Glycopyrrolate (intramuscular route, intravenous route)


    Description

    Glycopyrrolate injection is used before and during surgery to lessen mouth, throat, or stomach secretion (eg, saliva, stomach acid), or to prevent heart rhythm problems (during anesthesia, intubation, or surgery), or unwanted effects caused by certain medicines (eg, neostigmine, pyridostigmine). It is also used to treat peptic ulcer when you cannot take medicine by mouth or when treatment needs to be fast.

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

    This product is available in the following dosage forms:

    • 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 have not been performed on the relationship of age to the effects of glycopyrrolate injection in children to treat peptic ulcer. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glycopyrrolate injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    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.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Potassium Chloride
    • Potassium Citrate

    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.

    • Aclidinium
    • Amantadine
    • Amifampridine
    • Amitriptyline
    • Amoxapine
    • Atropine
    • Belladonna
    • Benzhydrocodone
    • Benztropine
    • Biperiden
    • Brompheniramine
    • Buprenorphine
    • Bupropion
    • Carbinoxamine
    • Carisoprodol
    • Chlorpheniramine
    • Chlorpromazine
    • Clemastine
    • Clidinium
    • Clomipramine
    • Clozapine
    • Codeine
    • Cyclobenzaprine
    • Cyclopentolate
    • Cyproheptadine
    • Darifenacin
    • Desipramine
    • Dicyclomine
    • Dihydrocodeine
    • Dimenhydrinate
    • Diphenhydramine
    • Donepezil
    • Doxepin
    • Fentanyl
    • Fesoterodine
    • Flavoxate
    • Fluphenazine
    • Glucagon
    • Glycopyrronium Tosylate
    • Homatropine

    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:

    • Brain damage or
    • Down syndrome or
    • Spastic paralysis (persistent muscle spasms)—Use with caution in children with these conditions. May increase risk for more serious side effects.
    • Glaucoma or
    • Heart or blood vessel problem with bleeding, unstable or
    • Myasthenia gravis (severe muscle weakness) or
    • Problems passing urine (eg, bladder neck obstruction, prostatic hypertrophy) or
    • Stomach or bowel blockage (eg, achalasia, pyloroduodenal stenosis, paralytic ileus) or
    • Stomach or bowel problems (eg, bowel weakness, ulcerative colitis, toxic megacolon)—Should not be used in patients with these conditions.
    • Heart disease or
    • Heart failure or
    • Heart rhythm problems (eg, arrhythmia) or
    • Hiatal hernia or
    • Hypertension (high blood pressure) or
    • Hyperthyroidism (overactive thyroid) or
    • Kidney disease or
    • Liver disease or
    • Neuropathy (nerve disease) or
    • Surgery in your bowels (eg, colostomy, ileostomy)—Use with caution. May cause side effects to become worse.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into a muscle or as a needle placed into a vein. This medicine may be given 30 to 60 minutes before receiving anesthesia, a narcotic pain reliever, or sleep medicine, or during surgery.


    Precautions

    It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    Check with your doctor right away if blurred vision, difficulty with reading, sensitivity of the eyes to light, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

    This medicine may make you dizzy, drowsy, or cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during hot weather, or while doing activities, including exercising or using a sauna or whirlpool.

    This medicine may cause delayed stomach emptying. Check with your doctor right away if you have vomiting, heartburn, indigestion, stomach discomfort, upset, or pain, swelling or pressure in the stomach area, full or bloated feeling, or increased stomach pain.

    This medicine may cause heart rhythm problems. Tell your doctor right away if you or your child gets dizzy or lightheaded, have fast or irregular heart beats, or feels like fainting.

    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:

    Incidence not known

    • Bloated feeling
    • blurred or double vision or other changes in vision
    • change in near or distance vision
    • chest pain or discomfort
    • confusion
    • constipation
    • cough
    • difficulty in focusing eyes
    • difficulty swallowing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • fast, pounding, or irregular heartbeat or pulse
    • headache
    • high fever
    • hives, itching, skin rash
    • irregular heartbeat
    • recurrent lightheadedness
    • nervousness
    • pain or discomfort in the eye
    • pounding in the ears
    • pounding or rapid pulse
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • rigid muscles
    • seizures
    • slow or fast heartbeat
    • sweating
    • tightness in the chest
    • trouble in urinating
    • unusual tiredness or weakness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Agitation
    • anxiety
    • irritability
    • mood or other mental changes
    • muscle weakness or paralysis
    • nightmares
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • tremor
    • unusual feeling of excitement

    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:

    Incidence not known

    • Bleeding, blistering, burning, coldness, discoloration of 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
    • decreased amount of breast milk
    • decreased interest in sexual intercourse
    • decreased sweating
    • drowsiness
    • dry mouth
    • inability to have or keep an erection
    • loss in sexual ability, desire, drive, or performance
    • loss of taste
    • mental excitement
    • nausea
    • sensitivity of the eyes to sunlight
    • trouble sleeping
    • vomiting

    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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