Phenylephrine Hydrochloride

Phenylephrine Hydrochloride Manufacturers

• Baxter Healthcare Corporation
  

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  Phenylephrine Hydrochloride | Baxter Healthcare Corporation

  

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  Phenylephrine Hydrochloride Injection is generally injected subcutaneously, intramuscularly, slowly intravenously or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, Phenylephrine Hydrochloride Injection is administered directly intravenously. The dose should be adjusted according to the pressor response.

  DOSAGE CALCULATIONS Dose Required Use Phenylephrin Hydrochloride Injection 1% 10 mg 1 mL 5 mg 0.5 mL 1 mg 0.1 mL

   

  For convenience in intermittent intravenous administration, dilute 1 mL Phenylephrine Hydrochloride Injection 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% Phenylephrine Hydrochloride Injection.

  Dose Required Use Diluted Phenylephrine Hydrochloride Injection (0.1%) 0.1 mg 0.1 mL 0.2 mg 0.2 mL 0.5 mg 0.5 mL Mild or Moderate Hypotension

  SUBCUTANEOUSLY OR INTRAMUSCULARLY: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

  INTRAVENOUSLY: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.

  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the blood pressure for about 15 minutes.

  Severe Hypotension and Shock - Including Drug-Related Hypotension

  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids and phenothiazines tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, Phenylephrine Hydrochloride Injection is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion:

  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 mcg to 180 mcg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 mcg to 60 mcg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia-Hypotension

  Routine parenteral use of phenylephrine has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.

  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia

  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia

  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia

  Rapid intravenous injection (within 20 to 30 seconds) is recommended. The initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg and should never  exceed 1 mg.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• General Injectables & Vaccines
  

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  Phenylephrine Hydrochloride | General Injectables & Vaccines

  

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  Phenylephrine Hydrochloride Injection is generally injected subcutaneously, intramuscularly, slowly intravenously or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, Phenylephrine Hydrochloride Injection is administered directly intravenously. The dose should be adjusted according to the pressor response.

  DOSAGE CALCULATIONS Dose Required Use Phenylephrine Hyrdochloride Injection 1% 10 mg
  1 mL
  5 mg
  0.5 mL
  1 mg
  0.1 mL
  For convenience in intermittent intravenous administration, dilute 1 mL Phenylephrine Hydrochloride Injection 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% Phenylephrine Hydrochloride Injection.
  
  Dose Required Use Diluted Phenylephrine Hydrochloride injection (0.1%) 0.1 mg
  0.1 mL
  0.2 mg
  0.2 mL
  0.5 mg
  0.5 mL
  Mild or Moderate Hypotension
  SUBCUTANEOUSLY OR INTRAMUSCULARLY: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.
  INTRAVENOUSLY: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.
  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the blood pressure for about 15 minutes.
  
  Severe Hypotension and Shock - Including Drug-Related Hypotension
  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine can be administered before and concurrently with blood volume replacement. Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids and phenothiazines tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, Phenylephrine Hydrochloride Injection is a suitable agent for restoring blood pressure. Higher initial and maintenance doses of phenylephrine are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or pheochromocytomectomy may also require more intensive therapy.
  
  Continuous Infusion:
  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 mcg to 180 mcg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 mcg to 60 mcg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL the dose must be adjusted accordingly. If a prompt initial pressor response is not obtained, additional increments of phenylephrine (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.
  
  Spinal Anesthesia-Hypotension
  Routine parenteral use of phenylephrine has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose. To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.
  
  Prolongation of Spinal Anesthesia
  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting or blood pressure disturbances.
  
  Vasoconstrictor for Regional Analgesia
  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.
  
  Paroxysmal Supraventricular Tachycardia
  Rapid intravenous injection (within 20 to 30 seconds) is recommended. The initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg and should never exceed 1 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• West-ward Pharmaceutical Corp.
  

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  Phenylephrine Hydrochloride | West-ward Pharmaceutical Corp.

  

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  Phenylephrine Hydrochloride Injection is generally injected subcutaneously, intramuscularly, slowly intravenously or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, Phenylephrine Hydrochloride Injection is administered directly intravenously. The dose should be adjusted according to the pressor response.

