arginine (Rx)

Brand and Other Names:L-arginine, RGene-10

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravenous solution

  • 30g/300mL

Pituitary Stimulation

Used as a diagnostic pituitary stimulant to measure human growth hormone (hGH) reserve for conditions such as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism, and problems of growth and stature

300 mL (30 g) IV infused over 30 minutes

Test procedure

  • Schedule AM
  • Fast overnight and continue through test period
  • Place patient on bed rest for at least 30 minutes before infusion begins
  • Take sample draws at -30, 0, 30, 60, 90, 120 and 150 minutes
  • To confirm negative response to insulin hypoglycemia test allow 1 day waiting period after insulin test patients may not respond during first test, second test may be performed after 1 day waiting period

Hemoglobinopathies & Thalassemia (Orphan)

Indicated for treatment of beta-hemoglobinopathies and beta-thalassemia

Orphan indication sponsor

  • Perrine, Susan P, MD; Boston University, Cancer Research Center; Boston, MA 02118

Dosage Forms & Strengths

intranvenous solution

  • 30g/300mL

Pituitary Stimulation

Used as a diagnostic pituitary stimulant to measure human growth hormone (hGH) reserve for conditions such as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism, and problems of growth and stature

0.5 g/kg IV infused over 30 minutes; not to exceed 30 g/dose

Test procedure

  • Schedule AM
  • Fast overnight and continue through test period
  • Place patient on bed rest for at least 30 minutes before infusion begins
  • Take sample draws at -30, 0, 30, 60, 90, 120 and 150 minutes
  • To confirm negative response to insulin hypoglycemia test allow 1 day waiting period after insulin test patients may not respond during first test, second test may be performed after 1 day waiting period
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Interactions

Interaction Checker

and arginine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (12)

                • amyl nitrite

                  amyl nitrite, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • dichlorphenamide

                  dichlorphenamide, arginine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

                • glyceryl trinitrate pr

                  glyceryl trinitrate pr, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • isosorbide dinitrate

                  isosorbide dinitrate, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • isosorbide mononitrate

                  isosorbide mononitrate, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nicorandil

                  nicorandil, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin IV

                  nitroglycerin IV, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin PO

                  nitroglycerin PO, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin sublingual

                  nitroglycerin sublingual, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin topical

                  nitroglycerin topical, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin transdermal

                  nitroglycerin transdermal, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                • nitroglycerin translingual

                  nitroglycerin translingual, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

                Minor (0)

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                  Adverse Effects

                  1-10%

                  Headache (3%)

                  Flushing (3%)

                  Nausea (3%)

                  Vomiting (3%)

                  Numbness (3%)

                  Local venous irritation (3%)

                  <1%

                  Macular rash

                  Swelling of hands and feet

                  Hematuria

                  Hyperkalemia

                  Skin burn/necrosis

                  Loss of consciousness

                  Perioral tingling

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                  Warnings

                  Contraindications

                  Hypersensitivity to product or components

                  Cautions

                  Hypersensitivity reactions, including anaphylaxis, reported; appropriate medical support should be available during therapy; discontinue therapy if anaphylaxis or other serious hypersensitivity reaction occurs and initiate appropriate medical treatment

                  Confirm with 2nd test if diagnosis results show hGH deficiency; allow 1 day waiting period between tests

                  Always administer by intravenous infusion because of its hypertonicity

                  Use extreme caution when infusing drug into pediatric patients; overdosage in pediatric patients may result in hyperchloremic metabolic acidosis, cerebral edema, or possibly death; avoid overdosage in pediatric patients (risk of causing metabolic acidosis, cerebral edema, or death)

                  Electrolyte imbalances including hypophosphatemia, hyponatremia (following overdose) and acidosis, and hyperkalemia reported with arginine infusions; risk may increase in renal impairment, diabetes mellitus, and hepatic impairment

                  Not intended for therapeutic use

                  Use caution in diabetes mellitus (may lead to life-threatening hyperkalemia)

                  Tissue damage may occur with extravasation; formulation is a hypertonic (950 mOsmol/liter) and acidic (average pH of 5.6) solution that can cause irritation and damage to tissues; care should be used to ensure administration through a patent catheter within a patent vein; excessive rates of infusion may result in local irritation and in flushing, nausea, or vomiting. Inadequate dosing or prolongation of infusion period may diminish stimulus to pituitary and nullify the test

                  Avoid use in myocardial infarction

                  Arginine can be metabolized resulting in nitrogen-containing products for excretion; the effect of an acute amino acid or nitrogen burden upon patients with impairment of renal function should be considered when product is to be administered

                  Chloride content of this formulation is 47.5 mEq per 100 mL of solution, and effect of infusing this amount of chloride into patients with electrolyte imbalance should be evaluated before the test is undertaken

                  The basal and post-stimulation levels of growth hormone are elevated in patients who are pregnant or are taking oral contraceptives

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                  Pregnancy & Lactation

                  Pregnancy

                  There have been no adequate or well-controlled studies for use of this product in pregnant women; reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to fetus due to drug (10% arginine hydrochloride Injection, USP); because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy

                  Lactation

                  It is not known whether intravenous administration of this product could result in significant quantities of arginine in breast milk; systemically administered amino acids are secreted into breast milk in quantities not likely to have a deleterious effect on infant; nevertheless, caution should be exercised when therapy is to be administered to nursing women

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Induces rise of human growth hormone (HGH); patients with impaired pituitary function have lower or no increase in plasma concentration of growth hormone following arginine administration; used as test for pituitary function

                  Pharmacokinetics

                  Peak serum time: ~20-30 min (IV)

                  Half-life: 0.7-1.3 hr

                  Vd: ~33 L/kg following 30 g IV dose

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                  Administration

                  IV Preparation

                  A special air-inletting, air-filtering set w/ bacterial air filter is required

                  No airway needle is needed

                  Remove metal seal and metal disc from bottle to expose rugger stopper

                  Do not contaminate target site of stopper

                  With shut-off clamp closed, remove sterility protector from spike of administration set and immediately insert set with quick trust into center of stopper with bottle upright on table (ie, push straight in, DO NOT twist)

                  Invert bottle to establish fluid level in drip chamber and to check for vacuum by observing rising air bubbles

                  Discard bottle if no vacuum or solution not clear

                  Clear tubing of air and proceed with infusion

                  Patients ≤59 kg: Withdraw weight based dose from a sealed bottle and place in a separate container for IV infusion to avoid inadvertent administration of the total volume from the commercially available container

                  IV Administration

                  Infuse through indwelling needle or soft catheter; take blood samples from contralateral arm

                  Infuse over 30 min

                  Storage

                  Avoid excessive heat, store at 25 C

                  Do not use solution previously frozen

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  arginine (L-arginine) oral
                  -
                  500 mg tablet

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  arginine (L-arginine) oral

                  NO MONOGRAPH AVAILABLE AT THIS TIME

                  USES: Consult your pharmacist.

                  HOW TO USE: Consult your pharmacist.

                  SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Consult your pharmacist.

                  DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: No monograph available at this time.

                  MISSED DOSE: Consult your pharmacist.

                  STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                  Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.