Unasyn

Name: Unasyn

Unasyn Drug Class

Unasyn is part of the drug class:

  • Combinations of penicillins, incl. beta lactamase inhibitors

What is the most important information I should know about Unasyn (ampicillin and sulbactam)?

You should not use this medicine if you have ever had a severe allergic reaction to any type of penicillin or cephalosporin antibiotic, or if you have had liver problems while using ampicillin and sulbactam.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I avoid while using Unasyn (ampicillin and sulbactam)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Commonly used brand name(s)

In the U.S.

  • Unasyn

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Ampicillin

Before Using Unasyn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ampicillin and sulbactam combination in children with skin infections. However, safety and efficacy have not been established in children younger than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of ampicillin and sulbactam combination in children with bowel or stomach infections. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of ampicillin and sulbactam combination in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion
  • Chlortetracycline
  • Cholera Vaccine, Live
  • Demeclocycline
  • Donepezil
  • Doxycycline
  • Lymecycline
  • Meclocycline
  • Methacycline
  • Minocycline
  • Oxytetracycline
  • Rolitetracycline
  • Tetracycline
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Khat

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea—Use with caution. May make this condition worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal from the body.
  • Liver disease (eg, cholestatic jaundice), history of or
  • Mononucleosis (”mono”)—Should not be used in patients with this condition.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • For females, vaginal yeast infection. Report itching or discharge.
  • Redness or white patches in mouth or throat.
  • It is common to have diarrhea when taking Unasyn. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
  • Very bad and sometimes deadly liver problems have happened with Unasyn. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Contraindications

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.

Compatibility, reconstitution and stability

When concomitant therapy with aminoglycosides is indicated, Unasyn and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.

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.

Introduction

Antibacterial; β-lactam antibiotic; fixed combination of ampicillin (an aminopenicillin) and sulbactam (a β-lactamase inhibitor).1 3 29 30 64 69

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