  DOSAGE CALCULATIONS  Dose Required    Use Phenylephrine Hydrochloride Injection 1%  10 mg  1 mL  5 mg  0.5 mL  1 mg  0.1 mL

  
  

  For convenience in intermittent intravenous administration, dilute 1 mL Phenylephrine Hydrochloride Injection 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% Phenylephrine Hydrochloride Injection.

   Dose Required  Use Diluted Phenylephrine Hydrochloride Injection (0.1%)  0.1 mg  0.1 mL  0.2 mg  0.2 mL  0.5 mg  0.5 mL Mild or Moderate Hypotension

  SUBCUTANEOUSLY OR INTRAMUSCULARLY: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.
  INTRAVENOUSLY: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.
  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the blood pressure for about 15 minutes.

  Severe Hypotension and Shock - Including Drug-Related Hypotension

  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, Phenylephrine Hydrochloride Injection is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion:

  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 mcg to 180 mcg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 mcg to 60 mcg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia-Hypotension

  Routine parenteral use of phenylephrine has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.

  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia

  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia

  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia

  Rapid intravenous injection (within 20 to 30 seconds) is recommended. The initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg and should never  exceed 1 mg.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• American Regent, Inc.
  

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  Phenylephrine Hydrochloride | American Regent, Inc.

  

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  Phenylephrine hydrochloride is generally injected subcutaneously, intramuscularly, slowly intravenously, or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, phenylephrine hydrochloride is administered directly intravenously. The dose should be adjusted according to the pressor response.

  Dosage Calculations

  
  Dose Required
  10 mg
  5 mg
  1 mg Use
  Phenylephrine HCl Injection 1%
  1 mL
  0.5 mL
  0.1 mL

  For convenience in intermittent intravenous administration, dilute 1 mL phenylephrine hydrochloride 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% phenylephrine hydrochloride.

  
  Dose Required
  0.1 mg
  0.2 mg
  0.5 mg Use Diluted
  Phenylephrine HCI Injection 0.1%
  0.1 mL
  0.2 mL
  0.5 mL

  Mild or Moderate Hypotension Subcutaneously or lntramuscularly: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

  Intravenously: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.

  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes.

  Severe Hypotension and Shock – Including Drug-Related Hypotension Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine hydrochloride can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids, and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, phenylephrine hydrochloride is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine hydrochloride are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine, or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion – Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP, or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 µg to 180 µg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual) a maintenance rate of 40 µg to 60 µg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL, the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine hydrochloride (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia – Hypotension Routine parenteral use of phenylephrine hydrochloride has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine hydrochloride may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting, or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia Rapid intravenous injection (within 20 to 30 seconds) is recommended;  the initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg, and should never exceed 1 mg.

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• Sandoz Inc.
  

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  Phenylephrine Hydrochloride | Sandoz Inc.

  

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  Phenylephrine hydrochloride is generally injected subcutaneously, intramuscularly, slowly intravenously, or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, phenylephrine hydrochloride is administered directly intravenously. The dose should be adjusted according to the pressor response.

  Dosage Calculations Dose Required Use Phenylephrine HCl Injection 1% 10 mg 1 mL 5 mg 0.5 mL 1 mg 0.1 mL

  For convenience in intermittent intravenous administration, dilute 1 mL phenylephrine hydrochloride 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% phenylephrine hydrochloride.

  Dose Required Use Diluted Phenylephrine HCl Injection 1% 0.1 mg 0.1 mL 0.2 mg 0.2 mL 0.5 mg 0.5 mL Mild or Moderate Hypotension

  Subcutaneously or Intramuscularly: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

  Intravenously: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.

  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes.

  Severe Hypotension and Shock – Including Drug-Related Hypotension

  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine hydrochloride can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids, and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, phenylephrine hydrochloride is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine hydrochloride are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine, or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion

  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP, or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 µg to 180 µg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual) a maintenance rate of 40 µg to 60 µg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL, the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine hydrochloride (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia – Hypotension

  Routine parenteral use of phenylephrine hydrochloride has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine hydrochloride may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose. To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia

  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting, or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia

  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia

  Rapid intravenous injection (within 20 to 30 seconds) is recommended; the initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg, and should never exceed 1 mg.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE

  The pharmacy bulk package is for use in a Pharmacy Admixture Service only.

