Glycopyrrolate .2 mg/mL
Glycopyrrolate · INJECTION, SOLUTION · Henry Schein, Inc.
Glycopyrrolate injection is a prescription medication that belongs to a class of drugs called anticholinergics, commonly used to reduce saliva and other secretions before surgery or certain medical procedures. It works by blocking certain nerve signals that stimulate fluid production in the body.
Key Facts
- Brand Name
- Glycopyrrolate
- Generic Name
- Glycopyrrolate
- NDC Code (Product)
0404-9782- Manufacturer
- Henry Schein, Inc.
- Strength
- .2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA210842
- Marketing Start
- 05/08/2025
Recall History
Pharmedium Services, LLC
Lack of sterility assurance.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
West-ward Pharmaceutical Corp.
Subpotent Drug
Cantrell Drug Company
Lack of Sterility Assurance.
Brookfield Prescription Center Inc
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Aidapak Services, LLC
Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.
NCS Healthcare of Kentucky Inc
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE In Anesthesia Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer For use in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. Limitations of Use Glycopyrrolate Injection is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Dosage & Administration
DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL ( see PRECAUTIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. For single-dose vials only, discard unused portion. Glycopyrrolate injection may be administered intramuscularly, or intravenously, without dilution, in the following indications. Adults PREANESTHETIC MEDICATION The recommended dose of glycopyrrolate injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered. INTRAOPERATIVE MEDICATION Glycopyrrolate injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed. REVERSAL OF …
Warnings
WARNINGS This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS, Pediatric Use ). Glycopyrrolate injection may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring men…
Contraindications
CONTRAINDICATIONS Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in 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.
Drug Interactions
Drug Interactions The concurrent use of glycopyrrolate injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.
Adverse Reactions
ADVERSE REACTIONS Anticholinergics, including glycopyrrolate injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may 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. In addition, 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 pro…
Frequently Asked Questions
What is Glycopyrrolate used for?
Glycopyrrolate injection is a prescription medication that belongs to a class of drugs called anticholinergics, commonly used to reduce saliva and other secretions before surgery or certain medical procedures. It works by blocking certain nerve signals that stimulate fluid production in the body.
Is Glycopyrrolate a controlled substance?
Glycopyrrolate is not classified as a controlled substance by the DEA.
What is the generic name for Glycopyrrolate?
The generic name for Glycopyrrolate is Glycopyrrolate. There are 3 other brand versions of Glycopyrrolate.
What is the NDC code for Glycopyrrolate .2 mg/mL?
The NDC (National Drug Code) for Glycopyrrolate .2 mg/mL is 0404-9782, listed by Henry Schein, Inc..