Product Overview
[Drug Name]
Generic Name: Valsartan and Amlodipine Tablets (I)
Trade Name: LiShuDe Valsartan and Amlodipine Tablets (I) 7 Tablets * 2 Packs
Pinyin Full Code: LiShuDe ZuoShaTanAnLvDiPingPian (I) 7 Tablets * 2 Packs
[Main Ingredients]
This product is a compound preparation. Each tablet contains 80mg of valsartan and 5mg of amlodipine. Excipients include: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and film coating premix.
[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]
7 tablets * 2 plates
[Dosage and Administration]
Amlodipine 2.5mg to 10mg once daily is effective for the treatment of hypertension, while the effective dose of valsartan is 80mg to 320mg. In clinical trials of once-daily valsartan-amlodipine tablets, using 5mg-10mg of amlodipine and 80-320mg of valsartan, the antihypertensive effect increased with increasing dose. Valsartan's adverse reactions are generally dose-independent; amlodipine's adverse reactions 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 to monotherapy for patients whose blood pressure is not adequately controlled. Add-on therapy: Patients whose blood pressure is not adequately controlled with amlodipine or valsartan monotherapy can be treated with this product in combination therapy. Patients who experience dose-limiting adverse reactions with amlodipine or valsartan monotherapy can be treated with this product. Blood pressure control can be achieved by combining a lower dose of a single component with another component. The majority of the therapeutic effect is typically achieved within 2 weeks of initiating or changing the dose. Alternative Therapy: For ease of dosing, patients receiving amlodipine and valsartan monotherapy can be switched to this product at the same dose. Both amlodipine and valsartan can be taken with or without food. This product is recommended for administration with water. No dose 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 currently available for use in patients with severe renal impairment (creatinine clearance <10 mL/min). This product should not be used in patients with hereditary angioedema or those who develop angioedema early in treatment with ACE inhibitors or angiotensin receptor blockers. 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 package insert for details.
