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• Dosage of Tadalis SX in details
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Dosage of Tadalis SX in details

Tadalis SX Dosage

Generic name: Tadalis SX 2.5mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Do not split Tadalis SX tablets; entire dose should be taken.

Tadalis SX for Use as Needed for Erectile Dysfunction

• The recommended starting dose of Tadalis SX for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
• Tadalis SX for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of Tadalis SX, this should be taken into consideration.

Tadalis SX for Once Daily Use for Erectile Dysfunction

• The recommended starting dose of Tadalis SX for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The Tadalis SX dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Tadalis SX for Once Daily Use for Benign Prostatic Hyperplasia

• The recommended dose of Tadalis SX for once daily use is 5 mg, taken at approximately the same time every day.
• When therapy for BPH is initiated with Tadalis SX and finasteride, the recommended dose of Tadalis SX for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

Tadalis SX for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of Tadalis SX for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use with Food

Tadalis SX may be taken without regard to food.

Use in Specific Populations

Renal Impairment

Tadalis SX for Use as Needed

• Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.
• Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours.

Tadalis SX for Once Daily Use

Erectile Dysfunction

• Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalis SX for once daily use is not recommended.

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

• Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.
• Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalis SX for once daily use is not recommended.

Hepatic Impairment

Tadalis SX for Use as Needed

• Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of Tadalis SX once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.
• Severe (Child Pugh Class C): The use of Tadalis SX is not recommended.

Tadalis SX for Once Daily Use

• Mild or moderate (Child Pugh Class A or B): Tadalis SX for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if Tadalis SX for once daily use is prescribed to these patients.
• Severe (Child Pugh Class C): The use of Tadalis SX is not recommended.

Concomitant Medications

Nitrates

Concomitant use of nitrates in any form is contraindicated.

Alpha-Blockers

ED — When Tadalis SX is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and Tadalis SX should be initiated at the lowest recommended dose.

BPH — Tadalis SX is not recommended for use in combination with alpha-blockers for the treatment of BPH.

CYP3A4 Inhibitors

Tadalis SX for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalis SX is 10 mg, not to exceed once every 72 hours.

Tadalis SX for Once Daily Use — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg.

More about Tadalis SX (Tadalis SX)

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Professional resources

• Tadalis SX (AHFS Monograph)
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Related treatment guides

• Erectile Dysfunction
• Benign Prostatic Hyperplasia

What other drugs will affect Tadalis SX?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Tadalis SX, especially:

• bosentan;

• imatinib;

• nefazodone;

• St. John's wort;

• an antibiotic--clarithromycin, erythromycin, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart or blood pressure medication--amlodipine nicardipine, quinidine;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

• tuberculosis medication--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with Tadalis SX, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Tadalis SX interactions

5 mg Film-coated Tablet: Interaction studies were conducted with Tadalis SX 10 mg and/or 20 mg, as indicated as follows. With regard to those interaction studies where only the Tadalis SX 10 mg dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Effects of Other Substances on Tadalis SX: Cytochrome P450 Inhibitors: Tadalis SX is principally metabolized by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased Tadalis SX (10 mg) AUC 2-fold and C_max by 15%, relative to the AUC and C_max values for Tadalis SX alone. Ketoconazole (400 mg daily) increased Tadalis SX (20 mg) AUC 4-fold and C_max by 22%. Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased Tadalis SX (20 mg) AUC 2-fold with no change in C_max. Although specific interactions have not been studied, other protease inhibitors such as saquinavir and other CYP3A4 inhibitors eg, erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of Tadalis SX.

Consequently the incidence of the adverse reactions might be increased..

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

Cytochrome P450 Inducers: A CYP3A4 inducer, rifampicin, reduced Tadalis SX AUC by 88%, relative to the AUC values for Tadalis SX alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of Tadalis SX; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of Tadalis SX.

Effects of Tadalis SX on Other Medicinal Products: Nitrates: In clinical studies, Tadalis SX (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Tadalis SX to patientswho are using any form of organic nitrate is contraindicated.

Based on the results of a clinical study in which 150 subjects receiving daily doses of Tadalis SX 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 Tadalis SX dose. Thus, in a patient prescribed any dose of Tadalis SX (2.5 mg-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 Tadalis SX before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

Antihypertensives (Including Calcium-Channel Blockers): The co-administration of doxazosin (4 and 8 mg daily) and Tadalis SX (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 twelve hours and may be symptomatic, including syncope. Therefore, this combination is not recommended.

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 Tadalis SX 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 Tadalis SX to augment the hypotensive effects of antihypertensive agents was examined. Major classes of antihypertensive agents 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). Tadalis SX (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 Tadalis SX (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 medications, Tadalis SX 20 mg may induce a blood pressure decrease, which (with the exception of α-blockers previously mentioned) 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 Tadalis SX with or without antihypertensive medications. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medications.

5-Alpha Reductase Inhibitors: In a clinical trial that compared Tadalis SX 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 Tadalis SX and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when Tadalis SX is co-administered with 5-ARIs.

CYP1A2 Substrates (e.g. Theophylline): When Tadalis SX 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 medications.

Ethinylestradiol and Terbutaline: Tadalis SX has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.

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

Cytochrome P450 Metabolized Drugs: Tadalis SX is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by CYP450 isoforms. Studies have confirmed that Tadalis SX does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

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

Aspirin: Tadalis SX (10 and 20 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid.

Antidiabetic Medicinal Products: Specific interaction studies with antidiabetic medicinal products were not conducted.

20 mg: Potential for Other Drugs to Affect Tadalis SX: Tadalis SX is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (400 mg daily), increased Tadalis SX single-dose exposure (AUC) by 312% and C_max by 22%, and ketaconazole (200 mg daily), increased Tadalis SX single-dose exposure (AUC) by 107% and C_max by 15% relative to the AUC and C_max values for Tadalis SX (10 mg) alone.

Ritonavir (200 mg twice daily), an inhibitor of CYP3A4, 2C9, 2C19, and 2D6, increased tadalafi single-dose exposure (AUC) by 124% with no change in C_max. Although specific interactions have not been studied, other HIV protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, and itraconazole should be co-administered with caution because they would be expected to increase plasma concentrations of Tadalis SX.

A selective CYP3A4 inducer, rifampicin (600 mg daily), reduced Tadalis SX single-dose exposure(AUC) by 88%, and C_max by 46% relative to the AUC and C_max values for Tadalis SX (10 mg) alone. It can be expected that concomitant administration of other CYP3A4 inducers such as phenobarbital, phenytoin and carbamazepine would also decrease plasma concentrations of Tadalis SX.

Studies with the CYP3A4 probe substrates midazolam with Tadalis SX 10 mg and lovastatin with Tadalis SX 20 mg showed little alteration in the kinetics suggesting that Tadalis SX is unlikely to have interactions with CYP3A4 substrates.

Antacids (Magnesium hydroxide/Aluminium hydroxide): Simultaneous administration of an antacid(magnesium hydroxide/aluminium hydroxide) and Tadalis SX reduced the apparent rate of absorption of Tadalis SX without altering exposure (AUC) to Tadalis SX (10 mg).

H₂ Antagonists: An increase in gastric pH resulting from administration of nizatidine had no significant effect on Tadalis SX (10 mg) pharmacokinetics.

References

1. DailyMed. "TADALAFIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "742SXX0ICT: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Vasodilator Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology