Glycopyrrolate (Page 3 of 4)

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 a clear, colorless solution available in:

Strength (mg of glycopyrrolate) Pack NDC
0.2 mg/mL Carton of 25 Single-dose vials 70710-1645-7
0.4 mg/2 mL (0.2 mg/mL) Carton of 25 Single-dose vials 70710-1646-7
1 mg/5 mL (0.2 mg/mL) Carton of 25 Multiple-dose vials 70710-1647-7
4 mg/20 mL (0.2 mg/mL) Carton of 10 Multiple-dose vials 70710-1648-6

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

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

All brands listed are the trademarks of their respective owners and are not trademarks of Zydus Pharmaceuticals (USA) Inc.

Manufactured by:

Liva Pharmaceuticals Ltd.

Vadodara, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Revised: 04/20

PRINCIPAL DISPLAY PANEL

NDC 70710-1645 -1

Glycopyrrolate Injection, USP

0.2 mg/mL

NOT FOR USE IN NEWBORNS

CONTAINS BENZYL ALCOHOL

FOR INTRAMUSCULAR OR

INTRAVENOUS ADMINISTRATION

1 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals Logo

vial-label-1ml
(click image for full-size original)

NDC 70710-1645 -7

Glycopyrrolate Injection, USP

0.2 mg/mL

NOT FOR USE IN NEWBORNS

CONTAINS BENZYL ALCOHOL

FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION

25 x 1 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

carton-1ml
(click image for full-size original)

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