Show posts

This section allows you to view all posts made by this member. Note that you can only see posts made in areas you currently have access to.

Μηνύματα - aaa

91
Πουθενά παραπάνω δεν γράφει για παλίνδρομη εκσπερμάτωση. Όμως και εγώ το έπαθα και άλλος ένας χρήστης του φόρουμ. Συμφέροντα παγκόσμια, αλλιώς πως θα τα πουλούσαν στην καλοήθη υπερπλασία του προστάτη.
Μου είπε ο ουρολόγος ότι με την συνέχιση της αγωγής με α-αποκλειστές μπορεί να υποχωρήσει η παλινδρόμηση. Ξέρει κανένας τίποτε για αυτό;
Επίσης ένας άλλος ότι το xatral κάνει λιγότερο την παρενέργεια της μη ορατής εκσπερμάτισης. Πάντως υπάρχει μεγάλο κενό γνώσης στην ιατρική για την πάθησή μας
Άμα το πιο αναγνωρισμένο συνδρομητικό ιατρικό site δεν τα λέει καλά, τότε τι να περιμένουμε
92
Με την σπερματέγχυση καθαρίζουν πριν το σπέρμα; Είναι δυνατό αυτό;
Η θα έχει πάλι τον ίδιο κίνδυνο να κολλήσει η σύζυγος;
93
Η φάση είναι ότι στη βιβλιογραφία λένε στις παρενέργειες είναι ότι είναι κάτω από 1%. Το έπαθα και εγώ από το ΟΜΝΙC και φοβήθηκα. Μίλησα με δύο ουρολόγους μου είπαν ότι είναι σπάνιο και ότι με τη συνέχιση της θεραπείας μπορεί να αποκατασταθεί η έξοδος του σπέρματος. Μου έιπε ο ένας ότι το XATRAL δεν κάνει τόσο παλίνδρομη εκσπερμάτιση όσο το ΟΜΝΙC
Ευτυχώς που το είπες και εσύ! Γενικά αλληλοβοηθά πολύ το φόρουμ
94
Δυστυχώς τενοντίτιδα και ρήξη τενόντων είναι από τις παρενέργειες της μακρόχρονης χρήσης κινολονών. Που ανήκει σε αυτές το prixina-ciproxin
http://www.ifet.gr/drugs/ingredients/ciprofloxacin.htm
http://www.faran.gr/node/263
95
Πάντως από το πρώτο χάπι βλέπω αποτελέσματα. Όχι όμως τρομερά. Βελτίωση υπάρχει, αλλά αισθάνομαι ότι δεν μπορεί να με οδηγήσει στην ίαση. Είμαι στο τέλος του πρώτου κουτιού.
Πήρα και άλλα δύο κουτιά
Επίσης περιμένω να μου έλθει και άλλο ένα κουτί από την ίδια εταιρία που είναι λίγο πιο ακριβό και ενισχυμένο. http://www.amazon.com/dp/B000O6J74K/ref=pe_175190_21431760_M2T1_ST1_3p_dp_1
Τελικά όμως όταν τελειώσουν θα αγοράσω από Ελλάδα, γιατί δεν νομίζω να έχουν εντυπωσιακή διαφορά
Η πιο μεγάλη διαφορά είναι με την αντιβίωση και το OMNIC TOCAS
http://www.chronic-prostatitis.com/index.php?topic=246.0
96
Dietary Considerations
Take immediately following a meal at the same time each day.
Pricing: U.S. (www.drugstore.com)
Tablet, 24-hour (Alfuzosin HCl)
10 mg (30): $45.99
Tablet, 24-hour (Uroxatral)
10 mg (30): $142.99
Monitoring Parameters
Urine flow, blood pressure, PSA
International Brand Names
•   Alfsin XL (KP);
•   Alfu-Kal XL (IL);
•   Alfurix XL (KP);
•   Alfusin (IN);
•   Alfuzo XL (TW);
•   Alfuzon XL (KP);
•   Azosin SR (TW);
•   Bearxat XL (KP);
•   Benestan (PT);
•   Benestan OD (PT);
•   Dalfaz (AR, ES, PL, RU);
•   Flotral (PE);
•   Fozal (PH);
•   Lafuzo (TW);
•   Profuzosin (PH);
•   Ranfuzosin (SG);
•   Uroxatral (CN);
•   Uroxatral OD (AR, UY);
•   Uroxatral uno (CH, DE);
•   Xatosin XL (KP);
•   Xatral (AT, BE, BF, BJ, CH, CI, CL, CZ, DK, ET, FI, FR, GB, GH, GM, GN, GR, IE, IL, IT, KE, LR, MA, ML, MR, MU, MW, NE, NG, NL, NO, PH, SC, SD, SE, SL, SN, TN, TR, TZ, UG, ZA, ZM, ZW);
•   Xatral LP (BG, FR, HK);
•   Xatral OD (BR, CO, CR, DO, EC, GT, HN, MX, NI, PA, PE, PH, PY, SE, SV, VE);
•   Xatral SR (AU, EE, EG, HK, IL, PK, SG);
•   Xatral XL (ID, IL, KP, TH, TW);
•   Xatral XR 10 (SG);
•   Zapros XL (KP)
Mechanism of Action
An antagonist of alpha1-adrenoreceptors in the lower urinary tract. Smooth muscle tone is mediated by the sympathetic nervous stimulation of alpha1-adrenoreceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in BPH symptoms.
Pharmacodynamics/Kinetics
Absorption: Decreased 50% under fasting conditions
Distribution: Vd: 3.2 L/kg
Protein binding: 82% to 90%
Metabolism: Hepatic, primarily via CYP3A4; metabolism includes oxidation, O-demethylation, and N-dealkylation; forms metabolites (inactive)
Bioavailability: 49% following a meal
Half-life elimination: 10 hours
Time to peak, plasma: 8 hours following a meal
Excretion: Feces (69%); urine (24%; 11% as unchanged drug)
Use of UpToDate is subject to the Subscription and License Agreement.
REFERENCES
1.   Agrawal M, Gupta M, Gupta A, et al, "Prospective Randomized Trial Comparing Efficacy of Alfuzosin and Tamsulosin in Management of Lower Ureteral Stones," Urology, 2009, 73(4):706-9. [PubMed 19193417]
2.   Ahmed AF and Al-Sayed AY, "Tamsulosin versus Alfuzosin in the Treatment of Patients with Distal Ureteral Stones: Prospective, Randomized, Comparative Study," Korean J Urol, 2010, 51(3):193-7. [PubMed 20414396]
3.   Gurbuz MC, Polat H, Canat L, et al, "Efficacy of Three Different Alpha 1-Adrenergic Blockers and Hyoscine N-butylbromide for Distal Ureteral Stones," Int Braz J Urol, 2011, 37(2):195-202. [PubMed 21557836]
Topic 9105 Version 31.0

97
Alfuzosin: Drug information (XATRAL)

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: U.S.
•   Uroxatral®
Brand Names: Canada
•   Apo-Alfuzosin®;
•   Sandoz-Alfuzosin;
•   Teva-Alfuzosin PR;
•   Xatral
Pharmacologic Category
•   Alpha 1 Blocker
Dosing: Adult
Benign prostatic hyperplasia (BPH): Oral: 10 mg once daily
Ureteral stones, expulsion (unlabeled use): Oral: 10 mg once daily, discontinue after successful expulsion (average time to expulsion 1-2 weeks) (Agrawal, 2009; Ahmed, 2010; Gurbuz, 2011). Note: Patients with stones >10 mm were excluded from studies.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment
Bioavailability and maximum serum concentrations are increased by ~50% with mild (Clcr 60-80 mL/minute), moderate (Clcr 30-59 mL/minute), or severe (Clcr <30 mL/minute) renal impairment.
