Ampicillin Sodium and Sulbactam Sodium 10 g/15g
ampicillin sodium, sulbactam sodium · INJECTION, POWDER, FOR SOLUTION · ONESOURCE SPECIALTY PHARMA LIMITED
Ampicillin Sodium and Sulbactam Sodium is a injection, powder, for solution containing ampicillin sodium, sulbactam sodium at 10 g/15g, taken intramuscular. Manufactured by ONESOURCE SPECIALTY PHARMA LIMITED.
Key Facts
- Brand Name
- Ampicillin Sodium and Sulbactam Sodium
- Generic Name
- ampicillin sodium, sulbactam sodium
- NDC Code (Product)
83270-308- Manufacturer
- ONESOURCE SPECIALTY PHARMA LIMITED
- Strength
- 10 g/15g
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA202197
- Marketing Start
- 05/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ampicillin and Sulbactam for Injection, USP, 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 …
Dosage & Administration
DOSAGE AND ADMINISTRATION The pharmacy bulk package is for preparation of solutions for IV infusion only. Ampicillin and Sulbactam for injection should be administered 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. 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 is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total …
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.
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 rel…
Frequently Asked Questions
What is Ampicillin Sodium and Sulbactam Sodium used for?
Ampicillin Sodium and Sulbactam Sodium contains ampicillin sodium, sulbactam sodium. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Ampicillin Sodium and Sulbactam Sodium a controlled substance?
Ampicillin Sodium and Sulbactam Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Ampicillin Sodium and Sulbactam Sodium?
The generic name for Ampicillin Sodium and Sulbactam Sodium is ampicillin sodium, sulbactam sodium. There are no other listed brand versions of ampicillin sodium, sulbactam sodium.
What is the NDC code for Ampicillin Sodium and Sulbactam Sodium 10 g/15g?
The NDC (National Drug Code) for Ampicillin Sodium and Sulbactam Sodium 10 g/15g is 83270-308, listed by ONESOURCE SPECIALTY PHARMA LIMITED.
Other Ampicillin Sodium and Sulbactam Sodium Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)