Epinephrine

Epinephrine Manufacturers

• Mckesson Packaging Services Business Unit Of Mckesson Corporation
  

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  Epinephrine | Mckesson Packaging Services Business Unit Of Mckesson Corporation

  

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  Epinephrine Injection, USP is administered by intravenous injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber or via endotracheal tube directly into the bronchial tree. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg (1 to 2.5 mL of 1:10,000 solution), injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  In cardiac arrest, 0.5 to 1.0 mg (5 to 10 mL of 1:10,000 solution) may be given. During a resuscitation effort, 0.5 mg (5 mL) should be administered intravenously every five minutes.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. The intracardiac dose usually ranges from 0.3 to 0.5 mg (3 to 5 mL of 1:10,000 solution).

  Alternatively, if the patient has been intubated, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dosage as for intravenous injection. It is rapidly absorbed through the lung capillary bed.

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

  To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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• Mckesson Packaging Services Business Unit Of Mckesson Corporation
  

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  Epinephrine | Mckesson Packaging Services Business Unit Of Mckesson Corporation

  

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  Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  Hypersensitivity Reactions

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  Cardiac Resuscitation

  A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

  External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Ophthalmologic Use

  Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to 1:1000 (1 mg/mL).

  Regional Anesthesia

  A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to 0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

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• Amphastar Pharmaceuticals, Inc.
  

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  Epinephrine | Amphastar Pharmaceuticals, Inc.

  

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  Subcutaneously or intramuscularly — 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required.

  For cardiac resuscitation - A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection, can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

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

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• General Injectables & Vaccines, Inc
  

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  Epinephrine | General Injectables & Vaccines, Inc

  

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  Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.
  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  Hypersensitivity Reactions
  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for
  hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.
  Cardiac Resuscitation
  A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.
  Ophthalmologic Use
  Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to
  1:1000 (1 mg/mL).
  Regional Anesthesia
  A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to
  0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)
  

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• Amphastar Pharmaceuticals, Inc.
  

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  Epinephrine | Amphastar Pharmaceuticals, Inc.

  

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  Please note that the optional STICK-GARD® Safety Needle, featured with stock number 2016 is interchangeable with a standard needle.

  EPINEPHRINE 1:10,000 As Cardiac Stimulant Intravenous or Intracardiac Injection

  Administer by I.V. injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

  Adult Dosage

  1–10 mL (0.1 – 1 mg of epinephrine), repeated every five minutes, if necessary.

  Pediatric Dosage

  0.05 – 0.1 mL/ kg of body weight (0.005 – 0.01 mg/ kg) e.g., 2 kg infant would receive 0.1 – 0.2 mL of epinephrine 1:10,000.

  NOTE: Do not inject if fibrillation is occurring.

  As Vasopressor (Anaphylaxis) Intravenous Injection Adult Dosage

  1–2.5 mL (0.1 – 0.25 mg of epinephrine), administered slowly. May be repeated every 5 to 15 minutes as needed.

  Pediatric Dosage

  3 mL (0.3 mg of epinephrine), repeated every 15 minutes for 3 or 4 doses, if necessary.

  EPINEPHRINE 1:1000 Anaphylactic shock - due to insect stings, etc. Intramuscular or Subcutaneous Injection Adult Dosage

  0.2 mL – 0.5 mL (0.2 mg – 0.5 mg), repeated every 10 to 15 minutes as needed. As much as 1 mL (1 mg) per dose may be administered if necessary.

  Subcutaneous Injection Pediatric Dosage

  0.01 mL/ kg of body weight (0.01 mg/ kg of body weight) or 0.3 mg per square meter of body surface, up to a maximum of 0.5 mg per dose, repeated every 15 minutes for 2 doses, then every 4 hours as needed.

  Cardiopulmonary Resuscitation Adult Dosage

  The effect of the I.V. administration of epinephrine 1:10,000 may last only a few minutes, so the I.V. epinephrine may be followed with 0.3 mL of 1:1000 (0.3 mg) subcutaneously.