Note: Safety data is limited in patients with severe renal impairment (Clcr <30 mL/minute). Use with caution.
Dosing: Hepatic Impairment
Mild hepatic impairment: Use has not been studied; use caution.
Moderate or severe hepatic impairment (Child-Pugh class B or C): Clearance is decreased 1/3 to 1/4 and serum concentration is increased three- to fourfold; use is contraindicated.
Dosage Forms: U.S.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, extended release, oral, as hydrochloride: 10 mg
Uroxatral®: 10 mg
Generic Equivalent Available: U.S.
Yes
Administration
Tablet should be swallowed whole; do not crush or chew. Administer once daily (immediately following a meal); should be taken at the same time each day.
Use
Treatment of the functional symptoms of benign prostatic hyperplasia (BPH)
Use - Unlabeled
Facilitation of expulsion of ureteral stones
Adverse Reactions Significant
1% to 10%:
Central nervous system: Dizziness (6%), fatigue (3%), headache (3%), pain (1% to 2%)
Gastrointestinal: Abdominal pain (1% to 2%), constipation (1% to 2%), dyspepsia (1% to 2%), nausea (1% to 2%)
Genitourinary: Impotence (1% to 2%)
Respiratory: Upper respiratory tract infection (3%), bronchitis (1% to 2%), pharyngitis (1% to 2%), sinusitis (1% to 2%)
<1% (Limited to important or life-threatening): Angina pectoris (pre-existing CAD), angioedema, atrial fibrillation, chest pain, cholestatic liver injury, diarrhea, edema, flushing, hepatocellular injury, intraoperative floppy iris syndrome (with cataract surgery), jaundice, priapism, pruritus, rash, rhinitis, tachycardia, urticaria
Contraindications
Hypersensitivity to alfuzosin or any component of the formulation; moderate or severe hepatic insufficiency (Child-Pugh class B and C); concurrent use with potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir) or other alpha1-blocking agents
Warnings/Precautions
Concerns related to adverse effects:
• Angina: Discontinue if symptoms of angina occur or worsen.
• Floppy iris syndrome: Intraoperative floppy iris syndrome has been observed in cataract surgery patients who were on or were previously treated with alpha1-blockers; causality has not been established and there appears to be no benefit in discontinuing alpha-blocker therapy prior to surgery.
• Orthostatic hypotension/syncope: May cause significant orthostatic hypotension and syncope, especially with first dose; anticipate a similar effect if therapy is interrupted for a few days, if dosage is rapidly increased, or used with antihypertensives (particularly vasodilators), PDE-5 inhibitors, nitrates or other medications which may result in hypotension. Patients should be cautioned about performing hazardous tasks when starting new therapy or adjusting dosage upward.
• Priapism: Priapism has been associated with use (rarely).
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with mild hepatic impairment; contraindicated in moderate-to-severe impairment.
• Prostate cancer: Rule out prostatic carcinoma before beginning therapy (many symptoms of BPH and prostate cancer are similar).
• QT prolongation: Alfuzosin has been shown to prolong the QT interval alone (minimal) and with other drugs with comparable effects on the QT interval (additive). Use with caution in patients with known QT prolongation (congenital or acquired).
• Renal impairment: Use with caution in patients with severe renal impairment (Clcr <30 mL/minute).
Concurrent drug therapy issues:
• High potential for interactions: Contraindicated in patients receiving strong CYP3A4 inhibitors or other alpha1-blockers.
Other warning/precautions:
• Antihypertensive agent: Not intended for use as an antihypertensive drug.
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions
(For additional information: Launch Lexi-Interact™ Drug Interactions Program)
Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Risk X: Avoid combination
Antihypertensives: Alfuzosin may enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Beta-Blockers: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Exceptions: Levobunolol; Metipranolol. Risk D: Consider therapy modification
Calcium Channel Blockers: Alpha1-Blockers may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Alfuzosin. Risk X: Avoid combination
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy
Mifepristone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification
Nitroglycerin: Alfuzosin may enhance the hypotensive effect of Nitroglycerin. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification
Protease Inhibitors: May increase the serum concentration of Alfuzosin. Risk X: Avoid combination
QTc-Prolonging Agents: Alfuzosin may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Telaprevir: May increase the serum concentration of Alfuzosin. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Food increases the extent of absorption. Management: Administer immediately following a meal at the same time each day.
Herb/Nutraceutical: St John's wort may decrease alfuzosin levels. Management: Avoid St John's wort.
Pregnancy Risk Factor
B (show table)
Pregnancy Implications
Teratogenic effects were not observed in animal studies.
98
weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Fasting increases bioavailability by 30% and peak concentration 40% to 70%. Management: Administer 30 minutes after the same meal each day.
Herb/Nutraceutical: St John's wort may decrease the levels/effects of tamsulosin. Some herbal medications have hypotensive properties or may increase the hypotensive effect of tamsulosin. Limited information is available regarding combination with saw palmetto. Management: Avoid St John's wort, black cohosh, California poppy, coleus, golden seal, hawthorn, mistletoe, periwinkle, quinine, and shepherd's purse. Avoid saw palmetto.
Pregnancy Risk Factor
B (show table)
Pregnancy Implications
Teratogenic effects were not observed in animal studies.
Dietary Considerations
Take once daily, 30 minutes after the same meal each day.
Pricing: U.S. (www.drugstore.com)
Capsules (Flomax)
0.4 mg (30): $153.99
Capsules (Tamsulosin HCl)
0.4 mg (30): $122.99
International Brand Names
•   Alna (AT, DE);
•   Comadex (EC);
•   Flomax (NZ, TR);
•   Flomaxtra (AU, NZ);
•   Flomaxtra XL (GB);
•   Harnal (CL, HK, JP, PH, TH);
•   Harnal D (ID);
•   Harnal OCAS (ID, MY, PH, SG);
•   Harnalidge D (TW);
•   Harusin SR (KP);
•   Josir (FR);
•   Lutsnal (KP);
•   Mecir LP (FR);
•   Omexel LP (FR);
•   Omic (BE, LU);
•   Omix Ocas (CH);
•   Omnexel (IE);
•   Omnic (AR, CN, CO, CZ, DE, DK, EE, ES, FI, GR, HU, IL, IT, NL, NO, PE, PL, PT, PY, RU);
•   Omnic OCAS (IL);
•   Omnic Tocas (BG);
•   Pimax (PH);
•   Pradif (PT);
•   Promnix (IL);
•   Prozelax (PH);
•   Secotex (AR, CN, CO, CR, DO, GT, HN, MX, NI, PA, PE, PY, SV, UY, VE);
•   Secotex OCAS (CR, DO, EC, GT, HN, NI, PA, SV);
•   Sulosin (KP);
•   Sulosin D (KP);
•   Tabphyn MR (GB);
•   Tamlosin (TW);
•   Tamlosin SR (KP);
•   Tamsulin (IL);
•   Tamsulo (KP);
•   Tamsulon (CR, DO, EC, GT, HN, NI, SV);
•   Tamunal (KP);
•   Tarunal (KP);
•   Urimax (IN);
•   Urnal (TW);
•   Urotams SR (KP);
•   Zotan (TW)
Mechanism of Action
Tamsulosin is an antagonist of alpha1A-adrenoreceptors in the prostate. Smooth muscle tone in the prostate is mediated by alpha1A-adrenoreceptors; blocking them leads to relaxation of smooth muscle in the bladder neck and prostate causing an improvement of urine flow and decreased symptoms of BPH. Approximately 75% of the alpha1-receptors in the prostate are of the alpha1A subtype.
