Cuvposa (Glycopyrrolate Oral Solution)
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Cuvposa (Glycopyrrolate Oral Solution)

CUVPOSA
(glycopyrrolate) Oral Solution

DRUG DESCRIPTION

CUVPOSA is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is:

CUVPOSA (glycopyrrolate) Structural Formula Illustration

The empirical formula for CUVPOSA is C19H28BrNO3 and the molecular weight is 398.33. The inactive ingredients in CUVPOSA are: citric acid, glycerin, natural and artificial cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol solution, and purified water.

What are the possible side effects of glycopyrrolate (Cuvposa, Robinul, Robinul Forte)?

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...

Read All Potential Side Effects and See Pictures of Cuvposa »

What are the precautions when taking glycopyrrolate oral solution (Cuvposa)?

Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, problems with urination (such as urinary tract blockage, severely enlarged prostate), stomach/intestinal problems (such as chronic constipation, slow gut, intestinal blockage/infection, ulcerative colitis), myasthenia gravis, kidney problems.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are...

Read All Potential Precautions of Cuvposa »

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

CUVPOSA must be measured and administered with an accurate measuring device [see PATIENT INFORMATION].

Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic 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. For greater detail, see Table 1.

During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient's caregiver.

CUVPOSA should be dosed at least one hour before or two hours after meals.

The presence of high fat food reduces the oral bioavailability of CUVPOSA if taken shortly after a meal [see CLINICAL PHARMACOLOGY].

Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily)

Weight Dose Level 1 (~0.02 mg/kg) Dose Level 2 (~0.04 mg/kg) Dose Level 3 (~0.06 mg/kg) Dose Level 4 (~0.08 mg/kg) Dose Level 5 (~0.1 mg/kg)
Kg lb
13-17 27-38 0.3 mg 1.5 mL 0.6 mg 3 mL 0.9 mg 4.5 mL 12 mg 6 mL 15 mg 7.5 mL
18-22 39-49 0.4 mg 2 mL 0.8 mL 4 mL 12 mg 6 mL 1.6 mg 8 mL 2.0 mg 10 mL
23-27 50-60 0.5 mg 2.5 mL 1.0 mg 5 mL 15 mg 7.5 mL 2.0 mg 10 mL 2.5 mg 12.5 mL
28-32 61-71 0.6 mg 3 mL 12 mg 6 mL 1.8 mg 9 mL 2.4 mg 12 mL 3.0 mg 15 mL
33-37 72-82 0.7 mg 3.5 mL 1.4 mg 7 mL 2.1 mg 10.5 mL 2.8 mg 14 mL 3.0 mg 15 mL
38-42 83-93 0.8 mg 4 mL 1.6 mg 8 mL 2.4 mg 12 mL 3.0 mg 15 mL 3.0 mg 15 mL
43-47 94-104 0.9 mg 4.5 mL 1.8 mg 9 mL 2.7 mg 13.5 mL 3.0 mg 15 mL 3.0 mg 15 mL
> 48 > 105 1.0 mg 5 mL 2.0 mg 10 mL 3.0 mg 15 mL 3.0 mg 15 mL 3.0 mg 15 mL

HOW SUPPLIED

Dosage Forms And Strengths

CUVPOSA is available as a 1mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles.

Storage And Handling

NDC 0259-0501-16; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle.

Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F)

[See USP Controlled Room Temperature].

Manufactured by: Mikart Inc., Atlanta, GA 30318. Manufactured for: Merz Pharmaceuticals, LLC, Greensboro, NC 27410. Rev 10/2012

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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 Trial 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 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

  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 Cuvposa (glycopyrrolate oral solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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 increase serum levels and enhance 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).
Amantadine

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.

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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 the use of anticholinergic drugs such as CUVPOSA. Advise patients/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. Patients/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.
  • 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 their healthcare practitioner.
  • 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.
  • 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. Patients/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 assay.

Glycopyrrolate has not been evaluated for potential to impair fertility.

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 fatal 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 3-16 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: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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. 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.

CONTRAINDICATIONS

CUVPOSA is contraindicated in:

  • Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis).
  • Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of CUVPOSA.

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

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.

Pharmacodynamics

Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

Pharmacokinetics

Absorption

In a parallel study of children (n=6 per group) aged 7-14 years undergoing intraocular surgery, subjects received either intravenous (IV) or oral glycopyrrolate as a premedication. The mean absolute bioavailability of oral glycopyrrolate tablets was low (approximately 3%) and highly variable among subjects (range 1.3 to 13.3%). A similar pattern of low and variable relative bioavailability is seen in adults.

