Drug: Cuvposa

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: 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.

Source: http://www.rxlist.com

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

Source: http://www.rxlist.com

CUVPOSA must be measured and administered with 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 consistent 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 1.2 mg 6 mL 1.5 mg 7.5 mL 18-22 39-49 0.4 mg 2 mL 0.8 mg 4 mL 1.2 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 1.5 mg 7.5 mL 2.0 mg 10 mL 2.5 mg 12.5 mL 28-32 61-71 0.6 mg 3 mL 1.2 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 0.48 0.105 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

Source: http://www.rxlist.com

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).
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 levels 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 Learn More »

Source: http://www.rxlist.com

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).

Source: http://www.rxlist.com

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: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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:
  • Maintaining 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.

Source: http://www.rxlist.com

Dosage Forms And Strengths CUVPOSA is available as a 1 mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles. Storage And Handling NDC 0259-0501-16: 1 mg/5 mL 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. Revised: May 2013 Last reviewed on RxList: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 use of anticholinergic drugs such as CUVPOSA. Advise parents/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:
  • Autonomic neuropathy
  • Renal disease
  • Ulcerative colitis – Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate “toxic megacolon,” a serious complication of the disease.
  • Hyperthyroidism
  • Coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension
  • Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition
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. Parents/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. x 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 a healthcare practitioner. x 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. x 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. Parents/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 ssay. Glycopyrrolate was assessed for effects on fertility or general reproductive function in rats. Rats of both genders received glycopyrrolate at dosages up to 100 mg/kg/day via oral gavage (approximately 50 times the maximum recommended human dose, when comparing on the basis of body surface area estimates). No treatment-related effects on fertility or reproductive parameters of both genders were observed in this study. 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 fetal 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 to 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: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Women's Health Care an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Cuvposa. Find what medications you are taking today.