Glycopyrrolate (Robinul)
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Glycopyrrolate (Robinul)

Robinul Injection
(Glycopyrrolate) Injection, USP

NOT FOR USE IN NEONATES

CONTAINS BENZYL ALCOHOL

DRUG DESCRIPTION

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 formulas is C19H28BrNO3 and the molecular weight is 398.33.

Its structural formula is as follows:

Robinul (glycopyrrolate)  structural formula illustration

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).

What are the possible side effects of glycopyrrolate (Cuvposa, Robinul, Robinul Forte)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using glycopyrrolate and call your doctor at once if you have a serious side effect such as:

  • severe constipation, severe stomach pain and bloating;
  • diarrhea (especially if you have a colostomy or ileostomy);
  • feeling like you might pass out;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, weak pulse, or hot and dry skin; or
  • dry...

Read All Potential Side Effects and See Pictures of Robinul »

What are the precautions when taking glycopyrrolate (Robinul)?

Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn...

Read All Potential Precautions of Robinul »

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

In Anesthesia: Robinul Injection (glycopyrrolate) 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 (glycopyrrolate) may be used intraoperatively to counteract surgically or drug- induced 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.

DOSAGE AND ADMINISTRATION

NOTE: CONTAINS BENZYL ALCOHOL (See PRECAUTIONS)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Robinul Injection (glycopyrrolate) may be administered intramuscularly, or intravenously, without dilution, in the following indications.

Adults

Preanesthetic Medication.

The recommended dose of Robinul Injection (glycopyrrolate) is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.

Intraoperative Medication.

Robinul Injection (glycopyrrolate) may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.

Reversal of Neuromuscular Blockade.

The recommended dose of Robinul Injection (glycopyrrolate) is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Peptic Ulcer.

The usual recommended dose of Robinul Injection (glycopyrrolate) is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose, and frequency of administration should be dictated by patient response up to a maximum of four times daily.

Robinul Injection (glycopyrrolate) is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS - Pediatric Use).

Pediatric Patients

(see PRECAUTIONS - Pediatric Use)

Preanesthetic Medication.

The recommended dose of Robinul Injection (glycopyrrolate) in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.

Infants.

(1 month to 2 years of age) may require up to 0.009 mg/kg.

Intraoperative Medication.

Because of the long duration of action of Robinul Injection (glycopyrrolate) if used as preanesthetic medication, additional Robinul Injection (glycopyrrolate) for anticholinergic effect intraoperatively is rarely needed; in the event it is required the recommended pediatric dose is 0.004 mg/kg intravenously, not to exceed 0.1 mg in a single dose which may be repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.

Reversal of Neuromuscular Blockade.

The recommended pediatric dose of Robinul Injection (glycopyrrolate) is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.

Peptic Ulcer.

Robinul Injection (glycopyrrolate) is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS - Pediatric Use)

Diluent Compatibilites

Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9% and Ringer's Injection.

Diluent InCompatibilites

Lactated Ringer's solution

Admixture Compatibilities

Physical Compatibility: This list does not constitute an endorsement of the clinical utility or safety of co-administration of Robinul with these drugs. Robinul Injection (glycopyrrolate) is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium® (physostigmine salicylate); Benadryl® (diphenhydramine HCl); codeine phosphate, USP; Emete-Con® (benz-quinamide HCl); hydromorphone HCl, USP; Inapsine® (droperidol); Levo-Dromoran® (levorphanol tartrate); lidocaine, USP; meperidine HCl, USP; Mestinon®/Regonol® (pyridostigmine bromide); morphine sulfate, USP; Nubain® (nalbuphine HCl); Numorphan® (oxymorphone HCl); procaine HCl, USP; promethazine HCl, USP; Prostigmin® (neostigmine methylsulfate, USP); scopolamine HBr, USP; Stadol® (butorphanol tartrate); Sublimaze® (fentanyl citrate); Tigan® (trimethobenzamide HCl); and Vistaril® (hydroxyzine HCl). Robinul Injection (glycopyrrolate) may be administered via the tubing of a running infusion of normal saline.

