Therapeutic drug levels: MedlinePlus Medical Encyclopedia
`
`Page 1 of 5
`
`National Institutes of Health / U.S. National Library of Medicine
`
`Home → Medical Encyclopedia → Therapeutic drug levels
`
`URL of this page: //medlineplus.gov/ency/article/003430.htm
`Therapeutic drug levels
`
`Therapeutic drug levels are lab tests to look for the presence and the amount of a drug in the blood.
`
`How the Test is Performed
`
`A blood sample is needed. Most of the time blood is drawn from a vein located on the inside of the
`elbow or the back of the hand.
`
`How to Prepare for the Test
`
`You will need to prepare for some drug level tests.
`
`• Your health care provider will tell you if you need to change the times you take any of your
`medicines.
`
`• DO NOT stop or change your medicines without talking to your provider first.
`
`How the Test will Feel
`
`You may feel slight pain or a sting when the needle is inserted. You may also feel some throbbing at the
`site after the blood is drawn.
`
`Why the Test is Performed
`
`With most medicines, you need a certain level of the drug in your blood to get the proper effect. Some
`medicines are harmful if the level rises too high and do not work if the levels are too low.
`
`Monitoring the amount of the drug found in your blood allows your provider to make sure the drug levels
`are in the proper range.
`
`Drug level testing is important in people taking drugs such as:
`
`• Flecainide, procainamide or digoxin, which are used to treat abnormal beating of the heart
`
`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0001
`
`Corcept Therapeutics, Inc.
`Exhibit 2004
`Neptune Generics, LLC v. Corcept Therapeutics, Inc.
`Case IPR2018-01494
`
`
`
`Page 1 of 5
`
`National Institutes of Health / U.S. National Library of Medicine
`
`Home → Medical Encyclopedia → Therapeutic drug levels
`
`URL of this page: //medlineplus.gov/ency/article/003430.htm
`Therapeutic drug levels
`
`Therapeutic drug levels are lab tests to look for the presence and the amount of a drug in the blood.
`
`How the Test is Performed
`
`A blood sample is needed. Most of the time blood is drawn from a vein located on the inside of the
`elbow or the back of the hand.
`
`How to Prepare for the Test
`
`You will need to prepare for some drug level tests.
`
`• Your health care provider will tell you if you need to change the times you take any of your
`medicines.
`
`• DO NOT stop or change your medicines without talking to your provider first.
`
`How the Test will Feel
`
`You may feel slight pain or a sting when the needle is inserted. You may also feel some throbbing at the
`site after the blood is drawn.
`
`Why the Test is Performed
`
`With most medicines, you need a certain level of the drug in your blood to get the proper effect. Some
`medicines are harmful if the level rises too high and do not work if the levels are too low.
`
`Monitoring the amount of the drug found in your blood allows your provider to make sure the drug levels
`are in the proper range.
`
`Drug level testing is important in people taking drugs such as:
`
`• Flecainide, procainamide or digoxin, which are used to treat abnormal beating of the heart
`
`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0001
`
`Corcept Therapeutics, Inc.
`Exhibit 2004
`Neptune Generics, LLC v. Corcept Therapeutics, Inc.
`Case IPR2018-01494
`
`
`
`Therapeutic drug levels: MedlinePlus Medical Encyclopedia
`
`Page 2 of 5
`
`• Phenytoin or valproic acid, which are used to treat seizures
`
`• Gentamicin or amikacin, which are antibiotics used to treat infections
`
`Testing may also be done to determine how well your body breaks down the drug or how it interacts
`with other drugs you need.
`
`Normal Results
`
`Following are some of the drugs that are commonly checked and the normal target levels:
`
`• Acetaminophen: varies with use
`
`• Amikacin: 15 to 25 mcg/mL (25.62 to 42.70 micromol/L)
`
`• Aminophylline: 10 to 20 mcg/mL (55.50 to 111.00 micromol/L)
`
`• Amitriptyline: 120 to 150 ng/mL (432.60 to 540.75 nmol/L)
`
`• Carbamazepine: 5 to 12 mcg/mL (21.16 to 50.80 micromol/L)
`
`• Cyclosporine: 100 to 400 ng/mL (83.20 to 332.80 nmol/L) (12 hours after dose)
`
`• Desipramine: 150 to 300 ng/mL (563.10 to 1126.20 nmol/L)
`
`• Digoxin: 0.8 to 2.0 ng/mL (1.02 to 2.56 nanomol/L)
`
`• Disopyramide: 2 to 5 mcg/mL (5.89 to 14.73 micromol/L)
`
`• Ethosuximide: 40 to 100 mcg/mL (283.36 to 708.40 micromol/L)
`
`• Flecainide: 0.2 to 1.0 mcg/mL (0.5 to 2.4 micromol/L)
`
`• Gentamicin: 5 to 10 mcg/mL (10.45 to 20.90 micromol/L)
`
`• Imipramine: 150 to 300 ng/mL (534.90 to 1069.80 nmol/L)
`
`• Kanamycin: 20 to 25 mcg/mL (41.60 to 52.00 micromol/L)
`
`• Lidocaine: 1.5 to 5.0 mcg/mL (6.40 to 21.34 micromol/L)
`
`• Lithium: 0.8 to 1.2 mEq/L (0.8 to 1.2 mmol/L)
`
`• Methotrexate: varies with use
`
`• Nortriptyline: 50 to 150 ng/mL (189.85 to 569.55 nmol/L)
`
`• Phenobarbital: 10 to 30 mcg/mL (43.10 to 129.30 micromol/L)
`
`• Phenytoin: 10 to 20 mcg/mL (39.68 to 79.36 micromol/L)
`
`• Primidone: 5 to 12 mcg/mL (22.91 to 54.98 micromol/L)
`
`• Procainamide: 4 to 10 mcg/mL (17.00 to 42.50 micomol/L)
`
`• Quinidine: 2 to 5 mcg/mL (6.16 to 15.41 micromol/L)
`
`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0002
`
`
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`Therapeutic drug levels: MedlinePlus Medical Encyclopedia
`
`Page 3 of 5
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`• Salicylate: varies with use
`
`• Sirolimus: 4 to 20 ng/mL (4 to 22 nmol/L) (12 hours after dose; varies with use)
`
`• Tacrolimus: 5 to 15 ng/mL (4 to 25 nmol/L) (12 hours after dose)
`
`• Theophylline: 10 to 20 mcg/mL (55.50 to 111.00 micromol/L)
`
`• Tobramycin: 5 to 10 mcg/mL (10.69 to 21.39 micromol/L)
`
`• Valproic acid: 50 to 100 mcg/mL (346.70 to 693.40 micromol/L)
`
`Normal value ranges may vary slightly among different laboratories. Talk to your provider about the
`meaning of your specific test results.
