PRZ-AMLODIPINE

1 Dosing Considerations Dosage should be individualized depending on patient's tolerance and responsiveness. 2 Recommended Dose and Dosage Adjustment • For both hypertension and angina, the recommended initial dose of PRZ-AMLODIPINE is 5 mg once daily.

If necessary, dose can be increased after 1-2 weeks to a maximum dose of 10 mg once daily. • Use in the Elderly or in Patients with Impaired Renal Function: The recommended initial dose in patients over 65 years of age or patients with impaired renal function is 5 mg once daily.

4 Geriatrics). • Use in Patients with Impaired Hepatic Function: Dosage requirements have not been established in patients with impaired hepatic function. When PRZ-AMLODIPINE is used in these patients, the dosage should be carefully and gradually adjusted depending on patients tolerance and response.

5 mg once daily should be considered (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). 5 mg to 5 mg once daily. 2 Pharmacodynamics). 4 Administration PRZ-AMLODIPINE can be administered once daily, at any time of the day, with or without food.

5 Missed Dose The patient should be advised that if they miss a dose, it should be taken immediately unless it has been more than 12 hours since the missed dose. In such an event, the patient should wait for the next scheduled dose and continue on the regular schedule.

A double dose should not be taken to make up for a missed dose.

, Hepatic/Biliary/Pancreatic). 5 mg to 5 mg once daily. 2 Pharmacodynamics). 4 Administration PRZ-AMLODIPINE can be administered once daily, at any time of the day, with or without food. 5 Missed Dose The patient should be advised that if they miss a dose, it should be taken immediately unless it has been more than 12 hours since the missed dose.

In such an event, the patient should wait for the next scheduled dose and continue on the regular schedule. A double dose should not be taken to make up for a missed dose. 5 OVERDOSAGE Symptoms: Overdosage can cause excessive peripheral vasodilation with marked and probably prolonged hypotension and possibly a reflex tachycardia.

In humans, experience with overdosage of amlodipine besylate tablets are limited. In healthy volunteers, the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.

A patient who took 70 mg of amlodipine with benzodiazepine developed shock which was refractory to treatment and died. In a 19 month old child who ingested 30 mg of amlodipine (about 2 mg/kg) there was no evidence of hypotension but tachycardia (180 bpm) was observed.

5 hrs after ingestion and on subsequent observation (overnight) no sequelae were noted.

Treatment:

Clinically significant hypotension due to overdosage requires active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.

A vasoconstrictor (such as norepinephrine) may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. As amlodipine besylate tablets are highly protein bound, hemodialysis is not likely to be of benefit.

PRZ-AMLODIPINE is contraindicated in patients:

PRZ-AMLODIPINE (amlodipine besylate) Page 5 of 37 • who are hypersensitive to this drug or to any ingredient in the formulation, including any non – medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• who are hypersensitive to other dihydropyridines. Amlodipine besylate is a dihydropyridine calcium channel blocker. 2 Breast-feeding). g. high grade aortic stenosis) • with haemodynamically unstable heart failure after acute myocardial infarction