Pharmacodynamics/Kinetics
Absorption: >90%
Distribution: Vd: 16 L
Protein binding: 94% to 99%, primarily to alpha1 acid glycoprotein (AAG)
Metabolism: Hepatic (extensive) via CYP3A4 and 2D6; metabolites undergo extensive conjugation to glucuronide or sulfate
Bioavailability: Fasting: 30% increase
Steady-state: By the fifth day of once-daily dosing
Half-life elimination: Healthy volunteers: 9-13 hours; Target population: 14-15 hours
Time to peak: Fasting: 4-5 hours; With food: 6-7 hours
Excretion: Urine (76%, <10% as unchanged drug); feces (21%)
Use of UpToDate is subject to the Subscription and License Agreement.
REFERENCES
1.   Agrawal M, Gupta M, Gupta A, et al, "Prospective Randomized Trial Comparing Efficacy of Alfuzosin and Tamsulosin in Management of Lower Ureteral Stones," Urology, 2009, 73(4):706-9. [PubMed 19193417]
2.   Ahmed AF and Al-Sayed AY, "Tamsulosin versus Alfuzosin in the Treatment of Patients with Distal Ureteral Stones: Prospective, Randomized, Comparative Study," Korean J Urol, 2010, 51(3):193-7. [PubMed 20414396]
3.   Chang DF and Campbell JR, "Intraoperative Floppy Iris Syndrome Associated With Tamsulosin," J Cataract Refract Surg, 2005, 31(4):664-73. [PubMed 15899440]
4.   Goldman HB and Zimmern PE, "The Treatment of Female Bladder Outlet Obstruction," BJU Int, 2006, 98(Suppl 1):17-23. [PubMed 16911596]
5.   Pischedda A, Pirozzi Farina F, Madonia M, et al, "Use of Alpha1-Blockers in Female Functional Bladder Neck Obstruction," Urol Int, 2005, 74(3):256-61. [PubMed 15812214]
6.   Rossi C, Kortmann BB, Sonke GS, et al, "Alpha-Blockade Improves Symptoms Suggestive of Bladder Outlet Obstruction But Fails to Relieve It," J Urol, 2001, 165(1):38-41. [PubMed 11125359]
99
Tamsulosin: Drug information (OMNIC)
For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: U.S.
•   Flomax®
Brand Names: Canada
•   Ava-Tamsulosin CR;
•   Flomax® CR;
•   JAMP-Tamsulosin;
•   Mylan-Tamsulosin;
•   RAN™-Tamsulosin;
•   ratio-Tamsulosin;
•   Sandoz-Tamsulosin;
•   Sandoz-Tamsulosin CR;
•   Teva-Tamsulosin
Pharmacologic Category
•   Alpha 1 Blocker
Dosing: Adult
Benign prostatic hyperplasia (BPH): Oral: 0.4 mg once daily ~30 minutes after the same meal each day; dose may be increased after 2-4 weeks to 0.8 mg once daily in patients who fail to respond. If therapy is interrupted for several days, restart with 0.4 mg once daily.
Bladder outlet obstruction symptoms (unlabeled use): Oral: 0.4 mg once daily (Rossi, 2001)
Ureteral stones, expulsion (unlabeled use): Oral: 0.4 mg once daily, discontinue after successful expulsion (average time to expulsion was 1-2 weeks) (Agrawal, 2009; Ahmed, 2010). Note: Patients with stones >10 mm were excluded from studies.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment
Clcr ≥10 mL/minute: No adjustment needed.
Clcr <10 mL/minute: Not studied.
Dosing: Hepatic Impairment
Mild-to-moderate impairment: No adjustment needed
Severe impairment: Not studied
Dosage Forms: U.S.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, oral, as hydrochloride: 0.4 mg
Flomax®: 0.4 mg
Generic Equivalent Available: U.S.
Yes
Administration
Administer 30 minutes after the same meal each day. Capsules should be swallowed whole; do not crush, chew, or open.
Use
Treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
Use - Unlabeled
Symptomatic treatment of bladder outlet obstruction or dysfunction; facilitation of expulsion of ureteral stones
Medication Safety Issues
Sound-alike/look-alike issues:
Flomax® may be confused with Flonase®, Flovent®, Foltx®, Fosamax®
Tamsulosin may be confused with tacrolimus, tamoxifen, terazosin
International issues:
Flomax [U.S., Canada, and multiple international markets] may be confused with Flomox brand name for cefcapene [Japan]; Volmax brand name for salbutamol [multiple international markets]
Flomax: Brand name for tamsulosin [U.S., Canada, and multiple international markets], but also the brand name for morniflumate [Italy]
Adverse Reactions Significant
>10%:
Cardiovascular: Orthostatic hypotension (6% to 19%)
Central nervous system: Headache (19% to 21%), dizziness (15% to 17%)
Genitourinary: Abnormal ejaculation (8% to 18%)
Respiratory: Rhinitis (13% to 18%)
Miscellaneous: Infection (9% to 11%)
1% to 10%:
Cardiovascular: Chest pain (4%)
Central nervous system: Somnolence (3% to 4%), insomnia (1% to 2%), vertigo (≤1%)
Endocrine & metabolic: Libido decreased (1% to 2%)
Gastrointestinal: Diarrhea (4% to 6%), nausea (3% to 4%), gum pain, toothache
Neuromuscular & skeletal: Weakness (8% to 9%), back pain (7% to 8%)
Ocular: Blurred vision (≤2%)
Respiratory: Pharyngitis (5% to 6%), cough (3% to 5%), sinusitis (2% to 4%)
<1% (Limited to important or life-threatening): Allergic reactions (angioedema, pruritus, rash, urticaria, respiratory symptoms); constipation, hypotension, intraoperative floppy iris syndrome, lightheadedness, orthostasis (symptomatic), palpitation, priapism, skin desquamation, syncope, vomiting
Contraindications
Hypersensitivity to tamsulosin or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Angina: Discontinue if symptoms of angina occur or worsen.
• Floppy iris syndrome: Intraoperative floppy iris syndrome has been observed in cataract surgery patients who were on or were previously treated with alpha1-blockers; causality has not been established and there appears to be no benefit in discontinuing alpha-blocker therapy prior to surgery. Instruct patients to inform ophthalmologist of tamsulosin use when considering eye surgery.
• Orthostatic hypotension/syncope: May cause significant orthostatic hypotension and syncope, especially with first dose; anticipate a similar effect if therapy is interrupted for a few days, if dosage is rapidly increased, or if another antihypertensive drug (particularly vasodilators) or a PDE-5 inhibitor (eg, sildenafil, tadalafil, vardenafil) is introduced. "First-dose" orthostatic hypotension may occur 4-8 hours after dosing; may be dose related. Patients should be cautioned about performing hazardous tasks when starting new therapy or adjusting dosage upward.
• Priapism: Priapism has been associated with use (rarely).
• Sulfonamide allergy: Rarely, patients with a sulfa allergy have also developed an allergic reaction to tamsulosin; avoid use when previous reaction has been severe.
Disease-related concerns:
• Prostate cancer: It is recommended to rule out prostatic carcinoma before beginning therapy.
Other warnings/precautions:
• Antihypertensive use: Not intended for use as an antihypertensive drug.
