Valturna获得FDA批准 FDA9月17日批准了缬沙坦和阿利吉仑的复方制剂Valturna片。 Valturna是第一个且仅有的一个在肾素系统内作用于两个关键靶点的药物，也被称为血管紧张素醛固酮（RAAS）系统在调节血压方面发挥关键作用。 Valturna的批准，表明在单独使用阿利吉仑或血管紧张素受体阻滞剂（ARB）治疗没有充分控制血压的患者和可能需要多种药物初步治疗的患者，可以更好地控制血压。 　　 Valturna在8周随机，双盲，安慰剂对照，1800名患者临床试验中，研究了阿利吉仑150毫克和300毫克和缬沙坦160毫克和320毫克。 最初阿利吉仑缬沙坦的剂量为150毫克和160毫克，分别在4个星期上升到300毫克和320毫克。8周主要终点表明阿利吉仑/缬沙坦组合降低血压均明显高于两种药的单一疗法或安慰剂。 Valturna approved for treatment of hypertension   The FDA has approved Valturna (aliskiren and valsartan tablets, from Novartis), a combination agent containing a direct renin inhibitor and an angiotensin receptor blocker, for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. This approval was based on data from an eight-week, randomized, double-blind, placebo-controlled clinical trial in approximately 1,800 patients that demonstrated blood pressure reductions with Valturna to be significantly greater than with aliskiren or valsartan monotherapy or placebo at the eight-week primary endpoint. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2mmHg for aliskiren 300mg/valsartan 320mg, compared with 13/9mmHg for aliskiren 300mg, 12.8/9.7mmHg for valsartan 320mg, and 4.6/4.1mmHg for placebo (p<0.05 for aliskiren/valsartan versus monotherapies or placebo). Valturna will be available in fixed-dose combinations tablets containing aliskiren and valsartan: 150mg/160mg and 300mg/320mg.   Valturna Generic Name: aliskiren and valsartan Date of Approval: September 17, 2009 Company: Novartis AG FDA Approves Valturna The US Food and Drug Administration (FDA) has approved Valturna, a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker). Valturna is indicated for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Valturna Patient InformationRead the Patient Information that comes with Valturna before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment. IMPORTANT WARNING: Valturna may harm an unborn baby, causing injury and death. If you get pregnant, stop taking Valturna and call your doctor right away. If you plan to become pregnant, talk to your doctor about other medicines to treat your high blood pressure before taking Valturna. What is Valturna?Valturna contains two prescription medicines in one tablet that work together to lower blood pressure. It contains: aliskiren (Tekturna), a direct renin inhibitor (DRI) valsartan (Diovan), an angiotensin receptor blocker (ARB) Aliskiren (Tekturna) reduces the effect of renin, and the harmful process that narrows blood vessels. Aliskiren also helps blood vessels relax and widen so blood pressure is lower. Valsartan (Diovan) can help lower your blood pressure by blocking a potent chemical, angiotensin II, that leads to blood vessel constriction and narrowing. Valturna may be used to lower high blood pressure in adults: when one medicine to lower high blood pressure is not enough as the first medicine to lower high blood pressure if your doctor decides that you are likely to need more than one medicine Valturna has not been studied in children under 18 years of age. Your doctor may prescribe other medicines for you to take along with Valturna to treat your high blood pressure. What is high blood pressure (hypertension)?Blood pressure is the force that pushes the blood through your blood vessels to all the organs of your body. You have high blood pressure when the force of your blood moving through your blood vessels is too great. One cause of high blood pressure is renin, a chemical in the body that starts a process that makes blood vessels narrow, leading to high blood pressure. Valturna reduces high blood pressure. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems. Blood pressure is reduced more with Valturna than when either Tekturna or Diovan is taken by itself. Who should not take Valturna?If you get pregnant, stop taking Valturna and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure. Do not take Valturna if you are allergic to any of its ingredients. See the end of this leaflet for a complete list of the ingredients in Valturna. What should I tell my doctor before taking Valturna?Tell your doctor about all your medical conditions, including whether you: have kidney problems have liver problems have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue, throat, arms and legs, and may cause difficulty breathing. are pregnant or planning to become pregnant. See IMPORTANT WARNING. are breast-feeding. It is not known if Valturna passes into your breast milk. Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking: other medicines for high blood pressure or a heart problem water pills (also called "diuretics") medicines for treating fungus or fungal infections cyclosporine (a medicine used to suppress the immune system) potassium-containing medicines, potassium supplements, or salt substitutes containing potassium atorvastatin Your doctor or pharmacist will know what medicines are safe to take together. Know your medicines. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine. How should I take Valturna?Take Valturna exactly as prescribed by your doctor. It is important to take Valturna every day to control your blood pressure. Take Valturna once each day, about the same time each day. Take Valturna the same way everyday, either with or without a meal. Your doctor may change your dose of Valturna if needed. If you miss a dose of Valturna, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time. If you take too much Valturna, call your doctor or a Poison Control Center, or go to the nearest hospital emergency room. What are the possible side effects of Valturna?Valturna may cause serious side effects: Injury or death to an unborn baby. See IMPORTANT WARNING. Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Drinking alcohol and taking certain medicines (barbiturates or narcotics) can cause low blood pressure to get worse. Lie down if you feel faint or dizzy, and call your doctor right away. Angioedema. Aliskiren, a component in Valturna, can cause swelling of the face, lips, tongue, throat, arms and legs, or the whole body. Get medical help right away and tell your doctor if you get any one or more of these symptoms. Angioedema can happen at any time while you are taking Valturna. Common side effects of Valturna include: Tiredness Sore throat Runny nose Diarrhea Upper respiratory tract infection Urinary tract infection Flu or flu-like symptoms Dizziness Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Valturna. For a complete list of side effects, ask your doctor or pharmacist. How do I store Valturna?Store Valturna tablets at room temperature between 59oF-86oF (15oC-30oC). Keep Valturna in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle. Keep Valturna and all medicines out of the reach of children. General information about ValturnaMedicines are sometimes prescribed for conditions not listed in the patient information leaflet. Do not take Valturna for a condition for which it was not prescribed. Do not give Valturna to other people, even if they have the same condition or symptoms you have. It may harm them. This leaflet summarizes the most important information about Valturna. If you have questions about Valturna talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals. For more information about Valturna, visit www.valturna.com or call 1-877-282-5887. What are the ingredients in Valturna?Active ingredients: Aliskiren and valsartan Inactive ingredients: The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, indigotin blue lake, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide, and hypromellose Call your doctor for medical advice about side effects. You may report side