What is Cuvposa?

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (e.g., cerebral palsy) in children 3 to 16 years of age. This medicine is an anticholinergic.

Glycopyrrolate may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Your doctor will tell you how much of this medicine to use and how often. The dose may need to be changed several times in order to find out what works best for you or your child. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

You should take this medicine at least one hour before or two hours after meals.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):
  • For severe drooling:
    • Children 3 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The dose is 0.02 milligram (mg) per kilogram (kg) of body weight three times a day. Your child's doctor may increase your child's dose as needed. However, the dose is usually not more than 1.5 to 3 mg per dose.
    • Children younger than 3 years of age—Use and dose must be determined by your child's doctor.
• For oral dosage form (tablet):
  • For peptic ulcers:
    • Adults and children 12 years of age and older—The initial dose is 1 mg three times daily. Your doctor will adjust the dose as needed. However, the dose is usually not more than 8 mg per day.
    • Children younger than 12 years of age—Use is not recommended.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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:

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.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glycopyrrolate in children 3 to 16 years of age. However, safety and efficacy have not been established in children younger than 3 years of age.

No information is available on whether the risk of glycopyrrolate-induced adverse effects are increased in the elderly; however, it should be used with caution because elderly patients are more likely to have age related liver disease, kidney disease, heart disease, or prostate problems. This may require a dosage adjustment or careful monitoring in elderly patients receiving glycopyrrolate.

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.

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 taking 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

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.

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

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.

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:

• Colostomy (bowel surgical procedure) or
• Congestive heart failure or
• Heart disease or
• Heart rhythm problems or
• Hiatal hernia with gastroesophageal reflux disease (GERD) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Ileostomy (bowel surgical procedure) or
• Liver disease or
• Nerve problems (e.g., neuropathy) or
• Prostatic hypertrophy (enlarged prostate) or
• Ulcerative colitis—Use with caution. May make these conditions worse.

• Glaucoma or
• Myasthenia gravis (severe muscle weakness) or
• Obstructive uropathy (urinary blockage due to enlarged prostate or other condition) or
• Paralytic ileus (bowel blockage) or
• Stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction), severe or
• Trouble urinating—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check for unwanted effects.

You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while is using this medicine. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.

This medicine may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Stop using this medicine and check with your doctor if you or your child has constipation, diarrhea, abdominal or stomach distention (swelling), pain, nausea, or vomiting.

Stop using this medicine and check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has the following symptoms while using this medicine: crying, irritability, decrease in the frequency of urine, or difficult or painful urination.

If you or your child develops a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

This medicine may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may make you or your child drowsy or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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.