Glycate

DESCRIPTION

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

Each tablet contains:

Glycopyrrolate, USP .... 1.5 mg

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

INDICATIONS

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

DOSAGE AND ADMINISTRATION

The dosage of Glycopyrrolate Tablets, USP should be adjusted to the needs of the individual patient to assure symptomatic controlwith 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.

HOW SUPPLIED

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 (15370-160-10) and a physician sample (15370-160-03).

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].

Manufactured for: Carwin Pharmaceutical Associates, LLC, Hazlet, NJ 07730. Revised: May 2018

SIDE EFFECTS

Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may includexerostomia;decreased sweating; urinary hesitancy and retention; blurred vision;tachycardia;palpitations;dilationof thepupil;cycloplegia; increasedoculartension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling;impotence;抑制lactation; severe allergic reaction or drug idiosyncrasies includinganaphylaxis,urticariaand otherdermalmanifestations.

Glycopyrrolate Tablets, USP is chemically a quaternary ammonium compound; hence, its passage acrosslipidmembranes, such as theblood-brain barrier, is limited in contrast toatropinesulfate andscopolaminehydrobromide. 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. You may voluntarily report side effects to FDA AT 1-800-FDA-1088. Questions or comments? Call Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.

DRUG INTERACTIONS

No Information Provided

警告

In the presence of a high environmental temperature,heat prostration(fever andheat strokedue to decreased sweating) can occur with the use of Glycopyrrolate Tablets, USP.

Diarrhea may be an early symptom of incompleteintestinal obstruction, especially in patients withileostomyorcolostomy. 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, acurare-like action may occur, i.e.,neuromuscularblockade leading tomuscularweakness and possibleparalysis.

PRECAUTIONS

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 aparalytic ileusand for this reason may precipitate or aggravate the "toxic megacolon," a seriouscomplicationof the disease.
• Hyperthyroidism, coronaryheart disease,congestive heart failure, cardiac tachyarrhythmias, tachycardia,hypertensionand prostatichypertrophy.
• Hiatal hernia与refluxesophagitis, since anticholinergic drugs may aggravate this condition.

Interactions

There are no known drug interactions.

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 noteratogeniceffects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates ofconceptionand 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.S

OVERDOSE

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

1. To guard against further absorption of the drug - usegastriclavage, cathartics, and/or enemas.
2. To combat peripheral anticholinergic effects (residualmydriasis,dry mouth, etc.) - utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate.
3. To combathypotension- usepressoramines (norepinephrine, metaraminol) i.v.; andsupportive care.
4. To combatrespiratory depression- administer oxygen; utilize a respiratory stimulant such as Dopram^®i.v.; artificialrespiration.

CONTRAINDICATIONS

Glaucoma;obstructive uropathy (for example,bladderneck obstruction due to prostatic hypertrophy); obstructive disease of thegastrointestinal tract(as inachalasia, pyloroduodenalstenosis, etc.); paralyticileus;intestinal atony of the elderly or debilitated patient; unstablecardiovascularstatus in acutehemorrhage;severe ulcerativecolitis;toxicmegacoloncomplicating ulcerative colitis;myasthenia gravis. Glycopyrrolate tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

CLINICAL PHARMACOLOGY

Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action ofacetylcholineon structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine by lack cholinergicinnervation. These peripheral cholinergic receptors are present in the autonomic effector cells ofsmooth muscle,cardiac muscle, the sino-atrialnode, theatrioventricularnode,exocrineglands, and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessivepharyngeal, 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.

PATIENT INFORMATION

No information provided. Please refer to the警告andPRECAUTIONSsections.