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Tadalafil 20 mg film-coated tablets

Consequently, the incidence of the adverse reactions listed in section 4.8 might be increased.

Tadalafil Sublingual Tablets 20mg

Apcalis SX – Tadalafil pills, released by Ajanta in 20mg dosage. Being equal to Cialis by an outcome and the way of an action, this innovative medical mean is also directed at enhancing the hardness of the male sexual organ and reducing the period on the restoration of the male potency after the sexual act.

Brand Cialis improves erection and helps to achieve a successful sexual intercourse. It is the original medication, intended for use in adult men, who have problems with achieving and maintaining an erection. The pills start acting in 30 to 60 minutes. You can benefit from their effects for up to 36 hours. Therefore, you can take the pills on Saturday evening and enjoy a wonderful weekend, full of sex and pleasant emotions both for you and your partner. The active substance is Tadalafil.

Cialis is a latest medicine for treatment of disturbances of erection at men. Sialis’s feature is its high-speed performance (30 minutes) and a long-term effect (up to 36 hours). In this regard you can choose the moment which is most suitable for sexual intercourse, having accepted a drug in advance. It is possible to take Sialis in the morning and to be ready even next day. Active ingredient – Tadalafil, the recommended dosage – 20 mg.

Tadalafil contains the same active ingredient as Cialis (tadalafil) and is a cheaper, reliable ED treatment that lasts up to 36hrs.

Cialis Oral Jelly is a new form of medcine which is so popular among a great number of men, a wonderful drug for quick improvement of potentiality and, as a result, a longer and more sensual sexual intercourse. It has the gel form. It is made in wide assortment of pleasant tastes, everyone will find what he likes. It is possible not to wash down the medicine, to dissolve it in a drink, but not in a strong beverage. And its action is about 36 hours!

Cialis Oral Jelly (Orange) – a new formula of Cialis which you can have, without washing down with water. Against background of ordinary drug it differs in increased influence speed. It is prescribed for improvement of sexual endurance of men during intimate proximity. It simplifies the excitative process of penis and strengthens erection. Noticeably increases duration of sexual intercourse. Besides, the drug possesses a pleasant orange flavor.

Tadalafil Oral Strips are based on the Tadalafil 20 mg, the active component that provides the 36 hours effect.

Cialis Professional – effective tablets for improvement of erection. They begin to work in 15 minutes from the moment of taking and actions for 36 hours. They can cause not less than 10, but no more than 16 erections. The medicine increases duration of sexual intercourse. The tablets are successfully used for reduction of time for recovery of erection after ejaculation.

Cialis Soft Tabs differs from a usual tablet of Cialis in the fact that its action comes quicker. Cialis Soft is chewed and dissolved under a tongue that allows to reach a required effect in 10-15 minutes. Important. Cialis Soft is compatible to alcohol and greasy food!

Cialis Super Active is a generic drug, against erectile dysfunction, containing 20 mg of tadalafil. The tablets in this series have a gel inside. This form allows the active substance, Tadalafil, to immediately enter the blood, thus providing an immediate effect. The result from the Cialis Super Active tablets appears after 5 minutes! The action lasts for two days. The drug is safe and has virtually no contraindications.

Cialis with Dapoxetine – a combination of 2 ED preparations. Thanks to the complex solution combining the two most active elements, Tadalafil plus Dapoxetine, this remedy eliminates several problems associated with poor male potency: a flaccid erection and too early ejaculation.

Dulcolax – purgative. Causes irritation of the receptor of bowels, exerts direct impact at mucous membrane of intestines, strengthening its peristaltics and increasing secretion of slime in a large intestine. It is effective at hypotonic and colonic inertia for regulation of fecal matter. Sometimes it is taken at preparation for surgeries, instrumental examinationand and radiological researches.

ED Trial Pack (2 Viagra + 2 Cialis + 2 Levitra) – a trial set consists of six tablets, for those who want to understand what medicine is better for him. Includes 6 tablets (by 2 pсs.): Viagra, Cialis and Levitra. It can be taken by people older than 18 years, in case of problems in private life related to fatigue, stress, sleep debt, slow-moving way of life and abuse of addictions.

Female Cialis – Cialis for women – the drug, intended for strengthening of sexual feelings at women who feel discomfort during a sexual intercourse. It causes a high-level excitation in 10-15 minutes after taking of a tablet and keeps efficiency within 36 hours. The drug works due to natural excitement of reproductive system, reacts at tactile proximity. Increases blood circulation of small pelvis, thereby improves secretion of vulval muscles. Increases release of lubricant at sex. Sensitivity of erogenous zones improves.

