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.

2.5 Instructions for Use of Prefilled Syringe

1. Perform visual inspection on the syringe by verifying:

Absence of syringe damage
Absence of external particles
Absence of internal particles
Proper drug color
Drug name
Drug strength
Fill volume
Route of administration
Expiration date to be sure the drug has not expired

2. Push plunger rod slightly in to break the stopper lose while tip cap is still on

3. Remove tip cap by twisting off. (See Figure 1):

Figure 1.

figure 1

4. Discard the tip cap.

5. Expel air bubble.

6. Adjust dose into sterile material (if applicable).

7. Connect the syringe to an appropriate intravenous connection.

Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD).

8. Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.

9. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle.

To prevent needle stick injuries, do not recap needle when needle is connected to syringe.

NOTES:

All steps must be done sequentially

-
Do not re-sterilize syringe
-
Do not use this product on a sterile field
-
Do not introduce any other fluid into the syringe at any time
-
This product is for single dose only

3 DOSAGE FORMS AND STRENGTHS

GLYRX® -PF (glycopyrrolate injection) is a clear, colorless, solution for injection available as 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vials and as 1 mg/5 mL (0.2 mg/mL) single-dose prefilled syringe.

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.
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