Glycopyrrolate

GLYCOPYRROLATE- glycopyrrolate tablet
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

Glycopyrrolate is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use
Glycopyrrolate is not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

  • Glycopyrrolate tablets 2 mg are not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., 1 mg tablet strength) is appropriate for initial or maintenance treatment because the dosage strength of glycopyrrolate tablets 2 mg may exceed the recommended initial and maintenance dosage of oral glycopyrrolate tablets.

2.2 Recommended Dosage

  • The recommended initial dosage of glycopyrrolate tablets 1 mg for adults is 1 mg three times daily (in the morning, early afternoon, and at bedtime). Some patients may require 2 mg at bedtime to assure overnight control of symptoms. For maintenance, a dosage of 1 mg twice a day is frequently adequate.
  • The recommended dosage of glycopyrrolate tablets 2 mg for adults is 2 mg two or three times daily at equally spaced intervals.
  • The maximum recommended daily dosage of glycopyrrolate is 8 mg.
  • Use the lowest effective dosage of glycopyrrolate to control symptoms. If patients can be titrated to a lower dose, switch from glycopyrrolate tablets 2 mg to glycopyrrolate tablets 1 mg or another 1 mg oral tablet of glycopyrrolate.

3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • Glycopyrrolate Tablets USP, 2 mg are white to off white, round, flat beveled edge tablet debossed with “AC 108” separated by break line on one side and plain on other side.
    Each tablet contains: Glycopyrrolate, USP 2 mg.

4 CONTRAINDICATIONS

Glycopyrrolate tablets are contraindicated in:

  • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including:
    • Glaucoma [ see Warnings and Precautions (5.1)]
    • Obstructive uropathies, including prostatic hypertrophy
    • Mechanical obstructive diseases of the gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [ see Warnings and Precautions (5.2)]
    • Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [ see Warnings and Precautions (5.3)]
    • Bleeding gastrointestinal ulcer
    • Active inflammatory or infectious colitis which can lead to toxic megacolon
    • History of or current toxic megacolon
    • Myasthenia gravis

5 WARNINGS AND PRECAUTIONS

5.1 Precipitation of Acute Glaucoma

Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. Instruct patients to discontinue glycopyrrolate tablets and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [ see Contraindications (4)].

5.2 Partial or Complete Mechanical Intestinal Obstruction

Glycopyrrolate may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. If partial or complete intestinal obstruction is suspected, discontinue the use of glycopyrrolate tablets and evaluate for potential intestinal obstruction [ see Contraindications (4) ].

5.3 Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

Glycopyrrolate reduces gastrointestinal motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon [ see Contraindications (4) ]. The risk of gastrointestinal adverse reactions is further increased with the use of other anticholinergics and other medications that decrease gastrointestinal peristalsis.
Monitor patients for symptoms of decreased gastrointestinal motility. Concomitant use of glycopyrrolate tablets and other anticholinergics or other medications that decrease GI peristalsis is not recommended [ see Drug Interactions (7.2)] .

5.4 Cognitive and Visual Adverse Reactions

Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery, or performing other hazardous work [ see Adverse Reactions (6) ]. Concomitant use of other drugs that have anticholinergic properties may increase these effects [ see Drug Interactions (7.1)].
Inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that glycopyrrolate tablets does not affect them adversely.

Discontinue glycopyrrolate tablets if signs or symptoms of cognitive or visual impairment develop.

5.5 Heat Prostration at High Environmental Temperatures

In the presence of a high environmental temperature, heat prostration resulting in fever and heatstroke can occur with the use of glycopyrrolate tablets due to decreased sweating, particularly in geriatric patients [ see Adverse Reactions (6)]. Advise patients to avoid exposure to hot or very warm environmental temperatures when taking glycopyrrolate tablets. Glycopyrrolate tablets are not recommended in geriatric patients [ see Warnings and Precautions (5.7) ].

5.6 Other Conditions Exacerbated by Anticholinergic Adverse Reactions

Glycopyrrolate tablets are not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications [ see Drug Interactions (7.1)].

5.7 Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

Geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. Glycopyrrolate tablets are not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [ see Contraindications (4), Warnings and Precautions (5.2, 5.5), Adverse Reactions (6) and Use in Specific Populations (8.5)].

6 ADVERSE REACTIONS

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or postmarketing reports. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders: chest, pain, hypertension, tachycardia
Endocrine Disorders: decreased sweating
Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension
Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting
Immune System Disorders: anaphylaxis [ see Contraindications (4)]
Nervous System Disorders: agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness
Respiratory Disorders: respiratory depression, throat irritation
Renal and Urinary Disorders: urinary hesitancy, urinary retention
Reproductive System and Breast Disorders: impotence, suppression of lactation
Vascular Disorders: flushing

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