Ampicillin


Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Bacterial meningitis, Septicaemia
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. Usual dose range: 8,000-14,000 mg daily or 150-200 mg/kg daily in divided doses 3-4 hourly. May give initial treatment via slow IV inj for at least 3 days and continued with deep IM inj. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: Infants and children Usual dose range: 100-200 mg/kg daily in divided doses 3-4 hourly; may give initial treatment via IV for 3 days and continue with IM inj. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intramuscular, Intravenous
Endocarditis, Intra-abdominal infections, Peritonitis, Respiratory tract infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. Usual dose range: 500 mg 4-6 hourly via slow IV inj or IV infusion, or via deep IM inj; may give higher doses in severe cases. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: Usual dose range: ≤40 kg: 25-50 mg/kg daily in divided doses 6 hourly; >40 kg: Same as adult dose. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intramuscular, Intravenous
Gastrointestinal infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. Usual dose range: 500 mg 6 hourly via slow IV inj or IV infusion, or via deep IM inj; may give higher doses in severe cases. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: Usual dose range: ≤40 kg: 50-100 mg/kg daily in divided doses 6 hourly via slow IV inj or IV infusion, or via deep IM inj; >40 kg: Same as adult dose. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Intramuscular, Intravenous
Urinary tract infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. Usual dose range: 500 mg 4-6 hourly; via slow IV inj or IV infusion, or via deep IM inj; may give higher doses in severe cases. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: Usual dose range: ≤40 kg: 50-100 mg/kg daily in divided doses 6 hourly via slow IV inj or IV infusion, or via deep IM inj; >40 kg: Same as adult dose. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Lower respiratory tract infections, Upper respiratory tract infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. Usual dose range: 250-1,000 mg 6 hourly. Consideration must be given to local treatment guidelines.
Child: Usual dose range: 50-100 mg/kg daily in divided doses 6 hourly. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Urinary tract infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. 500 mg 6 or 8 hourly. Consideration must be given to local treatment guidelines.
Child: Usual dose range: 50-100 mg/kg daily in divided doses 6 hourly. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Gastrointestinal infections
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. 500-750 mg tid to 4 times daily. Consideration must be given to local treatment guidelines.
Child: Usual dose range: 50-100 mg/kg daily in divided doses 6 hourly. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Gonorrhoea
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. In combination with probenecid: 2,000 mg as a single dose; repeated doses are recommended in females. Consideration must be given to local treatment guidelines.
Child: Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Paratyphoid fever, Typhoid fever
Adult: Dosage is individualised based on the type or severity of the infection, the age, and renal function of the patient. 1,000-2,000 mg 6 hourly. Consideration must be given to local treatment guidelines.
Child: Usual dose range: 50-100 mg/kg daily in divided doses 6 hourly. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Renal Impairment
Haemodialysis patient: Give a supplemental dose after each dialysis period (refer to specific product guidelines).
CrCl (mL/min) Dosage
<10 Reduction in dose or increase of dose interval may be required (refer to specific product guidelines).
Administration
Should be taken on an empty stomach.
Reconstitution
Adults and children: IV inj or infusion: Dilute with appropriate amount of sterile water for inj, NaCl 0.9% solution, dextrose 5% in water solution or Ringer's solution to prepare the desired concentration. IM inj: Reconstitute vial with the appropriate amount of sterile water for inj to make a final concentration of 125 mg/mL or 250 mg/mL. Neonates: IV inj or infusion: Reconstitute a vial with the labelled amount of sterile water for inj. Further dilute the reconstituted solution with NaCl 0.9% solution or other compatible diluents to prepare the desired concentration. IM inj: Reconstitute vial with the appropriate amount of sterile water for inj to make a final concentration of 250 mg/mL. Do not use bacteriostatic water for inj as a diluent for IV/IM inj. Instructions for reconstitution and stability recommendations may vary among individual products and between countries (refer to specific product guidelines).
Incompatibility
IV/IM: Powder for solution for inj or infusion: Incompatible with blood products, protein hydrolysates, or IV lipid emulsions; aminoglycosides (in same syringe, IV fluid container or giving set); metronidazole, and tetracycline derivatives inj (e.g. oxytetracycline, rolitetracycline, doxycycline).
Contraindications
Hypersensitivity or history of hypersensitivity (e.g. anaphylaxis) to ampicillin or other β-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, monobactams).
Special Precautions
Patient with glandular fever, spirochaete infections (particularly syphilis). Not recommended in patients suspected with or with infectious mononucleosis, acute and chronic lymphatic leukaemia, or cytomegalovirus infection. Renal impairment. Neonates and children. Pregnancy and lactation.
Adverse Reactions
Significant: Seizures (rapid infusion); bacterial or fungal superinfection (prolonged use); Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
Blood and lymphatic system disorders: Leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia, coagulation disorders.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, indigestion, epigastric discomfort, sore mouth, black hairy tongue.
General disorders and administration site conditions: Fever; inj site pain or phlebitis.
Hepatobiliary disorders: Rarely, hepatitis, cholestatic jaundice.
Immune system disorders: Serum sickness-like reaction.
Investigations: Moderate and transient increase in transaminases; prolonged prothrombin time (rare).
Musculoskeletal and connective tissue disorders: Joint pain.
Nervous system disorders: Encephalopathy; paraesthesia (prolonged use).
Renal and urinary disorders: Nephropathy, interstitial nephritis.
Skin and subcutaneous tissue disorders: Pruritus, purpura.
Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis, angioedema, erythematous or urticarial rash), Clostridium difficile-associated diarrhoea, pseudomembranous colitis.
IM/IV/Parenteral/PO: B
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Screen for a history of renal and liver impairment, or active mononucleosis. Monitor renal, hepatic, and haematologic functions periodically (prolonged use). Assess for signs and symptoms of anaphylaxis during the 1st dose.
Overdosage
Symptoms: Diarrhoea, nausea, vomiting, crystalluria; electrolyte disorders, altered consciousness, coma, haemolytic reactions, acidosis (parenteral). Management: Symptomatic and supportive treatment. May be removed by haemodialysis. Correct electrolyte and fluid imbalances as necessary.
Drug Interactions
Increased risk of allergic skin reactions with allopurinol. Decreased absorption with chloroquine. Reduced excretion and increased risk of toxicity with probenecid and sulfinpyrazone. May reduce the efficacy of oral contraceptives. May reduce the excretion of methotrexate. May reduce the efficacy of oral typhoid vaccine. Bacteriostatic drugs (e.g. erythromycin, chloramphenicol, tetracycline) may interfere with the bactericidal action of ampicillin. May enhance the effect of oral anticoagulants (e.g. warfarin). May increase the absorption of digoxin.
Food Interaction
Decreased absorption rate with food.
Lab Interference
May interfere with the results of urinary glucose tests using cupric sulfate (Benedict's solution, Fehling's solution); Coomb's test, and some tests for urinary or serum proteins.
Action
Description:
Mechanism of Action: Ampicillin prevents bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins resulting in the inhibition of the final transpeptidation step of peptidoglycan synthesis in the bacterial cell walls.
Pharmacokinetics:
Absorption: Moderately well absorbed from the gastrointestinal tract. Decreased absorption rate with food. Time to peak plasma concentration: Approx 1-2 hours (oral); approx 1 hour (IM).
Distribution: Widely distributed throughout the body and can be found in ascitic, pleural, and joint fluids. Crosses the placenta and enters breast milk (small amounts). Penetrates the CSF with inflamed meninges. Plasma protein binding: 15-18%.
Metabolism: Metabolised into penicilloic acid.
Excretion: Via urine (approx 90%, as unchanged drug within 24 hours); faeces. Elimination half-life: 1-1.8 hours.
Chemical Structure