Analysis of population pharmacokinetic data from normal adults and children with cerebral palsy associated chronic moderate to severe drooling failed to demonstrate linear pharmacokinetics across the dose range. In the same analysis, population estimates of the apparent oral clearance (scaled by weight in children and adults) ranged from 5.28 ~ 38.95 L/hr/kg for healthy adults and 8.07 ~ 25.65 L/hr/kg for patients with cerebral palsy, a reflection of the low and highly variable oral bioavailability of glycopyrrolate.

Absorption of CUVPOSA (fasting) was compared to that of a marketed glycopyrrolate oral tablet. The Cmax after oral solution administered was 23% lower compared to tablet administered and AUC0-inf was 28% lower after oral solution administered. Mean Cmax after oral solution administration in the fasting state was 0.318 ng/mL, and mean AUC0-24 was 1.74 ng.hr/mL. Mean time to maximum plasma concentration for CUVPOSA was 3.1 hours, and mean plasma half-life was 3.0 hours.

In healthy adults, a high fat meal was shown to significantly affect the absorption of glycopyrrolate oral solution (10 mL, 1 mg/5 mL). The mean Cmax under fed high fat meal conditions was approximately 74% lower than the Cmax observed under fasting conditions. Similarly, mean AUC0-T was reduced by about 78% by the high fat meal compared with the fasting AUC0-T. A high fat meal markedly reduces the oral bioavailability of CUVPOSA. Therefore, CUVOPSA should be dosed at least one hour before or two hours after meals. Pharmacokinetic results (mean ± SD) are described in Table 3.

Table 3: Pharmacokinetic Parameters (mean±SD) for CUVPOSA, Fasting and Fed, in Healthy Adults

  Cmax (ng/mL) Tmax (hrs) AUC0-T (ng•hr/mL) AUC0-Inf (ng•hr/mL) T½ (hrs)
Fasting (n=37) 0.318 ± 0.190 3.10 ± 1.08 1.74 ± 1.07 1.81 ± 1.09 3.0 ± 1.2
Fed (n=36) 0.084 ± 0.081 2.60 ± 1.12 0.38 ± 0.14 0.46 ± 0.13* 3.2 ± 1.1*
* n=35

Distribution

After IV administration, glycopyrrolate has a mean volume of distribution in children aged 1 to 14 years of approximately 1.3 to 1.8 L/kg, with a range from 0.7 to 3.9 L/kg. In adults aged 60-75 years, the volume of distribution was lower (0.42 L/kg +/- 0.22).

Metabolism

In adult patients who underwent surgery for cholelithiasis and were given a single IV does of tritiated glycopyrrolate, approximately 85% of total radioactivity was excreted in urine and < 5% was present in T-tube drainage of bile. In both urine and bile, > 80% of the radioactivity corresponded to unchanged drug. These data suggest a small proportion of IV glycopyrrolate is excreted as one or more metabolites.

Elimination

Approximately 65-80% of an IV glycopyrrolate dose was eliminated unchanged in urine in adults. In two studies, after IV administration to pediatric patients ages 1-14 years, mean clearance values ranged from 1.01- 1.41 L/kg/hr (range 0.32 -2.22 L/kg/hr). In adults, IV clearance values were 0.54 ± 0.14 L/kg/hr.

Pediatrics

The estimated apparent clearance of glycopyrrolate from a population pharmacokinetic analysis (scaled by weight in children and adults) of oral and IV data was found to be 13.2 L/hr/kg or 92.7 L/hr for a typical 70 kg subject. In the same population based analysis, gender was not identified as having an effect on either glycopyrrolate clearance or systemic exposure.

Gender

Population pharmacokinetic evaluation of adults and children administered IV or oral glycopyrrolate identified no effect of gender on glycopyrrolate clearance or systemic exposure.

Race

The pharmacokinetics of glycopyrrolate by race has not been characterized.

Elderly

Glycopyrrolate pharmacokinetics have not been characterized in the elderly.

Renal Impairment

In one study, glycopyrrolate 4 mcg/kg was administered intravenously in uremic patients undergoing renal transplantation surgery. Mean AUC (10.6 mcg·h/L), mean plasma clearance (0.43 L/hr/kg) and mean 3-hour urinary excretion (0.7%) for glycopyrrolate were significantly different than those of control patients (3.73 μg·h/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that elimination of glycopyrrolate is severely impaired in patients with renal failure.

