Glycopyrrolate (Page 3 of 3)

DOSAGE & 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 supplied as clear, colorless non pyrogenic solution as follows;

1 mL single dose vials packaged in 25s (NDC 65145-102-25)

2 mL single dose vials packaged in 25s (NDC 65145-103-25)

5 mL multiple dose vials packaged in 25s (NDC 65145-104-25)

20 mL multiple dose vials in 10s (NDC 65145-105-10)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured by:

Caplin Steriles Limited,

Gummidipoondi – 601 201,

INDIA.

February, 2019
CP4/AWC/088-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Glycopyrrolate Injection, USP
0.2 mg/mL
1 mL Single Dose Vial NDC 65145-102-01

Glycopyrrolate Injection, USP
0.2 mg/mL
25×1 mL Single Dose VialsNDC 65145-102-25

Glycopyrrolate Injection, USP
0.4 mg/2 mL (0.2 mg/mL)
2 mL Single Dose VialNDC 65145-103-01

Glycopyrrolate Injection, USP
0.4 mg/2 mL (0.2 mg/mL)
25×2 mL Single Dose VialsNDC 65145-103-25

Glycopyrrolate Injection, USP
1 mg/5 mL (0.2 mg/mL)
5 mL Multiple Dose VialNDC 65145-104-01

Glycopyrrolate Injection, USP
1 mg/5 mL (0.2 mg/mL)
25×5 mL Multiple Dose VialsNDC 65145-104-25

Glycopyrrolate Injection, USP
4 mg/20 mL (0.2 mg/mL)
20 mL Multiple Dose VialNDC 65145-105-01

Glycopyrrolate Injection, USP
4 mg/20 mL (0.2 mg/mL)
10×20 mL Multiple Dose VialsNDC 65145-105-25

GLYCOPYRROLATE glycopyrrolate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-102 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 HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65145-102-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (65145-102-01) 1 NDC:65145-102-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65145-102-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211705 05/01/2019

GLYCOPYRROLATE glycopyrrolate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-103 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.4 mg in 2 mL

Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65145-103-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (65145-103-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211705 05/01/2019

GLYCOPYRROLATE glycopyrrolate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-104 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 1 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65145-104-25 25 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (65145-104-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211705 05/01/2019

GLYCOPYRROLATE glycopyrrolate injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65145-105 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 4 mg in 20 mL

Inactive Ingredients Ingredient Name Strength WATER BENZYL ALCOHOL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65145-105-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (65145-105-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211705 05/01/2019

Labeler — Caplin Steriles Limited (650744670)

Establishment
Name	Address	ID/FEI	Operations
Caplin Steriles Limited		650744670	ANALYSIS (65145-102), ANALYSIS (65145-103), ANALYSIS (65145-104), ANALYSIS (65145-105), MANUFACTURE (65145-102), MANUFACTURE (65145-103), MANUFACTURE (65145-104), MANUFACTURE (65145-105), PACK (65145-102), PACK (65145-103), PACK (65145-104), PACK (65145-105)

Revised: 03/2019 Caplin Steriles Limited