  NOTE: 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, Inc
  

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  Epinephrine | General Injectables & Vaccines, Inc

  

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  Epinephrine Injection, USP is administered by intravenous injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber or via endotracheal tube directly into the bronchial tree. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg (1 to 2.5 mL of 1:10,000 solution), injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks. In cardiac arrest, 0.5 to 1.0 mg (5 to 10 mL of 1:10,000 solution) may be given. During a resuscitation effort, 0.5 mg (5 mL) should be administered intravenously every five minutes. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. The intracardiac dose usually ranges from 0.3 to 0.5 mg (3 to 5 mL of 1:10,000 solution). Alternatively, if the patient has been intubated, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dosage as for intravenous injection. It is rapidly absorbed through the lung capillary bed. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.) To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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• Physicians Total Care, Inc.
  

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  Epinephrine | Physicians Total Care, Inc.

  

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  The physician who prescribes epinephrine auto-injector should review this Prescribing Information insert in detail with the patient. This review should include the proper use of epinephrine auto-injector to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet and Wrap Label should also be reviewed with the patient.

  Epinephrine auto-injector is capable of delivering one dose of either 0.15 mg or 0.3 mg (0.15 mL or 0.3 mL of epinephrine). This dose is available for auto-injection by the patient.

  Selection of the appropriate epinephrine auto-injector dosage strength is determined according to patient body weight.

     Epinephrine auto-injector 0.15 mg  For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds)    Epinephrine auto-injector 0.3 mg  For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater

  The usual dose of epinephrine for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of epinephrine).

  Since the doses of epinephrine delivered from epinephrine auto-injector are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from epinephrine auto-injector are felt to be necessary. The prescribing physician should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is being prescribed.

  Patients should be instructed to periodically visually inspect the epinephrine solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.

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• Physicians Total Care, Inc.
  

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  Epinephrine | Physicians Total Care, Inc.

  

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  Epinephrine Injection, USP is administered by intravenous injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber or via endotracheal tube directly into the bronchial tree. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg (1 to 2.5 mL of 1:10,000 solution), injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  In cardiac arrest, 0.5 to 1.0 mg (5 to 10 mL of 1:10,000 solution) may be given. During a resuscitation effort, 0.5 mg (5 mL) should be administered intravenously every five minutes.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. The intracardiac dose usually ranges from 0.3 to 0.5 mg (3 to 5 mL of 1:10,000 solution).

  Alternatively, if the patient has been intubated, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dosage as for intravenous injection. It is rapidly absorbed through the lung capillary bed.

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

  To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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• Rebel Distributors Corp
  

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  Epinephrine | Rebel Distributors Corp

  

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  The physician who prescribes epinephrine auto-injector should review this Prescribing Information insert in detail with the patient. This review should include the proper use of epinephrine auto-injector to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet and Wrap Label should also be reviewed with the patient.

  Epinephrine auto-injector is capable of delivering one dose of either 0.15 mg or 0.3 mg (0.15 mL or 0.3 mL of epinephrine). This dose is available for auto-injection by the patient.

  Selection of the appropriate epinephrine auto-injector dosage strength is determined according to patient body weight.

     Epinephrine auto-injector 0.15 mg  For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds)    Epinephrine auto-injector 0.3 mg  For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater

  The usual dose of epinephrine for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of epinephrine).

  Since the doses of epinephrine delivered from epinephrine auto-injector are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from epinephrine auto-injector are felt to be necessary. The prescribing physician should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is being prescribed.

  Patients should be instructed to periodically visually inspect the epinephrine solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.

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• Apotheca Company
  

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  Epinephrine | Apotheca Company

  

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  DIRECTIONS:  1-10 drops under the tongue, 3 times a day or as directed by a health professional.  Consult a physician for use in children under 12 years of age.

  
  

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• American Regent, Inc.
  

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  Epinephrine | American Regent, Inc.

  

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  Subcutaneously or intramuscularly − 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required.

  For cardiac resuscitation − A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

  Protect from light.

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

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• American Regent, Inc.
  

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  Epinephrine | American Regent, Inc.

  

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  Intramuscularly or subcutaneously — 0.2 to 1 mL. Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mL/kg or 0.3 mL/m2 to a maximum of 0.5 mL subcutaneously, repeated every four hours if required.

  For cardiac resuscitation —

  A dose of 0.5 mL diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Intraspinal use —

  Usual dose is 0.2 to 0.4 mL added to anesthetic spinal fluid mixture (may prolong anesthetic action by limiting absorption). For use with local anesthetic – Epinephrine 1:100,000 to 1:20,000 is the usual concentration employed with local anesthetics.