Admixture Incompatibilities

Physical Incompatibility: Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine Robinul Injection (glycopyrrolate) in the same syringe with Brevital® (methohexital Na); Chloromycetin® (chloramphenicol Na succinate); Dramamine® (dimenhydrinate); Nembutal® (pentobarbital Na); Pentothal® (thiopental Na); Seconal® (secobarbital Na); sodium bicarbonate (Abbott); Valium® (diazepam); Decadron® (dexamethasone Na phosphate); or Talwin® (pentazocine lactate). These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.

HOW SUPPLIED

Robinul (glycopyrrolate) Injection, 0.2 mg/mL, is available in:

1  mL single dose vials packaged in 25s (NDC 60977-155-01)
2 mL single dose vials packaged in 25s (NDC 60977-155-02)
5 mL multiple dose vials packaged in 25s (NDC 60977-155-03)
20 mL multiple dose vials in 6s (NDC 60977-155-05)

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Robinul (glycopyrrolate) is a registered trademark of Wyeth and used under license. Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. For Product Inquiry: 1 800 ANA DRUG (1-800-262-3784). FDA Rev date: 5/26/2005

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Anticholinergics, including Robinul Injection (glycopyrrolate) , can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons.

In addition, the following adverse events have been reported from post-marketing experience with Robinul (glycopyrrolate) : malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.

Robinul (glycopyrrolate) is 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.

Read the Robinul (glycopyrrolate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

The concurrent use of Robinul Injection (glycopyrrolate) with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.

Concomitant administration of Robinul Injection (glycopyrrolate) and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

This drug should be used with great caution, if at all, in patients with glaucoma.

Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. (see PRECAUTIONS, Pediatric Use).

Robinul Injection (glycopyrrolate) may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Robinul Injection (glycopyrrolate) would be inappropriate and possibly harmful.

PRECAUTIONS

General

Investigate any tachycardia before giving Robinul Injection (glycopyrrolate) since an increase in the heart rate may occur.

Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism.

Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with renal failure. Dosage adjustments may be necessary (see Pharmacokinetics - Renally Impaired).

Use Robinul (glycopyrrolate) with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions.

The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception 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.

Pregnancy

Teratogenic Effects - Pregnancy Category B.

Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m2 basis). These studies produced no teratogenic effects to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier.

Nonteratogenic effects

Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and aterial blood and in the amniotic fluid are low after intramuscular administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a dose-related manner.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Robinul Injection (glycopyrrolate) is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation (see ADVERSE REACTIONS).

Pediatric Use

Due to its benzyl alcohol content, Robinul Injection (glycopyrrolate) should not be used in neonates, i.e., patients less than 1 month of age.

Safety and effectiveness in pediatric patients below the age of 16 years have not been established.

Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer.

Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients.

Infants, patients with Down's syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects.

A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including Robinul Injection (glycopyrrolate) . Infants and young children are especially susceptible to the toxic effects of anticholinergics.

Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The "gasping syndrome," (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages > 99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome," the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Geriatric Use

Clinical Studies of Robinul Injection (glycopyrrolate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting a the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds.

If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood-brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients.

To combat hypotension, administer IV fluids and/or pressor agents along with supportive care.

Fever should be treated symptomatically.

Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

CONTRAINDICATIONS

Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.

In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, Robinul Injection (glycopyrrolate) may be contraindicated in patients with the following concurrent conditions: 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.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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 sinoatrial 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 highly non-polar tertiary amines which penetrate lipid barriers easily.

With intravenous injection, the onset of action is generally evident within one minute. Following intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine.

Pharmacokinetics

The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods.

Distribution: The mean volume of distribution of glycopyrrolate was estimated to be 0.42 ± 0.22L/kg.

Metabolism: The in vivo metabolism of glycopyrrolate in humans has not been studied.

Excretion: The mean clearance and mean T1/2 values were reported to be 0.54 ± 0.14 L/kg/hr and 0.83 ± 0.13 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the mean T1/2 value is reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study.


