GLYCOPYRROLATE- glycopyrrolate injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Available from:
Medical Purchasing Solutions, LLC
Administration route:
INTRAMUSCULAR
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
In Anesthesia Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. In Peptic Ulcer For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of pe
Product summary:
Glycopyrrolate Injection, USP, 0.2 mg/mL , is a clear colorless solution, and supplied as single and multiple dose vials available in following strengths and package sizes: 0.2 mg/mL, 1 mL vial Single dose vial: NDC 66794-202-02 25 single dose vials in a carton: NDC 66794-202-42 0.2 mg/mL, 2 mL vial Single dose vial: NDC 66794-203-02 25 single dose vials in a carton: NDC 66794-203-42 0.2 mg/mL, 5 mL vial Multiple dose vial: NDC 66794-204-02 25 multiple dose vials in a carton: NDC 66794-204-42 0.2 mg/mL, 20 mL vial Multiple dose vial: NDC 66794-205-02 10 multiple dose vials in a carton: NDC 66794-205-41 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care at 1-800-414-1901, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Piramal Critical Care Bethlehem, PA 18017, USA Product of India Issued: 07/2018
Authorization status:
Abbreviated New Drug Application
Authorization number:
71872-7174-1

GLYCOPYRROLATE- glycopyrrolate injection, solution

Medical Purchasing Solutions, LLC

----------

Rx ONLY

NOT FOR USE IN NEONATES

CONTAINS BENZYL ALCOHOL

DESCRIPTION

Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains:

Glycopyrrolate, USP 0.2 mg

Water for Injection, USP q.s.

Benzyl Alcohol, NF 0.9% (preservative)

pH adjusted, when necessary, with hydrochloric acid.

For Intramuscular (IM) or Intravenous (IV) administration.

Glycopyrrolate is a quaternary ammonium salt with the following chemical name:

3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is

BrNO

and the molecular weight is 398.33.

Its structural formula is as follows:

Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and

practically insoluble in chloroform and ether.

Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate

Injection, USP is a clear, colorless, sterile liquid; pH 2.0 –3.0. The partition coefficient of

glycopyrrolate in a n-octanol/water system is 0.304 (log

P= -1.52) at ambient room temperature

(24°C).

CLINICAL PHARMACOLOGY

Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine

on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to

acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in

the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular

node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume

and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial

secretions.

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and

intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases.

The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid

membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine

hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily.

With intravenous injection, the onset of action is generally evident within one minute. Following

intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring

within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the

antisialagogue effects persist up to 7 hours, periods longer than for atropine.

Pharmacokinetics

The following pharmacokinetic information and conclusions were obtained from published studies that

used nonspecific assay methods.

DISTRIBUTION

The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22 L/kg.

METABOLISM

The in vivo metabolism of glycopyrrolate in humans has not been studied.

EXCRETION

The mean clearance and mean T

values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.13 hr,

respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate,

85% of dose recovered was recovered in urine 48 hours postdose and some of the radioactivity was

also recovered in bile. After IM administration of glycopyrrolate to adults, the mean T

value is

reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and

the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table

summarizes the mean and standard deviation of pharmacokinetic parameters from a study.

Group

(hr)

(L/kg)

(L/kg/hr)

(min)

(μg/L)

(μg/Lhr)

(6 μg/kg IV)

0.83 ± 0.27

0.42 ± 0.22

0.54 ± 0.14

8.64 ± 1.49*

(8 μg/kg IM)

27.48 ± 6.12

3.47 ± 1.48

6.64 ± 2.33*

* 0-8 hr

SPECIAL POPULATIONS

Gender

Gender differences in pharmacokinetics of glycopyrrolate have not been investigated.

Renal Impairment

In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation.

The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6

minutes). The mean area-under-the-concentration-time curve (10.6 hr-μg/L), mean plasma clearance

(0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly

different than those of controls (3.73 hr-μg/L, 1.14 L/hr/kg, and 50%, respectively). These results

suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure.

Hepatic Impairment

Pharmacokinetic information in patients with hepatic impairment is unavailable.

Pediatrics

Following IV administration (5 μg/kg glycopyrrolate) to infants and children, the mean T

values were

reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

INDICATIONS & USAGE

In Anesthesia

Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary,

tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric

secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.

When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or

drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral

muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as

neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing

muscle relaxants.

In Peptic Ulcer

For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic

effect is desired or when oral medication is not tolerated.

CONTRAINDICATIONS

Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.

In addition, in the management of peptic ulcer patients, because of the longer duration of therapy,

glycopyrrolate injection may be contraindicated in 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.

WARNINGS

This drug should be used with great caution, if at all, in patients with glaucoma.

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension,

metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in

small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated

with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications

is usually considered negligible compared to that received in flush solutions containing benzyl alcohol.

Administration of high dosages of medications containing this preservative must take into account the

total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur

is not known. If the patient requires more than the recommended dosages or other medications

containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol

from these combined sources (see PRECAUTIONS, Pediatric Use).

Glycopyrrolate injection may produce drowsiness or blurred vision. The patient should be cautioned

regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or

performing hazardous work while taking this drug.

In addition, in the presence of fever, high environmental temperature and/or during physical exercise,

heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to

decreased sweating), particularly in children and the elderly.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with

ileostomy or colostomy. In this instance treatment with glycopyrrolate injection would be inappropriate

and possibly harmful.

