APIS

Active Pharmaceutical Ingredient	CAS NO.	Molecular Formula	Definition	Structural Formula
Ampicillin Sodium	69-52-3	C16H18N3NaO4S	4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, [6-(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-, monosodium salt, [2S-[2α,5α,6β(S*)]]-; Monosodium D-(−)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
Cloxacillin Sodium	642-78-4	C19H18Cl2N3NaO6S	4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2-chlorophenyl)-5-methyl-4-isoxazolyl]carbonyl]amino]-3,3-dimethyl-7-oxo-, sodium salt, (2S,5R,6R)- (1:1); Sodium (2S,5R,6R)-6-({[3-(2-chlorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate; [(5R,6R)-6-({[3-(2,6-dichlorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylato-kappaO]sodium hydrate (1:1)

Products Specications

Products	Specification	Vomume of vials	Packing form
Ampicillin Sodium and Cloxacillin Sodium for Injection 0.5g,1g	In-house Standard	7ml mould vials/ 7ml tube vials	50vials/box
			10vials/box
			1vial/box
		10ml mould vials/ 10ml tube vials	50vials/box
			10vials/box
			1vial/box
			1+1WFI/box
		12ml mould vials	50vials/box
		12ml mould vials	10vials/box
		15ml mould vials	50vials/box

Composition:

Each vial contains Ampicillin Sodium Equivalent to Ampicillin 250mg; Cloxacillin sodium Equivalent to Cloxacillin 250mg

Pharmacotherapeutic group: Penicillins with extended spectrum

API mixing

Filling

Vial sterilization

Description

Ampicillin Sodium And Cloxacillin Sodium For Injection is a combination of ampicillin, a broad spectrum antibiotic andcloxacillin, semi-synthetic beta-lactamase resistant penicillin with activityagainst gramnegative and gram-positive bacteria including betalactamaseproducing staphylococci.Both ampicillin and cloxacillin are bactericidal antibiotics and act byinterfering with the formation of new bacterial cell wall by dividingorganisms.The main mechanism of resistance to ampicillin/cloxacillin is alteration of penicillin-binding proteins (PBPs), which reduce the affinity of theantibacterial agent for the targetPharmacokinetics Peak blood levels are achieved 1 hour after administration.

There is a linear dose response in peak serum levels. Ampicillin has a plasma half-life of approximately 1-2 hours and is excreted mainly in the bile and urine. Cloxacillin is excreted in the urine and bile with a serum half-life ofapproximately 30 minutes

Indications and Usage

Ampicillin Sodium And Cloxacillin Sodium For Injection is indicated for the treatment of the following bacterial infections:

Surgery: post-operative wound infections, post-operative pulmonary infections

Respiratory infections: bronchopneumonia, acute exacerbations of chronic bronchitis, otitis media

Obstetrics: puerperal fever

Skin and soft tissue infections

Typhoid fever

Urinary tract infection

Bacteraemia when associated with, or suspected to be associated with, any of the infections:shigellosis, leptospirosis, peritonitis, pyelonephritis, endocarditis, meningitis, gastroenteritis, pharyngitis, sinusitis, intra-abdominal infection

Dosage and Administrations：

Intramuscular: Dissolve vial contents in 1.5 mL water for Injections.

Intravenous: Dissolve vial contents in 10 mL water for Injections and administer slowly over 3 to 4 minutes.

Adult dosage (including elderly): 500mg to 1g every four to six hours.

Children's dosage (Neonates up to 10years):50-150mg/kg every 8 hours

Hepatic impairment: Reduce frequency of administration depending on the severity of the condition

Precautions: Before initiating therapy with ampicillin/cloxacillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactams. Caution should be observed when administering Ampicillin/cloxacillin Injection to babies whose mothers are hypersensitive to penicillin.

Ampicillin/cloxacillin should be avoided if infectious mononucleosis is suspected.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Dosage should be adjusted in patients with renal impairment

Contraindications:

Penicillin hypersensitivity; ocular administration. Attention should be paid to possible crosssensitivity with other beta-lactam antibiotics, e.g. cephalosporins, penicillins

Very high dosage of i.v. administered ampicillin and/or high dosage of cloxacillin in renal failure may provoke neurotoxic reactions similar to those seen with benzylpenicillin in excess.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident.

Gastrointestinal effects should be treated symptomatically.

Further management should be as clinically indicated or as recommended by the national poisons center, where Available