Glycopyrrolate: Package Insert and Label Information (Page 2 of 2)

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 prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.

Glycopyrrolate is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

OVERDOSAGE

To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.

If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients.

To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.

Fever should be treated symptomatically.

Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

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.

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 NEUROMUSCULAR BLOCKADE

The recommended dose of glycopyrrolate injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 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

The usual recommended dose of glycopyrrolate injection 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, and frequency of administration should be dictated by patient response up to a maximum of four times daily.

Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients ( see PRECAUTIONS — Pediatric Use) .

Pediatric Patients

(see PRECAUTIONS — Pediatric Use )

PREANESTHETIC MEDICATION

The recommended dose of glycopyrrolate injection 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.

INFANTS

(1 month to 2 years of age) may require up to 0.009 mg/kg.

INTRAOPERATIVE MEDICATION

Because of the long duration of action of glycopyrrolate injection if used as preanesthetic medication, additional glycopyrrolate injection 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. 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 NEUROMUSCULAR BLOCKADE

The recommended pediatric dose of glycopyrrolate injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 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

Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients ( see PRECAUTIONS — Pediatric Use) .

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. Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium® (physostigmine salicylate); Benadryl® (diphenhydramine HCl); codeine phosphate, USP; Emete-Con® (benzquinamide HCl); hydromorphone HCl, USP; Inapsine® (droperidol); Levo-Dromoran® (levorphanol tartrate); lidocaine, USP; meperidine HCl, USP; Mestinon® /Regonol® (pyridostigmine bromide); morphine sulfate, USP; Nubain® (nalbuphine HCl); Numorphan® (oxymorphone HCl); procaine HCl, USP; promethazine HCl, USP; Prostigmin® (neostigmine methylsulfate, USP); scopolamine HBr, USP; Stadol® (butorphanol tartrate); Sublimaze® (fentanyl citrate); Tigan® (trimethobenzamide HCl); and Vistaril® (hydroxyzine HCl). Glycopyrrolate injection may be administered via the tubing of a running infusion of normal saline.

Admixture Incompatibilities

PHYSICAL INCOMPATIBILITY

Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital® (methohexital Na); Chloromycetin® (chloramphenicol Na succinate); Dramamine® (dimenhydrinate); Nembutal® (pentobarbital Na); Pentothal® (thiopental Na); Seconal® (secobarbital Na); sodium bicarbonate (Abbott); Valium® (diazepam); Decadron® (dexamethasone Na phosphate); or Talwin® (pentazocine lactate). These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.

HOW SUPPLIED

Glycopyrrolate injection, USP, 0.2 mg/mL, is available in:

1 mL single dose vials (NDC 16714-536-01) packaged in 25s (NDC 16714-536-25)
2 mL single dose vials (NDC 16714-620-01) packaged in 25s (NDC 16714-620-25)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821, or the FDA at 1-800‑FDA‑1088 or www.fda.gov/medwatch.

All registered trademarks in this document are the property of their respective owners.

Manufactured by: Manufactured for:
Indoco Remedies Limited L-32, 33, 34, Verna Industrial Area, Verna, Goa-403722, India Northstar Rx LLCMemphis, TN 38141

Revised: April 2022

NDC 16714-536-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2 mg/1 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
1 mL Single Dose Vial Rx Only

//druginserts.com/lib/images-rx/glycopyrrolate-17/1-ml-vial-label-300x101.jpg
(click image for full-size original)

NDC 16714-536-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2mg/1 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 1 mL Single Dose Vials
Rx Only

//druginserts.com/lib/images-rx/glycopyrrolate-17/1-ml-carton-label-300x176.jpg
(click image for full-size original)

NDC 16714-620-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
2 mL Single Dose Vial Rx Only

//druginserts.com/lib/images-rx/glycopyrrolate-17/2-ml-vial-label-300x99.jpg
(click image for full-size original)

NDC 16714-620-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 2 mL Single Dose Vials Rx Only

//druginserts.com/lib/images-rx/glycopyrrolate-17/2-ml-carton-label-300x177.jpg
(click image for full-size original)
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-536
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-536-25 25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-25)
2 NDC:16714-536-01 1 VIAL in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 08/10/2022
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-620
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-620-25 25 VIAL in 1 CARTON contains a VIAL
1 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-25)
2 NDC:16714-620-01 1 VIAL in 1 CARTON contains a VIAL
2 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 11/18/2022
Labeler — NORTHSTAR RX LLC (830546433)
Registrant — Apotex Inc. (209429182)

Revised: 11/2022 NORTHSTAR RX LLC

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