Ampicillin Sodium And Sulbactam Sodium
Loading...Ampicillin Sodium And Sulbactam Sodium Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
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.
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.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ampicillin and Sulbactam for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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,1 Klebsiella spp.1 (including K. pneumoniae1), Proteus mirabilis,1 Bacteroides fragilis,1 Enterobacter spp.,1 and Acinetobacter calcoaceticus.1
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. pneumoniae1), Bacteroides spp. (including B. fragilis), and Enterobacter spp.1
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,1 and Bacteroides spp.1 (including B. fragilis1).
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 with Ampicillin and Sulbactam for Injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.History
There is currently no drug history available for this drug.
Other Information
Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration.
Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is:
Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is:
Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10.
Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same.
Ampicillin and Sulbactam for Injection, USP pharmacy bulk package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion.
(See DIRECTIONS FOR USE – Directions for Proper Use of Pharmacy Bulk Package.)
Each 15 g Ampicillin and Sulbactam for Injection Pharmacy Bulk Package bottle contains ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam. The sodium content per 1.5 gram is 115.1 mg and 5 mEq.
Sources
Ampicillin Sodium And Sulbactam Sodium Manufacturers
-
Mylan Institutional Llc
![Ampicillin Sodium And Sulbactam Sodium Injection, Powder, For Solution [Mylan Institutional Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ampicillin Sodium And Sulbactam Sodium | Mylan Institutional Llc
The pharmacy bulk package is for preparation of solutions for IV infusion only. Ampicillin and Sulbactam should be administered by slow intravenous injection over at least 10 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 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 OlderThe 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 ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous Ampicillin and Sulbactam for Injection (see CLINICAL STUDIESsection).
Impaired Renal FunctionIn patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of Ampicillin and Sulbactam for Injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:
TABLE 5
Ampicillin and Sulbactam for Injection, USP Dosage Guide For Patients With Renal Impairment
Creatinine Clearance(mL/min/1.73m2)
Ampicillin/Sulbactam Half-Life (Hours)Recommended
Ampicillin and Sulbactam for Injection, USP Dosage
≥30
1
1.5 to 3 g q 6h to q 8h
15 to 29
5
1.5 to 3 g q 12h
5 to 14
9
1.5 to 3 g q 24h
When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males weight (kg) × (140 – age)
72 × serum creatinine
Females 0.85 × above value
-
Mylan Institutional Llc
Ampicillin Sodium And Sulbactam Sodium | Mylan Institutional Llc
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 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 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 OlderThe 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 ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection. (see CLINICAL STUDIES section).
Impaired Renal FunctionIn patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:
TABLE 5 AMPICILLIN AND SULBACTAM FOR INJECTION Dosage Guide for Patients with Renal Impairment Creatinine Clearance
(mL/min/1.73m2) Ampicillin/Sulbactam
Half-Life (Hours) Recommended
Ampicillin and Sulbactam for Injection Dosage≥30
1
1.5 to 3 g q 6h to q 8h
15 to 29
5
1.5 to 3 g q 12h
5 to 14
9
1.5 to 3 g q 24h
When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males weight (kg)×(140 – age)
72 × serum creatinineFemales 0.85 × above value
-
Agila Specialties Private Limited
Ampicillin Sodium And Sulbactam Sodium | Agila Specialties Private Limited
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 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 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 OlderThe 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 ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of Ampicillin and Sulbactam for Injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous Ampicillin and Sulbactam for Injection (See CLINICAL STUDIES section.)
Impaired Renal FunctionIn patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of Ampicillin and Sulbactam for Injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:
TABLE 5: Ampicillin and Sulbactam for Injection, USP Dosage Guide For Patients With Renal Impairment Creatinine Clearance
Ampicillin/Sulbactam
Recommended
(mL/min/1.73m2)
Half-Life (Hours)
Ampicillin and Sulbactam
for Injection, USP Dosage
≥30
1
1.5 to 3 g q 6h to q 8h
15 to 29
5
1.5 to 3 g q 12h
5 to14
9
1.5 to 3 g q 24h
When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
COMPATIBILITY, RECONSTITUTION AND STABILITYWhen concomitant therapy with aminoglycosides is indicated, Ampicillin and Sulbactam for Injection and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.
