Robinul

ROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:

Glycopyrrolate, USP 0.2 mg
Water for Injection, USP q.s.
Benzyl Alcohol, NF 0.9% (preservative)
pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.

For Intramuscular (IM) or Intravenous (IV) administration.

Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33. Its structural formula is as follows:

C19H28BrNO3     MW 398.33

Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.

Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. ROBINUL (glycopyrrolate) Injection is a clear, colorless, sterile liquid; pH 2.0- 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).

In Anesthesia

ROBINUL Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, ROBINUL Injection may be used intraoperatively to counteract surgically or druginduced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.

In Peptic Ulcer

For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

You should not use glycopyrrolate if you are allergic to it, or if you have bladder obstruction or other urination problems, a bowel obstruction called paralytic ileus, a blockage in your stomach or intestines, severe constipation, severe ulcerative colitis or toxic megacolon, glaucoma, myasthenia gravis, or if you also take potassium chloride.

Before you take glycopyrrolate, tell your doctor if you have kidney disease, heart disease, a heart rhythm disorder, a stomach disorder, a colostomy or ileostomy, a thyroid disorder, high blood pressure, vision problems, or numbness and tingling.

Take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of glycopyrrolate, such as dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

• Peptic Ulcer (Stomach Ulcer)

Storage

Oral

20–25°C.a

Parenteral

20–25°C.b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

If the pH of the admixture is >6, rapid ester hydrolysis of glycopyrrolate generally occurs.b c

Generally incompatible with drugs that have a pH >6.b c If the pH of the admixture is >6, rapid ester hydrolysis of glycopyrrolate generally occurs.b c

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

In the U.S.

• Cuvposa
• Glycate
• Robinul
• Robinul Forte

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (e.g., cerebral palsy) in children 3 to 16 years of age. This medicine is an anticholinergic.

Glycopyrrolate may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

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

Robinul® (glycopyrrolate, 1 mg) tablets in bottles of 100 (NDC 59630-200-10).

Robinul® Forte (glycopyrrolate, 2 mg) tablets in bottles of 100 (NDC 59630-205-10).

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

Dispense in tight container

Rx only

Manufactured by:
MIKART, INC.
Atlanta, GA 30318

Manufactured for:
Shionogi Inc.
Florham Park, NJ 07932

ROB-PI-3

Rev. 12/11

Printed in USA