GLYRX-PF

GLYRX-PF- glycopyrrolate injection, solution
Exela Pharma Sciences, LLC

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)

as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration Information

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
GLYRX-PF may be administered intramuscularly or intravenously, with or without dilution.

2.2 Dosing in Adults

Preanesthetic Medication

The recommended dose of GLYRX-PF 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

GLYRX-PF 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. Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance.

Reversal of Neuromuscular Blockade

The recommended dose of GLYRX-PF is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Peptic Ulcer

The usual recommended dose of GLYRX-PF is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily, intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose. Frequency of administration should be dictated by patient response up to a maximum of four times daily.

2.3 Dosing in Pediatric Patients

Preanesthetic Medication

The recommended dose of GLYRX-PF in pediatric patients is 0.004 mg/kg intramuscularly, 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. Patients under 2 years of age, may require up to 0.009 mg/kg.

Intraoperative Medication

Because of the long duration of action of GLYRX-PF if used as preanesthetic medication, additional GLYRX-PF for anticholinergic effect intraoperatively is rarely needed; in the event it is required, the recommended pediatric dose is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose, which may be repeated, as needed, at intervals of 2 to 3 minutes. Attempt to determine the etiology of the arrhythmia, and perform the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance.

Reversal of Neuromuscular Blockade

The recommended pediatric dose of GLYRX-PF is 0.2 mg for each 1 mg of neostigmine or 5 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Peptic Ulcer

GLYRX-PF is not indicated for the treatment of peptic ulcer in pediatric patients.

2.4 Preparation and Handling

Diluent Compatibilities

Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer’s Injection.

Diluent Incompatibilities

Lactated Ringer’s solution.

Admixture Compatibilities

Physical Compatibility

This list does not constitute an endorsement of the clinical utility or safety of co-administration of glycopyrrolate with these drugs. GLYRX-PF is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; physostigmine salicylate; diphenhydramine HCl; codeine phosphate, USP; benz-quinamide HCl; hydromorphone HCl, USP; droperidol; levorphanol tartrate; lidocaine, USP; meperidine HCl, USP; pyridostigmine bromide; morphine sulfate, USP; nalbuphine HCl; oxymorphone HCl; procaine HCl, USP; promethazine HCl, USP; neostigmine methylsulfate, USP; scopolamine HBr, USP; butorphanol tartrate; fentanyl citrate; trimethobenzamide HCl; and hydroxyzine HCl. GLYRX-PF may be administered via the tubing of a running infusion of normal saline.

Admixture Incompatibilities

Physical Incompatibility

Because the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine GLYRX-PF in the same syringe with methohexital Na, chloramphenicol Na succinate, dimenhydrinate, pentobarbital Na, thiopental Na, secobarbital Na, sodium bicarbonate, diazepam, dexamethasone Na phosphate, or pentazocine lactate. These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.

3 DOSAGE FORMS AND STRENGTHS

GLYRX-PF (glycopyrrolate injection), 0.2 mg/mL, is a clear, colorless, solution for injection available as 0.2 mg/mL glycopyrrolate in 1 mL or 2 mL single-dose vials.

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.

5 WARNINGS AND PRECAUTIONS

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).

5.2 Drowsiness or Blurred Vision

GLYRX-PF may cause drowsiness or blurred vision. Warn patients not to participate in activities requiring mental alertness, such as operating a motor vehicle or other machinery, or performing hazardous work, until these issues resolve.

5.3 Heat Prostration

In the presence of fever, high environmental temperature, and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including GLYRX-PF (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving GLYRX-PF.

5.4 Intestinal Obstruction

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with GLYRX-PF is inappropriate and possibly harmful. Avoid use in patients with these conditions.

5.5 Tachycardia

Investigate any tachycardia before giving GLYRX-PF because an increase in the heart rate may occur. Use with caution in patients with coronary artery disease, congestive heart failure, cardiac arrhythmias, hypertension, or hyperthyroidism.

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