Cuvposa

Cuvposa

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Constipation or Intestinal Pseudo-obstruction

Constipation is a common dose-limiting adverse reaction which sometimes leads to glycopyrrolate discontinuation [see ADVERSE REACTIONS]. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting.

Incomplete Mechanical Intestinal Obstruction

Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If incomplete mechanical intestinal obstruction is suspected, discontinue treatment with CUVPOSA and evaluate for intestinal obstruction.

High Ambient Temperatures

In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of anticholinergic drugs such as CUVPOSA. Advise parents/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures.

Operating Machinery or an Automobile

CUVPOSA may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking CUVPOSA.

Anticholinergic Drug Effects

Use CUVPOSA with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:

Patient Counseling Information

See FDA-Approved Patient Labeling.

  • Advise parent/caregivers to measure CUVPOSA with an accurate measuring device. A household teaspoon is not an accurate measuring device. Parents/caregivers should use a dosing cup available in pharmacies to accurately measure the correct milliliter dose for the patient. An oral syringe, also available in pharmacies, should be used to dispense CUVPOSA into the child's mouth from the cup. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.
  • Administering CUVPOSA with a high fat meal substantially reduces the amount of glycopyrrolate absorbed. Administer CUVPOSA at least one hour before or two hours after meals. x CUVPOSA is started at a low dose and gradually titrated over a period of weeks based on therapeutic response and adverse reactions. Parents/caregivers should not increase the dose without the physician's permission.
  • Common adverse reactions from CUVPOSA include overly dry mouth, constipation, vomiting, flushing of the skin or face, and urinary retention. Side effects can sometimes be difficult to detect in some patients with neurologic problems who cannot adequately communicate how they feel. If side effects become troublesome after increasing a dose, decrease the dose to the prior one and contact your physician.
  • Constipation is the most common side effect of glycopyrrolate, and if constipation occurs, stop administering glycopyrrolate to the patient and call a healthcare practitioner. x Inability of the patient to urinate, dry diapers or undergarments, irritability or crying may be signs of urinary retention, and if urinary retention occurs, parents/caregivers should stop administering glycopyrrolate and call their healthcare practitioner. x If the patient develops a skin rash, hives or an allergic reaction, parents/caregivers should stop administering glycopyrrolate and call their healthcare practitioner as this could be a sign of hypersensitivity to this product.
  • Drugs like glycopyrrolate can reduce sweating, and if the patient is in a hot environment and flushing of the skin occurs, this may be due to overheating. Parents/caregivers should be advised to avoid exposure of the patient to hot or very warm environmental temperatures to avoid overheating and the possibility of heat exhaustion or heat stroke.

Nonclinical Toxicology

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 ssay.

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.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with glycopyrrolate. It is also not known whether glycopyrrolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CUVPOSA should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CUVPOSA is administered to a nursing woman.

Pediatric Use

CUVPOSA was evaluated for chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling. CUVPOSA has not been studied in subjects under the age of 3 years.

Geriatric Use

Clinical studies of CUVPOSA did not include subjects aged 65 and over.

Renal Impairment

Because glycopyrrolate is largely renally eliminated, CUVPOSA should be used with caution in patients with renal impairment (see CLINICAL PHARMACOLOGY).

Last reviewed on RxList: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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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.


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