  Use of this product is restricted to a suitable work area, such as a laminar flow hood. Prior to entering the vial, remove the flip-off seal and cleanse the rubber closure with a suitable antiseptic agent.

  The container closure may be penetrated only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents. The date and time the vial was initially opened should be recorded. For dilution, transfer individual dose(s) to appropriate volume(s) of Sterile Water for Injection, USP for intravenous solutions. Use of a syringe with needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination.

  The withdrawal of container contents should be accomplished without delay using aseptic technique. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations.

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• Falcon Laboratory Ltd
  

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  Phenylephrine Hydrochloride | Falcon Laboratory Ltd

  

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  Vasoconstriction and Pupil Dilation: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% is especially useful when rapid and powerful dilation of the pupil without cycloplegia and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% on the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimination. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

  Uveitis: Posterior Synechiae: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of this solution and atropine or other cycloplegics to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be applied to the upper surface of the cornea and be repeated as necessary, not to exceed three times. Treatment may be continued the following day, if necessary. Atropine sulfate and the application of hot compresses should also be used if indicated.

  Glaucoma: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used with miotics in patients with open angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure in open angle glaucoma. Hence, there may be marked improvement in visual acuity after using Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% in conjunction with miotic drugs.

  Surgery: When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be applied topically from 30 to 60 minutes before the operation.

  Refraction: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used effectively to increase mydriasis with homatropine hydrobromide, cyclopentolate hydrochloride, tropicamide hydrochloride and atropine sulfate.

  FOR ADULTS: One drop of the preferred cycloplegic is placed in each eye, followed in 5 minutes by one drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%. Since adequate cycloplegia is achieved at different time intervals after the instillation of the necessary number of drops, different cycloplegics will require different waiting periods to achieve adequate cycloplegia.

  FOR CHILDREN: For a “one application method,” Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.

  Ophthalmoscopic Examination: One drop of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts from one to three hours.

  Diagnostic Procedures: Provocative Test for Angle Closure Glaucoma: Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used cautiously as a provocative test when interval narrow angle closure glaucoma is suspected. Intraocular tension and gonioscopy are performed prior to and after dilation of the pupil with phenylephrine HCl. A “significant” intraocular pressure (IOP) rise combined with gonioscopic evidence of angle closure indicates an anterior segment anatomy capable of angle closure. A negative test does not rule this out. This pharmacologically induced angle closure glaucoma may not simulate real life conditions and other causes for transient elevations of IOP should be excluded.

  Retinoscopy (Shadow Test): When dilation of the pupil without cycloplegic action is desired for retinoscopy, Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% may be used.

  NOTE: Heavily pigmented irides may require larger doses in all of the above procedures.

  Blanching Test: One or two drops of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iridocyclitis.

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  Phenylephrine Hydrochloride | General Injectables & Vaccines, Inc

  

  ---

  Phenylephrine hydrochloride is generally injected subcutaneously, intramuscularly, slowly intravenously, or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, phenylephrine hydrochloride is administered directly intravenously. The dose should be adjusted according to the pressor response.

  Dosage Calculations
  Use
  Dose Required
  Phenylephrine HCl Injection 1%
  10 mg
  1 mL
  5 mg
  0.5 mL
  1 mg
  0.1 mL
  
  
  For convenience in intermittent intravenous administration, dilute 1 mL phenylephrine hydrochloride 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% phenylephrine hydrochloride.
  
  
  
  Use Diluted
  Dose Required
  Phenylephrine HCI Injection 0.1%
  0.1 mg
  0.1 mL
  0.2 mg
  0.2 mL
  0.5 mg
  0.5 mL
  Mild or Moderate Hypotension Subcutaneously or lntramuscularly: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.
  Intravenously: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg. Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes.
  Severe Hypotension and Shock – Including Drug-Related Hypotension Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine hydrochloride can be administered before and concurrently with blood volume replacement.
  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids, and phenothiazine tranquilizers. Patients
  who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, phenylephrine hydrochloride is a suitable agent for restoring blood pressure.
  Higher initial and maintenance doses of phenylephrine hydrochloride are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine, or pheochromocytomectomy may also require more intensive therapy.
  Continuous Infusion – Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP, or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 μg to 180 μg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual) a maintenance rate of 40 μg to 60 μg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL, the dose must be adjusted accordingly.
  If a prompt initial pressor response is not obtained, additional increments of phenylephrine hydrochloride (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.
  Spinal Anesthesia – Hypotension Routine parenteral use of phenylephrine hydrochloride has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine hydrochloride may be injected intravenously, using an initial
  dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose. To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.
  Prolongation of Spinal Anesthesia The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting, or blood pressure disturbances.
  Vasoconstrictor for Regional Analgesia Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.
  Paroxysmal Supraventricular Tachycardia Rapid intravenous injection (within 20 to 30 seconds) is recommended; the initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg, and should never exceed 1 mg.
  

