Description
Neostigmine methylsulfate and glycopyrrolate combination injection is used to reverse the effects (eg, bradycardia and excess secretion) of non-depolarizing neuromuscular blocking agents (NMBA) after surgery.
This medicine is to be given only by or under the 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
Use of neostigmine methylsulfate and glycopyrrolate combination injection in children younger than 2 years of age is not recommended. 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 neostigmine methylsulfate and glycopyrrolate combination injection in the elderly. However, elderly patients are more likely to have age-related kidney 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
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.
- Succinylcholine
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:
- Bradycardia (slow heartbeat) or
- Heart failure or
- Heart rhythm problems or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid)—Use with caution. May make these conditions worse.
- Glaucoma (eye problem) or
- Heart and blood vessel disease, unstable or
- Kidney disease or
- Liver disease or
- Myasthenia gravis (severe muscle weakness) or
- Peritonitis (swelling of the lining of the stomach) or
- Stomach or intestinal problems (eg, achalasia, pyloroduodenal stenosis, paralytic ileus, toxic megacolon, ulcerative colitis) or
- Trouble passing urine (eg, prostatic hypertrophy)—Should not be used in patients with these conditions.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 minute.
Precautions
Your doctor will check your progress closely while your or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. 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 cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child has chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.
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 you sweat less, which can cause your body temperature to rise. Be careful when you exercise and during hot weather. You could overheat or get heat stroke. Check with your doctor right away if you or your child has dizziness, fast, shallow breathing, fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, thirst, or extremely high fever or body temperature.
Check with your doctor right away if you or your child have diarrhea or stomach pain. These may be symptoms of a serious stomach or bowel problem (eg, blockage).
This medicine may cause tachycardia. Check with your doctor right away if you have fast, pounding, or irregular heartbeat or pulse.
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
- Blurred vision
- change in color vision
- chest pain, discomfort, or tightness
- confusion
- cough
- decrease in frequency of urination
- decrease in urine volume
- difficult and painful urination
- difficulty in passing urine [dribbling]
- difficulty seeing at night
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- excitement
- fast, pounding, or irregular heartbeat or pulse
- headache
- hives, itching, skin rash
- increased sensitivity of eyes to sunlight
- mental confusion
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sleeplessness
- slow or irregular heartbeat
- sweating
- thirst
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
Incidence not known
- Constricted, pinpoint, or small pupils [black part of the eye]
- diarrhea
- high fever
- loss of consciousness
- no blood pressure or pulse
- no breathing
- noisy breathing
- pale or blue lips, fingernails, or skin
- rigid muscles
- seizures
- sleepiness
- stopping of the heart
- unconsciousness
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:
Less common
- Bloated
- constipation
- dry skin
- loss of taste
- nausea
- vomiting
Incidence not known
- Difficulty in moving
- excess air or gas in the stomach or intestines
- feeling of warmth
- full feeling
- increased sweating
- joint pain
- muscle pain, stiffness, cramps, or spasms
- passing gas
- redness of the face, neck, arms and occasionally, upper chest
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.
CON-XXXXXXXX