  Ophthalmologic use

  (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) — Use concentration of 1:10,000 to 1:1,000.

  Store below 23°C (73°F). Do not freeze.
  Protect from light (see PRECAUTIONS).

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

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• Mwi (Vetone)
  

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  Epinephrine | Mwi (vetone)

  

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  Cattle, Horses, Sheep and Swine—Inject subcutaneously or intramuscularly 1 mL per 100 lbs. of body weight. Intravenous injection is not recommended, but if it is found to be clinically necessary, ¼ to ½ of the intramuscular dose should be used.
  

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• General Injectables And Vaccines, Inc.
  

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  Epinephrine | General Injectables And Vaccines, Inc.

  

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  Subcutaneously or intramuscularly — 0.2 to 1 mL. Start with a small dose and increase if required.
  Note: The subcutaneous is the preferred route of administration. If given intramuscularly,
  injection into the buttocks should be avoided.
  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated
  every four hours if required.
  For cardiac resuscitation — A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.
  
  Store at 20°-25°C (68°-77°F). excursions permitted to 15°-30°C (59° - 86°F) (See USP Controlled Room Temperature).
  Protect from light
  Parenteral drug products should be inspected visually for particulate matter and discoloration,
  whenever solution and container permit.

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• Hospira, Inc.
  

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  Epinephrine | Hospira, Inc.

  

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  Epinephrine Injection, USP is administered by intravenous injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber or via endotracheal tube directly into the bronchial tree. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg (1 to 2.5 mL of 1:10,000 solution), injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  In cardiac arrest, 0.5 to 1.0 mg (5 to 10 mL of 1:10,000 solution) may be given. During a resuscitation effort, 0.5 mg (5 mL) should be administered intravenously every five minutes.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route. The intracardiac dose usually ranges from 0.3 to 0.5 mg (3 to 5 mL of 1:10,000 solution).

  Alternatively, if the patient has been intubated, epinephrine can be injected via the endotracheal tube directly into the bronchial tree at the same dosage as for intravenous injection. It is rapidly absorbed through the lung capillary bed.

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

  To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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• Deseret Biologicals, Inc.
  

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  Epinephrine | Cardinal Health

  

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  2.1 Asthma

  Montelukast sodium should be taken once daily in the evening. The following doses are recommended:

  For adults and adolescents 15 years of age and older: one 10 mg tablet.

  For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.

  For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.

  Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

  There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning vs. evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

  2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older

  For prevention of EIB, a single dose of montelukast should be taken at least 2 hours before exercise. The following doses are recommended:

  For adults and adolescents 15 years of age and older: one 10 mg tablet.

  An additional dose of montelukast should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

  Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  2.3 Allergic Rhinitis

  For allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

  The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

  For adults and adolescents 15 years of age and older: one 10 mg tablet.

  For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.

  For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.

  Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

  The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

  For adults and adolescents 15 years of age and older: one 10 mg tablet.

  For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.

  For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.

  Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

  2.4 Asthma and Allergic Rhinitis

  Patients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.

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• International Medication Systems, Limited
  

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  Epinephrine | Golden State Medical Supply, Inc.

  

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  The optimal daily dose of calcitriol must be carefully determined for each patient. Calcitriol can be administered orally as a capsule (0.25 mcg or 0.50 mcg). Calcitriol Capsule therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium.

  The effectiveness of calcitriol therapy is predicated on the assumption that each patient is receiving an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake of calcium at a minimum of 600 mg daily. The U.S. RDA for calcium in adults is 800 mg to 1200 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

  Because of improved calcium absorption from the gastrointestinal tract, some patients on calcitriol may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all.

  During the titration period of treatment with calcitriol, serum calcium levels should be checked at least twice weekly. When the optimal dosage of calcitriol has been determined, serum calcium levels should be checked every month (or as given below for individual indications). Samples for serum calcium estimation should be taken without a tourniquet.

  Dialysis Patients

  The recommended initial dose of calcitriol is 0.25 mcg/day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, dosage may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this titration period, serum calcium levels should be obtained at least twice weekly, and if hypercalcemia is noted, the drug should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Phosphorus, magnesium, and alkaline phosphatase should be determined periodically.