Metabolism/Transport Effects
Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions
(For additional information: Launch Lexi-Interact™ Drug Interactions Program)
Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Risk X: Avoid combination
Beta-Blockers: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Exceptions: Levobunolol; Metipranolol. Risk D: Consider therapy modification
Calcium Channel Blockers: Alpha1-Blockers may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tamsulosin. Risk X: Avoid combination
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy
Mifepristone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2
100
Εμένα γνωστός ουρολόγος που πρότεινε να πάρω OMNIC TOKAS. Βλέπω μάλιστα αποτελέσματα. Τα φάρμακα αυτά έχουν σημαντική θέση στη θεραπεία της χρόνιας προστατίτιδας- χρόνιου πυελικού άλγους. Σύμφωνα με τις παγκόσμιες ιατρικές οδηγίες από το καλύτερο συνδρομητικό ιατρικό site
http://www.chronic-prostatitis.com/index.php?topic=244.0
όλοι οι α1 αποκλειστές (Οmnic ή Xatral) λαμβάνονται μία φορά την ημέρα μετά το φαγητό. εσείς έχετε πάρει ποτέ;;;;;
από κάτω οδηγίες πρώτα για το Οmnic tocas (Tamsulosin) και έπειτα για το δέυτερο α1 αποκλειστή Xatral OD (Alfuzosin)
101
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Phosphodiesterase 5 Inhibitors. Risk D: Consider therapy modification
Antihypertensives: Phosphodiesterase 5 Inhibitors may enhance the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Boceprevir: May increase the serum concentration of Tadalafil. Management: Avoid tadalafil when used for treatment of pulmonary arterial hypertension in patients receiving boceprevir. Tadalafil for erectile dysfunction should be limited to 10 mg every 72 hours with close monitoring for tadalafil toxicity. Risk X: Avoid combination
Bosentan: Phosphodiesterase 5 Inhibitors may increase the serum concentration of Bosentan. Bosentan may decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Tadalafil. Management: Erectile dysfunction: monitor for decreased effectiveness - no standard dose adjustments recommended. Avoid use of tadalafil for pulmonary arterial hypertension in patients receiving a strong CYP3A4 inducer. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Tadalafil. Management: Recommendations regarding use of tadalafil in patients also receiving strong CYP3A4 inhibitors may vary based on indication and/or international labeling. Consult appropriate product labeling. Exceptions: Ritonavir. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Etravirine: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Management: No empiric dosage adjustments are recommended with concomitant therapy; however, dose of the phosphodiesterase inhibitor may need to be altered based on clinical response. Risk C: Monitor therapy
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Mifepristone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification
Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Ritonavir: May increase the serum concentration of Tadalafil. Management: Recommendations regarding use of tadalafil in patients also receiving ritonavir may vary based on indication and/or international labeling. Consult appropriate product labeling. Risk D: Consider therapy modification
Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Telaprevir: May increase the serum concentration of Tadalafil. Management: Concurrent use of tadalafil for treatment of pulmonary arterial hypertension is contraindicated with telaprevir. Tadalafil for erectile dysfunction should be limited to 10 mg per 72 hours, with close monitoring for tadalafil toxicity. Risk X: Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Ethanol: Substantial consumption of ethanol may increase the risk of hypotension and orthostasis. Lower ethanol consumption has not been associated with significant changes in blood pressure or increase in orthostatic symptoms. Management: Avoid or limit ethanol consumption.
Food: Rate and extent of absorption are not affected by food. Grapefruit juice may increase serum levels/toxicity of tadalafil. Management: Use of grapefruit juice should be limited or avoided.
Herb/Nutraceutical: St John's wort may decrease the levels/effectiveness of tadalafil. Management: Avoid or use caution with concomitant use.
Pregnancy Risk Factor
B (show table)
Pregnancy Implications
Teratogenic events were not reported in animal reproduction studies. Postnatal development and pup survival was decreased at some doses. There are no adequate and well-controlled studies in pregnant women. Less than 0.0005% is found in the semen of healthy males.
Lactation
Excretion in breast milk unknown/use caution
Dietary Considerations
May be taken with or without food.
Pricing: U.S. (www.drugstore.com)
Tablets (Adcirca)
20 mg (60): $1348.95
Tablets (Cialis)
2.5 mg (15): $75.99
5 mg (10): $49.99
5 mg (30): $133.97
10 mg (10): $224.99
20 mg (10): $224.99
Monitoring Parameters
Blood pressure, response and adverse effects; urine flow, PSA
International Brand Names
•   36 Horas (PY);
•   Adcirca (AT, CZ, DK, EE, FR, GB, IE, NO, PT, SE);
•   Cialis (AR, AT, AU, BB, BE, BF, BG, BJ, BR, BS, CH, CI, CL, CN, CO, CR, CZ, DE, DK, DO, EE, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HN, ID, IE, IL, IT, JM, KE, KP, LR, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NO, NZ, PA, PE, PH, PL, PT, RU, SC, SD, SE, SG, SK, SL, SN, SV, TH, TN, TR, TT, TW, TZ, UG, VE, ZA, ZM, ZW);
•   Forzest (IN);
•   Pasport (TR);
•   Xpandyl (GT);
•   Zydalis (IN)
Mechanism of Action
BPH: Exact mechanism unknown; effects likely due to PDE-5 mediated reduction in smooth muscle and endothelial cell proliferation, decreased nerve activity, and increased smooth muscle relaxation and tissue perfusion of the prostate and bladder
Erectile dysfunction: Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Tadalafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by tadalafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. At recommended doses, it has no effect in the absence of sexual stimulation.
PAH: Inhibits phosphodiesterase type 5 (PDE-5) in smooth muscle of pulmonary vasculature where PDE-5 is responsible for the degradation of cyclic guanosine monophosphate (cGMP). Increased cGMP concentration results in pulmonary vasculature relaxation; vasodilation in the pulmonary bed and the systemic circulation (to a lesser degree) may occur.
Pharmacodynamics/Kinetics
Onset of action: Within 1 hour
Peak effect (pulmonary artery vasodilation): 75-90 minutes (Ghofrani, 2004)
Duration: Erectile dysfunction: Up to 36 hours
Distribution: Vd: 63-77 L
Protein binding: 94%
Metabolism: Hepatic, via CYP3A4 to metabolites (inactive)
Half-life elimination: 15-17.5 hours; Pulmonary hypertension (not receiving bosentan): 35 hours
Time to peak, plasma: ~2-4 hours (range: 30 minutes to 8 hours)
Excretion: Feces (~61%, predominantly as metabolites); urine (~36%, predominantly as metabolites)
Use of UpToDate is subject to the Subscription and License Agreement.
REFERENCES
1.   Andersson KE, de Groat WC, McVary KT, et al, "Tadalafil for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Pathophysiology and Mechanism(s) of Action," Neurourol Urodyn, 2011, 30(3):292-301.
2.   Anderson JL, Adams CD, Antman EM, et al, "2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines," Circulation, 2011, 123(18):e426-579. [PubMed 21444888]
3.   Antman EM, Anbe DT, Armstrong PW, et al, "ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction)," Circulation, 2004, 110(9):e82-292. [PubMed 15339869]
4.   Cheitlin MD, Hutter AM Jr, Brindis RG, et al, "Use of Sildenafil (Viagra®) in Patients With Cardiovascular Disease," J Am Coll Cardiol, 1999, 33(1):273-82. [PubMed 9935041]
5.   Curran M and Keating G, "Tadalafil," Drugs, 2003, 63(20):2203-12; discussion 2213-4. [PubMed 14498756]
6.   Daugan A, Grondin P, Ruault C, et al, "The Discovery of Tadalafil: A Novel and Highly Selective PDE-5 Inhibitor. 2: 2,3,6,7,12,12a-hexahydropyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione Analogues," J Med Chem, 2003, 46(21):4533-42.
