Cuvposa

What Is Cuvposa?

Cuvposa (glycopyrrolate) Oral Solution is an anticholinergic drug used to control conditions such as peptic ulcers that involve excessive stomach acid production. Cuvposa is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

What Are Side Effects of Cuvposa?

Common side effects of Cuvposa include:

• drowsiness,
• dizziness,
• blurred vision,
• dry mouth,
• stuffy nose,
• sinus pain,
• constipation,
• vomiting, or
• flushing (warmth, redness, or tingly feeling).

Tell your doctor if you have serious side effects of Cuvposa including:

• stomach or abdominal bloating or pain,
• persistent constipation,
• persistent nausea or vomiting,
• diarrhea,
• decreased sweating,
• fast or irregular heartbeat,
• mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), or
• difficulty urinating or inability to urinate.

Dosage for Cuvposa

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.

What Drugs, Substances, or Supplements Interact with Cuvposa?

Cuvposa may interact with amantadine, atenolol, digoxin, haloperidol, levodopa, or metformin. Tell your doctor all medications and supplements you use.

Cuvposa During Pregnancy or Breastfeeding

During pregnancy, Cuvposa should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

 

Cuvposa Consumer Information

Get emergency medical help if you have 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:

• 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 glycopyrrolate) dry diapers, fussiness, or excessive crying.

Common side effects may include:

• constipation, nausea, vomiting, bloating;
• drowsiness, dizziness, weakness, feeling nervous;
• slow heartbeats;
• sleep problems (insomnia);
• 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.

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

 

Cuvposa Professional Information

SIDE EFFECTS

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 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 increase

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)