  Patients with normal or only slightly reduced serum calcium levels may respond to Calcitriol doses of 0.25 mcg every other day. Most patients undergoing hemodialysis respond to doses between 0.5 and 1 mcg/day.

  Oral calcitriol may normalize plasma ionized calcium in some uremic patients, yet fail to suppress parathyroid hyperfunction. In these individuals with autonomous parathyroid hyperfunction, oral calcitriol may be useful to maintain normocalcemia, but has not been shown to be adequate treatment for hyperparathyroidism.

  Hypoparathyroidism

  The recommended initial dosage of calcitriol is 0.25 mcg/day given in the morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease is not observed, the dose may be increased at 2- to 4-week intervals. During the dosage titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia is noted, calcitriol should be immediately discontinued until normocalcemia ensues (see PRECAUTIONS: General). Careful consideration should also be given to lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium should be determined periodically.

  Most adult patients and pediatric patients age 6 years and older have responded to dosages in the range of 0.5 mcg to 2 mcg daily. Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given 0.25 mcg to 0.75 mcg daily. The number of treated patients with pseudohypoparathyroidism less than 6 years of age is too small to make dosage recommendations.

  Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of calcitriol may be needed.

  Predialysis Patients

  The recommended initial dosage of calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age and older. This dosage may be increased if necessary to 0.5 mcg/day.

  For pediatric patients less than 3 years of age, the recommended initial dosage of calcitriol is 10 to 15 ng/kg/day.

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• International Medication Systems, Limited
  

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  Epinephrine | International Medication Systems, Limited

  

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  Subcutaneously or intramuscularly - 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.
  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required.

  For cardiac resuscitation - A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection, can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.
  Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• Cardinal Health
  

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  Epinephrine | Qualitest Pharmaceuticals

  

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  Oral: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets.

  Extended and repeated use of this product is not recommended because of the potential for physical dependence.

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• Sparhawk Laboratories, Inc.
  

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  Epinephrine | Amneal Pharmaceuticals Of New York, Llc

  

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  2.1 Asthma

  Montelukast sodium, USP should be taken once daily in the evening. The following doses are recommended:

           For adults and adolescents 15 years of age and older: 10 mg tablet.

  There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

  2.2 Exercise-Induced Bronchoconstriction (EIB)

  For prevention of EIB, a single dose of montelukast should be taken at least 2 hours before exercise. The following doses are recommended:

        For adults and adolescents 15 years of age and older: 10 mg tablet.

  An additional dose of montelukast should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium, USP daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Daily administration of montelukast sodium, USP for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

  2.3 Allergic Rhinitis

  For allergic rhinitis, montelukast sodium, USP should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

  The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

  For adults and adolescents 15 years of age and older: 10 mg tablet.

  The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

  For adults and adolescents 15 years of age and older: 10 mg tablet.

  2.4 Asthma and Allergic Rhinitis

  Patients with both asthma and allergic rhinitis should take only one montelukast sodium, USP dose daily in the evening.

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• Valesco Pharmaceuticals Llc.
  

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  Epinephrine | Valesco Pharmaceuticals Llc.

  

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  Subcutaneously or intramuscularly − 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required.

  For cardiac resuscitation − A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

  ​Protect from light.

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

  ​

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• Hospira, Inc.
  

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  Epinephrine | Hospira, Inc.

  

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  Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  Hypersensitivity Reactions

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  Cardiac Resuscitation

  A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

  External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Ophthalmologic Use

  Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to 1:1000 (1 mg/mL).

  Regional Anesthesia

  A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to 0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

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• Hospira, Inc.
  

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  Epinephrine | Hospira, Inc.

  

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  Subcutaneously or intramuscularly — 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  Hypersensitivity Reactions
  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  Cardiac Resuscitation
  A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

  External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Ophthalmologic Use
  Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) — use a concentration of 1:10,000 (0.1 mg/mL) to 1:1000 (1 mg/mL).

  Regional Anesthesia
  A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to 0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

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• Cardinal Health
  

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  Epinephrine | Cardinal Health

  

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  Subcutaneously or intramuscularly - 0.2 to 1 mL (mg). Start with small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

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• Lineage Therapeutics Inc.
  

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  Epinephrine | Lineage Therapeutics Inc.

  

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  Selection of the appropriate epinephrine injection, USP auto-injector dosage strength is determined according to patient body weight.

