Ampicillin and Sulbactam 10 g/1

Ampicillin Sodium and Sulbactam Sodium · INJECTION, POWDER, FOR SOLUTION · Meitheal Pharmaceuticals Inc.

10 Recalls on RecordCurrently in Shortage

Plain English

Ampicillin and Sulbactam is a injection, powder, for solution containing ampicillin sodium and sulbactam sodium at 10 g/1, taken intravenous. Manufactured by Meitheal Pharmaceuticals Inc..

Key Facts

Brand Name: Ampicillin and Sulbactam
Generic Name: Ampicillin Sodium and Sulbactam Sodium
NDC Code (Product): 71288-033
Manufacturer: Meitheal Pharmaceuticals Inc.
Strength: 10 g/1
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: ANDA065314
Marketing Start: 11/27/2006

Recall History

10 Recalls on Record

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class I01/02/2018

Aurobindo Pharma Ltd.

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective78 reports

pyrexia71 reports

pneumonia49 reports

off label use46 reports

condition aggravated37 reports

sepsis31 reports

septic shock30 reports

acute kidney injury29 reports

dyspnoea29 reports

rash29 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli ,* Klebsiella spp.* (including K. pneumoniae *), Proteus mirabilis ,* Bacteroides fragilis ,* Enterobacter spp.,* and Acinetobacter calcoaceticus .* NOTE: For information on use in pediatric patients (see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli , Klebsiella spp. (including K. pneumoniae *), Bacteroides spp. (including B. fragilis ), and Enterobacter spp.* Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli ,* and Bacteroides spp.* (including B. fragilis *). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment wi…

Dosage & Administration

DOSAGE AND ADMINISTRATION Ampicillin and sulbactam for injection may be administered by either the IV or the IM routes. For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes. Ampicillin and sulbactam for injection may be administered by deep intramuscular injection (see DIRECTIONS FOR USE-Preparation for Intramuscular Injection section). The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day. Pediatric Patients 1 Year of Age or Older The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients i…

Warnings

WARNINGS Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, ampicillin and sulbactam for injection should be discontinued and the appropriate therapy instituted. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin and sulbactam for injection. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. Severe Cutaneous Adverse Reactions Ampicillin and sulbactam for injection may cause severe skin reactions, …

Contraindications

CONTRAINDICATIONS The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.

Drug Interactions

Drug Interactions Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam for injection may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam for injection and allopurinol administered concurrently. Ampicillin and sulbactam for injection and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of ampicillin and sulbactam for injection.

Adverse Reactions

ADVERSE REACTIONS Adult Patients Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported in clinical trials. Local Adverse Reactions Pain at IM injection site – 16% Pain at IV injection site – 3% Thrombophlebitis – 3% Phlebitis – 1.2% Systemic Adverse Reactions The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients. Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding. Pediatric Patients Available safety data for pediatric patients treated with ampicillin and sulbactam for injection demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin and sulbactam for injection. Adverse Laboratory Changes Adverse laboratory changes without regard to drug relat…

Frequently Asked Questions

What is Ampicillin and Sulbactam used for?

Ampicillin and Sulbactam contains Ampicillin Sodium and Sulbactam Sodium. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.

Is Ampicillin and Sulbactam a controlled substance?

Ampicillin and Sulbactam is not classified as a controlled substance by the DEA.

What is the generic name for Ampicillin and Sulbactam?

The generic name for Ampicillin and Sulbactam is Ampicillin Sodium and Sulbactam Sodium. There are 4 other brand versions of Ampicillin Sodium and Sulbactam Sodium.

What is the NDC code for Ampicillin and Sulbactam 10 g/1?

The NDC (National Drug Code) for Ampicillin and Sulbactam 10 g/1 is 71288-033, listed by Meitheal Pharmaceuticals Inc..

Product NDC

71288-033

Package NDC

Other Ampicillin and Sulbactam Dosages

Other Ampicillin Brands

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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