`
`The examples above show the common measurements for results for these tests. Some laboratories
`use different measurements or may test different specimens.
`
`What Abnormal Results Mean
`
`Values outside the target range may be due to minor changes or be a sign that you need to adjust your
`dosages. Your provider may tell you to skip a dose if the values measured are too high.
`
`Following are toxic levels for some of the drugs that are commonly checked:
`
`• Acetaminophen: greater than 250 mcg/mL (1653.50 micromol/L)
`
`• Amikacin: greater than 25 mcg/mL (42.70 micromol/L)
`
`• Aminophylline: greater than 20 mcg/mL (111.00 micromol/L)
`
`• Amitriptyline: greater than 500 ng/mL (1802.50 nmol/L)
`
`• Carbamazepine: greater than 12 mcg/mL (50.80 micromol/L)
`
`• Cyclosporine: greater than 400 ng/mL (332.80 micromol/L)
`
`• Desipramine: greater than 500 ng/mL (1877.00 nmol/L)
`
`• Digoxin: greater than 2.4 ng/mL (3.07 nmol/L)
`
`• Disopyramide: greater than 5 mcg/mL (14.73 micromol/L)
`
`• Ethosuximide: greater than 100 mcg/mL (708.40 micromol/L)
`
`• Flecainide: greater than 1.0 mcg/mL (2.4 micromol/L)
`
`• Gentamicin: greater than 12 mcg/mL (25.08 micromol/L)
`
`• Imipramine: greater than 500 ng/mL (1783.00 nmol/L)
`
`• Kanamycin: greater than 35 mcg/mL (72.80 micromol/L)
`
`• Lidocaine: greater than 5 mcg/mL (21.34 micromol/L)
`
`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0003
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`Therapeutic drug levels: MedlinePlus Medical Encyclopedia
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`Page 4 of 5
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`• Lithium: greater than 2.0 mEq/L (2.00 millimol/L)
`
`• Methotrexate: greater than 10 mcmol/L (10,000 nmol/L) over 24-hours
`
`• Nortriptyline: greater than 500 ng/mL (1898.50 nmol/L)
`
`• Phenobarbital: greater than 40 mcg/mL (172.40 micromol/L)
`
`• Phenytoin: greater than 30 mcg/mL (119.04 micromol/L)
`
`• Primidone: greater than 15 mcg/mL (68.73 micromol/L)
`
`• Procainamide: greater than 16 mcg/mL (68.00 micromol/L)
`
`• Quinidine: greater than 10 mcg/mL (30.82 micromol/L)
`
`• Salicylate: greater than 300 mcg/mL (2172.00 micromol/L)
`
`• Theophylline: greater than 20 mcg/mL (111.00 micromol/L)
`
`• Tobramycin: greater than 12 mcg/mL (25.67 micromol/L)
`
`• Valproic acid: greater than 100 mcg/mL (693.40 micromol/L)
`
`Alternative Names
`
`Therapeutic drug monitoring
`
`References
`
`Diasio RB. Principles of drug therapy. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th
`ed. Philadelphia, PA: Elsevier Saunders; 2016:chap 29.
`
`Nelson LS, Ford MD. Acute poisoning. In: Goldman L, Schafer AI, eds. Goldman-Cecil Medicine. 25th
`ed. Philadelphia, PA: Elsevier Saunders; 2016:chap 110.
`
`Pincus MR, Bluth MH, Abraham NZ. Toxicology and therapeutic drug monitoring. In: McPherson RA,
`Pincus MR, eds. Henry's Clinical Diagnosis and Management by Laboratory Methods. 23rd ed. St
`Louis, MO: Elsevier Saunders; 2017:chap 23.
`
`Review Date 5/21/2017
`
`Updated by: Laura J. Martin, MD, MPH, ABIM Board Certified in Internal Medicine and Hospice and
`Palliative Medicine, Atlanta, GA. Also reviewed by David Zieve, MD, MHA, Medical Director, Brenda
`Conaway, Editorial Director, and the A.D.A.M. Editorial team.
`
`How helpful is this web page to you?
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`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0004
`
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`Therapeutic drug levels: MedlinePlus Medical Encyclopedia
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`Page last updated: 13 November 2018
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`https://medlineplus.gov/ency/article/003430.htm
`
`11/19/2018
`
`Ex. 2004-0005
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