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Published on April 18, 2022

2024 – January 23, 2024

The U. S. Food and Drug Administration (FDA) announced that the drug Viagra, brand name Cialis, had been granted a 30-day supply exclusivity on May 19, 2024, to allow its generic competitor to produce and market its generic version, sildenafil citrate.

The FDA is advising consumers not to purchase or use this medication, as it has been found to be unsafe for use on its own.

The FDA has issued a public advisory on sildenafil and advised consumers that their healthcare professional has determined that sildenafil is not appropriate for use in the treatment of erectile dysfunction (ED).

“This is the first time that a drug is approved to treat erectile dysfunction (ED), and it is the first drug that has been approved to help patients sustain erections after ejaculation,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA’s guidance is a clear step in the right direction to help ensure that consumers can purchase this effective treatment for their erectile dysfunction.”

Cialis, the brand name of sildenafil, is manufactured by Lilly and is available in 30-milligram tablets. Cialis is the only FDA-approved treatment for ED, and is available as a generic version. The 30-milligram tablets must be taken as needed, approximately one hour before anticipated sexual activity. For individuals who have difficulty achieving an erection or have ED, sildenafil can be taken in pill form or as needed. The tablets are disintegrating tablets with no active ingredients.

The 30-milligram tablets have not been evaluated for safety, efficacy or storage stability, but they are considered stable and can be stored at room temperature in a dry place, under normal conditions. Cialis is available only with a prescription from your healthcare professional. It is not recommended for use by women or children.

As of 2023, the FDA has not approved Cialis in any form. This product is not intended for pediatric or adult use. Safety and effectiveness in treating ED have not been established and may not have been the basis for the FDA’s decision to issue the following warning:

  • Safe for use on its own
  • Avoid in combination with other medications, including nitrates, alpha-blockers and certain heart and lung drugs
  • Use in combination with other ED treatments, including psychosexual therapy
  • Inform your healthcare professional if you have: heart problems, blood pressure issues
  • Difficulty urinating due to diabetes, kidney or liver disease
  • Heart attack or stroke history
  • Bleeding problems, such as blood disorder (high blood sugar, low blood pressure or if there is loss of blood from the penis)
  • Severe liver problems

Cialis is not indicated for use by women or children and has not been evaluated for safety, efficacy or storage stability, but it is considered stable and can be stored at room temperature in a dry place. Its storage conditions ensure it remains out of reach of children and pets, and it cannot be shipped or handled by international companies.

This press release may contain forward-looking statements, based on the current beliefs and expectations of management and management purposes as set forth in the statements. While management and management may have the authority to make any changes to these expectations and beliefs, there is no assurance or assurance that such actions or decisions will not cause actual results, achievements or events to be materially different.

This press release includes forward-looking statements, which are being subject to risks and uncertainties that could cause actual results, achievements or events to differ materially from the expectations of management and management purposes. Factors that could cause actual results, achievements or events to differ materially from the expectations and beliefs expressed in the forward-looking statements include, but are not limited to: changes in healthcare policies and regulation, including from the Federal Government’s health and safety programs, the introduction of generic competition, the introduction of new drugs and the withdrawal of patent exclusivity. Actual results, achievements or events may differ materially from those in the forward-looking statements contained herein.

Interactions

A. Top Drug-Drug Interactions:

1.Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Cialis and nitrates both lower blood pressure. Taking them together can cause a significant and potentially life-threatening drop in blood pressure (hypotension), leading to dizziness, fainting, or even heart attack or stroke. It is contraindicated to use Cialis with nitrates or recreational "poppers" (amyl nitrites).

2.Alpha-blockers (e.g., prazosin, terazosin, tamsulosin): Both Cialis and alpha-blockers relax blood vessels, which can lead to excessive blood pressure reduction when used together. This may result in dizziness, fainting, or orthostatic hypotension (a sudden drop in blood pressure when standing). If needed, your doctor may adjust the dosage or recommend spacing the medications.

3.Other antihypertensive drugs (e.g., atenolol, propranolol, enalapril, lisinopril): Cialis can enhance the blood-pressure-lowering effects of these medications. While this interaction is usually less severe than with nitrates or alpha-blockers, it can still cause dizziness or fainting in sensitive individuals. Close monitoring of blood pressure is recommended.

