Katerzia

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

• •Hypertension (
  1.1 Hypertension

  KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine.

  Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

  Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

  Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

  Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

  KATERZIA may be used alone or in combination with other antihypertensive agents.
  )
  • oKATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• •Coronary Artery Disease (
  1.2 Coronary Artery Disease (CAD)

  Chronic Stable Angina
  
  

  KATERZIA is indicated for the symptomatic treatment of chronic stable angina. KATERZIA may be used alone or in combination with other antianginal agents.

  Vasospastic Angina (Prinzmetal’s or Variant Angina)
  
  

  KATERZIA is indicated for the treatment of confirmed or suspected vasospastic angina. KATERZIA may be used as monotherapy or in combination with other antianginal agents.

  Angiographically Documented CAD
  
  

  In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, KATERZIA is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
  )
  • oChronic Stable Angina
  • oVasospastic Angina (Prinzmetal’s or Variant Angina)
  • oAngiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.

• •Adult recommended starting dose: 5 mg orally once daily with maximum dose 10 mg once daily. (
  2.1 Adults

  The usual initial antihypertensive oral dose of KATERZIA is 5 mg orally once daily, and the maximum dose is 10 mg once daily.

  Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding KATERZIA to other antihypertensive therapy

  [see Use in Specific Populations ]

  .

  Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

  Angina

  : The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg once daily for adequate effect.

  Coronary artery disease

  : The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg once daily

  [see Clinical Studies ]

  .
  )
  • oSmall, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (
    2.1 Adults

    The usual initial antihypertensive oral dose of KATERZIA is 5 mg orally once daily, and the maximum dose is 10 mg once daily.

    Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding KATERZIA to other antihypertensive therapy

    [see Use in Specific Populations ]

    .

    Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

    Angina

    : The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg once daily for adequate effect.

    Coronary artery disease

    : The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg once daily

    [see Clinical Studies ]

    .
    )
• •Pediatric starting dose: 2.5 mg to 5 mg once daily. (
  2.2 Children

  The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients

  [see Clinical Pharmacology , Clinical Studies ]

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  )

KATERZIA oral suspension contains 1 mg/mL of amlodipine (equivalent to 1.30 mg of amlodipine benzoate) in an aqueous, white to off-white, liquid suspension.

• •Pediatric: Effect on patients less than 6 years old is not known. (
  8.4 Pediatric Use

  Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years

  [see Clinical Studies ]

  . Effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
  )
• •Geriatric: Start dosing at the low end of the dose range. (
  8.5 Geriatric Use

  Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required

  [see Dosage and Administration ]

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• •Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. (
  5.1 Hypotension

  Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
  )
• •Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. (
  5.2 Increased Angina or Myocardial Infarction

  Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of KATERZIA, particularly in patients with severe obstructive coronary artery disease.
  )
• •Titrate slowly in patients with severe hepatic impairment. (
  5.3 Patients with Hepatic Failure

  Because KATERZIA is extensively metabolized by the liver and the plasma elimination half-life (t_1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering KATERZIA to patients with severe hepatic impairment.
  )