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Robinul

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Robinul

Robinul

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.

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