Cuvposa

What is Cuvposa?

• Cuvposa (Glycopyrrolate) is an anticholinergic used to treat severe drooling.

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Glycopyrrolate

What are the uses of this medicine?

• Cuvposa (Glycopyrrolate) is used to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

How does this medicine work?

• Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands.
• Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• 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 drug interactions can this medicine cause?

• Use of digoxin with glycopyrrolate can increase digoxin serum levels. Monitor patients and consider use of alternative dosage forms of digoxin.
• Effects of glycopyrrolate may be increased with concomitant administration of amantadine. Consider decreasing the dose of glycopyrrolate during concomitant use.
• Glycopyrrolate may increase serum levels of atenolol or metformin. Consider dose reduction when used with glycopyrrolate.
• Glycopyrrolate may decrease serum levels of haloperidol or levodopa. Consider a dose increase when used with glycopyrrolate.

Is this medicine FDA approved?

• Initial U.S. Approval: 1961

How should this medicine be used?

Recommended dosage:

• Initiate dosing at 0.02 mg/kg three times daily and titrate in increments of 0.02 mg/kg every 5-7 days, based on therapeutic response and adverse reactions.
• Maximum recommended dose is 0.1 mg/kg three times daily, not to exceed 1.5-3 mg per dose based upon weight.

Administration:

• Take 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 1 mg/5 mL, oral solution in 16 ounce bottles.

This medicine is available in fallowing brand namesː

• Cuvposa

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry mouth
• vomiting
• flushing of the face or skin
• nasal congestion
• headache
• swollen sinuses (sinusitis)
• upper respiratory tract infection
• problems urinating, difficulty starting urination

Cuvposa can cause serious side effects including:

• Constipation
• Diarrhea and intestinal blockage
• Problems with control of body temperature (overheating or
• heat stroke

What special precautions should I follow?

• 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. To reduce the risk of heat prostration, avoid high temperatures.
• Constipation is a common dose-limiting adverse reaction. 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.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents.

Management of overdosage: In case of accidental overdose, therapy may include:

• Maintain an open airway, providing ventilation as necessary.
• Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage.
• Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus.
• Administering activated charcoal orally as appropriate.

Can this medicine be used in pregnancy?

• There are no available data in pregnant women for Cuvposa to inform decisions concerning any drug-associated risks.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• 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

Who manufactures and distributes this medicine?

Manufactured by: Mikart, LLC Atlanta, GA 30318

Manufactured for: Merz Pharmaceuticals, LLC Raleigh, NC 27615

What should I know about storage and disposal of this medication?

• Store Cuvposa between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Cuvposa
• FDA Cuvposa

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