AMPIVIL 1000mg 

Ampicillin

Vial.1000 mg

Ampivil^® (Ampicillin)

Description

Ampivil^® is a beta-lactam antibiotic, with a broad spectrum of bactericidal activity.

Clinical pharmacology

Ampivil ^® is similar to amoxicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Ampicillin has been shown to be active against most strains of the following microorganisms.

Antibacterial activity

Aerobic Gram-Positive Microorganisms:

Enterococcus faecalis, Streptococcus pneumonia, Listeria monocytogenes,

Aerobic Gram-Negative Microorganisms:

Moraxella catarrhalies(branhamella catarrhalis), Escherichia coli, Haemophilus influenzae ,Neisseria gonorrhoeae ,Proteus mirabilis ,Salmonella and Shigella spp.

Pharmacokinetics

Oral absorption -----

Presystemic metabolism -----

Plasma half – life range 1 -1.5 h

Volume of distribution 0.17-0.31 L.kg^-1

Plasma protein binding ~ 20%

Indication

1- Respiratory tract infections

2- Bacterial meningitis

3- Septicemia and endocarditis

4- Urinary tract infections

5- GI infections

6- Genitourinary tract infections:

Contraindication

Ampivil^® is contraindicated for patients known to have hypersensitivity to any of the penicillins.

Precaution

· Ampivil^® should be stopped if a skin rash occurs

· It should preferably not be given to patients with infectious mononucleosis

· Care is necessary if very high doses of Ampivil^® are given, especially if renal function is poor, because of the risk of neurotoxicity.

· High doses of Ampivil^® should also be used with caution in patients receiving potassium-containing drugs or potassium-sparing diuretics

· Renal, hepatic, and haematological status should be monitored during prolonged and high-dose therapy

· Take particular care with IV administration beause of the possibility of thrombophelebitis.

· Higher than recommended IV doses of most of the penicillins may cause neuromuscular excitability or convulsions.

· Avoid subcutaneous and fat layer injections; pain and induration may occur. if these occur, apply an ice pack.

Pregnancy

Pregnancy category B.

Adequate and well-controlled studies in humans have not been done; this drug should be used during pregnancy only if clearly needed.

Breast feeding

Ampivil^® may lead to sensitization of infants;therefore , decide whether to discontinue breast-feeding or Ampivil^® , taking into account the importance of the drug to the mother.

Dosage

Usual adult and adolescent dose

· Respiratory tract infections: Patients weighing 40 kg or more -250 to 500 mg every 6 hours

· GI and Genitourinary tract infections: Patients weighing 40 kg or more –in female , 500 mg every 6 hours

· Urethritis in males: two doses of 500 mg each at an interval of 8 to 12 hours

· Treatment may be repeated if necessary or extended if required

· Bacterial meningitis: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours ( treatment may be initiated with IV infusion therapy and continued with IM injection)

· Septicemia: 150 to 200 mg/kg/day. Start with IV for at least 3 days and continue with IM every 3 to 4 hours

Note: treatment of all infections should be continued for a minimum of 48 to 72 hours

A minimum of 10 days treatment is recommended for any infection caused by group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

Usual pediatric dose

· Respiratory tract infections: Patients weighing less than 40 kg -25 to 50 mg/kg/day in equally divided doses at 6 to 8 hours intervals

· GI and Genitourinary tract infections: Patients weighing less than 40 kg - 50 mg/kg/day every 6 hours in equally divided doses at 6 to 8 hours intervals

· Bacterial meningitis: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours ( treatment may be initiated with IV infusion therapy and continued with IM injection)

· Septicemia: 150 to 200 mg/kg/day. Start with IV for at least 3 days and continue with IM every 3 to 4 hours

· Preparation for administration : use only freshly prepared solutions.

· IM and IV injections should be administered within 1 hour after preparation , since the potency may decrease significantly after this period

· For IM use : dissolve contents of a vial 250 and 500 mg with 1.5 ml sterile water for injection and vial 1 g with 3.5 ml sterile water for injection

· For direct IV use: add 5 ml sterile water for injection to the 250 and 500 mg vials and administer slowly over a 3 to 5 minute period. Ampivil^® for injection, 1 g, may also be given by direct IV administration .dissolve in 10 ml sterile water for injection, and administer slowly over at least 10 to 15 minutes.

Note: more rapid administration may result in convulsive seizures.

· For IV Infusion : reconstitute as directed above ( for direct IV use) prior to diluting with IV solution such as: sterile water for injection, sodium chloride injection 0.9%, M/6 sodium lactate injection , 5% dextrose in water, 5%dextrose and 0.45 NaCl injection, 10% invert sugar in water.

Warning

· Before initiating therapy with Ampivil^®, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Ampivil^® should be discontinued and appropriate therapy instituted.

Interaction

· Concurrent use of Ampivil^® and Probenecid may result in increased and prolonged blood levels of Ampivil^®.

· Do not mix Ampivil^® and aminoglycosides in the same IV solution.

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