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地瑞那韦|Prezista(darunavir ethanolate)

——FDA批准美国强生公司一种治疗艾滋病新药Prezista

2006-06-29 11:54:50  作者:新特药房  来源:中国新特药网天津分站  浏览次数:281  文字大小:【】【】【

地瑞那韦(darunavir ethanolate),商品名为Prezista,是由强生公司冰岛分公司Tibotec研发的一种非肽类HIV蛋白酶抑制剂,2006年6月23日美国FDA批准其上市,

FDA近日批准darunavir(Prezista)用于治疗现有抗逆转录病毒药物疗效不佳的HIV感染成年患者。Darunavir是一种新的HIV蛋白酶抑制剂,FDA批准其与小剂量利托那韦或其他抗HIV药合用治疗HIV感染。

FDA是根据2项随机对照研究结果做出快速批准的。这2项研究比较了darunavir/利托那韦联合治疗与其他利托那韦增强蛋白酶抑制剂联合治疗(对照组)的安全性和疗效。两组患者还接受其他抗HIV药(核苷逆转录酶抑制剂)加或不加恩夫韦肽(enfuvirtide)治疗。

结果显示,darunavir/利托那韦联合治疗组患者HIV病毒载量减少率比对照组高。治疗24周后,联合组70%患者达到病毒学应答,临床转归获改善,对照组为21%。Darunavir最常见的不良反应为腹泻、恶心和头痛,联合治疗组7%的患者出现皮疹(轻度到严重)。
 
FDA要求生产厂家做上市后研究,以进一步确定darunavir的临床疗效(包括对患儿的疗效),与其他药可能发生的相互作用以及有肝损伤患者的合适剂量。

DARUVIR (Darunavir)
Stop HIV Meds for your payment.

DARUVIR is FDA approved generic from Cipla Pharmaceuticals PREZISTA (Darunavir)

What is DARUVIR (generic Prezista) (Darunavir)?
DARUVIR (Universal Prezista) (Darunavir) is an HIV drug. It is called an HIV protease inhibitor class of drugs. DARUVIR (Universal Prezista) (Darunavir) prevents HIV from infected cells to generate new viruses. This reduces the amount of virus in your body.

DARUVIR (Universal Prezista) (Darunavir) must use low-dose Norvir (ritonavir), and with a combination of other HIV drugs.

DARUVIR (Universal Prezista) (Darunavir), Tibotec company by the treatment, a Centocor Ortho Biotech Products, LP was originally proposed by the U.S. Food and Drug Administration (FDA) approved June 23, 2006, the division and manufacturing experience in the treatment HIV-positive adults. It is approved for HIV-positive began in October 22, 2008 for the first time for treatment.


We know DARUVIR (General Prezista) (Darunavir)?
There are two DARUVIR (General Prezista) (Darunavir) approved adult dose:

Initial treatment of patients: two 400 mg DARUVIR (General Prezista) (Darunavir) tablets plus one 100 mg Norvir capsule once a day.

Treatment experienced patients: a 600 mg DARUVIR (generic Prezista) (Darunavir) plus one tablet of 100 mg Norvir capsule, twice a day.
  
DARUVIR (Universal Prezista) (Darunavir), combined with Norvir should be taken with food. The type and quantity of food is not important. In other words, DARUVIR (generic Prezista) (Darunavir) / Norvir can be taken with meals or snacks.

Beginning of the first HIV-positive adults living with HIV drug therapy, DARUVIR (generic Prezista) (Darunavir) are classified as "preferred" protease inhibitor of Health and Human Services guidelines in the treatment of choice.

DARUVIR (Universal Prezista) (Darunavir) proposed by the U.S. Department of Health and Human Services (DHHS) HIV-positive who tried and failed other protease inhibitors in the past people.

Clinical trials have shown, DARUVIR (General Prezista) (Darunavir) patients who used protease inhibitors may not respond, especially when coupled with other HIV drugs, the patient is at least part of the virus is still sensitive to the effective integration of choice.

DARUVIR (Universal Prezista) (Darunavir) works, the best drugs and HIV, the virus is still sensitive to the sum. However, this may be challenging HIV-positive who have tried in the past few years, people living with HIV drug therapy.

DARUVIR (Universal Prezista) (Darunavir) does not approve of HIV-positive children under the age of 6 years of age.

How to drug interactions?
As DARUVIR (General Prezista) (Darunavir) and Norvir are in the body metabolism (break down) the way that they can be used to treat HIV, AIDS-related complications and other diseases and many other drugs. DARUVIR (Universal Prezista) (Darunavir) / Norvir may lead to other drugs in the blood to become too low (which can reduce their effectiveness) or high (this may increase the risk of side effects.) Similarly, other drugs may lead to DARUVIR (generic Prezista) (Darunavir) and / or Norvir blood become too high or low.