Hepatic Impairment

Glycopyrrolate is largely renally eliminated. The pharmacokinetics of glycopyrrolate have not been evaluated in patients with hepatic impairment.

Clinical Studies

CUVPOSA was evaluated in a multi-center, randomized, double-blind, placebo-controlled, parallel, eight-week study for the control of pathologic drooling in children (Study 1). The study enrolled 38 subjects aged 3-23 years; thirty-six subjects were aged 3-16 years and two patients were greater than 16 years. The subjects were male or female, weighed at least 13 kg (27 lbs), and had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days (approximately five to seven days per week). Subjects were randomized in a 1:1 fashion to receive CUVPOSA or placebo. Doses of study medication were titrated over a 4-week period to optimal response beginning at 0.02 mg/kg three times a day increasing doses in increments of approximately 0.02 mg/kg three times per day every 5-7 days, not to exceed the lesser of approximately 0.1 mg/kg three times per day or 3 mg three times per day.

Subjects were evaluated on the 9-point modified Teacher's Drooling Scale (mTDS), which is presented below. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose on evaluation days during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy.

Modified Teacher's Drooling Scale

1= Dry: never drools
2= Mild: only the lips are wet; occasionally
3= Mild: only the lips are wet; frequently
4= Moderate: wet on lips and chin; occasionally
5= Moderate: wet on the lips and chin; frequently
6= Severe: drools to the extent that clothing becomes damp; occasionally
7= Severe: drools to the extent that clothing becomes damp; frequently
8= Profuse: clothing, hands, tray, and objects became wet; occasionally
9= Profuse: clothing, hands, tray, and objects became wet; frequently

Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. Table 4 presents the proportion of responders at Week 8 and Figure 1 presents the mean mTDS values from baseline through Week 8.

Table 4: Percentage of Responders at Week 8

CUVPOSA GROUP
(N=20)
Placebo Group
(N=18)
15/20 (75%) 2/18 (11%)

Figure 1: Mean (± 2 Standard Errors) mDTS Scores

Mean (± 2 Standard Errors) mDTS Scores - Illustration

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

PATIENT and CAREGIVER INFORMATION

CUVPOSA
(glycopyrrolate) Oral Solution

Please read the Patient and Caregiver Information that comes with CUVPOSA before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment.

What is CUVPOSA?

CUVPOSA is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling.

Who should not take CUVPOSA?

Do not give CUVPOSA to anyone who:

  • 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 should I tell my doctor before giving CUVPOSA to my child?

Tell your doctor if your child:

  • has any allergies
  • has any stomach or bowel problems, including ulcerative colitis
  • has any problems with constipation
  • has thyroid problems
  • has high blood pressure
  • has heart problems or abnormal heart beats
  • has a hiatal hernia with gastroesophageal reflux disease (GERD)
  • has any eye problems
  • has any problems urinating
  • has any other medical conditions
  • is pregnant or plans to become pregnant. It is not known if CUVPOSA can harm an unborn baby
  • is breastfeeding or plans to breastfeed. It is not known if CUVPOSA passes into breast milk and if it can harm the baby

Tell your doctor about all of the medicines that your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way CUVPOSA works, and CUVPOSA may affect how some other medicines work.

How should I give CUVPOSA?

  • Give CUVPOSA exactly as prescribed by your child's doctor.
  • Give 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. See “What are the possible side effects of CUVPOSA?”

What should I avoid while taking CUVPOSA?

  • 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. See “What are the possible side effects of CUVPOSA?”

What are possible side effects of CUVPOSA?

CUVPOSA can cause serious side effects including:

  • Constipation. Constipation is common with CUVPOSA. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of CUVPOSA may need to be decreased or stopped.
  • Diarrhea and intestinal blockage. Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if you child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking CUVPOSA.
  • Problems with control of body temperature (overheating or heat stroke). CUVPOSA can cause child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heatstroke:
    • hot, red skin
    • decreased alertness or passing out (unconsciousness)
    • fast, weak pulse
    • fast, shallow breathing
    • increased body temperature (fever)

The most common side effects of CUVPOSA include:

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

Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of CUVPOSA.

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

How should I store CUVPOSA?

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

Keep CUVPOSA out of the reach of children.

