Cuvposa

Cuvposa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cuvposa (glycopyrrolate) Oral Solution is an anticholinergic drug used to control conditions such as peptic ulcers that involve excessive stomach acid production. It is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy. Common side effects include drowsiness, dizziness, blurred vision, dry mouth, stuffy nose, or constipation.

The initial dose of Cuvposa is 0.02 mg/kg orally three times daily, and then adjusted in increments of 0.02 mg/kg every 5-7 days based on the patient's response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. Cuvposa may interact with amantadine, atenolol, digoxin, haloperidol, levodopa, or metformin. Tell your doctor all medications and supplements you use. During pregnancy, Cuvposa should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cuvposa (glycopyrrolate) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cuvposa in Detail - Patient Information: Side Effects

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

Stop using glycopyrrolate and call your doctor at once if you have a serious side effect such as:

  • severe constipation, severe stomach pain and bloating;
  • diarrhea (especially if you have a colostomy or ileostomy);
  • feeling like you might pass out;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, weak pulse, or hot and dry skin; or
  • dry diapers, fussiness, or excessive crying in a child taking glycopyrrolate.

Less serious side effects may include:

  • dry mouth;
  • vomiting;
  • mild constipation;
  • stuffy nose, sinus pain; or
  • flushing (warmth, redness, or tingly feeling).

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.

Read the entire detailed patient monograph for Cuvposa (Glycopyrrolate Oral Solution) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cuvposa Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, dry mouth, stuffy nose, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult the pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: stomach/abdominal bloating or pain, persistent constipation, persistent nausea, vomiting, diarrhea, decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), eye pain, vision changes, difficulty urinating/inability to urinate.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cuvposa (Glycopyrrolate Oral Solution)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cuvposa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

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 a 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 from 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

  CUVPOSA
(N=20)
n (%)
Placebo
(N=18)
n (%)
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.

Gastrointestinal: Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue

General Disorders: Irritability, pain

Infections: Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection

Investigations: Heart rate increased

Metabolism and Nutrition: Dehydration

Nervous System: Headache, convulsion, dysgeusia, nystagmus

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

Vascular: Pallor

Postmarketing Experience

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 entire FDA prescribing information for Cuvposa (Glycopyrrolate Oral Solution) »

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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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