Intravenous AdministrationDirections for Proper Use of Pharmacy Bulk Package
Ampicillin and Sulbactam for Injection, USP sterile powder for intravenous use may be reconstituted with any of the compatible diluents described in this insert. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization. Ampicillin and Sulbactam concentrations between 3 and 45 mg (2 to 30 mg ampicillin/1 to 15 mg sulbactam/mL) are recommended for intravenous use.
The 15 gram bottle may be reconstituted with either 92 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection. The diluent should be added in two separate aliquots in a suitable work area, such as a laminar flow hood. Add 50 mL of solution, shake to dissolve. Then add an additional 42 mL and shake. The solution should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization. The resultant solution will have a final concentration of approximately 100 mg/mL ampicillin and 50 mg/mL sulbactam. The closure may be penetrated only one time after reconstitution, if needed, using a suitable sterile transfer device or dispensing set that allows for measured dispensing of the contents.
After reconstitution, use within two hours if stored at room temperature, or within four hours if stored under refrigeration.
Reconstituted Bulk Solution Should Not be Used For Direct Infusion
If the reconstituted bulk solution is stored for less than one hour at room temperature (20°C/68°F) prior to further dilution, the use periods indicated in Table 6 apply for the diluted solutions.
If the bulk solution is stored for one to two hours at room temperature (20°C/68°F) and then diluted with Sterile Water for Injection or 0.9% Sodium Chloride Injection to the following concentrations, the use periods indicated in Table 7 apply.
Any unused portions of solution that remain after the indicated time periods should be discarded.
TABLE 6:
Diluent
Maximum
Concentration (mg/mL)
Ampicillin and Sulbactam for Injection, USP (Ampicillin/Sulbactam)
Use Periods
Sterile Water for
45 (30/15)
8 hrs @ 21°C
Injection
45 (30/15)
48 hrs @ 4°C
30 (20/10)
72 hrs @ 4°C
0.9% Sodium Chloride
45 (30/15)
8 hrs @ 21°C
Injection
45 (30/15)
48 hrs @ 4°C
30 (20/10)
72 hrs @ 4°C
5% Dextrose Injection
30 (20/10)
2 hrs @ 21°C
30 (20/10)
4 hrs @ 4°C
3 (2/1)
2 hrs @ 21°C
Lactated Ringer’s
45 (30/15)
8 hrs @ 21°C
Injection
45 (30/15)
24 hrs @ 4°C
M/6 Sodium Lactate
45 (30/15)
8 hrs @ 21°C
Injection
45 (30/15)
12 hrs @ 4°C
5% Dextrose in 0.45%
3 (2/1)
4 hrs @ 21°C
Saline
15 (10/5)
4 hrs @ 4°C
10% Invert Sugar
3 (2/1)
4 hrs @ 21°C
30 (20/10)
3 hrs @ 4°C
Table 7:
IV Solution
Maximum
Concentration (mg/mL)
Ampicillin and Sulbactam for Injection, USP (Ampicillin/Sulbactam)
Use Periods
Sterile Water for
45 (30/15)
4 hrs @ 21°C
Injection, USP
45 (30/15)
24 hrs @ 4°C
0.9% Sodium Chloride Injection,
45 (30/15)
4 hrs @ 21°C
USP
45 (30/15)
24 hrs @ 4°C
Animal PharmacologyWhile reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.
-
Agila Specialties Private Limited
Ampicillin Sodium And Sulbactam Sodium | Agila Specialties Private Limited
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 to 15 minutes or can also be delivered, in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes.
Ampicillin and sulbactam for injection may be administered by deep intramuscular injection. (See Preparation for Intramuscular Injection.)
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 ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection (See CLINICAL STUDIES section.)
Impaired Renal FunctionIn patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:
TABLE 5:Ampicillin and Sulbactam for Injection Dosage Guide For Patients With Renal Impairment Creatinine Clearance
(mL/min/1.73m2)
Ampicillin/Sulbactam
Half-Life (Hours)
Recommended
Ampicillin and Sulbactam for Injection Dosage
≥30
1
1.5 to 3 g q 6h to q 8h
15 to 29
5
1.5 to 3 g q 12h
5 to 14
9
1.5 to 3 g q 24h
When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.
Males weight (kg) X (140 – age)
72 X serum creatinine
Females 0.85 X above value
COMPATIBILITY, RECONSTITUTION AND STABILITY
When concomitant therapy with aminoglycosides is indicated, ampicillin and sulbactam for injection and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.
DIRECTIONS FOR USE
General Dissolution Procedures: Ampicillin and sulbactam for injection sterile powder for intravenous and intramuscular use may be reconstituted with any of the compatible diluents described in this insert. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.
Preparation for Intravenous Use1.5 g and 3 g Vials: Initially, the vials may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg ampicillin and sulbactam per mL (250 mg ampicillin/125 mg sulbactam per mL). An appropriate volume should then be immediately diluted with a suitable parenteral diluent to yield solutions containing 3 to 45 mg ampicillin and sulbactam per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam/per mL). Reconstitution of ampicillin and sulbactam for injection, at the specified concentrations, with these diluents provide stable solutions for the time periods indicated in the following table: (After the indicated time periods, any unused portions of solutions should be discarded.)
TABLE 6: Diluent
Maximum Concentration (mg/mL) Ampicillin and Sulbactam
Use Periods
Sterile Water for Injection
45 (30/15)
8 hrs @ 25°C
45 (30/15)
48 hrs @ 4°C
30 (20/10)
72 hrs @ 4°C
0.9% Sodium Chloride Injection
45 (30/15)
8 hrs @ 25°C
45 (30/15)
48 hrs @ 4°C
30 (20/10)
72 hrs @ 4°C
5% Dextrose Injection
30 (20/10)
2 hrs @ 25°C
30 (20/10)
4 hrs @ 4°C
3 (2/1)
4 hrs @ 25°C
Lactated Ringer’s Injection
45 (30/15)
8 hrs @ 25°C
45 (30/15)
24 hrs @ 4°C
M/6 Sodium Lactate Injection
45 (30/15)
8 hrs @ 25°C
45 (30/15)
8 hrs @ 4°C
5% Dextrose in 0.45% Saline
3 (2/1)
4 hrs @ 25°C
15 (10/5)
4 hrs @ 4°C
10% Invert Sugar
3 (2/1)
4 hrs @ 25°C
30 (20/10)
3 hrs @ 4°C
Preparation for Intramuscular Injection1.5 g and 3 g Standard Vials: Vials for intramuscular use may be reconstituted with Sterile Water for Injection USP, 0.5% Lidocaine Hydrochloride Injection USP or 2% Lidocaine Hydrochloride Injection USP. Consult the following table for recommended volumes to be added to obtain solutions containing 375 mg ampicillin and per mL (250 mg ampicillin/125 mg sulbactam per mL). Note: Use only freshly prepared solutions and administer within one hour after preparation.
TABLE 7: Ampicillin and Sulbactam for Injection
Vial Size
Volume of Diluent
to be Added
Withdrawal
Volume*
1.5 g
3.2 mL
4 mL
3 g
6.4 mL
8 mL
*There is sufficient excess present to allow withdrawal and administration of the stated volumes.
Animal Pharmacology: While reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.
![Ampicillin Sodium And Sulbactam Sodium Injection, Powder, For Solution [Mylan Institutional Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7ed253b5-fcec-4518-bd74-b831064c5489&name=E4F0F4D1-C2C1-49E7-8442-1CF1B0BFE730-00.jpg)
![Ampicillin Sodium And Sulbactam Sodium Injection, Powder, For Solution [Agila Specialties Private Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc32d2db-3605-4c68-b1c9-71fb6c87e42c&name=ampi-sulbactam-for-inj-pbp-agila-figure-04.jpg)
![Ampicillin Sodium And Sulbactam Sodium Injection, Powder, For Solution [Agila Specialties Private Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0176eb3d-cabf-471c-87c7-b317f58b11b9&name=ampicillin-sulbactam-for-inj-agila-figure-03.jpg)
Login To Your Free Account