Product Overview
[Drug Name]
Generic Name: Valsartan and Amlodipine Tablets (I)
Trade Name: Valsartan and Amlodipine Tablets (I) 80mg: 5mg x 14 tablets
Pinyin Code: ZuoAnYue ZuoShaTanAnLvDiPingPian (I) 80mg: 5mg x 14 tablets
[Main Ingredients]
This product is a compound preparation containing 80mg of valsartan and 5mg of amlodipine per tablet.
[Properties]
This product is a film-coated tablet that appears white after removal of the film coating.
[Indications/Main Functions]
Treatment of essential hypertension. This product is used for patients whose blood pressure cannot be adequately controlled with monotherapy.
[Specifications]
80mg: 5mg x 14 tablets
[Dosage and Administration]
Amlodipine is effective for the treatment of hypertension at a dose of 2.5mg to 10mg once daily, while the effective dose of amlodipine is 80mg to 320mg. In clinical trials of once-daily valsartan and amlodipine tablets, using 5mg-10mg of amlodipine and 80-320mg of pinsartan, the antihypertensive effect increased with increasing dose. Adverse reactions of pinsartan are generally dose-independent; adverse reactions of amlodipine are both dose-dependent (primarily peripheral edema) and dose-independent, with the former being more common than the latter. This product can be used as an alternative for patients whose blood pressure is not adequately controlled with monotherapy. Add-on therapy: Patients whose blood pressure is not adequately controlled with amlodipine or valsartan monotherapy can be treated with this product as a combination therapy. Patients who experience dose-limiting adverse reactions with amlodipine or pinsartan monotherapy can be treated with this product. Blood pressure control is achieved by combining a lower dose of the individual component with the other component. The majority of the therapeutic effect is generally achieved within two weeks of initiation or dose change. Alternative therapy: For ease of administration, patients receiving amlodipine and pinsartan combination therapy can be treated with this product at the same dose. Amlodipine and valsartan can be taken with or without food. It is recommended that this product be taken with water. No dosage adjustment is required for patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (see [Contraindications]). This product should also be used with caution in patients with hepatic impairment or biliary obstructive disease (see [Precautions]).
[Adverse Reactions]
See the package insert for details.
[Contraindications]
This product is contraindicated in patients with hypersensitivity to the active ingredient or any of the excipients. It is contraindicated in pregnant and lactating women (see [Use in Pregnant and Lactating Women]). No data are available on its use in patients with severe renal impairment (creatinine clearance <10 mL/min). This product should be contraindicated in patients with hereditary angioedema and in patients who develop angioedema early in treatment with ACE inhibitors or angiotensin receptor antagonists. Angiotensin receptor blockers (ARBs) (including pinsartan) or angiotensin-converting enzyme inhibitors (ACEIs) should not be used concomitantly with aliskiren in patients with type 2 diabetes (see [Drug Interactions]).
[Precautions]
See instructions for details.