7.   Fraunfelder FW, "Visual Side Effects Associated With Erectile Dysfunction Agents," Am J Ophthal, 2005, 140 (4):723-24. [PubMed 16226525]
8.   Galie N, Brundage BH, Ghofrani HA, et al, "Tadalafil Therapy for Pulmonary Arterial Hypertenstion," Circulation, 2009, 119(22):2894-903. [PubMed 19470885]
9.   Ghofrani HA, Voswinckel R, Reichenberger F, et al, "Differences in Hemodynamic and Oxygenation Responses to Three Different Phosphodiesterase-5 Inhibitors in Patients with Pulmonary Arterial Hypertension," J Am Coll Cardiol, 2004, 44(7):1488-96. [PubMed 15464333]
10.   Jackson G, Rosen RC, Kloner RA, et al, "The Second Princeton Consensus on Sexual Dysfunction and Cardiac Risk: New Guidelines for Sexual Medicine," J Sex Med, 2006, 3(1):28-36. [PubMed 16409215]
11.   Kloner RA, Mitchell M, and Emmick JT, "Cardiovascular Effects of Tadalafil," Am J Cardiol, 2003, 92(9A):37M-46M. [PubMed 14609622]
12.   Kloner RA, Mitchell M, and Emmick JT, "Cardiovascular Effects of Tadalafil in Patients on Common Antihypertensive Therapies," Am J Cardiol, 2003, 92(9A):47M-57M. [PubMed 14609623]
13.   McLaughlin VV, Archer SL, Badesch DB, et al, "ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association Developed in collaboration with the American College of Chest Physicians; American Thoracic Society, Inc.; and the Pulmonary Hypertension Association," J Am Coll Cardiol, 2009, 53(17):1573–619. [PubMed 19389575]
14.   McVary KT, "Clinical Practice. Erectile Dysfunction," N Engl J Med, 2007, 357(24):2472-81. [PubMed 18077811]
15.   Padma-Nathan H, "Efficacy and Tolerability of Tadalafil, A Novel Phosphodiesterase 5 Inhibitor, in Treatment of Erectile Dysfunction," Am J Cardiol, 2003, 92(9A):19-25. [PubMed
102
Use
Adcirca®: Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability
Cialis®: Treatment of erectile dysfunction (ED); treatment of signs and symptoms of benign prostatic hyperplasia (BPH)
Medication Safety Issues
Sound-alike/look-alike issues:
Tadalafil may be confused with sildenafil, vardenafil
Adcirca® may be confused with Advair® Diskus®, Advair® HFA, Advicor®
Adverse Reactions Significant
Based upon usual doses for either indication. For erectile dysfunction, similar adverse events are reported with once-daily versus intermittent dosing, but are generally lower than with doses used intermittently.
>10%:
Cardiovascular: Flushing (1% to 13%; dose related)
Central nervous system: Headache (3% to 42%; dose related)
Gastrointestinal: Dyspepsia (1% to 13%), nausea (10% to 11%)
Neuromuscular & skeletal: Myalgia (1% to 14%; dose related), back pain (2% to 12%), extremity pain (1% to 11%)
Respiratory: Respiratory tract infection (3% to 13%), nasopharyngitis (2% to 13%)
2% to 10%:
Cardiovascular: Hypertension (1% to 3%)
Gastrointestinal: Gastroenteritis (viral; 3% to 5%), GERD (1% to 3%), abdominal pain (1% to 2%), diarrhea (1% to 2%)
Genitourinary: Urinary tract infection (≤2%)
Respiratory: Nasal congestion (≤9%), cough (2% to 4%), bronchitis (≤2%)
Miscellaneous: Flu-like syndrome (2% to 5%)
<2% (Limited to important or life-threatening): Amnesia (transient global), angina pectoris, arthralgia, blurred vision, chest pain, color vision decreased, conjunctival hyperemia, conjunctivitis, diaphoresis, dizziness, dysphagia, dyspnea, epistaxis, esophagitis, exfoliative dermatitis, eye pain, eyelid swelling, facial edema, fatigue, gastritis, GGTP increased, hearing decreased, hearing loss, hepatic enzymes increased, hypoesthesia, hypotension, insomnia, lacrimation, migraine, MI, neck pain, nonarteritic ischemic optic neuropathy (NAION), pain, palpitation, paresthesia, pharyngitis, postural hypotension, priapism, pruritus, rash, retinal artery occlusion, retinal vein occlusion, seizure, somnolence, spontaneous penile erection, Stevens-Johnson syndrome, stroke, sudden cardiac death, syncope, tachycardia, tinnitus, urticaria, vertigo, visual field loss, vomiting, weakness, xerostomia
Contraindications
Known serious hypersensitivity to tadalafil or any component of the formulation; concurrent use (regularly/intermittently) of organic nitrates in any form (eg, nitroglycerin, isosorbide dinitrate)
Warnings/Precautions
Concerns related to adverse effects:
• Anginal chest pain: Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention (also see "Concurrent drug therapy issues").
• Color discrimination: May cause dose-related impairment of color discrimination. Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases (no safety information available).
• Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. Instruct patients to seek medical assistance for sudden decrease in hearing or loss of hearing. A direct relationship between therapy and hearing loss has not been determined.
• Hypotension: Decreases in blood pressure may occur due to vasodilator effects; use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Avoid or limit concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.
• Priapism: Painful erection >6 hours in duration; rare. Instruct patient to seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia).
• Vision loss: Vision loss (rare) may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Instruct patients to seek medical assistance for sudden loss of vision in one or both eyes. Risk may be increased with history of vision loss or NAION in one eye. Other risk factors for NAION include low cup-to-disc ratio ("crowded disc"), coronary artery disease, diabetes, hypertension, hyperlipidemia, smoking, and >50 years of age. Safety has not been evaluated in patients with known degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended.
Disease-related concerns:
• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie's disease).
• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established. In vitro studies have suggested a decreased effect on platelet aggregation.
• Cardiovascular disease: Use is not recommended in patients with hypotension (<90/50 mm Hg), uncontrolled hypertension (>170/100 mm Hg), NYHA class II-IV heart failure within the last 6 months, uncontrolled arrhythmias, stroke within the last 6 months, MI within the last 3 months, unstable angina or angina during sexual intercourse; safety and efficacy have not been evaluated in these patients. Safety and efficacy in PAH have not been evaluated in patients with clinically significant aortic and/or mitral valve disease, life-threatening arrhythmias, hypotension (<90/50 mm Hg), uncontrolled hypertension, significant left ventricular dysfunction, pericardial constriction, restrictive or congestive cardiomyopathy, symptomatic coronary artery disease. Use caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy); may be more sensitive to vasodilator effects. There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.
• Hepatic impairment: Use with caution in patients with mild-to-moderate hepatic impairment; dosage adjustment/limitation is needed. Use is not recommended in patients with severe hepatic impairment or cirrhosis.
• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease due to effect on platelets (bleeding); safety and efficacy have not been established.
• Pulmonary veno-occlusive disease (PVOD): Pulmonary vasodilators may exacerbate the cardiovascular status in patients with PVOD. Use is not recommended; no clinical data exists in patients with PVOD. In patients with unrecognized PVOD, signs of pulmonary edema should prompt investigation into this diagnosis.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment/limitation is needed.
