Is Tadalafil Safe ?

Background

Tadalafil (Cialis) was one of the first waves of treatments to be approved for the treatment of erectile dysfunction and has been used by men across the world for over a decade with excellent results. Eli Lily was the original manufacturer of Cialis and developed a patent on the product in 1997. Originally Cialis was used for the treatment of heart disease, but during clinical trials, it was noticed that it also helped treat erectile dysfunction. In May 2002, the first reports regarding the efficacy and duration of action of tadalafil for erectile dysfunction were presented at the 97th Annual Meeting of the American Urological Association (AUA) in Orlando, Florida, USA.
In 2003,  Eli Lilly received FDA approval to license the product for the treatment of erectile dysfunction. The drug is similar to Viagra in many ways and belongs to the same class of drugs known as PDE-5 inhibitors.
Tadalafil offers many advantages over Viagra including how quickly the drug takes to work and the length of time. Tadalafil was approved for use in Europe in late 2002.

 

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Tadalafil: a generic version

In 2017, the Eli Lilly patent on Cialis ended in the EU, allowing generic manufacturers to start producing their own version. The generic version of the drug is known as tadalafil which is the active ingredient in Cialis.
Tadalafil is a generic drug which means that its price is not controlled by a single manufacturer. Since several manufacturers produce tadalafil, the market is very competitive which has helped drive down the price substantially.
Tadalafil has been proven to be a very effective treatment for erectile dysfunction with over 80% of men finding it works for them. Although it has been proven to be very effective, it is not without its side effects and alternatives.

 

Administration

Tadalafil may be orally administered with or without food. Do not split tablets; the entire dose should be taken.
Recommended starting doses of tadalafil are 10 mg for as required dosage, taken as needed 15-30 minutes before sexual activity (but not more than one in any 36 hour period). The dose may be increased to 20 mg, per its efficacy and the man’s personal tolerance of the drug.1

The recommended starting dose for the once a day medication is 2.5mg which may be increased to 5mg

 

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Cialis & Tadalafil (As Needed)

£16.98£260.00

Cialis works in a similar way to Viagra and is quicker acting and lasts longer. It can be taken when needed, 30 minutes before intercourse.

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Product Description

About Cialis

At least one in ten men has trouble getting an erection at some time. Cialis helps men to get and maintain an erection when sexually stimulated and/or excited. The medicine relaxes the blood vessels in the penis which results in more blood flowing to the penis. It reduces the action of the natural chemical in your body that makes erections go away.

How to take it?

You should take Cialis at least 30 minutes before intercourse. Cialis remains effective for 36 hours, meaning it will be easier to keep and maintain an erection when you are sexually excited. It doesn’t matter if you take this medicine with or without food; food has no impact on its effectiveness.

This medicine will only work when you’re sexually excited. You won’t get an erection just by taking Cialis.

What dose should I take?

The recommended starting dose for Cialis is 10mg tablets. If this dose is not effective you can try 20mg tablets. A maximum of one tablet should be taken in 24 hours, however it’s not recommended to take either the 10mg or 20mg tablet every day.

For patients who anticipate sexual activity at least twice weekly, the 5mg “daily” Cialis dose is more appropriate.

Patient Information Leaflet

Always read the patient information leaflet before commencing treatment. The Patient Information leaflets can be found here for 10mg and 20mg dosages.

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Two formulations of Tadalafil

Tadalafil is unique in the fact that it is available in two formulations in the branded version; for daily use and for use as needed.

Tadalafil for daily use (2.5 mg)

  • Take Tadalafil daily;
  • You can attempt sex anytime between doses;
  • No need to plan around a pill;
  • With a 2.5 mg or 5 mg tablet once a day, you may be able to have successful intercourse in as early as 4 to 5 days;
  • Do not take more than one time each day.

Tadalafil for use as needed (10 mg, 20 mg)

  • Take Tadalafil when you need it;
  • Cialis 20 mg can last for up to 36 hours;
  • A 20 mg dose works in as little as 30 minutes in some men;
  • Do not take more than one time each day.

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What is erectile dysfunction?

