Tadalafil for erectile dysfunction – composition, action, contraindications

Tadalafil is a drug used to treat erectile dysfunction and to treat benign prostatic hyperplasia. It is also used to treat pulmonary arterial hypertension and to improve exercise capacity in adults. It is a component of many prescription medications. What are the indications and contraindications for the use of tadalafil preparations? Can the use of this medicine cause side effects in the patient? How to dose the medicines with the active ingredient tadalalfil?

Tadalafil – general characteristics of the drug

Tadalafil is an organic chemical that belongs to a group of drugs called phosphodiesterase type 5 inhibitors. This substance is an enzyme found in the cavernous bodies of the penis.

Tadalafil is a component of preparations that are usually used by patients suffering from erectile dysfunction. After sexual stimulation, tadalafil helps the blood vessels of your penis to relax, allowing blood to flow to your penis. As a consequence, the erection improves.

There are several preparations available on the pharmaceutical market that contain this active ingredient. Some of these preparations have the same name as the active substance. In order to distinguish between them, the name of the entity responsible for the production and distribution of the drug is usually added to the term tadalafil. Thus, the following preparations are available on the market:

1. Tadalafil Aurovitas in coated tablets – the manufacturer is Aurovitas Pharma. 28 tablets of 5 mg cost about PLN 95;
2. Tadalafil Belupo in coated tablets – the manufacturer is Belupo. 4 tablets of 20 mg cost about PLN 63;
3. Tadalafil Maxigra in coated tablets – the manufacturer is Polpharma. 2 tablets of 10 mg cost about PLN 30;
4. Tadalafil Maxon in coated tablets – the manufacturer is Adamed. 4 tablets of 10 mg cost about PLN 46;
5. Tadalafil Mylan in coated tablets – the manufacturer is Mylan;
6. Tadalafil SUN in coated tablets – the manufacturer is Sun Pharmaceutical Industries. 4 tablets of 20 mg cost about PLN 32;
7. Tadalafil Teva in coated tablets – the manufacturer is Teva Pharmaceuticals Polska. 4 tablets of 20 mg cost about PLN 55.

In addition, tadalafil is a component of preparations under a different name. These preparations are:

1. Adalift in coated tablets – the manufacturer is Adamed. 4 tablets of 20 mg cost about PLN 64;
2. Cialis in coated tablets – the manufacturer is Eli Lilly. 4 tablets of 20 mg cost about PLN 270;
3. Erlis in coated tablets – the manufacturer is Polpharma. 4 tablets of 20 mg cost about PLN 40;
4. Menero WITH in coated tablets – the manufacturer is Hasco-Lek. 4 tablets of 5 mg cost about PLN 33;
5. Profit song in coated tablets – the manufacturer is Aflofarm Farmacja Polska. 4 tablets of 20 mg cost about PLN 33;
6. Tadamen in coated tablets – the manufacturer is Mylan. 2 tablets of 10 mg cost about PLN 36;
7. Tadaxin in coated tablets – the manufacturer is Synoptis Pharma. 4 tablets of 10 mg cost about PLN 30.

Of the above-mentioned preparations only Tadalafil Maxigra is available in pharmacies without a prescription.

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Tadalafil – action and auxiliary substances

Tadalafil is an ingredient of the preparations listed in the previous part of this article. It is an inhibitor of phosphodiesterase type 5. Depending on the selected preparation, the content of the active substance may vary. Usually, one film-coated tablet contains 5, 10 or 20 mg of tadalafil.

In order to understand the mechanism of action of tadalafil, it is necessary to take a closer look at the processes that take place in the corpora cavernosa of the penis as a result of sexual arousal. Well, as a result of sexual arousal, nitric oxide is released in the corpora cavernosa of the penis. Nitric oxide, in turn, activates the enzyme guanylate cyclase, which increases the concentration of cyclic guanosine monophosphate. This process causes the relaxation of smooth muscles in the corpora cavernosa, which affects the possibility of blood flow to the penis. This in turn results in an erection of the penis. Cyclic guanosine monophosphate is degraded in the corpus cavernosum, mainly by type 5 phosphodiesterase.

As a result of the inhibition of phosphodiesterase type 5, the concentration of cyclic guanosine monophosphate increases. As a result, smooth muscles contract in the corpora cavernosa, followed by the inflow of blood to the corpora cavernosa ending with an erection.

The substance that selectively inhibits this enzyme is tadalafil. Since this medicine does not increase the production of cyclic guanosine monophosphate but only inhibits its breakdown, it can only cause an erection if you are sexually aroused.

Tadalafil is rapidly absorbed after oral administration. The time after which the concentration of the drug in the plasma is highest is approx. 2 hours and is not dependent on the presence of food. The onset of action is 16–30 minutes after tablet intake and lasts for 12–36 hours. The drug is practically absent in the semen of healthy people. Tadalafil is metabolised in the liver and excreted mainly in the faeces as metabolites and to a lesser extent in the urine.

The excipients vary depending on the formulation selected. Therefore, it is worth reaching for the leaflet of a specific drug and choose the one that is safest for the patient’s health. This applies especially to any hypersensitivity and allergy to additional ingredients.

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Tadalafil – indications for use

Tadalafil is used to treat benign prostatic hyperplasia, erectile dysfunction, to treat pulmonary arterial hypertension, and to improve exercise capacity in adults. Tadalafil is also used in patients with pulmonary arterial hypertension associated with collagen vascular disease.

It helps the blood vessels in the lungs to relax, which improves blood flow to the lungs. The result is an improvement in the ability to be physically active.