Group t1/2
(hr)
Vss
(L/kg)
CL
(L/kg/hr)
Tmax
(min)
Cmax
(µg/L)
AUC
(µg/L • hr)
(6 µg/kg IV) 0.83±0.27 0.42±0.22 0.54±0.14 - - 8.64±1.49**
(8 µg/kg IM) - - - 27.48±6.12 3.47±1.48 6.64±2.33**
*0-12 hr
**0-8 hr

Special Populations

Gender: Gender differences in pharmacokinetics of glycopyrrolate have not been investigated

Renal Impairment: In one study glycopyrrolate was administered IV in uremic patients undergoing renal transplantation. The mean elimination half-life was significantly longer (46.8 minutes) than in healthy patients (18.6 minutes). The mean area-under-the-concentration-time curve (10.6 hr-µg/L), mean plasma clearance (0.43 L/hr/kg), and mean 3-hour urine excretion (0.7%) for glycopyrrolate were also significantly different than those of controls (3.73 hr-µg/L, 1.14 L/hr/kg, and 50%, respectively). These results suggest that the elimination of glycopyrrolate is severely impaired in patients with renal failure.

Hepatic Impairment: Pharmacokinetic information in patients with hepatic impairment is unavailable.

Pediatrics: Following IV administration (5 µg/kg glycopyrrolate) to infants and children, the mean T ½ values were reported to be between 21.6 and 130.0 minutes and between 19.2 and 99.2 minutes, respectively.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Because Robinul Injection (glycopyrrolate) may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (see WARNINGS).

The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.

The patient may experience a possible sensitivity of the eyes to light.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Because Robinul Injection (glycopyrrolate) may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (see WARNINGS).

The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke.

The patient may experience a possible sensitivity of the eyes to light.

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Robinul Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

GLYCOPYRROLATE - ORAL

(GLYE-koe-PIR-oh-late)

COMMON BRAND NAME(S): Robinul

USES: Glycopyrrolate is used with other drugs to treat a certain type of stomach/intestinal ulcer (peptic ulcer). This medication may help relieve stomach/abdominal pain. However, it has not been shown to be effective in healing these ulcers, preventing them from returning, or preventing other problems caused by ulcers. Glycopyrrolate works by decreasing the amount of acid in the stomach. It also slows the natural movements of the gut and relaxes the muscles in the stomach/intestines. Glycopyrrolate belongs to a class of drugs known as anticholinergics.

HOW TO USE: Take this medication by mouth, usually 2 to 3 times a day or as directed by your doctor.

The dosage is based on your medical condition and response to treatment. The manufacturer recommends that adults should not take more than 8 milligrams a day of glycopyrrolate.

Do not increase your dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may increase.

Tell your doctor if your condition persists or worsens.

Disclaimer

Robinul Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, weakness, blurred vision, dry eyes, dry mouth, constipation, or abdominal bloating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations, agitation, nervousness, unusual excitement), eye pain, vision changes, difficulty urinating, decreased sexual ability.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Robinul (glycopyrrolate) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking glycopyrrolate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, enlarged prostate, problems with urination due to a blocked urinary tract, other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, ileostomy/colostomy patients with diarrhea), overactive thyroid, heart problems (such as coronary artery disease, angina, congestive heart failure, fast/irregular heartbeat, heart problems due to severe bleeding), high blood pressure, heartburn problems (such as acid reflux, hiatal hernia, esophagus problems), certain nervous system problem (autonomic neuropathy), myasthenia gravis, liver problems, kidney problems.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you sweat less which can increase your risk for heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids, and dress lightly while in hot weather or when exercising. If you become overheated, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if you develop a fever, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, constipation, and urination problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Robinul Consumer (continued)

DRUG INTERACTIONS: See also the How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: potassium tablets/capsules, drugs that are affected by slowed gut movement (such as metoclopramide, pramlintide).

Glycopyrrolate may affect the absorption of other products such as levodopa, certain azole anti-fungal drugs (ketoconazole, itraconazole), slowly-dissolving forms of digoxin, among others. If you are taking either ketoconazole or itraconazole, take it at least 2 hours before glycopyrrolate.