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• Cardinal Health
  

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  Phenylephrine Hydrochloride | Cardinal Health

  

  ---

  Phenylephrine hydrochloride is generally injected subcutaneously, intramuscularly, slowly intravenously, or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, phenylephrine hydrochloride is administered directly intravenously. The dose should be adjusted according to the pressor response.

  Dosage Calculations

  
  Dose Required
  10 mg
  5 mg
  1 mg Use
  Phenylephrine HCl Injection 1%
  1 mL
  0.5 mL
  0.1 mL

  For convenience in intermittent intravenous administration, dilute 1 mL phenylephrine hydrochloride 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% phenylephrine hydrochloride.

  
  Dose Required
  0.1 mg
  0.2 mg
  0.5 mg Use Diluted
  Phenylephrine HCI Injection 0.1%
  0.1 mL
  0.2 mL
  0.5 mL

  Mild or Moderate Hypotension Subcutaneously or lntramuscularly: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

  Intravenously: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.

  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes.

  Severe Hypotension and Shock – Including Drug-Related Hypotension Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine hydrochloride can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids, and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, phenylephrine hydrochloride is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine hydrochloride are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine, or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion – Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP, or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 µg to 180 µg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual) a maintenance rate of 40 µg to 60 µg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL, the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine hydrochloride (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia – Hypotension Routine parenteral use of phenylephrine hydrochloride has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine hydrochloride may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting, or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia Rapid intravenous injection (within 20 to 30 seconds) is recommended;  the initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg, and should never exceed 1 mg.

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• Aaa Pharmaceutical, Inc.
  

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  Phenylephrine Hydrochloride | Aaa Pharmaceutical, Inc.

  

  ---

  adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours children under 12 years of age: ask a doctor

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  Phenylephrine Hydrochloride | Cardinal Health

  

  ---

  Phenylephrine Hydrochloride Injection is generally injected subcutaneously, intramuscularly, slowly intravenously or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, Phenylephrine Hydrochloride Injection is administered directly intravenously. The dose should be adjusted according to the pressor response.

  DOSAGE CALCULATIONS  Dose Required    Use Phenylephrine Hydrochloride Injection 1%  10 mg  1 mL  5 mg  0.5 mL  1 mg  0.1 mL

  
  

  For convenience in intermittent intravenous administration, dilute 1 mL Phenylephrine Hydrochloride Injection 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% Phenylephrine Hydrochloride Injection.

   Dose Required  Use Diluted Phenylephrine Hydrochloride Injection (0.1%)  0.1 mg  0.1 mL  0.2 mg  0.2 mL  0.5 mg  0.5 mL Mild or Moderate Hypotension

  SUBCUTANEOUSLY OR INTRAMUSCULARLY: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.
  INTRAVENOUSLY: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.
  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the blood pressure for about 15 minutes.

  Severe Hypotension and Shock - Including Drug-Related Hypotension

  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, Phenylephrine Hydrochloride Injection is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion:

  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 mcg to 180 mcg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 mcg to 60 mcg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia-Hypotension

  Routine parenteral use of phenylephrine has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.

  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia

  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia

  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia

  Rapid intravenous injection (within 20 to 30 seconds) is recommended. The initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg and should never  exceed 1 mg.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  Phenylephrine Hydrochloride | General Injectables & Vaccines, Inc

  

  ---

  2.1 General Administration Instructions

  Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion.

  Inspect the solution for particulate matter and discoloration prior to administration. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions.

  Discard any unused portion.

