Phenylephrine Hydrochloride Injection, Solution

Prescription

Nomes comerciais: phenylephrine hydrochloride injection, solution

Forma Farmacêutica

Injection

Via de Administração

INTRAVENOUS

Fabricante

Dr. Reddy's Laboratories Inc.

About This Medication

11 DESCRIPTION Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL), an alpha-1 adrenergic receptor agonist, contains the active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Phenylephrine hydrochloride chemical name is (-)-m-Hydroxy-α-[(methylamino) methyl]benzyl alcohol hydrochloride and has the following structural formula: Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride is sensitive to light. Phenylephrine Hydrochloride Injection, USP 80 mcg/mL (20 mg/250 mL, equivalent to 16.4 mg of phenylephrine base per 250 ml) is a clear and colorless sterile aqueous solution, essentially free of visible foreign matter. It is a ready-to-use solution intended for intravenous administration. Each mL contains: 0.08 mg of Phenylephrine Hydrochloride and 9.04 mg of Sodium Chloride in Water for Injection. Phenylephrine Hydrochloride Injection, USP 80 mcg/mL. Hydrochloric acid is added as needed to adjust pH (pH range is 3.0 to 5.0).

Princípios Ativos

Ingrediente	Concentração
Phenylephrine	-

Indicações e Uso

1 INDICATIONS AND USAGE Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in the setting of anesthesia ( 1 )

Como funciona

12.1 Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

Posologia e Administração

2 DOSAGE AND ADMINISTRATION Do NOT dilute prior to administration ( 2.1 ) Dosing for Perioperative Hypotension Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.2 ) 2.1 General Administration Instructions During Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) administration: Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) is supplied as a premixed, ready to administer product that requires no further dilution prior to infusion. Parenteral drug products should be inspected for particulate matter and discoloration prior to administration. Do not use if the solution is coloured or cloudy, or if it contains particulate matter. Discard any unused portion. 2.2 Recommended Dosage In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia: 50 mcg to 250 mcg by intravenous bolus administration. The most frequently reported initial bolus dose is 50 mcg or 100 mcg. 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Do not exceed 200 mcg/min.

Side Effects Overview

6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. 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: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions: Chest pain, extravasation Nervous system disorders : Headache, nervousness, paresthesia, tremor Psychiatric disorders: Excitability Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders: Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Advertências e Precauções

5 WARNINGS AND PRECAUTIONS Severe bradycardia and decreased cardiac output ( 5.2 ) Extravasation : during intravenous administration may cause necrosis or sloughing of tissue ( 5.4 ) Concomitant use with oxytocic drugs : pressor effect of sympathomimetic pressor amines is potentiated ( 5.5 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its pressor 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 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. 5.3 Risk in Patients with Autonomic Dysfunction The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries. 5.4 Skin and Subcutaneous Necrosis Extravasation of phenylephrine can cause necrosis or sloughing of tissue. Avoid extravasation by checking infusion site for free flow. 5.5 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including phenylephrine hydrochloride [ see Drug Interactions (7.1) ], with the potential for hemorrhagic stroke. 5.6 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. 5.7 Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

Contraindicações

4 CONTRAINDICATIONS The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with: Hypersensitivity to the product or any of its components Hypersensitivity to it or any of its components ( 4 )

Farmacocinética

12.3 Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output. A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine. Deamination by monoamino oxidase is the primary metabolic pathway resulting in the formation of the major metabolite (m-hydroxymandelic acid) which accounts for 57% of the total administered dose.

Frequently Asked Questions

1 INDICATIONS AND USAGE Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in the setting of anesthesia ( 1 )

2 DOSAGE AND ADMINISTRATION Do NOT dilute prior to administration ( 2.1 ) Dosing for Perioperative Hypotension Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.2 ) 2.1 General Administration Instructions During Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) administration: Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, …

5 WARNINGS AND PRECAUTIONS Severe bradycardia and decreased cardiac output ( 5.2 ) Extravasation : during intravenous administration may cause necrosis or sloughing of tissue ( 5.4 ) Concomitant use with oxytocic drugs : pressor effect of sympathomimetic pressor amines is potentiated ( 5.5 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase …

4 CONTRAINDICATIONS The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with: Hypersensitivity to the product or any of its components Hypersensitivity to it or any of its components ( 4 )

Phenylephrine Hydrochloride Injection, Solution is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Phenylephrine Hydrochloride Injection, Solution drug label (National Library of Medicine)
• openFDA — Phenylephrine Hydrochloride Injection, Solution label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 2717659 (NLM Normalized Drug Names)
• NDC Directory — Phenylephrine Hydrochloride Injection, Solution (FDA National Drug Code)

Aviso Médico

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Fontes de dados: DailyMed (NLM), openFDA, MFDS