Many other drugs that also cause dry mouth and constipation may interact with anticholinergics such as glycopyrrolate. Tell your doctor or pharmacist about all the products you take, including: amantadine, other anticholinergic drugs (such as atropine, scopolamine), antispasmodic drugs (such as clidinium, dicyclomine, propantheline), belladonna alkaloids, certain drugs used to treat Parkinson's disease (such as benztropine, trihexyphenidyl), certain drugs used to treat irregular heart rhythms (such as disopyramide, quinidine), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), phenothiazines (such as chlorpromazine), tricyclic antidepressants (such as amitriptyline).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or a fast heartbeat. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including gastric secretion tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: large pupils, hot/dry skin, fever, severe dizziness, severe thirst, difficulty swallowing, mental/mood changes (such as confusion, unusual excitement), fast/irregular heartbeat, muscle weakness, inability to move (paralysis), slowed breathing, fainting, seizures.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood cell counts, tests for blood in your stools, x-rays or examination of the inside of your stomach/intestines) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.

Robinul Patient Information Including Side Effects

Brand Names: Cuvposa, Robinul, Robinul Forte

Generic Name: glycopyrrolate (Pronunciation: glye koe PIE roe late)

What is glycopyrrolate (Robinul)?

Glycopyrrolate reduces the secretions of certain organs in the body.

Glycopyrrolate helps to control conditions such as peptic ulcers that involve excessive stomach acid production.

Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

Glycopyrrolate may also be used for purposes not listed in this medication guide.

Robinul 1 mg

round, white, imprinted with HPC 200

Robinul 2 mg

round, white, imprinted with HORIZON 205

What are the possible side effects of glycopyrrolate (Robinul)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using glycopyrrolate and call your doctor at once if you have a serious side effect such as:

  • severe constipation, severe stomach pain and bloating;
  • diarrhea (especially if you have a colostomy or ileostomy);
  • feeling like you might pass out;
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, weak pulse, or hot and dry skin; or
  • dry diapers, fussiness, or excessive crying in a child taking glycopyrrolate.

Less serious side effects may include:

  • dry mouth;
  • vomiting;
  • mild constipation;
  • stuffy nose, sinus pain; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Robinul (glycopyrrolate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about glycopyrrolate (Robinul)?

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.

Side Effects Centers

Robinul Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking glycopyrrolate (Robinul)?

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 digestive tract (stomach or intestines), severe constipation;
  • severe ulcerative colitis or toxic megacolon;
  • glaucoma;
  • myasthenia gravis; or
  • if you are also taking potassium chloride (Epiklor, K-Lor, K-Tab, Klor-Con, Micro-K, Rum-K, and others).

To make sure you can safely take glycopyrrolate, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • heart disease or a heart rhythm disorder;
  • a stomach disorder such as hiatal hernia, reflux disease, or slow digestion;
  • a colostomy or ileostomy;
  • a thyroid disorder;
  • high blood pressure;
  • vision problems; or
  • a nerve disorder that causes numbness or tingling.

FDA pregnancy category C. It is not known whether glycopyrrolate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether glycopyrrolate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Glycopyrrolate should not be given to a child younger than 3 years old.

How should I take glycopyrrolate (Robinul)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

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

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

Side Effects Centers

Robinul Patient Information including If I Miss a Dose

What happens if I miss a dose (Robinul)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Robinul)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weak or shallow breathing, feeling cold, jerky muscle movements, or seizure (convulsions).

What should I avoid while taking glycopyrrolate (Robinul)?

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.

What other drugs will affect glycopyrrolate (Robinul)?

Many drugs can interact with glycopyrrolate. Below is just a partial list. Tell your doctor if you are using:

  • amantadine (Symmetrel);
  • atenolol (Tenormin, Tenoretic);
  • digoxin (Lanoxin, Lanoxicaps);
  • haloperidol (Haldol);
  • levodopa (Larodopa); or
  • metformin (Glucophage, Actoplus Met, Avandamet, Janumet, Kombiglyze, PrandiMet).

This list is not complete and other drugs may interact with glycopyrrolate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about glycopyrrolate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 10/3/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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