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It’s been a year since the first FDA advisory on erectile dysfunction, Cialis, came out, and it’s going to be another month before they finally get to the ground. That means that they’ll be back in the news on September 11, where they’ll be the first drug to get into the market. A big new competitor is Levitra, which will be in late-stage development by the company that developed it.

“There’s a lot of excitement that’s going to happen, and we’re going to take some very important steps to make sure the market is as competitive as possible,” said Tadselfri Malek, who’s also an analyst for the pharmaceutical firm CVS.com.

Cialis is the brand name for Viagra, a drug used to treat erectile dysfunction. Viagra works by relaxing the blood vessels in the penis, allowing more blood to flow into it, which allows for better blood flow and a firmer erection.

Levitra’s patent for the drug expires in April 2018, but Malek said it’s planning to use it in its product line as a generic version of its brand-name product and will be on the market for about a year.

“I think this is a very strong move for Cialis,” Malek said, noting that Levitra will likely be in late-stage testing, as it’s not yet in Phase III trials.

The little blue pill has been on the market for more than a decade, with men who took it regularly for a few years getting erections. It’s been in use for about five years, according to Pfizer, which filed a lawsuit against Bayer in October 2009.

The drugs are similar to Levitra in how they work, and they’re generally prescribed to men who have low blood pressure or heart failure, Malek said.

Levitra’s active ingredient is vardenafil, which is the generic version of Viagra. It’s designed to help men who are unable to achieve or maintain an erection because they don’t have enough blood in them to pump blood throughout the body. The drug was first approved by the FDA in 1990.

Levitra was the first drug approved to treat erectile dysfunction, and it’s the only drug to get in the market since.

“I think it will be a game-changer in the sexual revolution,” Malek said. “It will change how people talk about and act. It will have a big impact in the way people think about sex. It’s going to make it easier for men to get hard and for them to want to get back to their normal sexual habits.”

Levitra is one of the drugs in its class of drugs known as PDE5 inhibitors, which are similar to the class of drugs used to treat erectile dysfunction.

Levitra is also the brand name for sildenafil, the generic version of Viagra. Viagra is similar to the brand name of sildenafil, and it’s designed to help men who have trouble with erections because they don’t have enough blood in them.

Levitra is the brand name for tadalafil, the generic version of Cialis. The drug was first approved by the FDA in 1998 and is designed to treat erectile dysfunction. It’s approved to be taken as needed and is in Phase IIb trials to see if it can get to the market within two to three years.

Levitra is the generic version of Cialis, but it’s also the brand name for Cialis, which works by relaxing the blood vessels in the penis. Cialis is the brand name for tadalafil, which works by increasing blood flow to the penis.

Levitra is an FDA-approved drug that was first approved to treat erectile dysfunction in 1998, but it wasn’t approved until 2006.

“There’s a lot of excitement that’s going to happen, and it’s going to be another month before we get to the ground,” Malek said.

Malek is not the only analyst who believes that Levitra will be a big competitor. He said that Cialis has already done better than Levitra last year, with Cialis getting approved in May of this year.

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.
Definition

C. Drug-Blood Pressure Interactions:

Ketoconazole: K. O. N. antishiremia drug topicals both lower blood pressure and may affect the blood-pressure-lowering effects of Cialis. This may cause a reduction in blood pressure when used with Cialis.

Vardenafil: V. P. Vardenafil is similar to Cialis in side effects like headache, flushing, and nasal congestion. If you need to take the medication multiple times, consult your healthcare provider.

Alpha-Blockers

Proton Pump Inhibitors (e.g., etravirine, lusithate): B. I. E.

Cialis 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 reactions, seek medical attention immediately.

Common side effects reported from Cialis use include:

  • Headache
  • Indigestion
  • Heartburn
  • Upset stomach
  • Gas
  • Nausea
  • Flushing

More severe side effects include:

  • Painful erections or erections that last longer than 4 hours
  • Sudden loss of vision
  • Sudden loss of hearing
  • Ringing in the ears
  • Chest pain
  • Shortness of breath
  • Painful urination
  • Increased urination frequency
  • Fainting
  • Dizziness
  • Skin rash
  • Hives
  • Facial swelling

If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate 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 Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.

Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.

In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.

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