【藥品訊息】 雙優惠脈錠5/40毫克 中文仿單

For the treatment of hypertension. This fixed-dose combination of Amlodipine/Olmesartan medoxomil is not indicated for initial therapy.

Dihydropyridine C.C Blockers

Absorption:
Amlodipine: Bioavailability 64-90%; peak at 6-12 hours.
Olmesartan: Rapidly bioactivated during absorption; bioavailability ~26%; peak at 1-2 hours.

Distribution:
Both are highly protein-bound (Amlodipine 93%; Olmesartan 99%). Amlodipine reaches steady-state in 7-8 days.

Metabolism & Excretion:
Amlodipine: Extensively hepatic metabolized (90%). Half-life is 30-50 hours, causing 2-3x accumulation. Excreted mostly in urine.
Olmesartan: No further metabolism post-activation. Half-life is ~13 hours with negligible accumulation. Excreted via urine (35-50%) and feces via bile.

The concomitant use of Amlodipine/Olmesartan medoxomil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (GFR < 60 mL/min/1.73 m2).

May reduces fetal renal function and increases fetal and neonatal morbidity and death, especially during the second and third trimesters

Discontinue immediately if pregnancy is detected, and use alternative antihypertensive therapy during pregnancy.

Limited data are available regarding the presence of Amlodipine/Olmesartan medoxomil in human milk, its effects on the breastfed infant, or its effects on milk production.
Amlodipine is excreted in human milk. Olmesartan is excreted in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment with Amlodipine/Olmesartan medoxomil.

Common adverse reactions include edema, upper respiratory tract infection, back pain, hyperkalemia, dizziness, headache, hypersensitivity, and orthostatic hypotension.

Starting dose: 5/20 mg once daily, may increase dose after 2 weeks if needed

Maximum dose: 10/40 mg once daily

Can be used as replacement therapy for individual components, and adjust dose of one or both components if blood pressure is not adequately controlled.

The safety and effectiveness of Amlodipine/Olmesartan medoxomil in pediatric patients have not been established.

There are no studies of Amlodipine/Olmesartan medoxomil in patients with renal impairment.

There are no studies of Amlodipine/Olmesartan medoxomil in patients with hepatic impairment, but exposure to both amlodipine and olmesartan medoxomil is increased in patients with hepatic insufficiency.

Store at controlled room temperature below 25°C (77°F).