{ "schema_version": 1, "kind": "condition", "id": "benign-prostatic-hyperplasia", "name": "Benign prostatic hyperplasia (BPH)", "category": "chronic", "sources": "Egyptian National Drug Formulary - Endocrine System Drugs 2024, Finasteride monograph (printed page 2): \"Benign prostatic hyperplasia (alternative agent) Oral: 5 mg once daily (either as a single agent or in combination with an alpha-1 blocker); 6 to 12 months of treatment is usually needed to improve symptoms.\" · EAU Guidelines on Non-neurogenic Male LUTS 2023 · Egyptian National Drug Formulary - Cardiovascular 2024 (doxazosin monograph) · Tadalafil 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) · GEMTESA (vibegron) tablets US prescribing information, section 1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia, section 2.1 Recommended Dosage, section 4 Contraindications and section 5 Warnings and Precautions (DailyMed SetID 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8)", "review_status": "reviewed", "verified_against": "Egyptian National Drug Formulary - Endocrine System Drugs 2024, Finasteride monograph (printed page 2): \"Benign prostatic hyperplasia (alternative agent) Oral: 5 mg once daily (either as a single agent or in combination with an alpha-1 blocker); 6 to 12 months of treatment is usually needed to improve symptoms.\" · EAU Guidelines on Non-neurogenic Male LUTS 2023 · Egyptian National Drug Formulary - Cardiovascular 2024 (doxazosin monograph) · Benign Prostatic Hyperplasia - disease-level clinical article (benign-prostatic-hyperplasia-clinical.txt) · Tadalafil 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) · GEMTESA (vibegron) tablets US prescribing information, section 1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia, section 2.1 Recommended Dosage, section 4 Contraindications and section 5 Warnings and Precautions (DailyMed SetID 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8) · Benign Prostatic Hyperplasia - disease-level clinical article (benign-prostatic-hyperplasia-full.txt)", "verified_date": "2026-08", "treatments": [ { "id": 268, "generic": "Tamsulosin", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 0.4, "adult_dose": "0.4 mg once daily after breakfast or first meal of the day", "adult_duration": "long-term", "dose_source": "EAU Guidelines on Non-neurogenic Male LUTS 2023", "rationale": "Alpha-1 blocker offering rapid relief of bladder outlet obstruction", "cautions": [ "There is a risk of intraoperative floppy iris syndrome (IFIS) during cataract surgery.", "Inform ophthalmologist before eye surgery.", "Caution with concurrent antihypertensives (orthostatic hypotension). The EAU Guidelines on the Management of Non-neurogenic Male LUTS 2023, under tolerability and safety of alpha1-blockers, give weakness, dizziness and orthostatic hypotension as the commonest adverse effects, and single out patients with cardiovascular disease or already on other vasoactive drugs as the ones most susceptible to the vasodilatation these drugs cause." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not indicated in pediatric populations", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "NORMIRAMA 0.4 MG 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EGPI > RAMAPHARMA", "price_egp": 60.0, "pack_count": 30, "unit_price": 2.0, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TAMSUNORM S.R. 0.4MG 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RAMEDA", "price_egp": 60.0, "pack_count": 30, "unit_price": 2.0, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TAMSULOSIN 0.4 MG 20 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLAXO SMITHKLINE > SANDOZ", "price_egp": 42.0, "pack_count": 20, "unit_price": 2.1, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CUREPRO XR 0.4 MG 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DEBEIKY > KHUFU PHARMA", "price_egp": 105.0, "pack_count": 30, "unit_price": 3.5, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "BLOCK ALPHA 0.4 MG MR 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ADWIA", "price_egp": 120.0, "pack_count": 30, "unit_price": 4.0, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "FIRAMAZIN 0.4MG 30 H.G.CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 54.0, "pack_count": null, "unit_price": null, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "OMNIC 0.4MG 30 MODIFIED RELEASE CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ASTELLAS PHARMA > MULTIPHARMA", "price_egp": 147.0, "pack_count": null, "unit_price": null, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "OMNIC OCAS 0.4 MG 30 PROLONGED RELEASE F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ASTELLAS PHARMA INC > MULTIPHARMA", "price_egp": 282.0, "pack_count": null, "unit_price": null, "strength_mg": 0.4, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "benign-prostatic-hyperplasia" }, { "id": 271, "generic": "Referral & safety-netting (no drug therapy)", "line": 1, "is_adjunct": false, "form": null, "strength_mg": null, "adult_dose": null, "adult_duration": null, "dose_source": "Benign Prostatic Hyperplasia - disease-level clinical article (benign-prostatic-hyperplasia-clinical.txt)", "rationale": "Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.", "cautions": [ "These are the red flags pointing to more sinister causes of urinary symptoms: prostate cancer, cauda equina, and chronic high-pressure retention with silent renal failure.", "RED FLAG - Acute urinary retention requires Foley catheter drainage as standard emergency therapy, a different pathway from routine oral BPH therapy.", "RED FLAG - The indications for urological/surgical referral are bladder stones, refractory hematuria, high-pressure or recurrent urinary retention, recurrent UTIs, and renal failure with hydronephrosis." