GLYCOPYRROLATE tablet

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

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Active ingredient:
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D)
Available from:
ORIT LABORATORIES LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
For use as adjunctive therapy in the treatment of peptic ulcer. 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. Glycopyrrolate Tablets    are contraindicated in those patients with a hypersensitivity to glycopyrrolate.
Product summary:
Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and “305” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets     (NDC 15955-305-01) Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and “318” below bisect on one side and plain on the other side. They are supplied as follows: Bottles of 100 Tablets     (NDC 15955-318-01) Store at 20˚to 25˚C (68˚to 77˚F) [See USP Controlled Room Temperature].  Dispense in a tight container as defined in the USP. Keep this and all drugs out of the reach of children.  Rx only   Manufactured By: Appco Pharma LLC Piscataway, NJ 08854 Manufactured For: Orit Laboratories LLC West Caldwell, NJ 07006 Rev. 10/15
Authorization status:
Abbreviated New Drug Application
Authorization number:
15955-305-01, 15955-318-01

GLYCOPYRROLATE - glycopyrrolate tablet

ORIT LABORATORIES LLC

----------

Glycopyrrolate Tablets, USP

Rx Only

DESCRIPTION

Glycopyrrolate Tablets contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a

quaternary ammonium compound with the following chemical name:

3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.

Glycopyrrolate Tablets 1 mg are white, round-shape, flat face bevel edge, scored, with “OL” above

bisect and “305” below bisect. Each tablet contains:

Glycopyrrolate, USP..........................1 mg

Glycopyrrolate Tablets 2 mg are white, round-shape, flat face bevel edge, scored, with “OL” above

bisect and “318” below bisect. Each tablet contains:

Glycopyrrolate, USP..........................2 mg

Inactive Ingredients: Copovidone, Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium

Stearate, Sodium Starch Glycolate.

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 sino-atrial 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 non-polar tertiary amines which penetrate lipid barriers easily.

INDICATIONS AND USAGE

For use as adjunctive therapy in the treatment of peptic ulcer.

CONTRAINDICATIONS

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. Glycopyrrolate Tablets are contraindicated in those patients with a hypersensitivity to

glycopyrrolate.

WARNINGS

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to

decreased sweating) can occur with use of Glycopyrrolate Tablets.

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

ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly

harmful.

Glycopyrrolate Tablets may produce drowsiness or blurred vision. In this event, the patient should be

warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other

machinery, or performing hazardous work while taking this drug.

Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading

to muscular weakness and possible paralysis.

Pregnancy

The safety of this drug during pregnancy has not been established. The use of any drug during

pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother

and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however,

the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival

at weaning, 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. Information on possible adverse

effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such

experience has revealed no reports of teratogenic or other fetus-damaging potential. No controlled

studies to establish the safety of the drug in pregnancy have been performed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be

undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use

Since there is no adequate experience in pediatric patients who have received this drug, safety and

efficacy in pediatric patients have not been established.

PRECAUTIONS

Use Glycopyrrolate Tablets with caution in the elderly and in all patients with:

Autonomic neuropathy.

Hepatic or renal disease.

Ulcerative colitis - large doses may suppress intestinal motility to the point of producing a paralytic

ileus and for this reason may precipitate or aggravate "toxic megacolon," a serious complication of the

disease.

Hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias,

tachycardia, hypertension and prostatic hypertrophy.

Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this

condition.

ADVERSE REACTIONS

Anticholinergics produce certain effects, most of which are extensions of their fundamental

pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia;

decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation

of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental

confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling;

impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including

anaphylaxis, urticaria and other dermal manifestations.

Glycopyrrolate Tablets 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

The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central.

1. To guard against further absorption of the drug - use gastric lavage, cathartics, and/or enemas.

2. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.) - utilize a

quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.

3. To combat hypotension - use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care.

4. To combat respiratory depression - administer oxygen; utilize a respiratory stimulant such as

Dopram® i.v.; artificial respiration.

DOSAGE AND ADMINISTRATION

The dosage of Glycopyrrolate Tablets should be adjusted to the needs of the individual patient to assure

symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily

dosage of glycopyrrolate is 8 mg.

Glycopyrrolate Tablets 1 mg. The recommended initial dosage of Glycopyrrolate Tablets 1 mg for

adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may

require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of

one tablet twice a day is frequently adequate.

Glycopyrrolate Tablets 2 mg. The recommended dosage of Glycopyrrolate Tablets 2 mg for adults is

one tablet two or three times daily at equally spaced intervals.

Glycopyrrolate Tablets are not recommended for use in pediatric patients under the age of 12 years.

DRUG INTERACTIONS

There are no known drug interactions.

HOW SUPPLIED

Glycopyrrolate Tablets USP, 1 mg are white, round tablets with debossing of “OL” above bisect and

“305” below bisect on one side and plain on the other side.

They are supplied as follows:

Bottles of 100 Tablets (NDC 15955-305-01)

Glycopyrrolate Tablets USP, 2 mg are white, round tablets with debossing of “OL” above bisect and

“318” below bisect on one side and plain on the other side.

They are supplied as follows:

Bottles of 100 Tablets (NDC 15955-318-01)

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

Dispense in a tight container as defined in the USP.

Keep this and all drugs out of the reach of children.

Rx only

Manufactured By:

Appco Pharma LLC

Piscataway, NJ 08854

Manufactured For:

Orit Laboratories LLC

West Caldwell, NJ 07006

Rev. 10/15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1 mg Strength

NDC 15955-305-01

Glycopyrrolate

Tablets, USP

1 mg

Rx only

100 Tablets

ORIT®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-2 mg Strength

NDC 15955-318-01

Glycopyrrolate

Tablets, USP

2 mg

Rx only

100 Tablets

ORIT®

GLYCOPYRROLATE

glycopyrrolate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:159 55-30 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

GLYCOPYRROLATE

1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

CALCIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: L11K75P9 2J)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

OL;30 5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:159 55-30 5-

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

10 /19 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 36 57

10 /19 /20 12

GLYCOPYRROLATE

glycopyrrolate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:159 55-318

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

GLYCOPYRROLATE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CO PO VIDO NE K2 5-3 1 (UNII: D9 C330 MD8 B)

CALCIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: L11K75P9 2J)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

OL;318

Contains

ORIT LABORATORIES LLC

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:159 55-318 -

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

10 /19 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 36 57

10 /19 /20 12

Labeler -

ORIT LABORAT ORIES LLC (167618912)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Appco Pharma LLC

0 78 510 18 6

MANUFACTURE(159 55-30 5, 159 55-318 )

Revised: 10/2019

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