Forzest is one of the best erectile dysfunction drugs. Sildenafil Citrate, Tadalafil, Vardenafil, Avanafil, Dapoxetine, and other active components provoke a hard and stable erection. Forzest contains 20 mg of Tadalafil that relaxes blood vessels. Thanks to that the blood can easily stream to the genitals and cause enough pressure to make the penis erect. The drug can be also used to treat other diseases like pulmonary hypertension and diabetes.

Levitra with Dapoxetine – a mixture of Levitra 20 mg with Dapoxetine 60 mg, often called Super Vilitra, which principal parts dilate the vessels, influence on the tissues of the small pelvis, better the hardness of the penis muscles, making erection more real and become the obstacle to a rapid ejaculation.

Sildalist – sildenafil plus tadalafil tablet, a preparation manufactured by Cipla Inc. One red colored rectangular pill is equivalent to 1 pill of sildenafil100mg and 1 pill of tadalafil 20mg mixed together. This is the most potent product to stop erectile malady. The task of Sildalist tablets is to make penis ready for a sex as soon as the user comes into a state of sexual arousal.

Super ED Trial Pack (6 Viagra + 6 Cialis + 6 Levitra) – a set sampler of Super ED Trial Pack generics which was created at numerous requests of customers. The set comprises 6 tablets (of big popularity) for solution of men’s intimate problems. The set consist of: Viagra 100 mg, Cialis (20 mg) and Levitra (20 mg) that is production of well known Indian companies. All medicine of the Super ED Trial Pack set contain optimum doses of active agent and therefore you can take it for several times. Besides, it is quite possible to save money, having divided each tablet into parts.

Tadacip – an Indian brand, whose main chemical element is tadalafil, which is also a principal part of Cialis pills. It’s been created by Cipla Ltd. with a more lucrative cost in comparison to Cialis made by the brand-maker Eli Lilly.

Tadalis SX – a marvelous Indian brand from Ajanta, which is used to get rid of sexual disorders in the stronger sex. Based on the same main ingredient as the famous Cialis, Tadalis SX provides the man with a sexual strength and stamina for all 36 hours.

Tadapox includes two medications combined for an even more effective approach of the problem of erectile dysfunction. The first one, Tadalafil, is a mighty restorative agent that reverses a male’s inability to achieve a satisfyingly firm erection. The second component, Dapoxetine, handles the other side of clinical impotency that shows as untimely ejaculation. Tadapox successfully manages said issues in populations of patients from 18 to 64 years of age. Its unique mix of therapeutic characteristics helps men revitalize their sexual function in a comparatively short time.

Tadora is a relatively new medicine designed for prevention of the erectile failure. It contains the same active ingredient as the majority of other drugs used in current medicinal practice – Tadalafil, though its mechanism of action is not identical. The main difference, which is simultaneously the main advantage of the medicine, is its prolonged half-life. It is often called a “weekend pill” because it may work for 36-48 hours, creating favorable conditions for a normal intercourse. It can be recommended for men suffering from various forms of impotence, especially those requiring prolonged therapeutic action.

Tadalafil 20 mg film-coated tablets

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Last updated on emc: 06 Apr 2022

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  • 1. Name of the medicinal product
  • 2. Qualitative and quantitative composition
  • 3. Pharmaceutical form
  • 4. Clinical particulars
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Fertility, pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. Pharmacological properties
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. Pharmaceutical particulars
  • 6.1 List of excipients
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. Marketing authorisation holder
  • 8. Marketing authorisation number(s)
  • 9. Date of first authorisation/renewal of the authorisation
  • 10. Date of revision of the text

This information is intended for use by health professionals

Each film-coated tablet contains 20 mg tadalafil.

Each 20 mg film-coated tablet contains 367.584 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Yellow, capsule shaped, approximately 14.3 mm in length and 7 mm in width, biconvex, bevelled edged, film coated tablet, debossed with “T 20” on one side and plain on other side.

Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

It is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).

Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of Tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil tablets might be considered suitable, based on patient choice and the physician’s judgement.

In these patients, the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.

The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.

Dose adjustments are not required in elderly patients.

Adult men with erectile dysfunction: Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose for on-demand treatment.

Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended. (see sections 4.4 and 5.2).

