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211 Robinul Aerosolization 211 / Page 1 of 5 General Description Robinul (Glycopyrrolate) is a quaternary ammonium derivative of atropine, and has the same indications and uses as Atropine.1 The intended use for aerosolized Robinul at SFGH is to dry excessive, non-purulent, watery secretions indicative of hyper-responsive pulmonary vagal activity. Drug Descriptions Atropine and its derivatives produce beneficial bronchodilating effects by inhibiting the actions of acetylcholine at muscarinic receptors, and by inhibiting acetylcholine-enhanced mast cell degranulation. Other effects of atropine include decreased salivary and bronchial secretions, increased heart rate through the suppression of parasympathetic stimulation, relaxation of GI tone and motility, and suppression of gastric acid secretion.1 Aerosolized atropine is limited clinically due to its systemic side effects.2 Because it is a quaternary ammonium compound Robinul has limited lipid solubility. Therefore it is poorly soluble across both the alveolar capillary membrane and the blood brain barrier.3, 4 As a result, aerosolized Robinul produces limited systemic side effects; especially CNS side effects that are commonly associated with atropine.1 Studies that have investigated the bronchodilatory effects of Robinul, in both acute and stable asthma, have found it to be as effective as atropine or Metaproterenol, but without the systemic side effects of either drug.5 , 6 Indications The traditional respiratory care use of atropine and its derivatives is cholinergic mediated bronchospasm.1 All clinically relevant studies to respiratory care have investigated the use of Robinul as a bronchodilator. However, the intended use for Robinul at SFGH is to dry excessive, non-purulent, watery secretions indicative of hyper-responsive pulmonary vagal activity. Patients with these secretions, who require suctioning q15" or greater, are candidates for Robinul therapy. Another clinical indication is when the coughing and suctioning associated with watery secretions maybe impairing the patient's pulmonary function to maintain spontaneous ventilation or gas exchange. Because of the availability of Atrovent at this institution, Robinul is not the drug of choice for treating cholinergic mediated bronchospasm. However, if a situation arises where Atrovent is not available, Robinul is a safe and effective alternative. RCS SFGH Reviewed: 8/98, 7/01, 6/04, 12/12, 6/12 Adopted:10/94 Revised: 10/94, 3/02, 11/10 211 Robinul Aerosolization 211 / Page 2 of 5 Dosage Robinul is supplied only as an injection solution of 0.2 mg/ml. For aerosol administration to dry secretions, the recommended dose is 1mg given tid or qid.1 Because of the dilution of the solution (0.2mg/cc), five vials are needed which provides a nebulized volume of 5cc. It has been recommended that this dose be diluted further with 3cc of normal saline.1, 7 Because of the synergistic bronchodilatory effect of anticholinerics and sympathomimetcs, robinul can be mixed with bronchodilators and given as a single treatment.4, 7, 8 The effectiveness and duration of robinul should be evaluated after the first dose, and after the first 24 hours of therapy. Robinul is to be administered as infrequently as possible. Limited clinical experience at SFGH has demonstrated effective control of secretions with q day treatments. Bronchodilatation has been reported with dosages as small as 0.08 to 0.1mg via MDI.9, 10 Effective nebulized dosages usually require ten-times the amount used in MDI's and may range up to 2mg. 7 Onset of action: 30 minutes 1,8 Peak effect: 1-2 hours 1 Duration: 6-12 hours 1,8,9 Contraindications The respiratory care practitioner must be extremely prudent in using any agent which dries pulmonary secretions. Therefore, it is imperative that robinul not be administered either to patients with infected secretions, or patients with cardiogenic or ARDS-related pulmonary edema. Patient Assessment / Reassessment The patient’s response to therapy should be assessed and reassessed. Patient assessment and reassessment should be performed according to the general RCS policy (see Section IV - Patient Assessment / Reassessment in the RCS Policy Manual). The need to continue therapy should be reassessed every 24 hours. Specific criteria for assessment and reassessment should include: • Changes in breathsounds • Patient’s tolerance to therapy • Development of the following complications or adverse reactions RCS SFGH Reviewed: 8/98, 7/01, 6/04, 12/12, 6/12 Adopted:10/94 Revised: 10/94, 3/02, 11/10 211 Robinul Aerosolization 211 / Page 3 of 5 Complications / Adverse Reactions Although robinul has been shown to have few side effects, the respiratory care practitioner needs to be familiar with general side effects of anticholinergic agents. Some of the adverse reactions associated with anticholinergics include dry mouth, urinary retention, blurred vision, tachycardia, palpitation, nausea and vomiting.3 CNS symptoms associated with anticholinergics are headache, nervousness, drowsiness, weakness, dizziness and insomnia. 