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Bactalev-750/Bactalev-1.5

Bactalev-750/Bactalev-1.5

ampicillin + sulbactam

Manufacturer:

Yeluri Formulations

Distributor:

HLM Pharma
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Bactalev-750 Ampicillin 500 mg, sulbactam 250 mg. Bactalev-1.5 Ampicillin 1,000 mg, sulbactam 500 mg
Indications/Uses
Infections due to β-lactamase-producing organisms.
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Dosage/Direction for Use
IV/IM Reconstitute w/ 1.6 mL (for Bactalev-750) or 3.2 mL (for Bactalev-1.5) sterile water for inj & use w/in 1 hr of reconstitution. Usual dose: Ampicillin 1 g + sulbactam 500 mg every 6 hr, may double dose in severe infections.
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Overdosage
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Contraindications
History of serious hypersensitivity reactions (eg, anaphylaxis or SJS) to ampicillin, sulbactam or to other β-lactam antibacterial drugs (eg, penicillins & cephalosporins). Previous history of cholestatic jaundice/hepatic dysfunction.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Bactalev-750/Bactalev-1.5 detailed prescribing information
Special Precautions
Discontinue use &/or institute appropriate therapy if superinfections occur (usually involving Pseudomonas or Candida). Discontinue use if allergic reaction occurs. Risk of hypersensitivity reactions in individuals w/ history of penicillin hypersensitivity &/or hypersensitivity reactions to multiple allergens. Not to be administered to patients w/ mononucleosis. Possibility of superinfections w/ mycotic or bacterial pathogens during therapy. May cause severe skin reactions eg, TEN, SJS, dermatitis exfoliative, erythema multiforme & acute generalized exanthematous pustulosis; closely monitor if patients develop skin rash & discontinue if lesions progress. Reports of Clostridium difficile-associated diarrhea (CDAD). Consider CDAD in all patients who present w/ diarrhea following antibacterial use. Discontinue use if CDAD is suspected or confirmed. Associated w/ hepatic dysfunction, including hepatitis & cholestatic jaundice; monitor hepatic function at regular intervals in patients w/ hepatic impairment. Pregnancy & lactation.
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Use In Pregnancy & Lactation
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Adverse Reactions
Urticarial reactions, erythematous maculopapular eruptions; erythema multiforme.
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Drug Interactions
Decreased renal tubular secretion & increased & prolonged blood levels w/ probenecid. Increased incidence of rashes w/ concurrent administration of allopurinol & ampicillin. Not to be reconstituted together w/ aminoglycosides due to in vitro inactivation of aminoglycosides by ampicillin.
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Caution For Usage
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Storage
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Description
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Action
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MIMS Class
Penicillins
ATC Classification
J01CR01 - ampicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Regulatory Classification
Rx
Presentation/Packing
Form
Bactalev-1.5 powd for inj 1.5 g
Packing/Price
1's
Form
Bactalev-750 powd for inj 750 mg
Packing/Price
1's