Adult men with erectile dysfunction: For the treatment of erectile dysfunction using on-demand Tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.

Once-a-day dosing of tadalafil for the treatment of erectile dysfunction has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation must be undertaken by the prescribing physician. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended. (see sections 4.4 and 5.2).

Adult men with erectile dysfunction: Dose adjustments are not required in diabetic patients.

There is no relevant use of Tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.

The safety and efficacy of tadalafil in the paediatric population has not yet been established. Currently available data are described in section 5.1.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contraindicated (See section 4.5).

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:

– patients with myocardial infarction within the last 90 days,

– patients with unstable angina or angina occurring during sexual intercourse,

– patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

– patients with uncontrolled arrhythmias, hypotension (< 90/50mmHg), or uncontrolled hypertension,

– patients with a stroke within the last 6 months.

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.

Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1), and as such potentiates the hypotensive effect of nitrates (see section 4.3).

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.

Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.

The following groups of patients with cardiovascular disease were not included in PAH clinical studies:

– Patients with clinically significant aortic and mitral valve disease

– Patients with pericardial constriction

– Patients with restrictive or congestive cardiomyopathy

– Patients with significant left ventricular dysfunction

– Patients with life-threatening arrhythmias

– Patients with symptomatic coronary artery disease

– Patients with uncontrolled hypertension.

Since there are no clinical data on the safety of tadalafil in these patients, the use of tadalafil is not recommended.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended. Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.

Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure. Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.

In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5). The combination of tadalafil and doxazosin is not recommended.

Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil and consult a physician immediately (see section 4.3).

Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.

Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of Tadalafil is not recommended in patients with severe renal impairment.

There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh class C). If Tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.

Priapism and anatomical deformation of the penis

Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia).

Use with CYP3A4 inducers or inhibitors

Caution should be exercised when prescribing Tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).

Tadalafil and other treatments for erectile dysfunction

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil in such combinations.

The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies. Therefore, caution is recommended in case of co-administration.

The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).

Tadalafil contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Effects of other substances on tadalafil

Tadalafil is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax. Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be co-administered with caution, as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).

Consequently, the incidence of the adverse reactions listed in section 4.8 might be increased.

The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known. Therefore, there is the potential of drug interactions mediated by inhibition of transporters.

P-glycoprotein substrates (e.g. digoxin)

Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.

A CYP3A4 inducer, rifampicin reduced tadalafil AUC by 88 %, relative to the AUC values for tadalafil alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil.

Endothelin-1 receptor antagonists (e.g. bosentan)

Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration. The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1). Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.

The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.

Effects of tadalafil on other medicinal products

In clinical studies, tadalafil (5 mg, 10 mg and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3). Based on the results of a clinical study in which 150 subjects received daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of Tadalafil (2.5 mg to 20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadalafil before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

Anti-hypertensives (including calcium channel blockers)

The co-administration of doxazosin (4 mg and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner. This effect lasts at least 12 hours and may be symptomatic, including syncope. Therefore, this combination is not recommended (see section 4.4).

In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted.

In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium-channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium-channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg, except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater, although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers -doxazosin see above) is, in general, minor and not likely to be clinically relevant. Analysis of Phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.

Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).

In a clinical trial that compared tadalafil 5 mg co-administered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.

When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction. The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate. Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicinal products.

At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo. There was no statistically significant effect of tadalafil on levonorgestrel which suggests the effect of ethinylestradiol is due to inhibition of gut sulphation by tadalafil. The clinical relevance of this finding is uncertain.

A similar increase in AUC and Cmax seen with ethinylestradiol may be expected with oral administration of terbutaline, probably due to inhibition of gut sulphation by tadalafil. The clinical relevance of this finding is uncertain.

Alcohol concentrations (mean maximum blood concentration 0.08 %) were not affected by co-administration with tadalafil (10 mg or 20 mg). In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol. Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).

Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 mL of 40 % alcohol [vodka] in an 80 kg male) but, in some subjects, postural dizziness and orthostatic hypotension were observed. When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone. The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).

Cytochrome P450 metabolised medicinal products

Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms. Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.

Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

Specific interaction studies with antidiabetic medicinal products were not conducted.

There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil during pregnancy.

Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk. A risk to the suckling child cannot be excluded. Tadalafil should not be used during breast-feeding.

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.

