Neostigmine methylsulfate and glycopyrrolate (Intravenous)

Neostigmine methylsulfate and glycopyrrolate combination injection is used to reverse the effects (for example, slow heart rate and too much secretion) of non-depolarizing neuromuscular blocking agents (NMBA) after surgery.

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

Your doctor will monitor your progress closely while you or your child are receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue taking it. Blood and urine tests may be needed to check for side effects.

Contact your doctor immediately if you notice blurred vision, difficulty reading, sensitivity to light, or any other changes in vision during or after treatment. Your doctor may want your eyes to be examined by an ophthalmologist (eye doctor).

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical help. Contact your doctor right away if you or your child experiences chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, swelling around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.

This medicine may make you feel dizzy, drowsy, or cause blurred vision. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

This medicine may reduce sweating, which can lead to an increase in body temperature. Be cautious during exercise and in hot weather. You could overheat or suffer from heat stroke. Contact your doctor immediately if you or your child experience dizziness, fast, shallow breathing, fast, weak heartbeat, headache, muscle cramps, pale, clammy skin, thirst, or extremely high fever or body temperature.

Contact your doctor immediately if you or your child have diarrhea or stomach pain. These may be signs of a serious stomach or bowel issue (e.g., blockage).

This medicine may cause tachycardia. Contact your doctor immediately if you have a fast, pounding, or irregular heartbeat or pulse.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. 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 inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

The use of neostigmine methylsulfate and glycopyrrolate combination injection in children younger than 2 years old is not recommended. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of neostigmine methylsulfate and glycopyrrolate combination injection in this age group. However, older patients are more likely to have age-related kidney issues, which may require caution and an adjustment in the dose for patients using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to change the dose, or other precautions may be needed. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Brompheniramine
• Buprenorphine
• Bupropion
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Loxapine
• Meclizine
• Mepenzolate
• Methacholine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Paroxetine
• Perphenazine
• Pimozide
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Solifenacin
• Stramonium
• Tapentadol
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Using this medicine with any of the following medicines may increase the 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 medicines.

• Succinylcholine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to inform 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 worsen these conditions.

• 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 (e.g., achalasia, pyloroduodenal stenosis, paralytic ileus, toxic megacolon, ulcerative colitis) or
• Trouble passing urine (e.g., prostatic hypertrophy)—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. 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.

In the U.S.

• Prevduo

Available Dosage Forms:

• Solution

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Neostigmine

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.