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Tadalafil – contraindications to use

Hypersensitivity to any of the ingredients of the preparation is a contraindication to taking Tadalafil.

The drug is not given to patients after a recent heart attack. It is also not indicated in case of arterial hypotension. Tadalafil must not be administered to people who have lost sight in one eye due to ischemic non-arterial optic neuropathy. Tadalafil must not be used in patients treated with nitric oxide donors.

Contraindication to taking tadalafil is also a stroke within the last 6 months and heart failure, arrhythmias and uncontrolled arterial hypertension.

Before administering the drug with tadalafil to a patient with erectile dysfunction, the patient’s condition should be carefully assessed and the dose of antihypertensive medication determined, if necessary.

Tadalafil is not recommended for use in people with defects in the heart valves (mitral and aortic valves) and with liver failure. Tadalafil is not intended for women. Especially pregnant and breastfeeding women should not take it.

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Tadalafil – precautions

Before using the drug containing tadalafil, read the precautions contained in the package leaflet.

Precautions to be aware of:

1. allergic reactions may occur in people who are allergic to any component of drugs with tadalafil;
2. tadalafil may interfere with the health of the patient with other medications taken by him, therefore you should inform your doctor about all medications you are taking, including those available without a prescription;
3. the drug should be stored at room temperature, out of the sight and reach of children;
4. tadalafil may cause visual disturbances and dizziness, therefore patients taking this medicine should, in principle, not drive or operate machinery. Only if there are no such side effects of Tadalafil treatment, you can carry out these activities.

In addition, before taking any medicine containing tadalafil, patients should inform their doctor if they have any of the following:

1. any heart problems other than pulmonary hypertension;
2. blood pressure problems;
3. any hereditary eye disease;
4. sickle cell anemia (an abnormality of red blood cells);
5. multiple myeloma (cancer of the bone marrow);
6. leukemia (cancer of the blood cells);
7. any distortion of a member;
8. severe liver diseases;
9. severe kidney disease.

In addition, it is not known if tadalafil is effective in patients who have undergone pelvic surgery, complete or partial removal of the prostate, in which nerves in the prostate are cut.

Deterioration or sudden loss of hearing has been reported in some patients taking tadalafil. Although it is not known whether the event is directly related to the effects of tadalafil, if you experience deterioration or sudden loss of hearing, you should stop taking the preparation and contact your doctor immediately.

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Tadalafil – dosage and method of use

The dosage of Tadalafil is determined by your doctor. For the treatment of erectile dysfunction, the usual starting dose is 10-20 mg and increased as needed.

The tadalafil preparation can be taken at least 30 minutes before planned sexual activity. Also note that the drug may still be effective up to 36 hours after taking the tablet.

You should not take tadalafil more than once a day. It is also not recommended to take the drug on a daily basis. It is important to be aware that tadalafil medications do not work in the absence of sexual stimulation. The patient and his partner should arrange foreplay, just as if the patient is not taking erectile dysfunction medication. Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, do not drink large amounts of alcohol as this may increase the risk of dizziness when standing up.

For the treatment of pulmonary arterial hypertension, tadalafil is administered as a 20 mg tablet. The usual dose is two 20 mg tablets once a day. Take both tablets at the same time, one after the other. If you have mild or moderate liver or kidney problems, your doctor may only advise you to take one 20 mg tablet a day.

The drug is intended for adults. There is no need to modify (reduce) the dose for the elderly and diabetics.

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Tadalafil – possible side effects

The drug with tadalafil, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

Tadalafil can cause a number of side effects, especially in patients whose general health is not the best. The most serious are vision impairment, even loss of vision, sudden pressure spikes and problems with the cardiovascular system. Should any of these symptoms occur, discontinue use of the drug immediately and consult a physician.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common side effects of taking the drug with tadalafil These include headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon side effects occurring after taking the drug with tadalafil are dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the esophagus (reflux), blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare side effects occurring with the use of the drug with tadalafil These include fainting, seizures and temporary loss of memory, swollen eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the surface of the skin), bleeding from the penis, blood in semen and increased sweating.

Myocardial infarction and stroke have been reported rarely in men taking tadalafil. Most of these men had heart problems before taking this drug. Partial, transient or permanent decrease or loss of vision in one or both eyes has been reported rarely.

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include migraine, swelling of the face, severe allergic reaction which causes swelling of the face or throat, severe skin rashes, certain problems affecting blood flow to the eyes, irregular heartbeat, angina pectoris and sudden cardiac death.

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Tadalafil – interactions with other drugs

Before starting treatment with tadalafil, please inform your doctor or pharmacist about all the medicines you are taking or have taken recently. You should also inform what medications the patient plans to take in the near future.

First of all, remember that you must not take medications with tadalafil if you are taking nitrates.

Please tell your doctor or pharmacist if you are taking the following medicines:

1. bosentan – another drug used in the treatment of pulmonary arterial hypertension;
2. nitrates – to treat chest pain;
3. an alpha-adrenergic blocker – used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia;
4. other medicines to treat high blood pressure;
5. riocyguat;
6. 5-alpha reductase inhibitors – used to treat benign prostatic hyperplasia;
7. medications such as ketoconazole tablets – used to treat fungal infections;
8. inhibitory proteazy used to treat AIDS or HIV infection;
9. phenobarbital, phenytoin and carbamazepine – anticonvulsants;
10. rifampicin, erythromycin, clarithromycin or itraconazole;
11. iother methods of treatment erectile dysfunction.

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