Glycate

What is Glycate and how is it used?

Glycate (glycopyrrolatetablets) is ananticholinergicindicated for use as adjunctive therapy in the treatment ofpeptic ulcer。

What are side effects of Glycate?

Common side effects of Glycate include:

• dry mouth,
• decreased sweating,
• urinary hesitancy and retention,
• blurred vision,
• fast heart rate,
• palpitations,
• dilated pupilsand other eye problems,
• loss of taste,
• headaches,
• nervousness,
• confusion,
• drowsiness,
• weakness,
• dizziness,
• insomnia,
• nausea,
• vomiting,
• constipation,
• bloating,
• impotence,
• suppression of lactation,
• severe allergic reaction includinganaphylaxis, hives, and other skin reactions.

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 (NDC59547-210-19).

Store at 20° C to 25° C (68° F to 77° F);excurs ions permitted to 15° C to 30° C(59° F to 86° F) [See USP ControlledRoom Temperature].

Keep out of reach of children.

Dispense in tight container.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92614. Manufactured for: Nuro Pharma, Inc., Las Vegas, NV 89118. Revised: Nov 2013

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; mentalconfusion; drowsiness;weakness; dizziness; insomnia; nausea;vomiting; constipation; bloated feeling;impotence; suppression of 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 incontrasttoatropinesulfate 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.

DRUG INTERACTIONS

There are no known drug interactions.

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 incomplete intestinal 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., neuro-muscularblockade leading to muscular weakness and possibleparalysis。

PRECAUTIONS

平板电脑,使用胃长宁USP th的谨慎e 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 “toxicmegacolon,” a seriouscomplicationof the disease.
• Hyperthyroidism, coronaryheart disease, congestive heart failure, cardiac tachyarrhythmias,tachycardia,hypertensionand prostatichypertrophy。
• Hiatal hernia与refluxesophagitis, sinceanticholinergicdrugs may aggravate this condition.

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

它不知道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.

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 peripheralanticholinergiceffects (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 asDopram® i.v.; artificialrespiration。

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

Glycopyrrolate, like otheranticholinergic(antimuscarinic) agents, inhibits the action ofacetylcholineon structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine by lack cholinergicinnervation。这些外围的胆碱能受体提出nt in the autonomic effector cells of smooth 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 ofgastricsecretions 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 theblood-brain barrier, incontrastto 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.