72 Agege Motor Road, Alakara, Mushin.
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Shijiazhuang No. 2 Pharmaceutical Factory, 188, Gongnong Road, Shijiazhuang Hebei, China.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection (NRN: 04-4059):Ampicillin sodium 1 g
How to identify the Product: Sterile dry powder for reconstitution.
Pack size: 1000 mg in vials.
Ampicillin sodium is a semi-synthetic penicillin which has broad antibacterial spectrum. It is markedly effective against gram positive bacteria as well as gram negative bacteria. Its action is bactercidal. Ampicillin sodium is a sterile powder. It is almost odourless. Easily soluble in water and very stable in acid solution.
Belonging to the penicillin group of beta-lactam antibiotics, ampicillin is able to penetrate Gram-positive and some Gram-negative bacteria. It differs from penicillin only by the presence of an amino group. That amino group helps the drug penetrate the outer membrane of gram-negative bacteria.
Ampicillin acts as an irreversible inhibitor of the enzyme transpeptidase, which is needed by bacteria to make their cell walls. It inhibits the third and final stage of bacterial cell wall synthesis in binary fission, which ultimately leads to cell lysis.
Treatment of infections caused by Gram negative bacteria as well as Gram positive bacteria such as typhoid fever, septicaemia, infections of the respiratory, urinary and biliary tracts. It is mainly indicated for the infections resistant to other drugs or at the appearances of severe toxic effects or in patients with renal lesions.
Hypersensitivity to Ampicillin or related penicillin group of drugs.
Skin test should be performed before use. The method and the dosage are the same as that of Potassium penicillin G. Slow and deep IM injection is suggested. Skin rash or other allergic reactions may occur during the course of therapy. Should it occur, use antihistaminic or hormone and continue the therapy under close observation. Stop the treatment if serious skin rash occurs.
When administered concurrently, the following drugs may interact with Ampicillin:
Allopurinol: Increased possibility of skin rash; particularly in hyperuricemic patients may occur.
Bacteriostatic antibiotics e.g., Chloramphenicol, Erythromycins, Sulfonamides, or Tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented.
Oral contraceptive: May be less effective and increased breakthrough bleeding may occur.
Probenecid: May decrease renal tubular secretion of Ampicillin resulting in increased blood levels and/or Ampicillin toxicity.
Dermatological: Skin rashes are the most common adverse reactions.
Gastrointestinal tract: Diarrheea, colitis, nausea and vomiting occur.
Genitourinary: Acute interstitial nephritis
Hematological : Eosinophilia, leukopaenia, granulocytopaenia, agranulocytopaenia
Hepatic: Intrahepatic cholestatic jaundice
Other: Febrile reactions local irritant effects.
Dosage & Administration
For IM injection, it should be dissolved in 3 mL of distilled water or normal sodium chloride solution and shake well before use.
Adults: Usually 4 g daily; up to 6 g in severely ill patient.
Children: 100 mg/kg bodyweight in 4 divided doses a day is suggested.
The dose may be reduced for patients with urinary tract nfections to 2 g, daily for adults.
Ampicillin Sodium should be kept in a well-closed container and stored at a temperature not exceeding 25oC