Drug manufacturer Levitra Pharmaceuticals will not be receiving final approval from the US Food and Drug Administration to market a generic version of its erectile dysfunction drug, Viagra, for its Levitra drug after it failed a clinical trial that showed the drug might reduce the risk of heart attacks and strokes in men.
The drug will be marketed by Pfizer, which makes Viagra, and the British drug firm Pfizer Laboratories.
Levitra's generic product, Levitra®, will have a similar mechanism to the original branded Viagra, with an active ingredient known as "sildenafil citrate," which is used to treat erectile dysfunction in men. It works by increasing blood flow to the penis when a man is sexually excited.
The company will manufacture the drug in a single unit of the same strength as the branded Viagra.
Levitra Pharmaceuticals will not be marketing the generic product after the FDA's final approval, a company statement said.
In its statement, Pfizer said the company failed to meet a certain criteria for evaluating "comprehensive" evidence. The FDA required a company to conduct a "comprehensive" review of a product and "report to Pfizer any changes in clinical trials, reports, or actions" that were negative for the company.
The company was required to conduct a "comprehensive" review of its Levitra drug and "report to Pfizer any changes in clinical trials, reports, or actions" that were negative for the company.
In its announcement, Pfizer said the drug was effective for six months and that men who used it for a year or longer had a higher risk of developing erectile dysfunction.
Levitra is expected to be available in the US in the fourth quarter of 2018 and in Canada in 2019.
Levitra's product information sheet provides more details about its generic equivalent, which Levitra Pharmaceuticals is developing for sale under a separate name and strength.The information was provided on the Levitra website by a company spokesman who did not wish to be identified by the public.
© 2018 AFP
Citation: Levitra Pharmaceuticals' "generic version of Viagra" published inThe British Medical Journal2019,38: 49-67.
: Levitra Pharmaceuticals "Levitra generic version of Viagra" published in: 67-80.
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UPTO article: Levitra generic version of Viagra (sildenafil citrate), Pfizer (avanafil), Bayer (avanafil citrate), Levitra (vardenafil), Pfizer (vardenafil), Levitra (avanafil) ©.
UPTO article: Levitra for treating erectile dysfunction (ED), Pfizer (avanafil), Bayer (avanafil), Levitra (vardenafil), Pfizer (vardenafil), Bayer (avanafil) ©UPTO article: Levitra for treating erectile dysfunction (ED), Pfizer (avanafil), Bayer (avanafil), Bayer (avanafil), Levitra (vardenafil), Pfizer (vardenafil) ©UPTO article: Levitra for treating erectile dysfunction (ED), Pfizer (avanafil), Bayer (avanafil), Bayer (avanafil), Levitra (vardenafil), Pfizer (vardenafil), Bayer (avanafil) ©
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MEDICINAL RESOURCESBrand Levitra | Generic | Strength | Ceritra 10mg | Usages | How to use this medication | Take with or without Food |
Dosage | 10mg | 5mg | ||||
Precautions | Talk to your doctor before using any nitrates (e.g., amyl nitrite, isosorbide dinitrate) before using levitra. You should consult your doctor before starting any new medication. | Inactive ingredients (e.g. |
Levitra usage has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious effects, seek medical attention immediately.
Common side effects reported from Levitra use include:
More serious side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a serious adverse reaction to this medication and immediately require treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Levitra. Levitra can interact with bodily substances, causing potentially serious adverse reactions.
Do not take Levitra if you take nitrate medications such as isosorbide dinitrate, isosorbide mononitrate, and nitroglycerin. It’s important to inform your doctor if you are taking any form of high blood pressure medication, alpha-blocker medication, prescription antifungals (like fluconazole), or other medications for erectile dysfunction. You should include information about herbal products, especially St. John’s wort.
Do not drink grapefruit juice while taking Levitra.
Talk to your health care provider about safe drinking practices during treatment with Levitra. Levitra can interact with alcohol and cause potentially serious adverse reactions like those above.
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If you are taking any form of salsalate, do not take more than the prescribed dose.
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If you are taking a nitrate, tell your doctor if you are taking nitroglycerin.
If you are taking an alpha-blocker, you should tell your doctor if you are taking diuretic.
If you are taking a prescription antifungal medication, you should let your doctor know if you are taking ketoconazole.
If you are taking a urinary steroidoid, you should let your doctor know if you are taking urinary steroids.
If you are taking a nonsteroidal anti-inflammatory drug (NSAID), you should let your doctor know if you are taking a nonsteroidal anti-seizure drug (NSAIDs) like quinapril. You should know that you will need to take these several times daily to work.
If you are taking a prescription anti- HIV (interferon), you should let your doctor know if you are taking anti-retroviral medication like retinoid abuse.
If you are taking a type of dietary supplement, you should let your doctor know if you are taking any form of dietary supplements.
Levitra will not affect your sex drive.
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Levitra Vardenafil is used to treat erectile dysfunction or male impotence. Levitra Vardenafil works by relaxing the muscles in the walls of blood vessels to increase blood flow, assisting a male in keeping a sufficient penile erection for sexual activity. This medication does not increase sexual desire and works when sexual stimulation occurs.
The recommended dose for Levitra is 10mg taken orally 25-60 minutes before sexual activity. Levitra has shown to take effect within about 15 minutes of taking the medication and, lasts up to 8-10 hours. The dose of Levitra can be decreased to 10mg or increased to a maximum of 20mg, based on the effectiveness and side effects.
is essential for a response to treatment. The maximum daily dose is 20mg once a day (per 24 hours). For Geriatric patients (65 years or older) the initial dose is 5mg once a day as needed about one hour before sexual activity. The doctor may adjust the dosage based on your medical history and side effects. Levitra can be taken with or without food. Do not eat grapefruit or drink grapefruit juice when taking his medication unless your doctor or pharmacist says you may do so safely.
| Medication | Onset | Duration |
|---|---|---|
| Vardenafil | 30-60 minutes | 4-5 hours |
This medication should be stored at room temperature away from moisture and light. Levitra should not be kept in the bathroom. Keep away from children and pets.
Many medications cause side effects and not everyone may experience side effects of Levitra. The following side effects can be mild and manageable.
If you are a heart patient, sexual activity could put extra strain on your heart. If you experience the following serious side effects while having sex, stop and get medical help right away. The side effects include:
Some patients may experience serious side effects, if you experience these get medical help right away. Serious side effects include:
Some patients experience side effects not listed. If you have any concerns regarding Levitra contact your physician.
Take Note: This medicine is available only with a valid doctor's prescription.Lifestyle changes including avoiding alcohol, smoking, and drugs including certain cancer drugs, or taking certain other medication can help with side effects.Serotonin syndrome/neuroleptic malignant syndrome reviewTheophylline/sodium nitrate/mixed-cholesterol patients: hydrochlorothiazide/sodium nitrite/nortonidine/nortonidine, are common treatment for neuroleptic malignant syndrome (NMS). This medication works by blocking the reuptake of stomach acid. It may take several weeks of consistent use before it disappears completely. Always follow your doctor's instructions for the treatment of NMS.
It may take several weeks of consistent use before you notice the full effects.
The suspension form is usually given every 6-8 hours while you are having sex. This medication should not be used by women or children. If you have the following side effects, do not use this medication:
Other medications may dangerous side effects, you should stop Levitra and seek medical help right away.
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