Glycate

Glycate® (GLYCOPYRROLATE TABLETS, USP 1.5 mg)

Intra-Sana Laboratories, LLC

PRODUCT OVERVIEW:

Glycopyrrolate TABLET

Glycopyrrolate Tablets, USP 1.5 mg, contain the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide.

Diagram, schematic Description automatically generated

Each tablet contains:

Glycopyrrolate, USP .............................. 1.5 mg

Inactive Ingredients: Dibasic Calcium Phosphate, Anhydrous Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.

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.

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.

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 Tablets, USP.

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, USP 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.

Use Glycopyrrolate Tablets, USP 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 tablets are 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.

Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

The dosage of Glycopyrrolate Tablets, USP 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 1 mg tablets 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, USP 2 mg. The recommended dosage of Glycopyrrolate 2 mg tablets for adults is one tablet two or three times daily at equally spaced intervals.

Glycopyrrolate Tablets, USP 1.5 mg. The Glycopyrrolate 1.5 mg tablets may be used to provide intermediate titration doses based on response of the patient.

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

Glycate® (Glycopyrrolate Tablets, USP 1.5 mg) are compressed white tablets debossed GP on one side and 1.5 on the other and are supplied in bottles of 100 (NDC 80056-160-10).

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Dispense in tight, light-resistant container, as defined in the USP, using a child-resistant closure.

Rx only.

Distributed by:
INTRA-SANA LABORATORIES LLC
LAS VEGAS, NV 89113
Rev 11/2021

1.5 mg Tablet Bottle Label

NDC 80056-160-10

Intra-Sana Laboratories
Glycate (Glycopyrrolate Tablets, USP 1.5 mg)

WHITE DYE-FREE

100 Tablets

RX Only

Usual Adult Dosage: Please see package insert for detailed prescribing information.

Storage and Dispense: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.]

Dispense in tight container.

KEEP OUT OF THE REACH OF CHILDREN.

Manufactured For:

INTRA-SANA LABORATORIES LLC
Las Vegas, NV 89113

Rev 08/2021

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PRINCIPAL DISPLAY PANEL – 1.5 mg Tablet Bottle Label NDC 80056-160-10 Intra-Sana Laboratories Glycate (Glycopyrrolate Tablets, USP 1.5 mg) WHITE DYE-FREE 100 Tablets RX Only Usu...