Ampicillin and sulbactam (injection route)


    Brand Name

    US Brand Name

    Unasyn


    Description

    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, this medicine will not work for colds, flu, or other virus infections.

    This medicine is to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    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.

    Breastfeeding

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

    Drug Interactions

    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.

    • Amifampridine
    • Bupropion
    • Chlortetracycline
    • Cholera Vaccine, Live
    • Demeclocycline
    • Desogestrel
    • Dichlorphenamide
    • Dienogest
    • Donepezil
    • Doxycycline
    • Drospirenone
    • Eravacycline
    • Estradiol
    • Ethinyl Estradiol
    • Ethynodiol
    • Gestodene
    • Levonorgestrel
    • Lymecycline
    • Meclocycline
    • Mestranol
    • Methacycline
    • Minocycline
    • Nitisinone
    • Nomegestrol
    • Norethindrone
    • Norgestimate
    • Norgestrel
    • Oxytetracycline
    • Probenecid
    • Rolitetracycline
    • Sarecycline
    • Tetracycline
    • Tigecycline
    • 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.

    • Chloroquine
    • Hydroxychloroquine
    • Khat

    Other Interactions

    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) caused by ampicillin/sulbactam, history of or
    • Mononucleosis (”mono”)—Should not be used in patients with this condition.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle or a vein.


    Precautions

    Your doctor will check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after taking this medicine.

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), erythema multiforme, and dermatitis exfoliative can occur with this medicine. Check with your doctor right away if you or your child has blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are receiving this medicine.

    Ampicillin and sulbactam combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. 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 medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

    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.


    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:

    Less common

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

    Rare

    • Bloody nose
    • burning while urinating
    • chest pain, discomfort, or pressure
    • chills
    • decrease in the 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

    Incidence not known

    • 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
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • large blisters on the arms, legs, hands, feet, or upper body
    • loss of heat from the body
    • lower back or side pain
    • nausea or vomiting
    • pain
    • red, irritated eyes
    • red skin lesions, often with a purple center
    • red, swollen skin
    • scaly skin
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stomach cramps, pains, or tenderness
    • 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:

    More common

    • 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

    Rare

    • 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 stomach area
    • white patches in the mouth or throat or on the tongue
    • white patches with diaper rash

    Incidence not known

    • 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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