The following serious adverse reactions are described elsewhere in the labeling:
- Constipation or intestinal pseudo-obstruction [see WARNINGS AND PRECAUTIONS]
- Incomplete mechanical intestinal obstruction [see WARNINGS AND PRECAUTIONS]
The most common adverse reactions reported with CUVPOSA are dry mouth, vomiting, constipation, flushing, and nasal congestion.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to CUVPOSA in 151 subjects, including 20 subjects who participated in an 8-week placebo-controlled study (Study 1) and 137 subjects who participated in a 24-week open-label study (six subjects who received CUVPOSA in the placebo-controlled study and 131 new subjects).
Table 2 presents adverse reactions reported by ≥ 15% of CUVPOSA-treated subjects for the placebo-controlled clinical trial.
Table 2: Adverse Reactions Occurring in ≥ 15% of
CUVPOSA-Treated Subjects and at a Greater Frequency than Placebo in Study 1
|Dry Mouth||8 (40%)||2 (11%)|
|Vomiting||8 (40%)||2 (11%)|
|Constipation||7 (35%)||4 (22%)|
|Flushing||6 (30%)||3 (17%)|
|Nasal Congestion||6 (30%)||2 (11%)|
|Headache||3 (15%)||1 (6%)|
|Sinusitis||3 (15%)||1 (6%)|
|Upper Respiratory Tract Infection||3 (15%)||0|
|Urinary Retention||3 (15%)||0|
The following adverse reactions occurred at a rate of < 2% of patients receiving CUVPOSA in the open-label study.
General Disorders: Irritability, pain
Investigations: Heart rate increase
Metabolism and Nutrition: Dehydration
Psychiatric: Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered
Respiratory: Increased viscosity of bronchial secretion, nasal congestion, nasal dryness
Skin: Dry skin, pruritus, rash
The following adverse reactions have been identified during postapproval use of other formulations of glycopyrrolate for other indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Additional adverse reactions identified during postapproval use of glycopyrrolate tablets include: loss of taste and suppression of lactation.
Read the Cuvposa (glycopyrrolate oral solution) Side Effects Center for a complete guide to possible side effects
Drugs Affected By Reduced GI Transit Time
Glycopyrrolate reduces GI transit time, which may result in altered release of certain drugs when formulated in delayed-or controlled-release dosage forms.
- The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of glycopyrrolate. Solid dosage forms of potassium chloride are contraindicated [see CONTRAINDICATIONS].
- Digoxin administered as slow dissolution oral tablets may have increased serum levels and enhanced action when administered with glycopyrrolate. Monitor patients receiving slow dissolution digoxin for increased action if glycopyrrolate is coadministered regularly. Consider the use of other oral dosage forms of digoxin (e.g., elixir or capsules).
The anticholinergic effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during coadministration of amantadine.
Drugs Whose Plasma Levels May Be Increased By Glycopyrrolate
Coadministration of glycopyrrolate may result in increased levels of certain drugs.
- Atenolol's bioavailability may be increased with coadministration of glycopyrrolate. A reduction in the atenolol dose may be needed.
- Metformin plasma levels may be elevated with coadministration of glycopyrrolate, increasing metformin's pharmacologic and toxic effects. Monitor clinical response to metformin with concomitant glycopyrrolate administration; consider a dose reduction of metformin if warranted.
Drugs Whose Plasma Levels May Be Decreased By Glycopyrrolate
Coadministration of glycopyrrolate may result in decreased levels of certain drugs.
- Haloperidol's serum level may be decreased when coadministered with glycopyrrolate, resulting in worsening of schizophrenic symptoms, and development of tardive dyskinesia. Closely monitor patients if coadministration cannot be avoided.
- Levodopa's therapeutic effect may be reduced with glycopyrrolate administration. Consider increasing the dose of levodopa.
Read the Cuvposa Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/1/2016
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.
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