Erectile dysfunction is the inability to achieve and maintain an erection sufficient to permit satisfactory sexual intercourse.
Affecting 150 million men worldwide, erectile dysfunction is growing rapidly, and its prevalence is expected to double to greater than 300 million men worldwide over the next 20 years. According to data extrapolated from the Massachusetts Male Aging Study, the incidence of erectile dysfunction is increasing at an astronomical rate, with an expected incidence of over 600,000 new cases per year in white men aged 40 to 69 alone.
The condition can be difficult for a man to deal with because it can cause embarrassment and insecurity due to an inability to perform sexually.
Fortunately for men with ED, there are a number of medications, treatments, and therapies that may prevent ED from becoming a long-term condition.
Continuing to engage in sexual activities is beneficial for the individual with penile erection problems because sexual activities can lead to partial erections and may have a positive impact on erectile dysfunction. The increased blood flow to the penis stimulates and improves the penile function.

 

What causes erectile dysfunction? 

  • Hormonal issues;
  • Nerve damage;
  • Medication side effects;
  • Poor blood flow to the penis;
  • Peyronie’s disease;
  • Psychological and emotional issues;
  • Obesity;
  • Chronic stress;

 

 

 

How Tadalafil works

In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.

 

Duration of action

The half-life of tadalafil is 17.5 hours in normal healthy men and 21.6 hours in elderly men, while the half-lives of sildenafil and vardenafil are the same at 4 hours. This longer half-life provides a therapeutic window of 36 hours for tadalafil.5
The prolonged half-life of tadalafil is due to the low volume of distribution, slow hepatic clearance, and approximately 80% bioavailability.

 

Is Tadalafil Safe?

Tadalafil is a safe medication.
Integrated analysis of data from phase III trials demonstrated that tadalafil, at doses from 5 mg to 20 mg versus placebo, significantly improved erectile function (EF) by all measures. In particular, 50%–65% of patients, regardless of erectile dysfunction severity at baseline, returned to normal erectile function with almost 60%–90% of success rate at intercourse attempts during active treatment.
In the “eleven trials analysis”, adverse events leading to study discontinuation were reported for 3.2% of patients taking tadalafil 20 mg, 1.6% of patients taking tadalafil 10 mg and 1.3% of patients on placebo. Respectively, 51%, 58%, and 39% of the subjects experienced at least one or more unwanted symptoms. Side-effects were generally mild to moderate and decreased in frequency during continued treatment. While no significant laboratory changes were assessed, the most common treatment-emergent adverse events were headache (15%, 12%, 5% respectively), dyspepsia (8%, 7%, 1% respectively), back pain/myalgia (8%, 11%, 3% respectively), nasopharyngitis and nasal congestion (4%, 11%, 5% respectively), flushing
(3%, 3%, 1% respectively), pain in limb (3%, 3%, 1% respectively).
Subgroup analyses have revealed no differences between incidences of adverse events in tadalafil-treated men over 65 years compared with the younger group. No relevant differences in the frequency and pattern of side-effects have been reported when tadalafil was administered on schedule (eg, three times per week, or daily).
As with every PDE5 inhibitor, tadalafil is absolutely contraindicated with nitrate medications for angina pectoris secondary to the potentiated hypotensive effect the drugs can have together. Because of the longer half-life, treatment with nitrate medications must be deferred for at least 48 hours after ingestion of tadalafil, compared with 24 hours for sildenafil and vardenafil.

 

Missed ‘Daily’ Dose


If you take this medication on a regular schedule and you miss a dose, take it as soon as you remember. If it is near the time for the next dose, skip the missed dose and resume the usual dosing schedule.
Do not double the dose to catch up.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • Heart problems (heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure);
  • Stroke in the past 6 months;
  • Liver disease;
  • Kidney disease;
  • High or low blood pressure;
  • A severe loss of body water (dehydration);
  • Penis conditions (angulation, fibrosis/scarring, Peyronie’s disease);
  • History of painful/prolonged erection (priapism);
  • Conditions that may increase the risk of priapism (such as sickle cell anaemia, leukaemia, multiple myeloma);
  • Bleeding disorders;
  • Eye problems (such as sudden decreased vision);
  • Active stomach ulcers.

 

Prolonged erection

There have been rare cases of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue.
Patients having an erection lasting more than 4 hours, whether painful or not, should seek emergency medical attention. Tadalafil should not be used in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), or in patients with anatomical penile deformity (such as angulation, cavernosal fibrosis, or Peyronie’s disease).

