GLYRX-PF .2 mg/mL
glycopyrrolate · INJECTION, SOLUTION · Exela Pharma Sciences, LLC
GLYRX-PF is a prescription injection, solution containing glycopyrrolate at .2 mg/mL, taken intramuscular. Manufactured by Exela Pharma Sciences, LLC.
Key Facts
- Brand Name
- GLYRX-PF
- Generic Name
- glycopyrrolate
- NDC Code (Product)
51754-6013- Manufacturer
- Exela Pharma Sciences, LLC
- Strength
- .2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA210997
- Drug Class
- Anticholinergic [EPC]; Cholinergic Antagonists [MoA]
- Marketing Start
- 06/01/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GLYRX ® -PF is indicated: in anesthesia (all ages) • 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, and • for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents. 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 when oral medication is not tolerated. • Limitations of Use GLYRX-PF is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. GLYRX ® -PF is an anticholinergic indicated: in anesthesia (adult and pediatric patients) • for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction o…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION GLYRX ® -PF may be administered intramuscularly (IM), or intravenously (IV), with or without dilution, in the following indications. ( 2.1 ): Adults ( 2.2 ) 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 ( 2.3 ) 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 for each 1 mg of neostigmine or 5 mg of pyridostigmine Peptic Ulcer: GLYRX ® -PF is not indicated for the treatment of peptic ulcer in pediatric patients 2.1 General Dosage and Administration Information • Parenteral drug prod…
Warnings
5.1 Precipitation of Acute Glaucoma Glycopyrrolate may cause mydriasis and increase intraocular pressure in patients with glaucoma. Advise patients with glaucoma to promptly seek medical care in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).
Contraindications
4 CONTRAINDICATIONS GLYRX ® -PF is contraindicated in: • patients with known hypersensitivity to glycopyrrolate 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 GLYRX ® -PF 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 GLYRX ® -PF 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. ( 7 ) Potassium Chloride in a Wax Matrix : May increase severity of potassium chloride-induced gastrointestinal lesions. ( 7 )
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 reactions have been reported from post-marketing experience with glycopyrrolate: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular f…
Frequently Asked Questions
What is GLYRX-PF used for?
GLYRX-PF contains glycopyrrolate. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is GLYRX-PF a controlled substance?
GLYRX-PF is not classified as a controlled substance by the DEA.
What is the generic name for GLYRX-PF?
The generic name for GLYRX-PF is glycopyrrolate. There are 12 other brand versions of glycopyrrolate.
What is the NDC code for GLYRX-PF .2 mg/mL?
The NDC (National Drug Code) for GLYRX-PF .2 mg/mL is 51754-6013, listed by Exela Pharma Sciences, LLC.
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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)