(glycopyrrolate) Oral Solution
Please read the Patient and Caregiver Information that comes with CUVPOSA before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment.
What is CUVPOSA?
CUVPOSA is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling. Who should not take CUVPOSA? Do not give CUVPOSA to anyone who:
- has problems urinating
- has a bowel problem called paralytic ileus
- lacks normal bowel tone or tension
- has severe ulcerative colitis or certain other serious bowel problems with severe ulcerative colitis
- has myasthenia gravis
What should I tell my doctor before giving CUVPOSA to my child? Tell your doctor if your child:
- has any allergies
- has any stomach or bowel problems, including ulcerative colitis
- has any problems with constipation
- has thyroid problems
- has high blood pressure
- has heart problems or abnormal heart beats
- has a hiatal hernia with gastroesophageal reflux disease (GERD)
- has any eye problems
- has any problems urinating
- has any other medical conditions
- is pregnant or plans to become pregnant. It is not known if CUVPOSA can harm an unborn baby.
- is breastfeeding or plans to breastfeed. It is not known if CUVPOSA passes into breast milk and if it can harm the baby.
Tell your doctor about all of the medicines that your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way CUVPOSA works, and CUVPOSA may affect how some other medicines work.
How should I give CUVPOSA?
- Give CUVPOSA exactly as prescribed by your child's doctor.
- Give CUVPOSA 1 hour before or 2 hours after meals.
- Your doctor will tell you how much (milliliters or mLs) of CUVPOSA to give your child.
- Do not change the dose of CUVPOSA unless your doctor tells you to.
- You must measure the dose of CUVPOSA before giving it to your child. Use a special marked dose measuring cup (available at most pharmacies) to measure the right dose of CUVPOSA.
- To help make sure that your child swallows the dose, you should use an oral syringe to give the child each dose of CUVPOSA, after you measure the dose needed with a dose measuring cup. Oral syringes are also available at most pharmacies.
- If you have questions about how to measure the dose or how to use an oral syringe, ask your pharmacist or doctor.
- The dose of CUVPOSA that is needed to control drooling may be different for each child. CUVPOSA is usually started at a low dose, and slowly increased as directed by your doctor. This slow increase in dose continues until the best dose for your child is reached, to control drooling.
- During this time it is important to stay in close contact with your child's doctor, and tell the doctor about any side effects that your child has. See "What are the possible side effects of CUVPOSA?"
What should I avoid while taking CUVPOSA?
- CUVPOSA may cause sleepiness or blurred vision. Do not drive a car, operate heavy machinery, or do other dangerous activities while taking CUVPOSA.
- Avoid overheating. See "What are the possible side effects of CUVPOSA?"
What are possible side effects of CUVPOSA?
CUVPOSA can cause serious side effects including:
- Constipation. Constipation is common with CUVPOSA. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of CUVPOSA may need to be decreased or stopped.
- Diarrhea and intestinal blockage. Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if you child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking CUVPOSA.
- Problems with control of body temperature (overheating or heat stroke). CUVPOSA can cause your child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heatstroke:
- hot, red skin
- decreased alertness or passing out (unconsciousness)
- fast, weak pulse
- fast, shallow breathing
- increased body temperature (fever)
The most common side effects of CUVPOSA include:
- dry mouth
- flushing of the face or skin
- nasal congestion
- swollen sinuses (sinusitis)
- upper respiratory tract infection
- problem urinating, difficulty starting urination
Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of CUVPOSA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CUVPOSA?
Store CUVPOSA between 68°F to 77°F (20°C to 25°C).
Keep CUVPOSA out of the reach of children.
General information and CUVPOSA:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CUVPOSA for a condition for which it was not prescribed. Do not give CUVPOSA to other people even if they have the same condition. It may harm them.
This leaflet summarizes the most important information about CUVPOSA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CUVPOSA that is written for health professionals.
For more information, go to: www.cuvposa.com or call 877-743-8454.
What are the ingredients in CUVPOSA?
Active Ingredient: glycopyrrolate
Inactive Ingredients: citric acid, glycerin, natural and artificial cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol solution, and purified water
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential of glycopyrrolate.
Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay.
Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage (approximately 50 times the maximum recommended human dose, when comparing on the basis of body surface area estimates). No treatment-related effects on fertility or reproductive parameters of both genders were observed in this study.
Last reviewed on RxList: 11/23/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Cuvposa Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Parenting and Pregnancy
Get tips for baby and you.