Other Drug-Drug interactions:

  • Ketoconazole, itraconazole (used to manage fungal infection)
  • Protease inhibitors (used to manage HIV infection) Ex. ritonavir, lopinavir
  • Phenobarbital, phenytoin, carbamazepine (medicines used for fits)
  • Rifampicin, erythromycin, clarithromycin (medicines used for bacterial infections)
  • Other medicines used to improve blood flow to the penis (Ex. sildenafil)

B. Drug-Food Interactions:

Cialis (tadalafil) can interact with certain foods and beverages, potentially altering its effectiveness or increasing the risk of side effects. Here are the key drug-food interactions to be aware of:

  1. Grapefruit and Grapefruit Juice: Grapefruit can increase the levels of tadalafil in your blood by interfering with its metabolism. This may amplify side effects, such as headaches, dizziness, or low blood pressure. Avoid consuming grapefruit or grapefruit juice while taking Cialis.
  2. Alcohol: Drinking alcohol with Cialis can enhance the blood pressure-lowering effects of the medication, leading to symptoms like dizziness, lightheadedness, or fainting. Limiting alcohol intake is recommended while using Cialis.
  3. High-Fat Meals: While Cialis can be taken with or without food, consuming it with a high-fat meal may delay its onset of action. Opt for lighter meals if rapid effectiveness is needed.
  4. Caffeine: Though not a direct interaction, combining Cialis with high caffeine intake might worsen side effects like headaches or increase heart rate in sensitive individuals.
EU globalement chél source: Urokotegénation: Cialis (tadalafil) a fait de l'interaction entraînant l'entente interna pour l'aillydissent.

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Ex. Viagra, sildenafil (a medication used to treat erectile dysfunction) – both Cialis and Viagra contain active ingredients that can interact with other medications and beverages, leading to adverse effects.

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Other Drug-Drug Interactions:

  • Ketoconazole, tamsulosin (used to manage fungal infection) – the active ingredient in Cialis and tadalafil can interact with certain medications and beverages, leading to adverse effects.

The cheapest erectile dysfunction (ED) pills are generic Viagra, called.

What is a generic drug?

The term "generic" refers to the active ingredient of a medicine or drug rather than to the advertised brand name under which the medicine is sold. It is a term referring to any drug marketed under its chemical name without advertising.

Pfizer made the originaltablet that is often referred to as the “blue pill”.The patent expired in 2013 which then allowed other pharmaceutical manufactures to make a generic version under the name of the active ingredient called Sildenafil. They are exactly the same medically and perform in the same way with the same side-effects.

As with most branded products, Viagra is sold at a higher price,therefore the generic tablets sold asare much cheaper.

What is the difference between generic and branded drugs?

Medically there is no difference between a generic medicine and the branded medicine, as they both have the same active ingredients to make them perform in the same way. They only differ in the “bulking” agents used to fill the tablet as the amount of active ingredient required, in this case Sildenafil, is very small. This makes the tablets bigger and easier to handle.

The main difference between generic andbranded named prescription medicines is cost with generics being much cheaper

Every pharmacy can choose what price they sell at, as there are no fixed prices. It will depend on what price the pharmacy can buy the drug from the wholesaler and the cost of their own overheads. They can they decide what mark-up they require and some pharmacies choose to sell some products at higher prices.

At Webmed pharmacy we aim to keep our prices as low as possible, without compromising the quality of service, as we arethe only online pharmacy to offercourier guaranteed next working day as standard

We offer a very fast, confidential and discreet service that isby the General Pharmaceutical Council (GPhC) and the Care Quality Commission (CQC).

A large proportion of our sales are made up of returning customers as they have been delighted with our service.

What is the best brand of sildenafil?

When you choose to buy any prescription medication online, you must first of check that the pharmacy is with the General Pharmaceutical Council (GPhC).

All pharmacies using a UK General Medical Council, to prescribe their medicines will also be registered with the UK government Agency the Care Quality Commission (CQC).

Those online pharmacies who are not registered with the CQC either use pharmacist prescribers or foreign doctors.

You will then know and have the confidence that all the brands being offered are genuine and will work in the same way. All the pharmaceutical companies are inspected by the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure they manufacturer the drugs to the same quality standard. This means that the key ingredient that is referred to as the “active” ingredient is exactly the same in all brands.

The other inactive ingredients that make up the bulk of the tablet are called “excipients” and can vary.

For those people who are allergic to or have an intolerance to lactose, then the is ideal for you as it is lactose free. You can check the additional excipients on the patient information leaflet supplied with your tablets.

Although medically all the generic tablets are identical, they may look different as they can vary in colour, shape and size due to the varying excipients.

The patent for, owned by Pfizer, expired in July 2013, which then allowed other pharmaceutical companies to produce generic. There are a number of companies now manufacturing which include Accord, Ajanta, Dr Reddy’s, Mylan, Teva, Torrent and Zentiva. Even Pfizer make a that they sell cheaper than Viagra although generally more expensive than the equivalent generic brands.

Author 19th September 2019

Active ingredient Sildenafil [ina length: 714]Active ingredient Publix [ina length: 10 -ot]Generic sildenafil is a branded version of the “active�” ingredient Sildenafil. The addition of excipients is regulated by the Medical Quality Commission (MQC).

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