  Patients greater than or equal to 30 kg (approximately 66 pounds or more): epinephrine injection, USP auto-injector 0.3 mg Patients 15 to 30 kg (33 pounds to 66 pounds): epinephrine injection, USP auto-injector 0.15 mg

  Inject epinephrine injection, USP auto-injector intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.

  Each epinephrine injection, USP auto-injector contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from epinephrine injection, USP auto-injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

  The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.

  With severe persistent anaphylaxis, repeat injections with an additional epinephrine injection, USP auto-injector may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].

  The epinephrine solution in the viewing window of epinephrine injection, USP auto-injector should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see How Supplied/Storage and Handling (16.2)].

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• Belcher Pharmaceuticals, Llc
  

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  Epinephrine | Belcher Pharmaceuticals, Llc

  

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

  Dilute epinephrine in 5 percent dextrose solution or 5 percent dextrose and sodium chloride solution. These dextrose containing fluids provide protection against significant loss of potency by oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

  Add 1 mL (1 mg) of epinephrine from its ampule to 1,000 mL of a 5 percent dextrose containing solution. Each mL of this dilution contains 1 mcg of epinephrine.

  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, epinephrine can be administered before and concurrently with blood volume replacement.

  Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger's disease) are more likely to occur in the lower than in the upper extremity; therefore, avoid the veins of the leg in elderly patients or in those suffering from such disorders. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.

  To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 mcg/kg/min to 2 mcg/kg/min, and is titrated to achieve a desired mean arterial pressure (MAP). The dosage may be adjusted periodically, such as every 10 - 15 minutes, in increments of 0.05 mcg/kg/min to 0.2 mcg/kg/min, to achieve the desired blood pressure goal.

  Continuous epinephrine infusion is generally required over several hours or days until the patient's hemodynamic status improves. The duration of perfusion or total cumulative dose cannot be predicted.

  After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 30 minutes over a 12- to 24-hour period.

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• Bpi Labs, Llc
  

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  Epinephrine | Bpi Labs, Llc

  

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

  Dilute epinephrine in 5 percent dextrose solution or 5 percent dextrose and sodium chloride solution. These dextrose containing fluids provide protection against significant loss of potency by oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

  Add 1 mL (1 mg) of epinephrine from its ampule to 1,000 mL of a 5 percent dextrose containing solution. Each mL of this dilution contains 1 mcg of epinephrine.

  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, epinephrine can be administered before and concurrently with blood volume replacement.

  Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger's disease) are more likely to occur in the lower than in the upper extremity; therefore, avoid the veins of the leg in elderly patients or in those suffering from such disorders. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein.

  To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 mcg/kg/min to 2 mcg/kg/min, and is titrated to achieve a desired mean arterial pressure (MAP). The dosage may be adjusted periodically, such as every 10 - 15 minutes, in increments of 0.05 mcg/kg/min to 0.2 mcg/kg/min, to achieve the desired blood pressure goal.

  Continuous epinephrine infusion is generally required over several hours or days until the patient's hemodynamic status improves. The duration of perfusion or total cumulative dose cannot be predicted.

  After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 30 minutes over a 12- to 24-hour period.

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• Remedyrepack Inc.
  

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  Epinephrine | Remedyrepack Inc.

  

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  Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.

  Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

  Hypersensitivity Reactions

  For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. The adult intravenous dose for hypersensitivity reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg injected slowly. Neonates may be given a dose of 0.01 mg per kg of body weight; for the infant 0.05 mg is an adequate initial dose and this may be repeated at 20 to 30 minute intervals in the management of asthma attacks.

  Cardiac Resuscitation

  A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection can be administered intravenously or intracardially to restore myocardial contractility.

  Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

  External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

  Ophthalmologic Use

  Ophthalmologic use (for producing conjunctival decongestion, to control hemorrhage, produce mydriasis and reduce intraocular pressure) – use a concentration of 1:10,000 (0.1 mg/mL) to 1:1000 (1 mg/mL).

  Regional Anesthesia

  A final concentration of 1:200,000 of epinephrine injection is recommended for infiltration injection, nerve block, caudal or other epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to 0.4 mL of 1:1000 solution) may be mixed with spinal anesthetic agents.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See PRECAUTIONS.)

   

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