Unasyn (Ampicillin and Sulbactam) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Unasyn

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UNASYN®
(ampicillin sodium/sulbactam sodium)

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of UNASYN® (ampicillin and sulbactam) and other antibacterial drugs, UNASYN (ampicillin and sulbactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

UNASYN (ampicillin and sulbactam) is an injectable antibacterial combination consisting of the semisynthetic antibiotic 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:

UNASYN® (ampicillin sodium) Structural Formula Illustration

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:

sulbactam sodium Structural Formula Illustration

UNASYN, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. UNASYN (ampicillin and sulbactam) 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.

UNASYN (ampicillin and sulbactam) pharmacy bulk package is a vial 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 UNASYN (ampicillin and sulbactam) for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE.)

What are the possible side effects of ampicillin and sulbactam (Unasyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
diarrhea that is watery or bloody; or
fever, chills, body aches, flu symptoms.

Less serious side effects may include:

nausea, vomiting, stomach...

Read All Potential Side Effects and See Pictures of Unasyn »

What are the precautions when taking ampicillin and sulbactam (Unasyn)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: viral infections (e.g., infectious mononucleosis), kidney disease.

This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (e.g., congestive heart failure).

Kidney function declines as you grow older. This medication is removed by the...

Read All Potential Precautions of Unasyn »

Last reviewed on RxList: 5/19/2008
This monograph has been modified to include the generic and brand name in many instances.