Tadalafila Sandoz Dosage
Generic name: Tadalafila Sandoz 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 Tadalafila Sandoz tablets; entire dose should be taken.
The recommended dose of Tadalafila Sandoz for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
Tadalafila Sandoz may be taken without regard to food.
Tadalafila Sandoz for Use as Needed
Tadalafila Sandoz for Once Daily Use
Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia
Tadalafila Sandoz for Use as Needed
Tadalafila Sandoz for Once Daily Use
Concomitant use of nitrates in any form is contraindicated.
ED — When Tadalafila Sandoz 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 Tadalafila Sandoz should be initiated at the lowest recommended dose.
BPH — Tadalafila Sandoz is not recommended for use in combination with alpha-blockers for the treatment of BPH.
Tadalafila Sandoz for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalafila Sandoz is 10 mg, not to exceed once every 72 hours.
Tadalafila Sandoz 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.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Tadalafila Sandoz, especially:
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 Tadalafila Sandoz, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
5 mg Film-coated Tablet: Interaction studies were conducted with Tadalafila Sandoz 10 mg and/or 20 mg, as indicated as follows. With regard to those interaction studies where only the Tadalafila Sandoz 10 mg dose was used, clinically relevant interactions at higher doses cannot be completely ruled out. Effects of Other Substances on Tadalafila Sandoz:
Effects of Other Substances on Tadalafila Sandoz:Cytochrome P450 Inhibitors: Tadalafila Sandoz is principally metabolized by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased Tadalafila Sandoz (10 mg) AUC 2-fold and Cmax by 15%, relative to the AUC and Cmax values for Tadalafila Sandoz alone. Ketoconazole (400 mg daily) increased Tadalafila Sandoz (20 mg) 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 Tadalafila Sandoz (20 mg) AUC 2-fold with no change in Cmax. 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 Tadalafila Sandoz.
Consequently the incidence of the adverse reactions might be increased..
Transporters: The role of transporters (for example p-glycoprotein) in the disposition of Tadalafila Sandoz is not known. Therefore, there is the potential of drug interactions mediated by inhibition of transporters.
Cytochrome P450 Inducers: A CYP3A4 inducer, rifampicin, reduced Tadalafila Sandoz AUC by 88%, relative to the AUC values for Tadalafila Sandoz alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of Tadalafila Sandoz; the magnitude of decreased efficacy is unknown. Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of Tadalafila Sandoz.
Effects of Tadalafila Sandoz on Other Medicinal Products: Nitrates: In clinical studies, Tadalafila Sandoz (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates. Therefore, administration of Tadalafila Sandoz 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 Tadalafila Sandoz 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 Tadalafila Sandoz dose. Thus, in a patient prescribed any dose of Tadalafila Sandoz (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 Tadalafila Sandoz 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 Tadalafila Sandoz (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 Tadalafila Sandoz 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 Tadalafila Sandoz 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). Tadalafila Sandoz (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 Tadalafila Sandoz (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, Tadalafila Sandoz 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 Tadalafila Sandoz 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 Tadalafila Sandoz 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 Tadalafila Sandoz and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when Tadalafila Sandoz is co-administered with 5-ARIs.
CYP1A2 Substrates (e.g. Theophylline): When Tadalafila Sandoz 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: Tadalafila Sandoz 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 Tadalafila Sandoz (10 or 20 mg). In addition, no changes in Tadalafila Sandoz 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). Tadalafila Sandoz (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 Tadalafila Sandoz 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 Tadalafila Sandoz (10 mg).
Cytochrome P450 Metabolized Drugs: Tadalafila Sandoz is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by CYP450 isoforms. Studies have confirmed that Tadalafila Sandoz does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
CYP2C9 Substrates (e.g. R-warfarin): Tadalafila Sandoz (10 and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did Tadalafila Sandoz affect changes in prothrombin time induced by warfarin.
Aspirin: Tadalafila Sandoz (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 Tadalafila Sandoz: Tadalafila Sandoz is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (400 mg daily), increased Tadalafila Sandoz single-dose exposure (AUC) by 312% and Cmax by 22%, and ketaconazole (200 mg daily), increased Tadalafila Sandoz single-dose exposure (AUC) by 107% and Cmax by 15% relative to the AUC and Cmax values for Tadalafila Sandoz (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 Cmax. 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 Tadalafila Sandoz.A selective CYP3A4 inducer, rifampicin (600 mg daily), reduced Tadalafila Sandoz single-dose exposure(AUC) by 88%, and Cmax by 46% relative to the AUC and Cmax values for Tadalafila Sandoz (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 Tadalafila Sandoz.Studies with the CYP3A4 probe substrates midazolam with Tadalafila Sandoz 10 mg and lovastatin with Tadalafila Sandoz 20 mg showed little alteration in the kinetics suggesting that Tadalafila Sandoz is unlikely to have interactions with CYP3A4 substrates. Antacids (Magnesium hydroxide/Aluminium hydroxide): H2 Antagonists:
Antacids (Magnesium hydroxide/Aluminium hydroxide):Simultaneous administration of an antacid(magnesium hydroxide/aluminium hydroxide) and Tadalafila Sandoz reduced the apparent rate of absorption of Tadalafila Sandoz without altering exposure (AUC) to Tadalafila Sandoz (10 mg).
H2 Antagonists:An increase in gastric pH resulting from administration of nizatidine had no significant effect on Tadalafila Sandoz (10 mg) pharmacokinetics.
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Information checked by Dr. Sachin Kumar, MD Pharmacology