Cuvposa belongs to a class of drugs known as anticholinergics.

Cuvposa inhibits acetylcholine receptors that are located on certain organs in the body, including salivary glands. Glycopyrrolate indirectly reduces the rate of saliva production by preventing the stimulation of these receptors.

Cuvposa is used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

You should not use Cuvposa if you have urination problems, a blockage in your stomach or intestines, severe constipation, severe ulcerative colitis or toxic megacolon, glaucoma, myasthenia gravis, or active bleeding with heart and blood circulation problems.

Before you take Cuvposa, tell your doctor if you have kidney disease, heart disease, a heart rhythm disorder, a stomach disorder, a colostomy or ileostomy, a thyroid disorder, high blood pressure, vision problems, or numbness and tingling.

Use Cuvposa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may need to take Cuvposa on an empty stomach, at least 1 hour before or 2 hours after a meal. Follow the instructions provided with your medicine.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Allow the orally disintegrating tablet to dissolve in your mouth without chewing. Swallow the tablet without water.

Glycopyrrolate doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Pediatric Dose for Excessive Salivation:

1 mg/5 mL oral liquid, children 3 to 16 years:
Initial dose: 0.02 mg/kg orally 3 times a day, at least one hour before or 2 hours after meals
-Titrate in increments of 0.02 mg/kg every 5 to 7 days, based on response and adverse effects
Maximum dose: 0.1 mg/kg 3 times a day, not to exceed 1.5 to 3 mg per dose based on weight

Use: To reduce chronic severe drooling in patients aged 3 to 16 years with conditions associated with problem drooling (e.g. cerebral palsy)

You should not use Cuvposa if you are allergic to glycopyrrolate, or if you have:

• a bladder obstruction or other urination problems;

• a stomach or bowel obstruction (including paralytic ileus);

• severe constipation;

• severe ulcerative colitis or toxic megacolon;

• glaucoma;

• myasthenia gravis; or

• active bleeding with fast heartbeats, low blood pressure, shortness of breath, and cold hands or feet.

To make sure Cuvposa is safe for you, tell your doctor if you have ever had:

• an enlarged prostate;

• liver or kidney disease;

• heart problems or a heart rhythm disorder;

• high blood pressure;

• a stomach disorder such as ulcerative colitis, hiatal hernia, reflux disease, or slow digestion;

• a colostomy or ileostomy;

• a thyroid disorder; or

• a nerve disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Cuvposa. Glycopyrrolate may slow breast milk production.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe muscle weakness, loss of movement, dilated pupils, jerky muscle movements, or seizure (convulsions).

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Cuvposa can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction to Cuvposa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Cuvposa and call your doctor at once if you have:

• severe constipation, severe stomach pain and bloating;

• diarrhea (especially if you have a colostomy or ileostomy);

• painful or difficult urination;

• fast or pounding heartbeats, fluttering in your chest;

• confusion, severe drowsiness;

• eye pain, seeing halos around lights;

• fever, shallow breathing, weak pulse, hot and red skin; or

• (in a child taking Cuvposa) dry diapers, fussiness, or excessive crying.

Common Cuvposa side effects may include:

• constipation, nausea, vomiting, bloating;

• drowsiness, dizziness, weakness, feeling nervous;

• slow or fast heartbeats;

• sleep problems (insomnia);

• flushing (sudden warmth, redness, or tingly feeling);

• blurred vision, sensitivity to light;

• dry mouth, decreased sense of taste;

• decreased sweating, decreased urination;

• impotence, sexual problems;

• headache; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• opioid medication;

• sleep medicine, cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder;

• bronchodilator asthma medication; or

• seizure medication.

This list is not complete. Other drugs may interact with glycopyrrolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.