Glycopyrrolate (Cuvposa)

Trade Name : Cuvposa

Merz Pharmaceuticals, LLC

LIQUID

Strength 1 mg/5mL

GLYCOPYRROLATE Anticholinergic [EPC],Cholinergic Antagonists [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Glycopyrrolate (Cuvposa) which is also known as Cuvposa and Manufactured by Merz Pharmaceuticals, LLC. It is available in strength of 1 mg/5mL per ml. Read more

Glycopyrrolate (Cuvposa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

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

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

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. ()
Administer at least one hour before or two hours after meals. ()

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

CUVPOSA is contraindicated in:

Medical conditions that preclude anticholinergic therapy. ()
Concomitant use of solid oral dosage forms of potassium chloride. ()

No data

Constipation or intestinal pseudo-obstruction: May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. ()
Incomplete mechanical intestinal obstruction: May present as diarrhea. If obstruction is suspected, discontinue CUVPOSA and evaluate. ()
High ambient temperature: To reduce the risk of heat prostration, avoid high temperatures. ()

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.
The most common adverse reactions (incidence u226530%) are dry mouth, vomiting, constipation, flushing, and nasal congestion. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merz Pharmaceuticals, LLC at 866-862-1211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn

No data

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

No data

Pediatric use: The safety and effectiveness of glycopyrrolate has not been established in patients less than 3 years of age. ()
Renal impairment: Use CUVPOSA with caution in patients with renal impairment. ()

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:

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 CHBrNO 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.

No data

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 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 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.

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 drools2= Mild: only the lips are wet; occasionally3= Mild: only the lips are wet; frequently4= Moderate: wet on the lips and chin; occasionally5= Moderate: wet on the lips and chin; frequently6= Severe: drools to the extent that clothing becomes damp; occasionally7= Severe: drools to the extent that clothing becomes damp; frequently8= Profuse: clothing, hands, tray, and objects become wet; occasionally9= 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.

NDC 0259-0501-16; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle.
Store at room temperature 20u00b0 - 25u00b0C (68u00b0 - 77u00b0F); excursions permitted to 15u00b0 - 30u00b0C (59u00b0 - 86u00b0F) [See USP Controlled Room Temperature].

tttttttSee n

Manufactured by:Mikart, Inc.Atlanta, GA 30318
Manufactured for:Merz North America, Inc. Raleigh, NC 27615
u00a9 2017 Merz Pharmaceuticals, LLCCUVPOSAu00ae 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:
What should I tell my doctor before giving CUVPOSA to my child?
Tell your doctor if your child:
Tell your doctor about all of the medicines that your child takes
How should I give CUVPOSA?
What should I avoid while taking CUVPOSA?
What are the possible side effects of CUVPOSA?
CUVPOSA can cause serious side effects including:
The most common side effects of CUVPOSA include:
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 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
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: 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
u00a9 2017 Merz Pharmaceuticals, LLCCUVPOSAu00ae is a registered trademark of Merz Pharmaceuticals, LLC
GLY-PPI-08 Rev 02/2018

NDC: 0259-0501-16
16 fl. oz.(473 mL)
Cuvposan- (glycopyrrolate) oral solution1 mg/5 mL(0.2 mg/mL)
Rx OnlyFor Oral Use Only
Manufactured for:Merz North America, Inc.
Manufactured by:Mikart, Inc.Atlanta, GA 30318

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Glycopyrrolate (Cuvposa)

Trade Name : Cuvposa

LIQUID

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Glycopyrrolate (Cuvposa)

Trade Name : Cuvposa

LIQUID

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?