 

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Drug interactions

  • In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates.
  • Alpha-blockers. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including tadalafil, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.
  • PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo.
  • Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including an increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

 

Overdose

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.9

 

Pharmacokinetics

  • Absorption. Tadalafil has the slowest absorption of the available PDE5 inhibitors with a mean of 2 hours to reach its maximum concentration, compared with about 50 minutes for sildenafil and vardenafil. The onset of action of tadalafil may occur in as early as 15 minutes of dosing, although successful erections occur in fewer than 40% of men at this time point. The absolute bioavailability of tadalafil following oral dosing has not been determined.10
  • Excretion. The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy subjects. Tadalafil is excreted predominantly as metabolites, mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).

 

What Are The Possible Side Effects of Tadalafil?

  • Indigestion;
  • A headache;
  • Muscle aches;
  • Back pain;
  • Flushing;
  • Stuffy or a runny nose.

These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

 

What should I avoid while taking Tadalafil?

Drinking alcohol with this medicine can cause side effects.
Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects.
Grapefruit juice inhibits the body’s absorption of the medication. The substances in the juice that do this are called furanocoumarins. They activate one of the body’s naturally-produced drug efflux mechanisms, known as P-glycoprotein, located in the intestinal tract. When grapefruit juice interacts with P-glycoprotein, the result is an increased likelihood that certain drugs will be stopped from entering the bloodstream. Tadalafil is, therefore, less effective when grapefruit juice is present in the body. Avoid the use of grapefruit products while taking this medicine.

 

Stop using Tadalafil and call your doctor at once if you have:

  • A light-headed feeling, like you might pass out;
  • An erection painful or lasting longer than 4 hours (prolonged erection can damage the penis);
  • Vision changes or sudden vision loss;
  • Ringing in your ears or sudden hearing loss;
  • Heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

 

 

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What Tadalafil does not do:

  • Tadalafil does not cure erectile dysfunction. It is a treatment for erectile dysfunction;
  • Tadalafil does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency Virus;
  • Tadalafil has only been approved for use in adult men, and therefore should not be taken by women or children.

 

How do I decide whether the daily tablets or as needed tablets will be most suitable for me?

If you are likely to have sex three or more times a week or are in a long-term relationship, the daily dose may be the best option for you. Many patients and their partners dislike the necessity of on-demand treatment for erectile dysfunction, citing a desire for greater spontaneity with sexual interactions.
If you feel you don’t need erectile dysfunction medication every time or you have sex less regularly then the as needed dose may be the best option. The 20 mg dose can be effective for up to 36 hours after its taken so is popularly known as the ‘The Weekender’. So if it is taken on Friday evening it could be effective until Sunday morning. It should be noted that efficiency of tadalafil does not decrease even after long-term use. There are many men who use it regularly for a long time and it works well each time. So, a regular tadalafil dosage does not usually require a dosage increase.

 

Can I order it online?

Yes, by addressing directly to our pharmacy and to our doctor on our website or on phone number 01625 460 621.

Tadalafil can be released following a short screening or a questionnaire provided by our physician. An evaluation from our pharmacist is necessary to confirm if Tadalafil is the appropriate medicinal product for you.

It is recommended for any man suffering from erectile dysfunction to consider lifestyle changes first and talk to a doctor before starting new medications, or any other remedies, or stopping a prescription medication that was listed as causing erectile dysfunction.

 

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References

  1. Robert M Coward and Culley C Carson. Tadalafil in the treatment of erectile dysfunction;
  2. https://www.drugs.com/ppa/tadalafil.html;
  3. Samuel L Washington and Alan W Shindel. A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy;
  4. https://www.webmd.com/drugs/2/drug-77875/tadalafil-oral/details;
  5. Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Porst H, Padma-Nathan H, Giuliano F, Anglin G, Varanese L, Rosen R. Urology. 2003 Jul; 62(1):121-5; discussion 125-6;
  6. Samuel L Washington and Alan W Shindel. A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy;
  7. The efficacy and safety of tadalafil: an update. Carson CC, Rajfer J, Eardley I, Carrier S, Denne JS, Walker DJ, Shen W, Cordell WH. BJU Int. 2004 Jun; 93(9):1276-81;
  8. Giovanni Vanni Frajese, Flavio Pozzi, and Gaetano Frajese. Tadalafil in the treatment of erectile dysfunction; an overview of the clinical evidence;
  9. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf;
  10. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins V, Anglin G, Whitaker S J. Urol. 2002 Oct; 168(4 Pt 1):1332-6.

 

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]