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": null, "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "benign-prostatic-hyperplasia" }, { "id": 269, "generic": "Finasteride", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 5.0, "adult_dose": "5 mg once daily with or without food", "adult_duration": "long-term (at least 6 months for clinical effect)", "dose_source": "Egyptian National Drug Formulary - Endocrine System Drugs 2024, Finasteride monograph (printed page 2): \"Benign prostatic hyperplasia (alternative agent) Oral: 5 mg once daily (either as a single agent or in combination with an alpha-1 blocker); 6 to 12 months of treatment is usually needed to improve symptoms.\"", "rationale": "5-alpha reductase inhibitor for enlarged prostate (>40g)", "cautions": [ "CONTRAINDICATED in women of childbearing potential (teratogenic).", "Reduces serum PSA by approximately 50% after 6 months; double PSA for screening.", "Warn patient regarding potential sexual dysfunction (decreased libido, ED)." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not indicated in pediatric populations", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "MIXOSTERIDE 5 MG 14 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SIGMA > PHARMA MIX", "price_egp": 30.0, "pack_count": 14, "unit_price": 2.14, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "FINCAR 5MG 10 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RAMEDA", "price_egp": 26.4, "pack_count": 10, "unit_price": 2.64, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROSTAT 5MG 14 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "CID > OCTOBER PHARMA", "price_egp": 46.0, "pack_count": 14, "unit_price": 3.29, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROSTEC 5 MG 14 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SIGMA", "price_egp": 47.0, "pack_count": 14, "unit_price": 3.36, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "FINASTURA 5MG 30 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLOBAL NAPI PHARMACEUTICALS", "price_egp": 111.0, "pack_count": 30, "unit_price": 3.7, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ROYALSTERIDE 5 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HI-PHARM > ROYAL LINK PHARMA", "price_egp": 132.0, "pack_count": 30, "unit_price": 4.4, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROSTRIDE 5MG 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ADWIA", "price_egp": 183.0, "pack_count": 30, "unit_price": 6.1, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROSCAR 5MG 28 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MERCK SHARP & DOHME > MERCK SHARP & DOHME SCIENTIFIC OFFICE", "price_egp": 258.0, "pack_count": 28, "unit_price": 9.21, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "benign-prostatic-hyperplasia" }, { "id": 270, "generic": "Doxazosin", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 4.0, "adult_dose": "Immediate release: 1 mg once daily, doubled at 1-2 week intervals to a maximum of 8 mg; usual maintenance 2-4 mg daily. Modified release: 4 mg once daily, increased to 8 mg after 4 weeks if needed", "adult_duration": "Long-term", "dose_source": "Egyptian National Drug Formulary - Cardiovascular 2024 (doxazosin monograph)", "rationale": "20 live products. Benign prostatic hyperplasia is the formulary's first listed indication. The practical advantage over the tamsulosin already listed is that it also lowers blood pressure, which suits the very common patient who has both problems and is paying for both prescriptions.", "cautions": [ "First-dose postural hypotension and syncope - give the first dose at bedtime and warn the patient to rise slowly.", "CONTRAINDICATED with a history of micturition syncope or of postural hypotension, and as monotherapy in overflow bladder or anuria.", "Contraindicated with potent CYP3A4 inhibitors including itraconazole and ketoconazole.", "Use one alpha-blocker only - it replaces the tamsulosin already listed rather than adding to it.", "Tell the ophthalmologist before any cataract surgery - intraoperative floppy iris syndrome.", "Less uroselective than tamsulosin, so more dizziness and more first-dose effect; the trade-off is the antihypertensive benefit." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not applicable - benign prostatic hyperplasia is an adult male condition and doxazosin has no paediatric indication.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "EPCURA MR 4MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EPCI", "price_egp": 10.0, "pack_count": 10, "unit_price": 1.0, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ELAXICOPA 4MG 10 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "COPAD PHARMA", "price_egp": 12.0, "pack_count": 10, "unit_price": 1.2, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DOXAZIN 4 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PHAROPHARMA", "price_egp": 18.0, "pack_count": 10, "unit_price": 1.8, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DOSIN 4 MG 20 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EIPICO", "price_egp": 46.0, "pack_count": 20, "unit_price": 2.3, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DOXARELAX 4 MG 21 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "OCTOBER PHARMA", "price_egp": 60.0, "pack_count": 21, "unit_price": 2.86, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DALIZOS XL 4 MG 7 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EGYPHAR", "price_egp": 20.5, "pack_count": 7, "unit_price": 2.93, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CARDURA 4 MG 14 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER > VIATRIS EGYPT", "price_egp": 80.0, "pack_count": 14, "unit_price": 5.71, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CARDURA XL 4 MG 28 PROLONGED R.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER > VIATRIS EGYPT", "price_egp": 255.0, "pack_count": null, "unit_price": null, "strength_mg": 4.