Concurrent drug therapy issues:
• Alpha-blockers: When used for erectile dysfunction, use with caution in patients taking alpha-blockers; may cause hypotension. Safety of this combination may be affected by other antihypertensives and intravascular volume depletion. Patients should be hemodynamically stable prior to initiating therapy. Initiate tadalafil at the lowest recommended dose. Alpha-blockers should be initiated at the lowest recommended dose in patients currently taking tadalafil. When used for treatment of BPH, concomitant use with alpha-blockers is not recommended; discontinue alpha-blocker at least 1 day before initiating tadalafil.
• High potential for interactions: BPH/Erectile dysfunction: Use with caution in patients taking strong CYP3A4 inhibitors (see Drug Interactions); consider alternative agents that avoid or lessen the potential for CYP-mediated interactions. Once-daily tadalafil dosing results in continuous plasma levels; use caution when administered concurrently with these medications. PAH: Avoid use in patients taking strong CYP3A4 inducers/inhibitors. Use in patients receiving or about to receive ritonavir requires dosage adjustment or interruption of therapy, respectively. Canadian labeling does not recommend use of tadalafil in patients with PAH who are also receiving protease inhibitors.
• Nitrates: Concomitant use (regularly/intermittently) with all forms of nitrates is contraindicated. Nitrate-mediated vasodilation is markedly exaggerated and prolonged in the presence of PDE-5 inhibitors. When tadalafil is used for BPH, erectile dysfunction, or PAH and nitrate administration is medically necessary (eg, chest pain refractory to other treatments) following the use of tadalafil, at least 48 hours should elapse after the tadalafil dose and nitrate administration. When used for PAH, per the manufacturer, nitrate may be administered within 48 hours of tadalafil. For both situations, administration of nitrates should only be done under close medical supervision with hemodynamic monitoring.
• Other phosphodiesterase-5 (PDE-5) inhibitors: Safety and efficacy with other tadalafil brands or other PDE-5 inhibitors (ie, sildenafil and vardenafil) have not been established. Patients should be informed not to take with other tadalafil brands or other PDE-5 inhibitors.
• Other treatments for erectile dysfunction: Safety and efficacy with other treatments for erectile dysfunction have not been established; use is not recommended.
Special populations:
• Elderly: Use with caution.
Other warnings/precautions:
• Appropriate use: Potential underlying causes of erectile dysfunction or BPH should be evaluated prior to treatment.
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Drug Interactions
(For additional information: Launch Lexi-Interact™ Drug Interactions Program)
Alpha1-Blockers: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification
Amyl Nitrite: Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Amyl Nitrite. Risk X: Avoid combination
103
Tadalafil: Drug information (CIALIS)

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: U.S.
•   Adcirca®;
•   Cialis®
Brand Names: Canada
•   Adcirca®;
•   Cialis®
Pharmacologic Category
•   Phosphodiesterase-5 Enzyme Inhibitor
Dosing: Adult
Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis®): Oral: 5 mg once daily
Dosing adjustment with concomitant medications: CYP3A4 inhibitors (strong): 2.5 mg once daily; maximum: 2.5 mg once daily
Erectile dysfunction (Cialis®): Oral:
As-needed dosing: 10 mg (U.S. labeling) or 20 mg (Canadian labeling) at least 30 minutes prior to anticipated sexual activity (dosing range: 5-20 mg); to be given as one single dose and not given more than once daily. Note: Erectile function may be improved for up to 36 hours following a single dose; adjust dose.
Once-daily dosing: 2.5 mg once daily (U.S. labeling) or 5 mg once daily (Canadian labeling) to be given at approximately the same time daily without regard to timing of sexual activity. Dose may be adjusted based on tolerability (dosage range: 2.5-5 mg/day).
Dosing adjustment with concomitant medications:
U.S. labeling: Alpha1-blockers: If stabilized on either alpha-blockers or tadalafil therapy, initiate new therapy with the other agent at the lowest possible dose.
Canadian labeling: Nonselective alpha-blockers (eg, doxazosin): As-needed dosing: 10 mg at least 30 minutes prior to anticipated sexual activity
CYP3A4 inhibitors (strong):
As-needed dosing:
U.S. labeling: Maximum: 10 mg, not to be given more frequently than every 72 hours
Canadian labeling: 10 mg, not to be given more frequently than every 48 hours (maximum 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.
Once-daily dosing:
U.S. labeling: 2.5 mg once daily; maximum: 2.5 mg once daily
Canadian labeling: 2.5-5 mg once daily
Pulmonary arterial hypertension (Adcirca®): Oral: 40 mg once daily
Dosing adjustment with concomitant medications: Coadministration with protease inhibitor regimen:
Concurrent use with atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir:
Coadministration of tadalafil in patients currently receiving one of these protease inhibitor regimens for at least 1 week: Initiate tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.
Coadministration of one of these protease inhibitor regimens in patients currently receiving tadalafil: Discontinue tadalafil at least 24 hours prior to the initiation of the protease inhibitor regimen. After at least 1 week of the protease inhibitor regimen, resume tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability.
Concurrent use with indinavir or nelfinavir:
Patient receiving indinavir/nelfinavir when initiating tadalafil: Initiate tadalafil at 20 mg once daily; increase to 40 mg once daily based on individual tolerability
Patient receiving tadalafil when initiating indinavir/nelfinavir: Adjust tadalafil to 20 mg once daily; increase to 40 mg once daily based on individual tolerability
Dosing: Geriatric
Refer to adult dosing. No dose adjustment for patients >65 years of age in the absence of renal or hepatic impairment.
Dosing: Renal Impairment
Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis®):
Clcr ≥51 mL/minute: No dosage adjustment necessary.
Clcr 30-50 mL/minute: Initial: 2.5 mg once daily; maximum: 5 mg once daily.
Clcr <30 mL/minute: Use not recommended.
ESRD requiring hemodialysis: Use not recommended.
Erectile dysfunction (Cialis®):
As-needed use:
U.S. labeling:
Clcr ≥51 mL/minute: No dosage adjustment necessary.
Clcr 30-50 mL/minute: Initial: 5 mg once daily; maximum: 10 mg (not to be given more frequently than every 48 hours).
Clcr <30 mL/minute: Maximum: 5 mg (not to be given more frequently than every 72 hours).
ESRD requiring hemodialysis: Maximum: 5 mg (not to be given more frequently than every 72 hours).
Canadian labeling:
Clcr >80 mL/minute: No dosage adjustment necessary.
Clcr ≥31-80 mL/minute: 10 mg, not to be given more frequently than every 48 hours (maximum 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.
Clcr <30 mL/minute: Use with extreme caution; has not been adequately studied.
ESRD requiring hemodialysis: Use with extreme caution; has not been adequately studied.
Once-daily use:
Clcr ≥31 mL/minute: No dosage adjustment necessary.
Clcr <30 mL/minute: Use not recommended.
ESRD requiring hemodialysis: Use not recommended.
Pulmonary arterial hypertension (Adcirca®):
Clcr >80 mL/minute: No dosage adjustment necessary.
Clcr 31-80 mL/minute: Initial: 20 mg once daily; increase to 40 mg once daily based on individual tolerability.
Clcr ≤30 mL/minute: Avoid use due to increased tadalafil exposure, limited clinical experience, and lack of ability to influence clearance by dialysis.
