Source: FDA, National Drug Code (US) Revision Year: 2017
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.
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.
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 may be administered intramuscularly, or intravenously, without dilution, in the following indications.
The recommended dose of ROBINUL Injection 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.
ROBINUL Injection 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.
The recommended dose of ROBINUL Injection 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.
The usual recommended dose of ROBINUL Injection 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 is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS – Pediatric Use).
(see PRECAUTIONS – Pediatric Use)
The recommended dose of ROBINUL Injection 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.
(1 month to 2 years of age) may require up to 0.009 mg/kg.
Because of the long duration of action of ROBINUL Injection if used as preanesthetic medication, additional ROBINUL Injection 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.
The recommended pediatric dose of ROBINUL Injection 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.
ROBINUL Injection is not recommended for the treatment of peptic ulcer in pediatric patients (see PRECAUTIONS – Pediatric Use).
Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer’s Injection.
Lactated Ringer’s solution.
This list does not constitute an endorsement of the clinical utility or safety of co-administration of ROBINUL with these drugs. ROBINUL Injection 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 may be administered via the tubing of a running infusion of normal saline.
Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine ROBINUL Injection 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.
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.
Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
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