Strength5 mg
Formoral.solid
5 mg once a day, at the same time each day - not the on-demand tablet. US label verbatim: "The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day." and, where a 5-alpha-reductase inhibitor is started with it, "the recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks." Kidney function changes it: "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." and "Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended." It may be taken with or without food. - Continued daily while it helps. The label sets one time limit and it belongs to the combination only, verbatim: "If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown."
Paediatric doseAdult-only condition - paediatric section not applicable
Dose sourceTadalafil tablets, film coated (NorthStar Rx LLC) US prescribing information, section 1.2 Benign Prostatic Hyperplasia, section 2.3 Once Daily Use for Benign Prostatic Hyperplasia, section 2.6 Use in Specific Populations and section 4 Contraindications (DailyMed SetID a10d464a-6ea7-4e5a-befa-71eceacc5039)
WhyThe disease article names the drug, the dose and the patient it suits, verbatim: "Tadalafil is generic, relatively inexpensive, with few side effects, and is a very reasonable, if underutilized, therapy choice for patients with both BPH and ED." and it draws the comparison with the drug already on this card - "Unlike tamsulosin, tadalafil does not risk an allergic reaction to sulfa or 'floppy iris' syndrome, and ED has not been associated with its use." The US label's indication section names the disease, verbatim: "Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)." and separately "for the treatment of ED and the signs and symptoms of BPH (ED/BPH)." The card carried tamsulosin, finasteride and doxazosin; a man facing cataract surgery, or one whose main complaint is as much sexual as urinary, had nothing else. Egypt registers the 5 mg once-daily strength widely, from CIALONG 5 mg at about 150 EGP for 30 tablets.
Cautions- RED FLAG - never with nitrates. US label verbatim: "Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated." A man of this age is likely to have a glyceryl trinitrate spray somewhere, and tadalafil's effect lasts far longer than sildenafil's. Riociguat and other guanylate cyclase stimulators are contraindicated too.
- The 5 mg once-daily tablet is a different medicine from the 20 mg on-demand tablet, even though Egypt sells both under the same brand names. What is prescribed here is 5 mg every day. A man given a 20 mg tablet to take before sex is not on BPH treatment.
- Kidney function sets the dose and can rule it out. US label verbatim, for BPH: a creatinine clearance of 30 to 50 mL/min starts at 2.5 mg, and below 30 mL/min or on haemodialysis once-daily tadalafil "is not recommended".
- Combining it with an alpha-blocker is not the routine move. Disease article verbatim: "the 2021 AUA Management Guidelines for BPH do not recommend combination therapy" - the combination raised efficacy in some studies but "side effects did increase", and both drugs lower blood pressure.
- Serious hypersensitivity is a listed contraindication and includes Stevens-Johnson syndrome and exfoliative dermatitis.
- Retention, haematuria, a palpably hard prostate or a rising PSA are not treated by any drug on this card. They are urology referrals.