Chemical Structure Image
Ampicillin

Source: National Center for Biotechnology Information. PubChem Database. Ampicillin, CID=6249, https://pubchem.ncbi.nlm.nih.gov/compound/Ampicillin (accessed on Jan. 20, 2020)

Storage
Store between 20-25°C. Powder for oral susp/cap: Protect from light and moisture.
MIMS Class
Penicillins
ATC Classification
J01CA01 - ampicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
References
Puopolo KM, Lynfield R, Cummings JJ, AAP Committee on Fetus and Newborn, AAP Committee on Infectious Diseases. Management of Infants at Risk for Group B Streptococcal Disease. Pediatrics. 2019;144(2):e20191881. https://doi.org/10.1542/peds.2019-1881. Accessed 17/04/2023

Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 17/04/2023.

Ampicillin 125 mg/5 mL Oral Suspension (Kent Pharmaceuticals Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/03/2022.

Ampicillin 2 g Powder for Solution for Injection/Infusion (Generics [UK] Limited t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 01/09/2021.

Ampicillin 500 mg Powder for Solution for Injection (Chemidex Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 14/03/2022.

Ampicillin Capsule (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/03/2022.

Ampicillin Capsules BP 250 mg (Crescent Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/03/2022.

Ampicillin Capsules BP 500 mg (Crescent Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/03/2022.

Ampicillin Injection Powder, for Solution (Methapharm Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 17/04/2023.

Ampicillin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 17/04/2023.

Anon. Ampicillin (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 17/04/2023.

Anon. Ampicillin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 17/04/2023.

Anon. Ampicillin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/09/2021.

Buckingham R (ed). Ampicillin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/04/2023.

Joint Formulary Committee. Ampicillin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2021.

Obocil 100 mg Powder for Injection (Singapore Pharmawealth Lifesciences, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 14/03/2022.

Paediatric Formulary Committee. Ampicillin. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 17/04/2023.

Disclaimer: This information is independently developed by MIMS based on Ampicillin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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