General information and CUVPOSA:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CUVPOSA for a condition for which it was not prescribed. Do not give CUVPOSA to other people even if they have the same condition. It may harm them.

This leaflet summarizes the most important information about CUVPOSA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CUVPOSA that is written for health professionals.

For more information, go to: www.cuvposa.com or call 877-743-8454.

What are the ingredients in CUVPOSA?

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

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

PATIENT and CAREGIVER INFORMATION

CUVPOSA
(glycopyrrolate) Oral Solution

Please read the Patient and Caregiver Information that comes with CUVPOSA before you start giving it to your child, and each time you get a refill. This leaflet does not take the place of talking with your doctor about your child's medical condition or treatment.

What is CUVPOSA?

CUVPOSA is a prescription medicine used in children with medical conditions that cause too much (abnormal) drooling.

Who should not take CUVPOSA?

Do not give CUVPOSA to anyone who:

  • 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 should I tell my doctor before giving CUVPOSA to my child?

Tell your doctor if your child:

  • has any allergies
  • has any stomach or bowel problems, including ulcerative colitis
  • has any problems with constipation
  • has thyroid problems
  • has high blood pressure
  • has heart problems or abnormal heart beats
  • has a hiatal hernia with gastroesophageal reflux disease (GERD)
  • has any eye problems
  • has any problems urinating
  • has any other medical conditions
  • is pregnant or plans to become pregnant. It is not known if CUVPOSA can harm an unborn baby
  • is breastfeeding or plans to breastfeed. It is not known if CUVPOSA passes into breast milk and if it can harm the baby

Tell your doctor about all of the medicines that your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicine may affect the way CUVPOSA works, and CUVPOSA may affect how some other medicines work.

How should I give CUVPOSA?

  • Give CUVPOSA exactly as prescribed by your child's doctor.
  • Give 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. See “What are the possible side effects of CUVPOSA?”

What should I avoid while taking CUVPOSA?

  • 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. See “What are the possible side effects of CUVPOSA?”

What are possible side effects of CUVPOSA?

CUVPOSA can cause serious side effects including:

  • Constipation. Constipation is common with CUVPOSA. Tell your doctor if your child strains with bowel movements, goes longer between bowel movements, cannot have a bowel movement, or their stomach is firm and large. The dose of CUVPOSA may need to be decreased or stopped.
  • Diarrhea and intestinal blockage. Diarrhea can be an early symptom of a blockage in the intestine. This is especially true if you child has a colostomy or ileostomy. Tell your doctor if your child has any diarrhea while taking CUVPOSA.
  • Problems with control of body temperature (overheating or heat stroke). CUVPOSA can cause child to sweat less. Your child can become overheated, and develop heat stroke if they are in an area that is very hot. Avoid overheating. Call your doctor right away if your child becomes sick and has any of these symptoms of heatstroke:
    • hot, red skin
    • decreased alertness or passing out (unconsciousness)
    • fast, weak pulse
    • fast, shallow breathing
    • increased body temperature (fever)

The most common side effects of CUVPOSA include:

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

Tell your doctor if your child has any side effect that concerns you or that does not go away. These are not all the possible side effects of CUVPOSA.

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

How should I store CUVPOSA?

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

Keep CUVPOSA out of the reach of children.

General information and CUVPOSA:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CUVPOSA for a condition for which it was not prescribed. Do not give CUVPOSA to other people even if they have the same condition. It may harm them.

This leaflet summarizes the most important information about CUVPOSA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CUVPOSA that is written for health professionals.

For more information, go to: www.cuvposa.com or call 877-743-8454.

What are the ingredients in CUVPOSA?

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

Last reviewed on RxList: 11/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Cuvposa Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

GLYCOPYRROLATE SOLUTION - ORAL

(GLYE-koe-PIR-oh-late)

COMMON BRAND NAME(S): Cuvposa

USES: Glycopyrrolate solution is used to reduce excessive drooling caused by medical conditions (such as cerebral palsy). This medication works by decreasing the amount of saliva you make. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

HOW TO USE: Read the Patient and Caregiver Information Leaflet if available from your pharmacist before you start taking glycopyrrolate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 3 times a day. Take it on an empty stomach, at least 1 hour before or 2 hours after a meal. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Dosage is based on your medical condition and response to treatment. For children, dosage is also based on weight. To reduce the risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase the dose. Follow your doctor's instructions carefully.