Tell all the medicines you take your doctor and pharmacist. This includes those you buy, such as St. John's Wort on-the-counter and herbal or natural therapies. Bring all your medicines when you see a doctor, or do their names, how much you take and how often you list them. Your doctor can tell you, if you need to change any of your dosage.

The following drugs should not be taken, and you are working with DARUVIR (generic Prezista) (Darunavir) / Norvir (The list includes a variety of taboos, can not put together, according to both DARUVIR (generic Prezista) (Darunavir drug treatment) and Norvir Packing ):
Antifungal agents: This product (voriconazole)
Anticonvulsant drugs: Tegretol (carbamazepine), lumen (phenobarbital), phenytoin (phenytoin)
Acid reflux / heartburn medications: Propulsid (cisapride)
Antibiotics: Rifadin (rifampin)
Antimigraine drugs: Methergine, Methylergometrine (methylergonovine); Ergostat, Cafergot, Ercaf, Wigraine (ergotamine); Ergotrate, Methergine (ergot); or DHE 45, Migranal (dihydroergotamine)
Antihistamines: Hismanal (astemizole) or Seldane (terfenadine)
Cholesterol-lowering drugs (statins): Zocor (simvastatin) and Mevacor (lovastatin)
Cardiac drugs: amiodarone (amiodarone), Vascor (Bepridil), Tambocor (flecainide), Rythmol (propafenone) or Quinaglute / Quinidex (quinidine)
Antipsychotics: Orap (pimozide)
Sedatives: Expert (midazolam) and Halcion (triazolam)
Prostatic hyperplasia: Uroxatral (alfuzosin)
Chinese medicine products: St. John's Wort

HIV protease inhibitors can interact DARUVIR (generic Prezista) (Darunavir) / Norvir. Use of Kaletra (lopinavir / ritonavir) and Invirase (saquinavir) can significantly reduce the DARUVIR (generic Prezista) (Darunavir) so it is not recommended DARUVIR (generic Prezista) (Darunavir) and Kaletra or Invirase combination of blood concentration. To DARUVIR (generic Prezista) (Darunavir) and Crixivan two drugs together can lead to increased blood levels. DARUVIR (Universal Prezista) (Darunavir) / Norvir does not seem to increase or decrease in blood Reyataz (atazanavir), Reyataz does not appear to increase or decrease DARUVIR (generic Prezista) (Darunavir) / Norvir blood levels. Conversely, it is possible to combine the two inspectors.

HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs) can also be interactive DARUVIR (generic Prezista) (Darunavir) / Norvir. DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase Sustiva (efavirenz) levels [and to a lesser extent, nevirapine (nevirapine)] in the blood. With DARUVIR (Universal Prezista) (Darunavir) / and Sustiva Norvir should be cautious.

DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase the blood VIREAD the (tenofovir), nucleotide reverse transcriptase inhibitor levels. However, both drugs can be combined without any dose adjustments (although it may be necessary to pay attention to kidney damage, potential side effects of VIREAD careful.) Videx / Videx EC (didanosine) must be taken fasting. Conversely, if the Videx / Videx EC is used to DARUVIR (generic Prezista) (Darunavir) / Norvir, should be taken an hour before the same program, two hours after the DARUVIR (generic Prezista) (Darunavir) / Norvir (should be taken and food).

DARUVIR (Universal Prezista) (Darunavir) / Norvir can interact in the treatment of thrush (Candida) and other drugs of fungal infections. DARUVIR (Universal Prezista) (Darunavir) / Norvir increase Nizoral (ketoconazole), and may increase Sporanox (itraconazole) in the blood level. People taking DARUVIR (generic Prezista) (Darunavir) / Norvir who also need to take Sporanox or Nizoral, Sporanox or Nizoral daily dose should not exceed 200 mg. It is also possible that DARUVIR (generic Prezista) (Darunavir) / Norvir reduce the product (voriconazole) blood levels (should not take this product if you are in an HIV drug therapy, which contains Norvir in.)

DARUVIR (Universal Prezista) (Darunavir) / Norvir can be used to treat TB, MAC number of drugs and other bacterial infections. DARUVIR (Universal Prezista) (Darunavir) / Norvir increase the blood Biaxin (clarithromycin) levels. The Biaxin dose not need to be reduced, although this is changing with the kidney function of people recommended. DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase the blood Mycobutin (rifabutin) levels (Mycobutin can also increase the DARUVIR (generic Prezista) in the blood (Darunavir) level). If Mycobutin at the same time as DARUVIR (generic Prezista) (Darunavir) / Norvir, suggested that the Mycobutin dose reduction to 150 mg per day. DARUVIR (Universal Prezista) (Darunavir) / Norvir should not be used Rifadin (rifampin), a common antibiotic used to treat tuberculosis.

