ampicillin and sulbactam (Injection route)

am-pi-SIL-in SOE-dee-um, sul-BAK-tam SOE-dee-um

Commonly used brand name(s):

In the U.S.

• Unasyn

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Ampicillin

Uses For ampicillin and sulbactam

Ampicillin and sulbactam combination is used to treat bacterial infections in many different parts of the body.

Ampicillin and sulbactam combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, ampicillin and sulbactam will not work for colds, flu, or other virus infections.

ampicillin and sulbactam is available only with your doctor's prescription.

Before Using ampicillin and sulbactam

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 ampicillin and sulbactam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ampicillin and sulbactam 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 below 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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using ampicillin and sulbactam 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.

• Ethinyl Estradiol
• Etonogestrel
• Khat
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestrel

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 ampicillin and sulbactam. 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.

• Mononucleosis (”mono”)—Should not be used in patients with this condition.

Proper Use of ampicillin and sulbactam

A nurse or other trained health professional will give you ampicillin and sulbactam in a hospital. ampicillin and sulbactam is given as a shot into one of your muscles or through a needle placed in one of your veins.

Precautions While Using ampicillin and sulbactam

Your doctor will check your progress closely while you are receiving ampicillin and sulbactam. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

ampicillin and sulbactam may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive ampicillin and sulbactam.

Ampicillin and sulbactam combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking ampicillin and sulbactam. The results of some tests may be affected by ampicillin and sulbactam.

ampicillin and sulbactam may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using ampicillin and sulbactam.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ampicillin and sulbactam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Changes in skin color
• diarrhea
• pain, tenderness, or swelling of the foot or leg

• Bloody nose
• burning while urinating
• chest pain, discomfort, or pressure
• chills
• decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• flushing or redness of the skin
• painful urination
• swelling
• swelling or puffiness of the face
• tightness in the throat
• unusually warm skin

• Abdominal or stomach cramps or tenderness
• black, hairy tongue
• blistering, peeling, or loosening of the skin
• bloating
• cough or hoarseness
• cracks in the skin
• diarrhea, watery and severe, which may also be bloody
• fever
• fever with or without chills
• general feeling of tiredness or weakness
• increased thirst
• itching
• joint or muscle pain
• loss of heat from the body
• lower back or side pain
• nausea or vomiting
• pain
• red, irritated eyes
• red, swollen skin
• scaly skin
• severe stomach pain
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling or inflammation of the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

• Excess air or gas in the stomach or intestines
• full or bloated feeling
• general feeling of discomfort or illness
• headache
• passing gas
• pressure in the stomach
• redness, swelling, or soreness of the tongue
• swelling of the abdominal or stomach area
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

• Burning feeling in the chest or stomach
• indigestion
• stomach upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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