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Robinul
Overview
What is Robinul?
ROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:
Glycopyrrolate, USP 0.2 mgWater 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 CHBrNO and the molecular weight is 398.33.
Its structural formula is as follows:
CHBrNO 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 (log P= -1.52) at ambient room temperature (24°C).
What does Robinul look like?
What are the available doses of Robinul?
Sorry No records found.
What should I talk to my health care provider before I take Robinul?
Sorry No records found
How should I use Robinul?
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 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.
NOTE: CONTAINS BENZYL ALCOHOL
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
ROBINUL Injection may be administered intramuscularly, or intravenously, without dilution, in the following indications.
What interacts with Robinul?
Sorry No Records found
What are the warnings of Robinul?
Sorry No Records found
What are the precautions of Robinul?
Sorry No Records found
What are the side effects of Robinul?
Sorry No records found
What should I look out for while using Robinul?
Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.
In addition, in the management of patients, because of the longer duration of therapy, ROBINUL Injection 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.
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 ).
ROBINUL Injection 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 would be inappropriate and possibly harmful.
What might happen if I take too much Robinul?
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.
How should I store and handle Robinul?
ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials packaged in 25s (NDC 0641-6106-25) 20 mL multiple dose vials in 10s (NDC 0641-6107-10)Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARD Revised June 2017462-185-06
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.In addition, in the management of patients, because of the longer duration of therapy, ROBINUL Injection 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.
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 ).
ROBINUL Injection 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 would be inappropriate and possibly harmful.
The concurrent use of ROBINUL Injection 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 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.
Investigate any tachycardia before giving ROBINUL Injection 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 ).
Use ROBINUL 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.
Anticholinergics, including ROBINUL Injection, 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: 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 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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