Summary of the safety profile of tadalafil in erectile dysfunction

The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil. The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

Tabulated summary of adverse reactions

The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

Tadalafil Sublingual Troches – Refill Medications Online

American Integrative Pharmacy provides Tadalafil Sublingual Troches. This is a flavored rectangle that is sublingual and dissolves easily under the tongue. It is created to treat Erectile Dysfunction (ED), impotence and can also be a treatment for an enlarged prostate caused from benign prostatic hyperplasia (BPH).

American Integrative Pharmacy (AIP), led by Dr. Neema Yazdanpanah, provides safe and proven compounding medications to patients in Long Beach, Torrance, Los Angeles, South Bay Orange County, Southern California areas, and online nationwide.

Benefits of Tadalafil Troche

Tadalafil can be found in tablet form, but it is best compounded as a troche. This is because as a troche it gets absorbed by the body faster. They are also less costly. Troche is a unique form of dosage that has been in use for several years where drug delivery is concerned. These are small lozenges that dissolve under the tongue (sublingual) or between the gum and cheek within 15 – 30 minutes.

The medication gets directly absorbed through the mouth’s mucus membranes. The drug is effective since the lining of the mouth is thin and has a rich blood supply. This allows the drugs to bypass the digestive system and get absorbed readily within the blood stream. Food in the digestive tract can interfere with absorption of the medication. It can cause the medicine to work at reduced capacities.

Tadalafil – An Overview

Tadalafil is a highly potent medication for the treatment of erectile dysfunction. It has a long effectiveness duration and is in the same class of drugs as sildenafil. It works by increasing the flow of blood to the penile tissues. However, unlike sildenafil, you don’t need to take tadalafil immediately before having sex. You can take it at lower dosages on a daily basis.

Even a single dose of the drug can be effective for as long as 36 hours. The best part is that the drug will promote an erection only when you are sexually stimulated. Tadalafil, because of its long duration, is sometimes also called the “Weekend Pill”.

How Does it Work?

Tadalafil troches inhibits PDE5 enzyme in order to increase blood flow to penile tissues. When PDE5 is inhibited, it relaxes the vascular smooth muscles which controls blood flow in the area. Blood supply to the penis is increased when the vascular smooth muscles are relaxed. This helps in maintaining an erection.

The medication will not work without sexual stimulation. You get to have more choice in initiating sexual activity as compared to sildenafil (active ingredient present in Viagra).

Additional Uses

Tadalafil can also be used for treating pulmonary arterial hypertension besides treating erectile dysfunction. It helps in improving ability to exercise in patients. The drug has long been FDA approved for treating benign prostatic hyperplasis (BPH) and erectile dysfunction under the brand name Cialis. BPH occurs because of issues arising from an enlarged prostate gland which can result in problems with bladder control.

Ingesting Tadalafil Troches

You should place the troche in your mouth and push it as deep as possible between the cheek and the gum. The troche should stay in place between the cheek and the gum. Do not chew or swallow the troche. It doesn’t take more than 15 to 20 minutes on an average for the troche to dissolve.

AIP provides advanced compounding pharmacy solutions, including online prescription refills to patients in Long Beach, Torrance, Los Angeles, South Bay Orange County, Southern California areas, and online nationwide.

Contact Us For More Information about American Integrative Pharmacy’s Online Compound Prescriptions

For more information on compound pharmacy medications available or to make an online prescription purchase, please click here or call Toll Free 1-855-247-7948.

American Integrative Pharmacy is located in Torrance, CA serving residents in and around Orange County, Los Angeles, Long Beach, Lomita and surrounding areas. Online prescription sales are available across the US.

Vidalista Professional 20mg N10 (Tadalafil)

Vidalista Professional contains 20mg of Tadalafil as its active ingredient. Tadalafil is a drug that relaxes smooth muscles in blood vessel walls thus improving blood flow to certain body parts. This action makes the drug efficient in treating men with erectile dysfunction. However, Tadalafil is also used to improve symptoms of benign prostatic pyperplasia, improve ability to exercise of people with pulmonary arterial hypertension.

Tadalafil belongs to a class of drugs called PDE5 inhibitors. It works in treating erectile dysfunction by inhibiting the action of PDE5 to prevent breakdown of cGMP in the penis. Increased levels of cGMP lead to smooth muscle relaxation thus increasing blood flow to produce an erection. Vidalista helps men get and maintain erections during sexual stimulation. However, it does not cure erectile dysfunction nor it increases a man’s libido. This drug does not prevent pregnancy and the spread of sexually transmitted diseases.