Dosing: Hepatic Impairment
Benign prostatic hyperplasia (with or without concomitant erectile dysfunction) (Cialis®):
Mild-to-moderate hepatic impairment (Child-Pugh class A or B): Use with caution.
Severe hepatic impairment (Child-Pugh class C): Use is not recommended.
Erectile dysfunction (Cialis®):
As-needed use:
U.S. labeling:
Mild-to-moderate impairment (Child-Pugh class A or B): Use with caution; dose should not exceed 10 mg once daily.
Severe impairment (Child-Pugh class C): Use is not recommended.
Canadian labeling:
Mild-to-moderate impairment (Child-Pugh class A or B): 10 mg, not to be given more frequently than every 48 hours (maximum 3 doses/week); may increase to 20 mg if lower dose is tolerated but ineffective. Discontinue use if 10 mg dose is not tolerated.
Severe impairment (Child-Pugh class C): Use with extreme caution; has not been adequately studied.
Once-daily use:
U.S. labeling:
Mild-to-moderate impairment (Child-Pugh class A or B): Use with caution.
Severe impairment (Child-Pugh class C): Use is not recommended.
Canadian labeling:
Mild-to-moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Use with extreme caution; has not been adequately studied.
Pulmonary arterial hypertension (Adcirca®):
Mild-to-moderate hepatic impairment (Child-Pugh class A or B): Use with caution; consider initial dose of 20 mg once daily.
Severe hepatic impairment (Child-Pugh class C): Avoid use; has not been studied in patients with severe hepatic cirrhosis.
Dosage Forms: U.S.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, oral:
Adcirca®: 20 mg
Cialis®: 2.5 mg, 5 mg, 10 mg, 20 mg
Generic Equivalent Available: U.S.
No
Administration
May be administered with or without food.
Adcirca®: Administer daily dose all at once; dividing doses throughout the day is not advised.
Cialis®: When used on an as-needed basis, should be taken at least 30 minutes prior to sexual activity. When used on a once-daily basis, should be taken at the same time each day, without regard to timing of sexual activity.
104
και εμένα μου πρότεινε το ίδιο χάπι CIALIS 5 γνωστός ουρολόγος Δεν το είχα διαβάσει πουθενα για αυτό δεν το πήρα αλλά ακόμα δεν το έχω ξεκινήσει γιατί δεν το έχω δει στις παγκόσμιες ιατρικές οδηγίες, από πολύ καταξιωμένο συνδρομητικό site που απευθύνεται σε ιατρούς. http://www.chronic-prostatitis.com/index.php?topic=244.0
Αφού έχω δει βελτίωση από την πρώτη οδηγία του που ήταν να πάρω OMNIC
Θα σκέφτομαι και το δεύτερο σκέλος της οδηγίας.
Από κάτω παγκόσμιες αναγνωρισμένες οδηγίες για το CIALIS
105
concluded that placebo-controlled studies are required to assess the role of antibiotic therapy and suggested that these studies might best be performed in a mixed group of patients with chronic prostatitis.
A network meta-analysis of treatment for chronic prostatitis/chronic pelvic pain syndrome found little evidence that a single strategy is likely to succeed in most patients, but there is some evidence that alpha-blockers, antibiotics, anti-inflammatories, finasteride, and physical therapy might all play a role [44]. Unfortunately, the quality and number of studies looking at these interventions is low and there could also be publication bias (especially with alpha-blockers). This review found only three studies comparing antibiotics to placebo and the total number of patients in both arms of these studies was about 200.
SUMMARY AND RECOMMENDATIONS
•   Prostatitis can be divided into the following categories:
•   I. Acute prostatitis
•   II. Chronic bacterial prostatitis
•   IIIA. Chronic prostatitis/pelvic pain syndrome, inflammatory
•   IIIB. Chronic prostatitis/pelvic pain syndrome, noninflammatory
•   IV. Asymptomatic inflammatory prostatitis (See 'Definitions' above.)
Acute prostatitis
•   Acute prostatitis is generally caused by the same organisms that cause urinary tract infections and urethritis. Gram-negative infections, especially with Enterobacteriaceae (typically Escherichia coli or Proteus spp), are most common. (See 'Microbiology' above.)
•   The most common symptoms of acute prostatitis are fevers, chills, dysuria, pelvic or perineal pain, and cloudy urine; obstructive symptoms, such as dribbling of urine, can also occur. (See 'Clinical presentation' above.)
•   Early diagnosis and treatment of acute prostatitis are important for both symptom control and the prevention of secondary problems, such as gram-negative sepsis, prostatic abscess, or metastatic infection (eg, spinal or sacroiliac infection). (See 'Clinical presentation' above.)
•   A combination of symptoms and a tender prostate on rectal examination makes the diagnosis. Digital rectal examination should be performed gently; vigorous prostate massage should be avoided since it is uncomfortable, allows no additional diagnostic or therapeutic benefit, and increases risk for bacteremia. (See 'Diagnosis' above.)
•   A urine Gram stain and culture should be obtained in all men suspected of having acute prostatitis. Gram stain of the urine, if positive, can be used as a guide to initial therapy. (See 'Diagnosis' above.)
•   Initial antibiotic treatment should cover gram-negative organisms (eg, trimethoprim-sulfamethoxazole or a fluoroquinolone) until cultures return. If parenteral therapy is required due to the toxic appearance of the patient, an aminoglycoside is frequently combined with a fluoroquinolone. Oral therapy can be initiated after the patient has been afebrile for 24 to 48 hours. (See 'Treatment' above.)
•   The total duration of antibiotics is four to six weeks to ensure eradication of the organisms. (See 'Treatment' above.)
Chronic bacterial prostatitis
•   Chronic bacterial prostatitis has more subtle clinical findings than acute prostatitis. Chronic bacterial prostatitis should be considered in men with dysuria and frequency who do not have symptoms of acute prostatitis or in those with recurrent UTIs in the absence of a bladder catheter. The infection is usually caused by gram-negative rods. (See 'Chronic bacterial prostatitis' above.)
•   The four-glass test is a method for collecting urine and prostatic secretions for quantitative analysis of leukocytes and bacteria (figure 1), but this test is not usually performed in clinical practice. Cultures of urine or expressed prostatic secretions are almost always positive in chronic bacterial prostatitis (table 1). (See 'Diagnosis' above.)
•   Chlamydia trachomatis should be considered in patients with clinical evidence of chronic prostatitis and negative results of urine and prostatic secretion cultures. (See 'Chlamydia infection' above.)
•   The fluoroquinolones are the most common antibiotics used in treatment of chronic bacterial prostatitis since they penetrate the less inflamed prostate well. The duration of treatment for chronic bacterial prostatitis is commonly four weeks. Courses exceeding four weeks should be considered only in patients who have previously failed treatment, who have a relatively difficult to treat organism, or who cannot tolerate first line therapy and need other agents. (See 'Treatment' above.)
•   C. trachomatis infection can be treated with doxycycline, minocycline, or azithromycin. (See 'Treatment' above.)
•   Recurrences of chronic bacterial prostatitis are common and are generally treated with a second course of antibiotics. If the first course was less than six weeks, a longer second course is recommended, preferably with an antibiotic from a different class with efficacy against usual pathogens responsible for prostatitis (eg, trimethoprim-sulfamethoxazole); in some cases, a second course of a fluoroquinolone can be given. (See 'Treatment' above.)
Use of UpToDate is subject to the Subscription and License Agreement.