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "benign-prostatic-hyperplasia" }, { "id": 272, "generic": "Tadalafil", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 5.0, "adult_dose": "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.", "adult_duration": "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.\"", "dose_source": "Tadalafil 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)", "rationale": "The 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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not a paediatric prescription. Benign prostatic hyperplasia is a disease of ageing men and the label carries no paediatric dose for it.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "CIALONG 5 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BORG", "price_egp": 150.0, "pack_count": 30, "unit_price": 5.0, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DIAMONRECTA 5 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 187.5, "pack_count": 30, "unit_price": 6.25, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ERECTOBACK 5 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "OCTOBER PHARMA", "price_egp": 187.5, "pack_count": 30, "unit_price": 6.25, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "COPADTADA 5 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "COPAD EGYPT > COPAD PHARMA", "price_egp": 195.0, "pack_count": 30, "unit_price": 6.5, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TADATRONA 5 MG 21 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AVERROES PHARMA", "price_egp": 136.5, "pack_count": 21, "unit_price": 6.5, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "STARKOPREX 5 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTI-APEX", "price_egp": 252.0, "pack_count": 30, "unit_price": 8.4, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TADAGOLD 5 MG 5 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RAMEDA", "price_egp": 46.25, "pack_count": 5, "unit_price": 9.25, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TADALANDRO 5 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MARCYRL PHARMACEUTICAL INDUSTRIES (MPI)", "price_egp": 300.0, "pack_count": 30, "unit_price": 10.0, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "benign-prostatic-hyperplasia" }, { "id": 273, "generic": "Vibegron", "line": 3, "is_adjunct": true, "form": "oral.solid", "strength_mg": 75.0, "adult_dose": "One 75 mg tablet once a day. US label verbatim: \"The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. Swallow GEMTESA tablets whole with a glass of water.\" and \"In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water.\" There is no titration and no dose adjustment for age; renal and hepatic limits are in the cautions.", "adult_duration": "Continued while the storage symptoms are controlled and the bladder empties. The label sets no course length; the practical review point is a post-void residual that is not rising.", "dose_source": "GEMTESA (vibegron) tablets US prescribing information, section 1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia, section 2.1 Recommended Dosage, section 4 Contraindications and section 5 Warnings and Precautions (DailyMed SetID 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8)", "rationale": "The disease article names the drug and the exact place it holds, verbatim: \"Those who fail antimuscarinic treatment may be considered for mirabegron or vibegron use (beta-3 adrenoreceptor agonists), which also cause detrusor relaxation and relieve symptoms of overactivity with no cholinergic or mental side effects.\" and it adds where such drugs belong - \"Bladder-relaxing therapies for men with BPH may be used alone if there is good urinary flow and low PVRs. However, they are often used together with alpha-blockers for most patients with symptomatic\" disease. The US label has an indication written for precisely this patient, verbatim: \"GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).\" That second indication is why vibegron rather than mirabegron lands on this card: it is the one whose label names men with BPH. Egypt registers no vibegron product, so no brand and no price can be shown.", "cautions": [ "RED FLAG - urinary retention, and this is the card where that risk is highest. US label verbatim: \"Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.\" Bladder outlet obstruction is what benign prostatic hyperplasia is. The label's own indication is for men already on treatment for the obstruction - it is an addition to that treatment, never a replacement for it.", "Check the residual volume before starting and after. The article's own condition for using a bladder-relaxing drug in a man is \"good urinary flow and low PVRs\". A man who is already emptying poorly should not be given a detrusor relaxant on a symptom description alone.", "Angioedema. US label verbatim: \"Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy.\"", "Advanced kidney or liver disease. US label verbatim: \"GEMTESA has not been studied in patients with eGFR <15 mL/min/1.73 m2 (with or without hemodialysis) and is not recommended in these patients.\" and \"GEMTESA has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in this patient population.\"", "It is contraindicated in known hypersensitivity to vibegron.", "No Egyptian product exists, so vibegron cannot be filled at a Cairo pharmacy. Mirabegron, the other drug in the article's sentence, is on the Egyptian register and is already used for urge incontinence - but its own label does not carry the men-with-BPH indication, which is the claim behind prescribing it here." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not a paediatric prescription. US label verbatim: \"The safety and effectiveness of GEMTESA in pediatric patients have not been established.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "benign-prostatic-hyperplasia" } ] }