data [2%:<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. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility When glycopyrrolate was administered via oral gavage to mice for up to 24 months at dosages of 2.5, 7, and 20 mg/kg/day in both genders, resulting in systemic exposures (estimated AUC 0-inf values) approximately 0.1, 0.3, and 0.8 times, respectively, the estimated systemic exposure in humans at the MRHD (9 mg per day, administered in three divided doses), no significant changes in tumor incidence were observed when compared to control. When glycopyrrolate was administered via oral gavage to rats for up to 24 months at dosages of 5, 15, and 40 mg/kg/day in both genders, resulting in systemic exposures approximately 0.2, 0.8, and 2 times, respectively, the estimated systemic exposure in humans at the MRHD, no significant changes in tumor incidence were observed when compared to control. Glycopyrrolate did not elicit any genotoxic effects in the Ames mutagenicity assay, the human lymphocyte chromosome aberration assay, or the micronucleus assay. 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, resulting in systemic exposures (estimated AUC 0-inf values) in males and females up to approximately 11 and 15 times, respectively, the estimated systemic exposure in humans at the MRHD. No treatment-related effects on fertility or reproductive parameters were observed in either gender in this study. 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 the 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 become wet; occasionally 9= Profuse: clothing, hands, tray, and objects become 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 How Supplied/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]. Patient Counseling Information See FDA-approved patient labeling (Patient Information) Advise patients/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. 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. Patients/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, patients/caregivers should stop administering glycopyrrolate and call their healthcare practitioner. If the patient develops a skin rash, hives or an allergic reaction, patients/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. Avoid exposure of the patient to hot or very warm environmental temperatures to avoid overheating and the possibility of heat exhaustion or heat stroke. Manufactured by: Mikart, Inc. Atlanta, GA 30318 Manufactured for: Merz North America, Inc. Raleigh, NC 27615 2017 Merz Pharmaceuticals, LLC Cuvposa is a registered trademark of Merz Pharmaceuticals, LLC GLY-PI-08 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 the 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 your 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 your 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 problems 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 about 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 866-862-1211. 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 Issued May 2011 Manufactured by: Mikart, Inc. Atlanta, GA 30318 Manufactured for: Merz North America, Inc. Raleigh, NC 27615 2017 Merz Pharmaceuticals, LLC Cuvposa is a registered trademark of Merz Pharmaceuticals, LLC GLY-PPI-08 Rev 09/2017 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Carton NDC: 0259-0501-16 16 fl. oz. (473 mL) Cuvposa (glycopyrrolate) oral solution 1 mg/5 mL (0.2 mg/mL) Rx Only For Oral Use Only Manufactured for: Merz North America, Inc. Manufactured by: Mikart, Inc. Atlanta, GA 30318 Cuvposa glycopyrrolate liquid Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0259-0501 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength glycopyrrolate (GLYCOPYRRONIUM) glycopyrrolate 1 mg in 5 mL Inactive Ingredients Ingredient Name Strength Sorbitol Glycerin Propylene Glycol Methylparaben Propylparaben Citric Acid Monohydrate Sodium Citrate, Unspecified Form Saccharin Sodium Water Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0259-0501-16 1 BOTTLE in 1 CARTON 1 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022571 01/01/2013 Labeler - Merz Pharmaceuticals, LLC (126209282) Establishment Name Address ID/FEI Operations Mikart, Inc. 013322387 MANUFACTURE(0259-0501) Establishment Name Address ID/FEI Operations Mikart, Inc. 030034847 PACK(0259-0501) Revised: 09/2017 Merz Pharmaceuticals, LLC Next Interactions Print this page Add to My Med List More about Cuvposa (glycopyrrolate) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: anticholinergic bronchodilators Consumer resources Cuvposa Cuvposa (Advanced Reading) Professional resources Glycopyrrolate (AHFS Monograph) Glycopyrrolate Tablets (FDA) Other brands: Robinul , Seebri Neohaler Related treatment guides Excessive Salivation ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Anticholinergic bronchodilators Anticholinergics / antispasmodics Related Drugs anticholinergic bronchodilators Spiriva , ipratropium , tiotropium , Atrovent , Spiriva Respimat , Tudorza Pressair anticholinergics / antispasmodics dicyclomine , Bentyl , hyoscyamine , Levsin , atropine , scopolamine Excessive Salivation glycopyrrolate , More... 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