3 Safety and efficacy of use during pregnancy, and use in children has not been established.1 Extreme caution should be used with anticholinergic agents in patients with myasthenia gravis.1 Reported side effects of robinul have included headache, dry mouth, blurred vision and lightheadedness;9 mild sore throat;10 tremors;5 and hypotension in a combination Albuterolrobinul treatment.4 In all of these studies the occurrence of side effects was mild and infrequent. Another study reported side effects for robinul that were indistinguishable from placebo.6 No cardiac rhythm disturbances attributable to robinul were reported in any of the studies reviewed.4, 5, 6, 9, 10 Two potential concerns regarding airway patency with the use of robinul are: (a) the precipitation of mucus plugging in patients with chronic lung disease; (b) bronchospasm in some asthmatics who are hypersensitive to the benzyl alcohol preservative used in robinul.4 Note: In any situation where adverse cardiovascular or pulmonary reactions coincide with the delivery of robinul, the treatment is to be DC'd and the physician notified. Immediately stop treatment if any of the following occurs: • Heart rate <50 or >140 bpm • Systolic BP <90 or >180 • Respiratory Rate <10 or >24 • Tremulousness • Diaphoresis • Any complaints of chest pain, palpitations, headache. Note: Notify the physician and document the event. If cardiac arrest occurs, follow the procedure for Resuscitation (Section 537 Resuscitation). RCS SFGH Reviewed: 8/98, 7/01, 6/04, 12/12, 6/12 Adopted:10/94 Revised: 10/94, 3/02, 11/10 211 Robinul Aerosolization 211 / Page 4 of 5 Physician Orders The initial physician order for use in excessive secretions should read: "Aerosolized robinul 1mg in 3cc normal saline x1". When effectiveness and duration has established in each patient, the order can be rewritten for "qd to qid x 24 hours". Robinul therapy must to be reevaluated on a 24 hour basis. In special situations where Atrovent is not available or standard delivery methods are judged to be ineffective to treat cholinergic mediated bronchospasm, the order may be written for robinul doses of 1-2mg up to qid. Physician orders must be explicit. If the order is not complete, or in the opinion of the therapist, the order is in error, (see Section 205 Aerosolization of Medications). Equipment and Procedure Refer to Section 205 Aerosolization of Medications and Section 205.1 Aerosolization Of Medications – Ventilators) Charting Refer to Section 205 Aerosolization of Medications. RCS SFGH Reviewed: 8/98, 7/01, 6/04, 12/12, 6/12 Adopted:10/94 Revised: 10/94, 3/02, 11/10 211 Robinul Aerosolization 211 / Page 5 of 5 References 1 Howder C. Anticholinergic (antimuscarinic) bronchodilators Chapter 9 in Cardiopulmonary pharmacology. Baltimore, 1992 Williams & Wilkins [Pub] pp 109-113. 2 Rebuck AS, Chapman KR, Braude AC. Anticholinergic therapy of asthma. Chest 1982; 82:55-57. 3 Physicians Desk Reference, Product information p 1811 4 Cydulka RK, Emerman CL. Effects of combined treatment with glycopyrrolate and albuterol in acute exacerbation of asthma. Annals of Emergency Med. 1994; 23:270-74. 5 Gilman MJ, Meyer L, Carter J, Slovis C. Comparison of aerosolized glycopyrrolate and metaproterenol in acute asthma. Chest 1990; 98:1095-1098. 6 Johnson BE, Suratt PM, Gal TJ, Wilhoit SC. Effect of inhaled glycopyrrolate and atropine in Asthma. Chest 1984; 85:325-328. 7 Self T, Joe R, Kellerman A. Glycopyrrolate for asthma [letter] American Journal of Emergency Medicine 1992; 10:395-396 8 Rebuck AS, Chapman KR, Abboud R, Pare PD, Kreisman H, Wolkove N, Vickson F. Nebulized anticholinergic and sympathomimetic treatment of asthma and chronic obstructive airways disease in the emergency room. American J Medicine 1987; 82:59-64 9 Walker FB, Kaiser DL, Kowal MB, Suratt PM. Prolonged effect of inhaled glycopyrrolate in asthma. Chest 1987; 91:49-51. 10 Schroeckenstein DC, Bush RK, Chervinsky P, Busse WW. Twelve-hour bronchodilation in asthma with a single aerosol dose of the anticholinergic compound glycopyrrolate. J. Allergy Clin Immunol 1988; 82:115-119. RCS SFGH Reviewed: 8/98, 7/01, 6/04, 12/12, 6/12 Adopted:10/94 Revised: 10/94, 3/02, 11/10