DARUVIR (Universal Prezista) (Darunavir) / Norvir may be associated with calcium channel blockers, drugs used to treat heart disease. Research DARUVIR (Universal Prezista) (Darunavir) / Norvir and calcium channel blocker has not. Health care providers should be careful prescription DARUVIR (generic Prezista) (Darunavir) / Norvir Either Cardizem (diltiazem), Plendil / Lexxel (felodipine), Cardene (nicardipine), Sular (nisoldipine), or Ocalan / Verelan (verapamil). DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase serum concentrations of cardiac medications Vascor (Bepridil), lidocaine, Quinidex (quinidine) and Cardarone (Amiodarone). These drugs should be used with caution, if and DARUVIR (generic Prezista) (Darunavir) / Norvir and monitoring blood levels of these drugs to take the recommendations, if any. DARUVIR (Universal Prezista) (Darunavir) / Norvir can significantly improve Lanoxin (digoxin) blood levels. The lowest dose of Lanoxin should use, blood concentration monitoring Lanoxin recommendations.

DARUVIR (Universal Prezista) (Darunavir) / Norvir, can reduce the blood thinner Coumadin (warfarin) in the blood level. The blood clotting (coagulation) of testing is necessary.

DARUVIR (Universal Prezista) (Darunavir) / Norvir may increase blood Norpramin (desipramine), drugs used to treat depression. Doses of Norpramin may need to decrease. DARUVIR (Universal Prezista) (Darunavir) / Norvir may also reduce the Zoloft (sertraline) and Paxil (paroxetine) level. This may need to increase the dose of paroxetine Zoloft, if you use the DARUVIR (generic Prezista) (Darunavir) / Norvir.

Cholesterol-lowering drug, also known as "statins," can interact DARUVIR (generic Prezista) (Darunavir) / Norvir. Two should not be the DARUVIR (General Prezista) (Darunavir) / Norvir statin drugs: Zocor (simvastatin) and Mevacor (lovastatin). Both drugs can be significantly increased levels of blood if they DARUVIR (generic Prezista) (Darunavir) Joint / Norvir, which increases the risk of side effects. Statins are considered the most secure combination of DARUVIR (generic Prezista) (Darunavir) / Norvir is Lescol (fluvastatin). It may also take DARUVIR (generic Prezista) (Darunavir) / and Lipitor Norvir (atorvastatin) or Crestor's (rosuvastatin) Although DARUVIR (generic Prezista) (Darunavir) / Norvir can increase these drugs in levels in the blood (such as Lipitor or Crestor is prescribed, the best possible start with the lowest dose of drug, then increase the dose, if necessary, or use a different drug. Although the FDA approved packaging materials) DARUVIR (General Prezista) (Darunavir) suggested Pravachol (pravastatin) can also be used, Tibotec company does not recommend combining DARUVIR (generic Prezista) (Darunavir) / Norvir Pravachol.



Mountain Ming, Sandimmune, Gengraf (cyclosporine), Bullock (tacrolimus), rapamycin (sirolimus) are examples of immunosuppressive agents, who often experienced a organ / tissue transplant patients prescription. DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase the blood levels of these drugs. In turn, the need for careful monitoring of serum concentrations of these drugs, if they DARUVIR (generic Prezista) (Darunavir) / Norvir combination.

DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase the Advair, Flovent, Flonase or blood levels (Kathan), by inhalation for the treatment of allergy and asthma drugs. In turn, these drugs may reduce the DARUVIR (generic Prezista) (Darunavir) / Norvir blood levels. Alternatives to these drugs should be considered, especially in long-term use.

Another painkiller, methadone, commonly used drug to treat heroin addiction, can DARUVIR (generic Prezista) (Darunavir) / Norvir. Methadone blood levels can drop DARUVIR (generic Prezista) (Darunavir) / Norvir combination. Because of this, it may need to increase the methadone dose.

Desyrel (trazodone) is used to treat depression. DARUVIR (Universal Prezista) (Darunavir) / Norvir can increase the drug levels in the blood, leading to increased risk of side effects of Desyrel. The use of low doses of Desyrel may be necessary.

DARUVIR (Universal Prezista) (Darunavir) / Norvir reduced the number of oral contraceptives (to help women avoid pregnancy) in the blood. This means that there may be pregnant, if DARUVIR (generic Prezista) (Darunavir) / Norvir and oral contraceptives are at the same time to take a higher risk. In order to reduce pregnancy, barrier protection (such as condoms) risk should be used.

Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil) levels in the blood may increase, and DARUVIR (generic Prezista) (Darunavir) / Norvir combination. In turn, the best dose to use these drugs to reduce the risk of side effects.