REFERENCES
1.   Pontari MA, Joyce GF, Wise M, et al. Prostatitis. J Urol 2007; 177:2050.
2.   Collins MM, Stafford RS, O'Leary MP, Barry MJ. How common is prostatitis? A national survey of physician visits. J Urol 1998; 159:1224.
3.   Krieger JN, Egan KJ, Ross SO, et al. Chronic pelvic pains represent the most prominent urogenital symptoms of "chronic prostatitis". Urology 1996; 48:715.
4.   Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol 2001; 165:842.
5.   Leigh DA. Prostatitis--an increasing clinical problem for diagnosis and management. J Antimicrob Chemother 1993; 32 Suppl A:1.
6.   Krieger JN, Nyberg L Jr, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA 1999; 282:236.
7.   Krieger JN, Jacobs RR, Ross SO. Does the chronic prostatitis/pelvic pain syndrome differ from nonbacterial prostatitis and prostatodynia? J Urol 2000; 164:1554.
8.   Wyndaele JJ. Complications of intermittent catheterization: their prevention and treatment. Spinal Cord 2002; 40:536.
9.   Cornia PB, Takahashi TA, Lipsky BA. The microbiology of bacteriuria in men: a 5-year study at a Veterans' Affairs hospital. Diagn Microbiol Infect Dis 2006; 56:25.
10.   Heyse AM, Dierick J, Vanhouteghem H, et al. A case of imported melioidosis presenting as prostatitis. Infection 2003; 31:60.
11.   Smith JW, Jones SR, Reed WP, et al. Recurrent urinary tract infections in men. Characteristics and response to therapy. Ann Intern Med 1979; 91:544.
12.   Orland SM, Hanno PM, Wein AJ. Prostatitis, prostatosis, and prostatodynia. Urology 1985; 25:439.
13.   Lipsky BA. Urinary tract infections in men. Epidemiology, pathophysiology, diagnosis, and treatment. Ann Intern Med 1989; 110:138.
14.   Siroky MB, Moylan R, Austen G Jr, Olsson CA. Metastatic infection secondary to genitourinary tract sepsis. Am J Med 1976; 61:351.
15.   Gamé X, Vincendeau S, Palascak R, et al. Total and free serum prostate specific antigen levels during the first month of acute prostatitis. Eur Urol 2003; 43:702.
16.   Aagaard J, Madsen PO. Bacterial prostatitis: new methods of treatment. Urology 1991; 37:4.
17.   Charalabopoulos K, Karachalios G, Baltogiannis D, et al. Penetration of antimicrobial agents into the prostate. Chemotherapy 2003; 49:269.
18.   Canale D, Turchi P, Giorgi PM, et al. Treatment of abacterial prostato-vesiculitis with nimesulide. Drugs 1993; 46 Suppl 1:147.
19.   Wagenlehner FM, Weidner W, Naber KG. Therapy for prostatitis, with emphasis on bacterial prostatitis. Expert Opin Pharmacother 2007; 8:1667.
20.   Arakawa S, Kamidono S. Assessment of the UTI criteria for bacterial prostatitis in Japan. Infection 1992; 20 Suppl 3:S232.
21.   Chia JK, Longfield RN, Cook DH, Flax BL. Computed axial tomography in the early diagnosis of prostatic abscess. Am J Med 1986; 81:942.
22.   Horcajada JP, Vilana R, Moreno-Martínez A, et al. Transrectal prostatic ultrasonography in acute bacterial prostatitis: findings and clinical implications. Scand J Infect Dis 2003; 35:114.
23.   Weinberger M, Cytron S, Servadio C, et al. Prostatic abscess in the antibiotic era. Rev Infect Dis 1988; 10:239.
24.   Leport C, Rousseau F, Perronne C, et al. Bacterial prostatitis in patients infected with the human immunodeficiency virus. J Urol 1989; 141:334.
25.   Clairmont GJ, Zon LI, Groopman JE. Hemophilus parainfluenzae prostatitis in a homosexual man with chronic lymphadenopathy syndrome and HTLV-III infection. Am J Med 1987; 82:175.
26.   Trauzzi SJ, Kay CJ, Kaufman DG, Lowe FC. Management of prostatic abscess in patients with human immunodeficiency syndrome. Urology 1994; 43:629.
27.   Larsen RA, Bozzette S, McCutchan JA, et al. Persistent Cryptococcus neoformans infection of the prostate after successful treatment of meningitis. California Collaborative Treatment Group. Ann Intern Med 1989; 111:125.
28.   Schaeffer AJ. Clinical practice. Chronic prostatitis and the chronic pelvic pain syndrome. N Engl J Med 2006; 355:1690.
29.   Meares, EM Jr. Prostatitis: A review. Urol Clin North Am 1975; 2:3.
30.   Müller A, Mulhall JP. Sexual dysfunction in the patient with prostatitis. Curr Opin Urol 2005; 15:404.
31.   Nickel JC, Costerton JW. Bacterial localization in antibiotic-refractory chronic bacterial prostatitis. Prostate 1993; 23:107.
32.   McNaughton Collins M, Fowler FJ Jr, Elliott DB, et al. Diagnosing and treating chronic prostatitis: do urologists use the four-glass test? Urology 2000; 55:403.
33.   Shoskes DA, Lee CT, Murphy D, et al. Incidence and significance of prostatic stones in men with chronic prostatitis/chronic pelvic pain syndrome. Urology 2007; 70:235.
34.   Bruce AW, Reid G. Prostatitis associated with Chlamydia trachomatis in 6 patients. J Urol 1989; 142:1006.
35.   Poletti F, Medici MC, Alinovi A, et al. Isolation of Chlamydia trachomatis from the prostatic cells in patients affected by nonacute abacterial prostatitis. J Urol 1985; 134:691.
36.   van der Linden PD, Sturkenboom MC, Herings RM, et al. Fluoroquinolones and risk of Achilles tendon disorders: case-control study. BMJ 2002; 324:1306.
37.   Martin DH, Mroczkowski TF, Dalu ZA, et al. A controlled trial of a single dose of azithromycin for the treatment of chlamydial urethritis and cervicitis. The Azithromycin for Chlamydial Infections Study Group. N Engl J Med 1992; 327:921.
38.   Chiarini F, Mansi A, Tomao P, et al. Chlamydia trachomatis genitourinary infections: laboratory diagnosis and therapeutic aspects. Evaluation of in vitro and in vivo effectiveness of azithromycin. J Chemother 1994; 6:238.
39.   Skerk V, Schönwald S, Krhen I, et al. Comparative analysis of azithromycin and ciprofloxacin in the treatment of chronic prostatitis caused by Chlamydia trachomatis. Int J Antimicrob Agents 2003; 21:457.
40.   Weidner W, Schiefer HG. Chronic bacterial prostatitis: therapeutic experience with ciprofloxacin. Infection 1991; 19 Suppl 3:S165.
41.   Schaeffer AJ, Darras FS. The efficacy of norfloxacin in the treatment of chronic bacterial prostatitis refractory to trimethoprim-sulfamethoxazole and/or carbenicillin. J Urol 1990; 144:690.
42.   Weidner W, Schiefer HG, Brähler E. Refractory chronic bacterial prostatitis: a re-evaluation of ciprofloxacin treatment after a median followup of 30 months. J Urol 1991; 146:350.
43.   Nickel JC, Downey J, Johnston B, et al. Predictors of patient response to antibiotic therapy for the chronic prostatitis/chronic pelvic pain syndrome: a prospective multicenter clinical trial. J Urol 2001; 165:1539.
44.   Anothaisintawee T, Attia J, Nickel JC, et al. Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA 2011; 305:78.