnancy should be avoided. Amoxicil in Sodium & Clavulanate Potassium may be given during lactation. With the exception of the risk of sensitization,
associated with the excretion of trace amount in breast milk, there are no detrimental effects for the infant.
UNDESIRABLE EFFECTS:
1. Hypersensitivity reactions: urticarial and erythematous rashes.
2. Gastrointestinal reactions: nausea, vomiting, diarrhoea, indigestion.
3. Hepatic effects: moderate rises in AST and/or ALT have been reported occasionally. Hepatitis and cholestatic jaundice have been reported rarely.
4. Rare effects on the central nervous system may occur, such as reversible hyperactivity, dizziness, headache and convulsions.
5. Phlebitis at the injection site has been reported occasionally.
SHELF-LIFE:
SPECIAL PRECAUTIONS FOR STORAGE:
* To use Amoxicil in Sodium & Clavulanate Potassium under the instructions of the doctors and pharmacists.
Suzhou Carenovo Biopharma Co., Ltd.
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Address:
NO# 108 Shzouzhou East Road Yangshe Town Zhangjiagang City Jiangsu China

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