  During phenylephrine hydrochloride administration:

  Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine. 2.2 Preparing a 100 mcg/mL Solution for Bolus Intravenous Administration

  For bolus intravenous administration, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

  2.3 Preparing a Solution for Continuous Intravenous Infusion

  For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).

  2.4 Dosing for Perioperative Setting

  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. 2.5 Dosing for Septic or Other Vasodilatory Shock

  In adult patients with septic or other vasodilatory shock:

  No bolus. 0.5 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.

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  Phenylephrine Hydrochloride | Cardinal Health

  

  ---

  Phenylephrine Hydrochloride Injection is generally injected subcutaneously, intramuscularly, slowly intravenously or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, Phenylephrine Hydrochloride Injection is administered directly intravenously. The dose should be adjusted according to the pressor response.

  DOSAGE CALCULATIONS Dose Required Use Phenylephrin Hydrochloride Injection 1% 10 mg 1 mL 5 mg 0.5 mL 1 mg 0.1 mL

   

  For convenience in intermittent intravenous administration, dilute 1 mL Phenylephrine Hydrochloride Injection 1% with 9 mL Sterile Water for Injection, USP, to yield 0.1% Phenylephrine Hydrochloride Injection.

  Dose Required Use Diluted Phenylephrine Hydrochloride Injection (0.1%) 0.1 mg 0.1 mL 0.2 mg 0.2 mL 0.5 mg 0.5 mL Mild or Moderate Hypotension

  SUBCUTANEOUSLY OR INTRAMUSCULARLY: Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

  INTRAVENOUSLY: Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.

  Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the blood pressure for about 15 minutes.

  Severe Hypotension and Shock - Including Drug-Related Hypotension

  Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine can be administered before and concurrently with blood volume replacement.

  Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglionic blocking agents, rauwolfia and veratrum alkaloids and phenothiazines tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, Phenylephrine Hydrochloride Injection is a suitable agent for restoring blood pressure.

  Higher initial and maintenance doses of phenylephrine are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or pheochromocytomectomy may also require more intensive therapy.

  Continuous Infusion:

  Add 10 mg of the drug (1 mL of 1 percent solution) to 500 mL of Dextrose Injection, USP or Sodium Chloride Injection, USP (providing a 1:50,000 solution). To raise the blood pressure rapidly, start the infusion at about 100 mcg to 180 mcg per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 mcg to 60 mcg per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL the dose must be adjusted accordingly.

  If a prompt initial pressor response is not obtained, additional increments of phenylephrine (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.

  Spinal Anesthesia-Hypotension

  Routine parenteral use of phenylephrine has been recommended for the prophylaxis and treatment of hypotension during spinal anesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anesthetic. The total requirement for high anesthetic levels is usually 3 mg, and for lower levels, 2 mg. For hypotensive emergencies during spinal anesthesia, phenylephrine may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose.

  To combat hypotension during spinal anesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds body weight, administered subcutaneously or intramuscularly, is recommended.

  Prolongation of Spinal Anesthesia

  The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting or blood pressure disturbances.

  Vasoconstrictor for Regional Analgesia

  Concentrations about ten times those employed when epinephrine is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anesthetic solution). Some pressor responses can be expected when 2 mg or more are injected.

  Paroxysmal Supraventricular Tachycardia

  Rapid intravenous injection (within 20 to 30 seconds) is recommended. The initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg and should never  exceed 1 mg.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• West-ward Pharmaceutical Corp.
  

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  Phenylephrine Hydrochloride | West-ward Pharmaceutical Corp.

  

  ---

  2.1 General Administration Instructions

  Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion. 

  Inspect the solution for particulate matter and discoloration prior to administration.  The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

  During phenylephrine hydrochloride administration:

  Correct intravascular volume depletion. Correct acidosis.  Acidosis may reduce the effectiveness of phenylephrine. 2.2 Preparing a 100 mcg/mL Solution of Bolus Intravenous Administration

  For bolus intravenous administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of phenylephrine injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.  This will yield a final concentration of 100 mcg/mL.  Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

  2.3 Preparing a Solution for Continuous Intravenous Infusion

  For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).

  2.4 Dosing for Perioperative Setting

  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. 2.5 Dosing for Septic or Other Vasodilatory Shock

  In adult patients with septic or other vasodilatory shock:

  No bolus. 0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.

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