Glycopyrrolate Oral Solution 1 mg/5mL

Glycopyrrolate · SOLUTION · AJENAT PHARMACEUTICALS LLC

1 Recall on Record

Plain English

Glycopyrrolate Oral Solution is a solution containing glycopyrrolate at 1 mg/5mL, taken oral. Manufactured by AJENAT PHARMACEUTICALS LLC.

Key Facts

Brand Name: Glycopyrrolate Oral Solution
Generic Name: Glycopyrrolate
NDC Code (Product): 82983-428
Manufacturer: AJENAT PHARMACEUTICALS LLC
Strength: 1 mg/5mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA219267
Marketing Start: 12/12/2025

Recall History

1 Recall on Record

Class III12/15/2025

NOVADOZ PHARMACEUTICALS LLC

Failed Impurities/Degradation Specifications

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,013 reports

asthma808 reports

wheezing698 reports

cough639 reports

pneumonia544 reports

drug ineffective418 reports

fatigue361 reports

off label use357 reports

malaise347 reports

chronic obstructive pulmonary disease346 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Glycopyrrolate oral solution 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). Glycopyrrolate oral solution is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy). (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Glycopyrrolate oral solution must be measured and administered with an accurate measuring device [see Patient Counseling Information (17) ]. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5 to 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 to 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. Glycopyrrolate oral solution should be dosed at least one hour before or two hours after meals. The presence of high fat food reduces the oral bioavailability of Glycopyrrolate oral solution if taken shortly after a meal [see Clinical Pharmacology (12.3) ]. Table 1: Recommended Dose Titration Schedule (each dose to be given three times daily) Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5 kg lbs (⁓…

Contraindications

4 CONTRAINDICATIONS Glycopyrrolate oral solution is contraindicated in: Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralyticileus, 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 Glycopyrrolate oral solution. Medical conditions that preclude anticholinergic therapy. ( 4 ) Concomitant use of solid oral dosage forms of potassium chloride. ( 4 )

Drug Interactions

7 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 (4) ]. 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 coadminist…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Constipation or intestinal pseudo-obstruction [see Warnings and Precautions (5.1) ] Incomplete mechanical intestinal obstruction [see Warnings and Precautions (5.2) ] The most common adverse reactions reported with Glycopyrrolate oral solution are dry mouth, vomiting, constipation, flushing, and nasal congestion. The most common adverse reactions (incidence ≥30%) are dry mouth, vomiting, constipation, flushing, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 Glycopyrrolate oral solution in 151 subjects, including 20 subjects who participated in an 8-week placebo-controlled study (Study 1) and 137 subjects who participated in …

Frequently Asked Questions

What is Glycopyrrolate Oral Solution used for?

Glycopyrrolate Oral Solution contains Glycopyrrolate. It is a solution taken oral. Consult your doctor for specific uses.

Is Glycopyrrolate Oral Solution a controlled substance?

Glycopyrrolate Oral Solution is not classified as a controlled substance by the DEA.

What is the generic name for Glycopyrrolate Oral Solution?

The generic name for Glycopyrrolate Oral Solution is Glycopyrrolate. There are 12 other brand versions of Glycopyrrolate.

What is the NDC code for Glycopyrrolate Oral Solution 1 mg/5mL?

The NDC (National Drug Code) for Glycopyrrolate Oral Solution 1 mg/5mL is 82983-428, listed by AJENAT PHARMACEUTICALS LLC.

Product NDC

82983-428

Package NDC

82983-428-47

Other Glycopyrrolate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)