Clinical Pharmacology Details


AMOXYCILLIN/ PIVOXIL SULBACTAM


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Indications & Dose:

Infections of skin and skin structures; gynecological infections; intra-abdominal infections caused by susceptible organisms


DOSE


Adults


Inj: Prophylaxis: 1.5-3g by i.v. inj. at induction of anaesthesia, then 2 further doses by i.v. or deep i.m. inj. 8 and 16 hours later.


Treatment: 1.5-3g by i.v. or deep i.m. inj. 6-8 hours. Max. 12g daily.


Gonorrhoea: Single i.v. dose of 3g.


Orally: Tab: 1-2 tab twice daily.


Children


Treatment: 150mg/kg. Dose interval: 12 hourly in neonates; 6-8 hourly in older children.

Contraindications:

 Hypersensitivity to penicillins.

Side Effects:

Cautions:

Precautions:

 Mononucleosis (incidence of rash 43%-100%); safety not established in children 

Interaction:

Drugs


 Chloramphenicol: Inhibited antibacterial activity of ampicillin/ sulbactam; administer ampicillin/ sulbactam 3 hr before chloramphenicol


Macrolide antibiotics: Inhibited antibacterial activity of ampicillin/ sulbactam; administer ampicillin/ sulbactarn 3 hr before macrolides


Methotrexate: Increased serum methotrexate concentrations


Oral contraceptives: Occasional impairment of oral contraceptive efficacy; consider use of supplemental contraception during cycles in which ampicillin/sulbactam is used


Tetracyclines: Inhibited antibacterial activity of ampicillin/sulbactarn; administer ampicillin/ sulbactam 3 hr before tetracyclines

Warnings:

Adverse Effects:

Lactations:

PREGNANCY AND LACTATION:
Pregnancy category B; animal studies at doses l Ox the human dose reveal no evidence of harm; low concentrations excreted in breast milk

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Fatigue, headache, malaise, seizures (overdosage)


EENT: Epitaxis, glossitis, stomatitis


GI: Abdominal distension, diarrhea (3%), elevated LFTs, flatulence, gastritis, nausea, pseudomembranous colitis, vomiting


GU: Dysuria, increased BUN/creatinine, urinary retention


HEME: Bone marrow depression


SKIN: Erythema multiform, exfoliative dermatitis, pain at injection site (16% for IM, 3% for IV), rash (2%), thrombophlebitis (3%), urticaria


MISC.: Anaphylaxis 

Patient And Carer Advice: