Ampicillin Sodium And Sulbactam Sodium (Unasyn)

Trade Name

UNASYN

Active Ingredient

Power

1; .5 g/1; g/1

Type / form

Tablets

Status

Manufacturer

Roerig

Storage and handling for UNASYN

AMPICILLIN SODIUM; SULBACTAM SODIUM Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ampicillin Sodium And Sulbactam Sodium (Unasyn) which is also known as UNASYN and Manufactured by Roerig. It is available in strength of 1; .5 g/1; g/1 per ml. Read more

Ampicillin Sodium And Sulbactam Sodium (Unasyn) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
  • UNASYN 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 CHNNaOS. 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 CHNNaOS with a molecular weight of 255.22. The structural formula is:
  • UNASYN, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. UNASYN 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 8.0 and 10.0.
  • 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.
  • 1.5 g of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium.
  • 3 g of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium.
  • No data
  • UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
  • Skin and Skin Structure Infectionsn- Staphylococcus aureusn- Escherichia colin- Klebsiellan- K. pneumoniaen- Proteus mirabilisn- Bacteroides fragilisn- Enterobactern- Acinetobacter calcoaceticus.
  • NOTE: For information on use in pediatric patients (see and sections).
  • Intra-Abdominal Infectionsn- Escherichia colin- Klebsiellan- K. pneumoniaen- Bacteroidesn- B. fragilisn- Enterobacter
  • Gynecological Infectionsn- Escherichia coli,n- Bacteroidesn- B. fragilis
  • While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN 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 UNASYN.
  • 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 UNASYN and other antibacterial drugs, UNASYN 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.
  • The use of UNASYN 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).
  • UNASYN is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with UNASYN.
  • No data
  • No data
  • No data
  • Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.
  • Data from a controlled clinical trial conducted in pediatric patients provided evidence supporting the safety and efficacy of UNASYN for the treatment of skin and skin structure infections. Of 99 pediatric patients evaluable for clinical efficacy, 60 patients received a regimen containing intravenous UNASYN, and 39 patients received a regimen containing intravenous cefuroxime. This trial demonstrated similar outcomes (assessed at an appropriate interval after discontinuation of all antimicrobial therapy) for UNASYN- and cefuroxime-treated patients:
  • Most patients received a course of oral antimicrobials following initial treatment with intravenous administration of parenteral antimicrobials. The study protocol required that the following three criteria be met prior to transition from intravenous to oral antimicrobial therapy: (1) receipt of a minimum of 72 hours of intravenous therapy; (2) no documented fever for prior 24 hours; and (3) improvement or resolution of the signs and symptoms of infection.
  • The choice of oral antimicrobial agent used in this trial was determined by susceptibility testing of the original pathogen, if isolated, to oral agents available. The course of oral antimicrobial therapy should not routinely exceed 14 days.
  • UNASYN 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 10u201315 minutes or can also be delivered in greater dilutions with 50u2013100 mL of a compatible diluent as an intravenous infusion over 15u201330 minutes.
  • UNASYN may be administered by deep intramuscular injection. (see section).
  • The recommended adult dosage of UNASYN 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 UNASYN, 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.
  • UNASYN sterile powder is to be stored at or below 30u00b0C (86u00b0F) prior to reconstitution.
  • When concomitant therapy with aminoglycosides is indicated, UNASYN and aminoglycosides should be reconstituted and administered separately, due to the inactivation of aminoglycosides by any of the aminopenicillins.
  • No data
  • UNASYN (ampicillin sodium/sulbactam sodium) is supplied as a sterile off-white dry powder in glass vials and piggyback bottles. The following packages are available:
  • Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt).
  • Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt).
  • ADD-Vantage package of 5 vials (NDC 0049-0031-02). Each vial containing 1.5 g (NDC 0049-0031-01) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) are distributed by Pfizer Inc.
  • ADD-Vantage package of 5 vials (NDC 0049-0032-02). Each vial containing 3 g (NDC 0049-0032-01) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) are distributed by Pfizer Inc.
  • The 1.5 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes.
  • The 3 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.
  • ADD-Vantage is a registered trademark of Hospira Inc., a Pfizer company.
  • To Open Diluent Container:
  • To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)
  • 1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
  • a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see ), pull the ring approximately half way around the cap and then pull straight up to remove the cap (see ).
  • Note: Do not access vial with syringe.
  • b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (see ).
  • 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180u00b0) after the first audible click. (see ). The clicking sound does not assure a seal; the vial must be turned as far as it will go.
  • Note: Once vial is sealed, do not attempt to remove. (see ).
  • 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
  • 4. Label appropriately.
  • To Prepare Admixture
  • 1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
  • 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (see ).
  • 3. Pull the inner cap from the drug vial. (see ). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.
  • 4. Mix container contents thoroughly and use within the specified time.
  • To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0017-19.0 Revised October 2019
  • NDC 0049-0013-83n n
  • Unasynn
  • Sterile
  • 1.5 g*
  • For IM or IV use
  • Pfizern- Roerig
  • NDC 0049-0013-81 n n
  • Unasynn
  • (ampicillin sodium/sulbactam sodium) for Injection
  • 1.5 g* per vial
  • Sterile For Intramuscular or Intravenous use
  • NDC 0049-0013-83contains 10 of NDC 0049-0013-81n n
  • 10 Vials
  • Unasynn
  • 1.5 g* per vial
  • Sterile
  • For Intramuscular or Intravenous use
  • Pfizer Injectables
  • NDC 0049-0014-81 n n
  • Unasynn
  • 3 g* per vial
  • Sterile For Intramuscular or Intravenous use
  • NDC 0049-0014-83 contains 10 of NDC 0049-0014-81 n n
  • 10 Vials
  • Unasynn
  • 3 g* per vial
  • Sterile
  • For Intramuscular or Intravenous use
  • Pfizer Injectables
  • NDC 0049-0022-83n n
  • Unasynn
  • 1.5 g* per vial
  • SterileFor Intravenous Use
  • NDC 0049-0022-83n n
  • 10 Bottles Unasynn
  • 1.5 g* per bottle
  • SterileFor Intravenous Use
  • Pfizer Injectables
  • NDC 0049-0023-83n n
  • Unasynn
  • Sterile
  • 3 g*
  • For Intravenous Use
  • Pfizern- Roerig
  • NDC 0049-0023-81 n n
  • Unasynn
  • (ampicillin sodium/sulbactam sodium) for Injection
  • 3 g* per vial
  • Pfizer Injectables
  • Sterile For Intravenous Use
  • NDC 0049-0023-83contains 10 of NDC 0049-0023-81
  • 10 Bottles Unasynn
  • (ampicillin sodium/sulbactam sodium) for Injection
  • 3 g* pre bottle
  • Sterile
  • For Intravenous Use
  • Pfizer Injectables
  • Rx only
  • Pfizer Injectables
  • NDC 0049-0024-28 n n
  • Unasynn
  • 15 g*
  • Sterile For Intravenous Use
  • PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
  • NDC 0049-0024-28 n n
  • 1 Bottle
  • Unasynn
  • 15 g*
  • PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
  • Sterile
  • For Intravenous Use
  • Pfizer Injectables
  • Single DoseADD-Vantageu00ae Vial
  • NDC 0049-0031-01n n
  • Unasynn (Ampicillin and Sulbactamfor Injection, USP)
  • 1.5 g*
  • For Intravenous Use Only
  • Distributed by Roerig Division of Pfizer Inc, NY, NY 10017
  • 5 Single DoseADD-Vantageu00ae Vials
  • NDC 0049-0031-02Contains 5 of NDC 0049-0031-01
  • Unasynn
  • 1.5 g*
  • (Ampicillin and Sulbactam for Injection, USP)
  • For IV UseSterile
  • Pfizer Injectables
  • Rx only
  • Single DoseADD-Vantageu00ae Vial
  • NDC 0049-0032-01n n
  • Unasynn
  • 3 g*
  • For Intravenous Use Only
  • Distributed by RoerigDivision of Pfizer Inc, NY, NY 10017
  • 5 Single DoseADD-Vantageu00ae Vials
  • NDC 0049-0032-02Contains 5 of NDC 0049-0032-01
  • Unasynn
  • 3 g*
  • (Ampicillin and Sulbactam for Injection, USP)
  • For IV UseSterile
  • Pfizer Injectables
  • Rx only

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