PHENYLEPHRINE HYDROCHLORIDE
Brand names: PHENYLEPHRINE HYDROCHLORIDE, Gencare-Nasal Decongestant PE, basic care nasal, phenylephrine hydrochloride, heb nasal, Medi-First Plus Sinus Decongestant, Phenylephrine hydrochloride, Phenylephrine Hydrochloride, Neo-Synephrine Severe, Nasal, IMMPHENTIV, equaline nasal, CareOne Fast Acting Nasal, Biorphen, Equate Nasal, nasal, Extra Strength Sinus Relief Nasal Decongestant, NASAL and SINUS DECONGESTANT, 4 Way Fast Acting, ValuMeds Nasal Decongestant Phenylephrine HCl, Neo-Synephrine Regular, Crane Safety Sinus Decongestant, PREPARATION H, Nasal Decongestant PE, Better Living, Nasal Four, NASAL, up and up, Good Sense Nasal Four, Topcare Nasal Four, CVS Health Four Actions Nasal Decongestant, Neo-Synephrine Mild, ValuMeds Nasal Decongestant PE Phenylephrine, QUALITY CHOICE, good neighbor pharmacy nasal four, Dover Sudanyl PE, Medi-First Sinus Decongestant, NO DRIP NASAL, Phenylephrine Hydrochloride Phenylephrine Hydrochloride, Ephrine Nose Drops, ReVIVOL-XR, Medique Medi-Phenyl, dg health nasal four, GoodMeds Nasal Decongestant, Quality Choice, Publix, Green Guard Allergy 2 Relief, Good Sense Nasal Decongestant PE, Sudafed PE Sinus Congestion, Childrens Sudafed PE NASAL DECONGESTANT, Neo-Synephrine Maximum, Extra Strength Nasal
Warnings
5 WARNINGS AND PRECAUTIONS • Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension: Phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. ( 5.1 ) • Peripheral and Visceral Ischemia: Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs. ( 5.2 ) • Skin and Subcutaneous Necrosis: Extravasation during intravenous administration may cause necrosis or sloughing of tissue. ( 5.3 ) • Bradycardia: Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. ( 5.4 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure effects, Phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. 5.2 Peripheral and Visceral Ischemia Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease. 5.3 Skin and Subcutaneous Necrosis Extravasation of Phenylephrine hydrochloride can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine hydrochloride. 5.4 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. 5.5 Allergic Reactions Phenylephrine hydrochloride contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 5.6 Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function. 5.7 Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including Phenylephrine hydrochloride, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries. 5.8 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine hydrochloride [see Drug Interactions (7.1)] , with the potential for hemorrhagic stroke.
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Overdose
10 OVERDOSAGE Overdose of phenylephrine hydrochloride can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.
Drug interactions
7 DRUG INTERACTIONS Agonistic effects ( increase in Phenylephrine hydrochloride blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids. ( 7.1 ) Antagonistic effects (decrease in Phenylephrine hydrochloride blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents ( 7.2 ) 7.1 Interactions that Augment Pressor Effect The increasing blood pressure effect of Phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI) Oxytocin and oxytocic drugs Tricyclic antidepressants Angiotensin, aldosterone Atropine Steroids, such as hydrocortisone Norepinephrine transporter inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate 7.2 Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of Phenylephrine hydrochloride is decreased in patients receiving: α-adrenergic antagonists Phosphodiesterase Type 5 inhibitors Mixed α- and β-receptor antagonists Calcium channel blockers, such as nifedipine Benzodiazepines ACE inhibitors Centrally acting sympatholytic agents, such as reserpine, guanfacine
Uses
1 INDICATIONS & USAGE Phenylephrine hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Dosage forms & strengths
Directions • adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours • children under 12 years: ask a doctor • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
Ingredients
Active ingredient Phenylephrine hydrochloride 1%
Inactive ingredients
All identified pills
Side effects
6 ADVERSE REACTIONS Adverse reactions to Phenylephrine hydrochloride are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of Phenylephrine hydrochloride are listed below by body system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders: Epigastric pain, vomiting, nausea Nervous system disorders: Headache, blurred vision, neck pain, tremors Vascular disorders: Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and subcutaneous tissue disorders: Pruritis Most common adverse reactions during treatment: nausea, vomiting, and headache. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .