APIS

Active Pharmaceutical Ingredient	CAS NO.	Molecular Formula	Definition	Structural Formula
Amoxicillin Sodium	34642-77-8	C16H18N3NaO5S	[2S-[2a,5a,6b(S*)]]-6-[[Amino(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid
Potassium clavulanate	61177-45-5	C8H8KNO5	(Z) - (2 S, 5 R - 3 - (2 - hydroxyl ethyl) - 7 - oxygen generation - miscellaneous - 1-4 - oxygen nitrogen mixed double loop - 3.2.0 - heptane - 2 - carboxylic acid potassium

Products Specications

Products	Specification	Vomume of vials	Packing form
Amoxicillin Sodium and Clavulanate Potassium for Injection 0.6g,1.2g	BP	10ml mould vials	50vials/box
			10vials/box
			5vials/box
			1+1WFI/box
			1vial/box
		12ml mould vials	1+1WFI/box
		15ml mould vials	1+1WFI/box
		20ml mould vials	25vials/box
			10vials/box
			5vials/box
			1+1WFI/box
			1vial/box

Composition:

Each vial contains:

Amoxicillin Sodium B.P. equivalent to 1.0g Amoxicillin anhydrous

Clavulanate Potassium B.P. equivalent to 0.2g Clavulanic Aicd

API mixing

Filling

Vial sterilization

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.

Administration and Dosage

Dosage And Administration

-Intravenous injection:

Dissolve one vial of Amoxicillin Sodium And Clavulanate Potassium For Injection in 20ml Water for Injection BP. Inject slowly.

The constituted solution must be used up within 20 minutes below 25℃

-Intravenous infusion:

Dissolve one vial of Amoxicillin Sodium And Clavulanate Potassium For Injection in 10ml Water for Injection BP and then add the reconstituted solution to 50ml 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.

For treatment of infections:

Adult and children over 12 years: 1.2g of AMOXICILLIN + CLAVULANIC ACID FOR INJECTION every 8 hours. In severe infections, increase frequency to six-hourly intervals.

Children 3 months to 12 years: 30mg/kg* of AMOXICILLIN + CLAVULANIC ACID FOR INJECTION every 8 hours. In severe infections, increase frequency to six-hourly intervals.

Children 0 - 3months: 30mg/kg* of AMOXICILLIN + CLAVULANIC ACID FOR INJECTION every 12 hours in premature infants and in full-term infants during the perinatal period, increasing to eight hours thereafter.

* each 30mg AMOXICILLIN + CLAVULANIC ACID FOR INJECTION 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

Before starting therapy with AMOXICILLIN + CLAVULANIC ACID FOR INJECTION, previous hypersensitivity reactions (e.g. penicillin hypersensitivity) should be inquired.

Use AMOXICILLIN + CLAVULANIC ACID FOR INJECTION with caution in patients with hepatic dysfunction and dosage adjustment should be made in patients with kidney dysfunction.

AMOXICILLIN + CLAVULANIC ACID FOR INJECTION cannot be used for intramuscular administration.

AMOXICILLIN + CLAVULANIC ACID FOR INJECTION 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.AMOXICILLIN + CLAVULANIC ACID FOR INJECTION 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.

AMOXICILLIN + CLAVULANIC ACID FOR INJECTION may reduce the efficacy of oral contraceptives.

PREGNANCY AND LACTATION:

Use in pregnancy should be avoided. AMOXICILLIN + CLAVULANIC ACID FOR INJECTION 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.