Manufacturer

Vidalista Professional is manufactured by Centurion Laboratories Ltd.

Dosage

The dosage of this drug will depend on the medical condition to be treated, age of patient, the strength of the drug, among other factors. A physician will determine the right dosage per patient.

A tablet of Vidalista Professional must be placed under the tongue, taken 15 to 30minutes before sexual activity. Sublingual tablets work faster than other tablets as it dissolves and quickly absorbed into the bloodstream sublingually. The effect of the drug starts within 30minutes and lasts for about 36 hours.

This drug may be taken daily or on an as needed basis:

  • Used for erectile dysfunction on an as needed basis, the usual adult dose is 10mg single dose, not more than 1 dose within 24 hours. A tablet is taken 30 minutes before an anticipated sexual activity.
  • For daily use, the recommended adult dose is 2.5mg once a day, taken at same times every day, without regard to the time of sexual activity.

In treating both erectile dysfunction and benign prostatic hyperplasia, the recommended dose is 5mg once daily, taken at same times every day, without regard to the time of sexual activity.

If this drug is taken on a daily basis and a dose is missed, the missed dose must be taken as soon as remembered, but skipped if it’s almost time for the next dose and resume regular dosing schedule. The dose must not be doubled only to make up for a missed dose. The maximum dose of this drug is one tablet per day.

The dose may be adjusted by a physician, depending on the response to the treatment.

Side effects

Common side effects of Vidalista Professional include:

  • headache,
  • nausea,
  • sinus pain,
  • nasal congestion,
  • muscle pain,
  • sore throat and diarrhea,
  • indigestion or heartburn,
  • flushing, cough.

A health care professional must be contacted if these side effects persist or become worse.

Use of Vidalista Professional must be stopped and health care professionals must be notified right away for any of the following serious side effects:

  • Ringing in the ears or sudden loss of hearing
  • Vision changes like blurring of vision, having a blue tinge on objects or difficult in telling blue and green colors apart
  • Irregular heartbeat
  • Seizure
  • Lightheadedness
  • Swelling of hands, ankles, feet
  • Sudden vision loss
  • Heart attack symptoms including chest pain, pain spreading to jaw, shoulder or left arm, nausea and sweating
  • Painful erection or erection lasting more than 4 hours, which can cause further damage to the penis
  • Signs of allergic reaction including hives, trouble breathing and swallowing, swelling of face, throat, lips, tongue

Vidalista Professional can reduce blood flow to the optic nerve of the eye that may result in sudden loss of vision which becomes permanent in some cases. People with pre-existing eye problems and risk factors for disorders of blood vessels may be at risk from this effect.

Consult a health care professional for more Vidalista Professional side effect information.

Contraindications

Vidalista Professional must not be taken by those with known allergy to the active ingredient Tadalafil, and all the tablet’s inactive ingredient.

This drug must not be used together with drugs that treat pulmonary arterial hypertension like Riociguat. Use of nitrate drugs including drugs for heart problems and recreational drugs, is also contraindicated as it may cause a serious sudden decrease in blood pressure.

Men advised to avoid sexual activity due to medical reasons must not use Vidalista Professional.

Warnings and Precautions

To make sure Vidalista Professional is safe for use, health care professionals must be informed of any of the following medical conditions:

  • Heart attack in the past 90 days
  • History of stroke or congestive heart failure in the past 6 months
  • Heart disease or problems with heart rhythm
  • Liver or kidney disease
  • Blood cell disorder
  • Bleeding disorder
  • Stomach ulcer
  • Retinitis pigmentosa
  • Deformity of penis

Vidalista Professional may also interact with other medications and herbal products such as, but not limited to:

Tadalafil may be used for pulmonary arterial hypertension in men and women. This drug is under Pregnancy Category B meaning no fetal harm is observed in animal studies and no adequate studies in humans. It is unknown if the drug passes into human breast milk. This drug may be used by pregnant and breastfeeding women only if a physician has outweighed benefits over risks.

Vidalista Professional and Alcohol

Consuming large amounts of alcohol when taking Vidalista Professional may increase the chances of experiencing side effects such as headache, dizziness, low blood pressure and fast heartbeat. Drinking alcohol while using this drug is not recommended.

Vidalista Professional and Grapefruit

Consuming grapefruit products must be avoided while taking this drug as it may cause interaction and result in undesirable effects.