e 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 anejection fraction <40%, KATERZIA is indicated to reduce the risk of hospitalization for anginaand to reduce the risk of a coronary revascularization procedure.
2 DOSAGE AND ADMINISTRATION
2.1 Adults
The usual initial antihypertensive oral dose of KATERZIA is 5 mg orally once daily, and themaximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mgonce daily and this dose may be used when adding KATERZIA to other antihypertensive therapy[see Use in Specific Populations (8.6)].
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titrationsteps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessedfrequently.
Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg oncedaily, 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 diseaseis 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg once daily[see Clinical Studies (14.4)].
2.2 Children
The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 to 5 mgonce daily. Doses in excess of 5 mg daily have not been studied in pediatric patients[see Clinical Pharmacology (12.3), Clinical Studies (14.1)].
3 DOSAGE FORMS AND STRENGTHS
KATERZIA oral suspension contains 1 mg/mL of amlodipine (equivalent to 1.30 mg ofamlodipine benzoate) in an aqueous, white to off-white, liquid suspension.
4 CONTRAINDICATIONS
KATERZIA is contraindicated in patients with known sensitivity to amlodipine.
5 WARNINGS AND PRECAUTIONS
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.
5.2 Increased Angina or Myocardial Infarction
Worsening angina and acute myocardial infarction can develop after starting or increasing thedose of KATERZIA, particularly in patients with severe obstructive coronary artery disease.
5.3 Patients with Hepatic Failure
Because KATERZIA is extensively metabolized by the liver and the plasma elimination half-life(t1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administeringKATERZIA to patients with severe hepatic impairment.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in practice.
Amlodipine has been eva luated for safety in more than 11,000 patients in U.S. and foreignclinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mgdaily. Most adverse reactions reported during therap |
