Glycopyrrolate Injection, Solution
FDA Label NDC 66794-204

44 label sections · Submitted to the FDA by Piramal Critical Care Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Piramal Critical Care Inc for the product Glycopyrrolate (NDC 66794-204). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding 1 indications and usage, 1.1 preanesthetic, 1.2 intraoperative, 1.3 reversal of neuromuscular blockade, 1.4 peptic ulcer, 2 dosage and administration, 2.1 important dosage and administration instructions, 2.2 recommended dosage of preanesthetic medication in adults and pediatric patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

1 Indications And Usage

2 Dosage And Administration

NOTE: CONTAINS BENZYL ALCOHOL [see Use in Specific Populations (8.4)].

4 Contraindications

Glycopyrrolate Injection is contraindicated in:

• patients with known hypersensitivity to Glycopyrrolate Injection or any of its inactive ingredients.

• peptic ulcer patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

6 Adverse Reactions

The following adverse reactions were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.

Adverse reactions to anticholinergics include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.

The following adverse events have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.

The following is discussed in more detail in other sections of the labeling.
• Benzyl Alcohol Toxicity: Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients less than 1 month of age [see Warnings and Precautions (5.10) and Use in Specific Populations (8.4)].

10 Overdosage

To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.

If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients.

To combat hypotension, administer IV fluids and/or pressor agents along with supportive care. Fever should be treated symptomatically.

Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

11 Description

Glycopyrrolate is a synthetic anticholinergic agent.

It is a quaternary ammonium salt with the following chemical name:

3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C 19H 28BrNO 3 and the molecular weight is 398.33.

Its structural formula is as follows:


Glycopyrrolate Structure (Glycopyrrolate Str)

Glycopyrrolate Structure (Glycopyrrolate Str)

Glycopyrrolate occurs as a white, odorless, crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether. It is completely ionized at physiological pH values. Glycopyrrolate Injection, USP, is a clear, colorless, sterile liquid with a pH of 2.0 to 3.0. The partition coefficient of glycopyrrolate in n-octanol/water system is 0.304 (log 10 P = -1.52) at ambient room temperature (24°C).

Glycopyrrolate injection, USP, is intended for intramuscular or intravenous administration. Each 1 mL contains 0.2 mg of glycopyrrolate, water for injection, Benzyl Alcohol, NF 0.9% (preservative) and hydrochloric acid as pH adjusters.

12 Clinical Pharmacology

16 How Supplied/Storage And Handling

Glycopyrrolate Injection, USP, 0.2 mg/mL, is a clear colorless solution, and supplied as single and multiple dose vials available in following strengths and package sizes:

0.2 mg/mL, 1 mL vial

Single dose vial: NDC 66794-202-02

25 single dose vials in a carton: NDC 66794-202-42

0.2 mg/mL, 2 mL vial

Single dose vial: NDC 66794-203-02

25 single dose vials in a carton: NDC 66794-203-42

0.2 mg/mL, 5 mL vial

Multiple dose vial: NDC 66794-204-02

25 multiple dose vials in a carton: NDC 66794-204-42

0.2 mg/mL, 20 mL vial

Multiple dose vial: NDC 66794-205-02

10 multiple dose vials in a carton: NDC 66794-205-41

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Discard unused portion.

* Please review the disclaimer below.