What are the known side effects?
The most common side effects reported to participate in clinical trials DARUVIR (generic Prezista) (Darunavir) and Norvir, including diarrhea, nausea, headache, abdominal pain patients. Some patients receiving DARUVIR (generic Prezista) (Darunavir) / Norvir experience rash, mostly mild to moderate. If a serious skin rash while taking DARUVIR (generic Prezista) (Darunavir) / Norvir, patients should immediately contact their health care institutions.

DARUVIR (Universal Prezista) (Darunavir), a sulfa containing drugs should be used with caution in patients with known sulfonamide allergy.

Some people may be in their blood lipid levels (triglycerides and cholesterol) increased significantly, while working with the protease inhibitor treatment. However, it is not known what impact, if any, DARUVIR (generic Prezista) (Darunavir) would lipids.

Diabetes and high blood sugar may occur in people who take DARUVIR (generic Prezista) (Darunavir) or other protease inhibitors.

HIV drug therapy with protease inhibitors, including DARUVIR (generic Prezista) (Darunavir) / Norvir, may lead to abnormal body shape changes (lipodystrophy, including increasing the fat in the abdomen, chest, neck and back, while reduce fat face, arms and legs).

HIV drugs, such as DARUVIR (generic Prezista) (Darunavir), can increase the risk of bleeding in hemophiliacs.

Drug-induced hepatitis (liver injury) reported taking DARUVIR (generic Prezista) (Darunavir) people. This usually occurs in people who had very low CD4 cells, were taking a variety of other drugs, who is also associated with hepatitis B virus (HBV) and / or hepatitis C virus (HCV) infection. People taking DARUVIR (generic Prezista) (Darunavir) who was with HBV or HCV, infection or who have a history of liver damage, liver function should have their own closely monitor their health care provider. Stop DARUVIR (generic Prezista) (Darunavir) treatment may be necessary, in consultation with health care providers, abnormal liver enzymes or liver injury (such as fatigue, nausea, yellow eyes and skin, dark urine and liver tenderness) symptoms case.

Who should not take DARUVIR (generic Prezista) (Darunavir)?
People with mild to moderate liver damage (liver damage) may be used without changing the dose DARUVIR (generic Prezista) (Darunavir). DARUVIR (Universal Prezista) (Darunavir) no studies of serious liver damage, which is not consistent with severe hepatic impairment of recommendation.

Pregnant women can take DARUVIR (generic Prezista) (Darunavir)?
DARUVIR (Universal Prezista) (Darunavir) is listed by the FDA as pregnancy category B drug. Pregnancy Category B refers to animal studies have failed to demonstrate the risk to the fetus, but there are not enough women and well-controlled studies.

It is not known whether the DARUVIR (General Prezista) (Darunavir) passed to the impact of what breast milk for nursing infants may be. To prevent transmission of the virus to uninfected babies, it is recommended that HIV positive mothers can not breastfeed.

You can buy and save Cipla drugs DARUVIR in:

Who is the Cipla Pharmaceuticals?
Cipla pharmaceutical company founded in 1935 by Dr. Abdul Hamied Khwaja. He set up the chemical, industrial and pharmaceutical laboratories, which came to be known popularly known as Cipla. He gave all of his several patents and proprietary drugs and drug formulations, the company does not charge any royalties. August 17, 1935, pharmaceutical company Cipla was registered as a public limited liability company of Rs 60,000 and the authorized capital of Rs.

Over 289 searches in the right place, Bellasis Road (now Corporation) Where a few rooms rented bungalow is Rs 350 per month to 20 years.

Cipla was officially opened 22 September 1937, the first product is ready for the market. Sunday Standard wrote: "This is Cipla birth to Boshi Jia Hamied launched in Mumbai industrial world a big day in the annals of the first city in India can now boast a concern, which will replace all existing . in its scale of operation of the enterprise. India has lagged behind the march of science, but she is now awakening from her lethargy. The new company has developed an ambitious plan, and intelligent direction, first-class production, the establishment of a fair offer high reputation in the East. "

Cipla pharmaceutical production base has adopted the following regulatory authorities:

Food and Drug Administration (FDA), United States
Medicines and Healthcare Products Regulatory Agency (UK MHRA), UK
Therapeutic Goods Administration (TGA), Australia
Medicines Control Council (MCC), South Africa
National Pharmaceutical (bonds), Hungary
Pharamaceutical Inspection Convention (PIC), Germany
World Health Organization (WHO), Department of Health, Canada
National Institute of Drug Control, Slovak Republic ANVISA, Brazil

Pharmaceutical company Cipla HIV / AIDS, cancer, hormones, asthma, pain management, and several other areas of wide range of products.

Cipla Pharmaceuticals buy products in over 180 countries worldwide.

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