PRECAUTIONS

GENERAL PRECAUTIONS

Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate

may occur.

Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias;

hypertension; hyperthyroidism.

Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be

severely impaired in patients with renal failure. Dosage adjustments may be necessary (see

Pharmacokinetics, Renal Impairment).

Use glycopyrrolate with caution in the elderly and in all patients with autonomic neuropathy, hepatic

disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may

aggravate these conditions.

The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric

emptying due to antral statis.

INFORMATION FOR PATIENTS

Because glycopyrrolate injection may produce drowsiness or blurred vision, the patient should be

cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a

motor vehicle or other machinery, or performing hazardous work while taking this drug (see

WARNINGS).

The patient also should be cautioned about the use of this drug during exercise or hot weather since

overheating may result in heat stroke.

The patient may experience a possible sensitivity of the eyes to light.

DRUG INTERACTIONS

The concurrent use of glycopyrrolate injection with other anticholinergics or medications with

anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may

intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.

Concomitant administration of glycopyrrolate injection and potassium chloride in a wax matrix may

increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower

gastrointestinal transit time.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to

evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in

rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-

related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion

which is evident at high doses of glycopyrrolate.

PREGNANCY

TERATOGENIC EFFECTS - PREGNANCY CATEGORY B.

Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65

mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2

mg on a mg/m

basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was

approximately 5 times the maximum recommended daily human dose on a mg/m

basis). These studies

produced no teratogenic effects to the fetus. Because animal reproduction studies are not always

predictive of human response, this drug should be used during pregnancy only if clearly needed.

Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental

barrier.

NONTERATOGENIC EFFECTS

Published literature suggest the following regarding the use of glycopyrrolate during pregnancy.

Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate

or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical

venous and aterial blood and in the amniotic fluid are low after intramuscular administration to

parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in

significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in

diminished rats of pup survival in a dose-related manner.

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when glycopyrrolate injection is administered to a nursing woman. As

with other anticholinergics, glycopyrrolate may cause suppression of lactation (see ADVERSE

REACTIONS).

PEDIATRIC USE

Due to its benzyl alcohol content, glycopyrrolate injection should not be used in neonates, i.e., patients

less than 1 month of age.

Safety and effectiveness in pediatric patients have not been established for the management of peptic

ulcer.

Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during

anesthesia have been observed in pediatric patients.

Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may

experience an increased response to anticholinergics, thus increasing the potential for side effects.

A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large

doses of anticholinergics including glycopyrrolate injection. Infants and young children are especially

susceptible to the toxic effects of anticholinergics.

Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and

death, particularly in pediatric patients. The “gasping syndrome", (characterized by central nervous

system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its

metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99

mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual

neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin

breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although

normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower

than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol

at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients

receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and

other medications containing benzyl alcohol should consider the combined daily metabolic load of

benzyl alcohol from all sources.

GERIATRIC USE

Clinical Studies of glycopyrrolate injection did not include sufficient numbers of subjects aged 65 and

over to determine whether they respond differently from younger subjects. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients. In

general, dose selection for an elderly patient should be cautious, usually starting at the low end of the

dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of

concomitant disease or other therapy.

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 & 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; 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. 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 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.

HOW SUPPLIED

Glycopyrrolate Injection, USP, 0.2 mg/mL, is a clear colorless solution, and supplied as single and

multiple dose vials available in following strengths and package sizes:

0.2 mg/mL, 1 mL vial

Single dose vial: NDC 66794-202-02

25 single dose vials in a carton: NDC 66794-202-42

0.2 mg/mL, 2 mL vial

Single dose vial: NDC 66794-203-02

25 single dose vials in a carton: NDC 66794-203-42

0.2 mg/mL, 5 mL vial

Multiple dose vial: NDC 66794-204-02

25 multiple dose vials in a carton: NDC 66794-204-42

0.2 mg/mL, 20 mL vial

Multiple dose vial: NDC 66794-205-02

10 multiple dose vials in a carton: NDC 66794-205-41

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care at 1-800-414-1901,

or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:

Piramal Critical Care

Bethlehem, PA 18017, USA

Product of India

Issued: 07/2018

Principal Display Panel - Glycopyrrolate Injection USP 0.2 mg/ mL - 1 mL fill volume

VIAL LABEL

Glycopyrrolate injection, USP 0.2 mg/mL

1 mL Single Dose Vial

OUTER PACKAGE LABEL

NDC 71872-7174-1

RX ONLY

Glycopyrrolate injection, USP 0.2 mg/mL

NOT FOR USE IN NEWBORNS

1 x 1 mL Single Dose Vial

Medical Purchasing Solutions, LLC

GLYCOPYRROLATE

glycopyrrolate injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:718 72-7174(NDC:6 6 79 4-

20 2)

Route of Administration

INTRAMUSCULAR,

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYCO PYRRO LATE (UNII: V9 2SO9 WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)

GLYCOPYRROLATE

0 .2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

9 mg in 1 mL

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:718 72-7174-1 1 in 1 BAG

0 7/15/20 19

1

1 mL in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA210 8 42

0 7/11/20 19

Labeler -

Medical Purchasing Solutions, LLC (601458529)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Medical Purchasing So lutio ns, LLC

6 0 1458 529

re pa c k(718 72-7174)

Revised: 8/2019

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