Do not increase the dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and your risk of side effects will increase.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Cuvposa Consumer (continued)

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 Cuvposa (glycopyrrolate oral solution) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, problems with urination (such as urinary tract blockage, severely enlarged prostate), stomach/intestinal problems (such as chronic constipation, slow gut, intestinal blockage/infection, ulcerative colitis), myasthenia gravis, kidney problems.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you sweat less which can increase the risk for heat stroke, a very serious condition. Avoid hot temperatures and activities that might cause you to overheat. Drink plenty of fluids, and dress lightly while in hot areas. If you become overheated, stop activity and promptly seek cooler shelter. Get medical help right away if you develop a fever, dry/hot skin, weakness, mental/mood changes, headache, or dizziness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to this drug's side effects, especially drowsiness, confusion, unusual excitement, constipation, and urination problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Cuvposa Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: potassium chloride tablets/capsules, pramlintide.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fever, mental/mood changes (such as confusion, unusual excitement), seizures, coma.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised January 2011. Copyright(c) 2011 First Databank, Inc.

Cuvposa Patient Information Including Side Effects

Brand Names: Cuvposa, Robinul, Robinul Forte

Generic Name: glycopyrrolate (Pronunciation: glye koe PIE roe late)

What is glycopyrrolate (Cuvposa)?

Glycopyrrolate reduces the secretions of certain organs in the body.

Glycopyrrolate helps to control conditions such as peptic ulcers that involve excessive stomach acid production.

Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

Glycopyrrolate may also be used for purposes not listed in this medication guide.

Robinul 1 mg

round, white, imprinted with HPC 200

Robinul 2 mg

round, white, imprinted with HORIZON 205

What are the possible side effects of glycopyrrolate (Cuvposa)?

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 Cuvposa (glycopyrrolate oral solution) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about glycopyrrolate (Cuvposa)?

You should not use glycopyrrolate if you are allergic to it, or if you have bladder obstruction or other urination problems, a bowel obstruction called paralytic ileus, a blockage in your stomach or intestines, severe constipation, severe ulcerative colitis or toxic megacolon, glaucoma, myasthenia gravis, or if you also take potassium chloride.

Before you take glycopyrrolate, tell your doctor if you have kidney disease, heart disease, a heart rhythm disorder, a stomach disorder, a colostomy or ileostomy, a thyroid disorder, high blood pressure, vision problems, or numbness and tingling.

Take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of glycopyrrolate, such as dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

Side Effects Centers

Cuvposa Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking glycopyrrolate (Cuvposa)?

You should not use glycopyrrolate if you are allergic to it, or if you have:

  • bladder obstruction or other urination problems;
  • a bowel obstruction called paralytic ileus;
  • a blockage in your digestive tract (stomach or intestines), severe constipation;
  • severe ulcerative colitis or toxic megacolon;
  • glaucoma;
  • myasthenia gravis; or
  • if you are also taking potassium chloride (Epiklor, K-Lor, K-Tab, Klor-Con, Micro-K, Rum-K, and others).

To make sure you can safely take glycopyrrolate, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • heart disease or a heart rhythm disorder;
  • a stomach disorder such as hiatal hernia, reflux disease, or slow digestion;
  • a colostomy or ileostomy;
  • a thyroid disorder;
  • high blood pressure;
  • vision problems; or
  • a nerve disorder that causes numbness or tingling.

FDA pregnancy category C. It is not known whether glycopyrrolate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether glycopyrrolate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Glycopyrrolate should not be given to a child younger than 3 years old.

How should I take glycopyrrolate (Cuvposa)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

Side Effects Centers

Cuvposa Patient Information including If I Miss a Dose

What happens if I miss a dose (Cuvposa)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Cuvposa)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weak or shallow breathing, feeling cold, jerky muscle movements, or seizure (convulsions).

What should I avoid while taking glycopyrrolate (Cuvposa)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of glycopyrrolate, such as dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

What other drugs will affect glycopyrrolate (Cuvposa)?

Many drugs can interact with glycopyrrolate. Below is just a partial list. Tell your doctor if you are using:

  • amantadine (Symmetrel);
  • atenolol (Tenormin, Tenoretic);
  • digoxin (Lanoxin, Lanoxicaps);
  • haloperidol (Haldol);
  • levodopa (Larodopa); or
  • metformin (Glucophage, Actoplus Met, Avandamet, Janumet, Kombiglyze, PrandiMet).

This list is not complete and other drugs may interact with glycopyrrolate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about glycopyrrolate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 10/3/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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