Label: GLYCOPYRROLATE tablet
Contains inactivated NDC Code(s)
NDC Code(s): 60763-475-02, 60763-476-02
- Packager: Stason Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 16, 2018
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- INDICATIONS & USAGE
- INACTIVE INGREDIENT
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.
MECHANISM OF ACTION
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 by 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
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 arenon-polar tertiaryamines which penetrate lipid barriers easily.
In the presence of a high environmental temperature. heat prostration (fever and heat stroke due
to decreased sweating) can occur with the use of Glycopyrrolate.
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 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 tomuscular weakness and possible paralysis.
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 dimished 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 safely of the
drug in pregnancy have been performed.
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 drygs are excreted in human milk.
Since there is no adequate experience in pediatric patients who have received this drug, safety and
efficacy in pediatric patients has not been established.
Use Glycopyrrolate 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 the "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.
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; dilation 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 is chemically a quarternary ammonium compound: hence. its passage across lipid
membranes such as the blood-brain barrier. is limited to 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.
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
2. To combat peripheral anticholinergic effects (residual hydriasis, dry mouth, etc.) -
utilize a quartenary ammonium anticholinesterase. such as neostigmine methylsulfate.
3. To combat hypotension- use pressor amines(norepinephrine, metaraminol) i.v.; and
4. To combat respiratory depression - administer oxygen: utilize a respuarory stimulant
such as Dopram(R) i.v., artificial respiration.
DOSAGE & ADMINISTRATION
Dosage and Administration
The dosage of glycopyrrolate 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 USP, 1 mg. The recommended initial dosage of Glycopyrrolate 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.
Glycopyrrolare tablets are not recommended for use in pediatric patients under the age of 12
- DRUG INTERACTIONS
- HOW SUPPLIED
- OTHER SAFETY INFORMATION
Glycopyrrolate Tablets, USP
Storage: Store at controlled room temperature, 20-25C (68-77F): excursions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature]. Keep out of reach of children.
Pharmacist: Dispense in tight container.
Usual Dosage: One or two tablets three times a day.
See accompanying information.
Manufactured by Stason Pharmaceuticals
Irvine, CA 92618
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60763-475 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 1 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 0475 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60763-475-02 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091182 04/10/2017 GLYCOPYRROLATE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60763-476 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 2 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 0476 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60763-476-02 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091182 04/10/2017 Labeler - Stason Pharmaceuticals, Inc. (807437553) Registrant - Stason Pharmaceuticals, Inc. (807437553) Establishment Name Address ID/FEI Business Operations Stason Pharmaceuticals, Inc. 807437553 manufacture(60763-475, 60763-476)