Ampexin 250 Injection

Description

Generics: Ampicillin.

Dosage Form: Liquid Solutions.

Indications:

• Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and non penicillinase -producing N. gononhoeae.
• Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.
• Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
• Meningitis: O. Meningitides.

Pharmacology:
Ampicillin inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Dosage guideline:
Dose dependent on physicians instruction.

Intra-articular:
Supplement in systemic therapy for treatment of susceptible infections-

• Adult: 500 mg daily.
• Child: <10 yr Half of adult routine dosage.

Intraperitoneal:
Supplement in systemic therapy for treatment of susceptible infections-

• Adult: 500 mg daily.
• Child: <10 yr Half of adult routine dosage.

Intrapleural:
Supplement in systemic therapy for treatment of susceptible infections-

• Adult: 500 mg daily.
• Child: <10 yr Half of adult routine dosageIntravenous:
  Meningitis-
• Adult: 2 gm 6 hrly.
• Child: 150 mg/kg daily in divided doses.

Intrapartum prophylaxis against group B Streptoccocal infection in neonates-

Adult: Initially, 2 gm via IV inj followed by 1 gm 4 hrly until delivery.

Oral:
Biliary tract infections, Bronchitis, Endocarditis, Gastroenteritis, Listeriosis, Otitis media, Perinatal streptococcal infections, Peritonitis-

• Adult: 0.25-1 gm 6 hrly.
• Child: <10 yr Half of adult routine dosage.

Typhoid and paratyphoid fever-

• Adult: 1-2 gm 6 hrly for 2 wk in acute infections, and 4-12 wk in carriers.Uncomplicated gonorrhoea-
• Adult: 2 gm with 1 gm of probenecid as single dose, recommended to be repeated in female patients.

Urinary tract infections-

• Adult: 500 mg 8 hrly.

Parenteral:
Susceptible infections-

• Adult: 500 mg 6 hrly, via IM or slow IV inj over 3-5 min or by infusion.
• Child: <10 yr Half of adult routine dosage.

Septicaemia-

• Adult: 150-200 mg/kg daily. Initiate with IV admin for at least 3 days, then continue with IM inj 3-4 hrly. Continue treatment for at least 48-72 hr after the patient has become asymptomatic or when there is evidence of bacterial eradication. Recommended treatment duration for infections caused by group-A β-haemolytic streptococci: At least 10-days, to prevent occurrence of acute rheumatic fever or acute glomerulonephritis.
• Child: Same as adult dose.

Route of administration:
Intravenous/ intraarticular/ intra peritoneal/ intra pleural.

Interaction:
May diminish the viability of verbal contraceptives. May modify INR whereas on warfarin and phenindione. May decrease the adequacy of verbal typhoid immunizations. May decrease the excretion of methotrexate. Decreased excretion with probenecid and sulfinpyrazone, coming about to expanded hazard of poisonous quality. Allopurinol increments ampicillin-induced skin responses. Decreased retention with chloroquine. Bacteriostatic antibacterials (e.g. erythromycin, chloramphenicol, tetracycline) may meddled with the bactericidal activity of ampicillin.

Contraindications:
Hypersensitivity to ampicillin and other penicillins.

Side Effects:
Queasiness, heaving, the runs, erythematous maculo-papular rashes, sore mouth, black/hairy tongue, hasty, erythema multiforme, Stevens-Johnson disorder, poisonous epidermal necrolysis, angioedema, fever, joint torments, serum sickness-like side effects, haemolytic weakness, thrombocytopenia, leucopenia, neutropenia, coagulation clutters, delayed dying time and prothrombin time, CNS poisonous quality (e.g. shakings); paraesthesia, nephropathy, interstitial nephritis, hepatitis, cholestatic jaundice, direct and temporal increment in transaminases, Anaphylaxis, Clostridium difficile-associated loose bowels (CDAD).

Pregnancy & Lactation:
Pregnancy Category B. Either animal-reproduction considers have not illustrated a fetal hazard but there are no controlled ponders in pregnant ladies or animal-reproduction ponders have appeared an antagonistic impact (other than a diminish in richness) that was not affirmed in controlled thinks about in ladies within the 1st trimester (and there’s no prove of a chance in afterward trimesters).

Precautions & Warnings:
Patient with history of β-lactam allergy. During renal impairment, Pregnancy and lactation.

Therapeutic Class:
Broad spectrum penicillins

Storage Conditions:
Store between 20-25° C. Reconstituted oral susp: Store between 2-8° C (discard after 14 days). Keep out of the reach of children.

Manufactured by: Opsonin Pharma Ltd.