Glycopyrrolate 1 mg/1
Glycopyrrolate · TABLET · REMEDYREPACK INC.
Glycopyrrolate is an oral tablet used to treat excessive drooling and to help reduce saliva production in certain conditions. It works by blocking the effects of acetylcholine, a chemical in the body that stimulates saliva glands.
Key Facts
- Brand Name
- Glycopyrrolate
- Generic Name
- Glycopyrrolate
- NDC Code (Product)
70518-4597- Manufacturer
- REMEDYREPACK INC.
- Strength
- 1 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207201
- Marketing Start
- 03/25/2026
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
1 INDICATIONS AND USAGE Glycopyrrolate Injection is an anticholinergic indicated: in anesthesia (adult and pediatric patients) for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation. intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias. for protection against peripheral muscarinic effects of cholinergic agents. ( 1 ) in peptic ulcer (adults) To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer when rapid anticholinergic effect is desired or 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. ( 1 ) 1.1 Preanesthetic Glycopyrrolate Injection is indicated in adults and pediatric patients for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intub…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Glycopyrrolate injection may be administered intramuscularly (IM), or intravenously (IV) without dilution, in the following indications. Adults ( 2.2 , 2.3 , 2.4 , 2.5 ) Preanesthetic Medication: 0.004 mg/kg IM, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia Intraoperative Medication: single doses of 0.1 mg IV and repeated, as needed, at intervals of 2 to 3 minutes Reversal of Neuromuscular Blockade: 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine Peptic Ulcer: 0.1 mg IV or IM at 4-hour intervals, 3 or 4 times daily Pediatric patients ( 2.2 , 2.3 , 2.4 ) Preanesthetic Medication: 0.004 mg/kg IM, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia. Patients under 2 years of age may require up to 0.009 mg/kg Intraoperative Medication: 0.004 mg/kg IV, not to exceed 0.1 mg in a single dose and repeated, as needed, at intervals of 2 to 3 minutes Reversal of Neuromuscular Blockade: 0.2 mg IV for each 1 mg of neostigmine or 5 mg of pyridostigmine Peptic Ulcer: Glycopyrrolate injection is not indicated for the treatment of peptic ulcer in pediatric patients 2.2 Recommended Dosage of Prean…
Contraindications
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. Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. ( 4 ) Peptic ulcer patients with glaucoma; obstructive uropathy; obstructive disease of the gastrointestinal tract; 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. ( 4 )
Drug Interactions
7 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 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. Other anticholinergics or drugs with anticholinergic activity : May intensify the antimuscarinic effects and result in an increase in anticholinergic side effects. Potassium Chloride in a Wax Matrix : May increase severity of potassium chloride-induced gastrointestinal lesions.
Adverse Reactions
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 fibr…
Frequently Asked Questions
What is Glycopyrrolate used for?
Glycopyrrolate is an oral tablet used to treat excessive drooling and to help reduce saliva production in certain conditions. It works by blocking the effects of acetylcholine, a chemical in the body that stimulates saliva glands.
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 1 mg/1?
The NDC (National Drug Code) for Glycopyrrolate 1 mg/1 is 70518-4597, listed by REMEDYREPACK INC..