TADLIQ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TADLIQ (TADLIQ).
Tadliq contains the active ingredient tadalafil, a phosphodiesterase-5 (PDE5) inhibitor. It enhances the effect of nitric oxide (NO) by inhibiting PDE5, which increases cGMP levels in corpus cavernosum smooth muscle, leading to relaxation and increased blood flow to the penis, facilitating erection. It also inhibits PDE5 in pulmonary vasculature, causing vasodilation.
| Metabolism | Primarily metabolized by CYP3A4 to an active metabolite (methylcatechol glucuronide). Also minor metabolism by CYP3A5 and CYP2C9. |
| Excretion | Primarily renal (approx. 80% as unchanged drug), with biliary/fecal elimination accounting for ~10-15%. |
| Half-life | 34-48 hours in healthy adults; may be prolonged in renal impairment (e.g., up to 100 hours in severe impairment), necessitating dose adjustment. |
| Protein binding | ~95% bound, primarily to albumin. |
| Volume of Distribution | Approximately 0.3-0.5 L/kg, indicating distribution mainly in extracellular fluid. |
| Bioavailability | Oral: 60-80%; subcutaneous: >90%. |
| Onset of Action | Oral: 1-2 hours; subcutaneous: 30-60 minutes. |
| Duration of Action | 24-48 hours (dose-dependent); therapeutic effect may persist 72 hours due to long half-life. |
TADLIQ (tadalafil) 2.5-5 mg orally once daily at approximately the same time of day; maximum 5 mg once daily.
| Dosage form | SUSPENSION |
| Renal impairment | CrCl 30-50 mL/min: 2.5 mg once daily; CrCl <30 mL/min: not recommended; hemodialysis: not studied. |
| Liver impairment | Child-Pugh A or B: 2.5 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Safety and efficacy not established; no approved dosing. |
| Geriatric use | No dose adjustment required; consider age-related renal impairment and increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TADLIQ (TADLIQ).
| Breastfeeding | No human data on excretion into breast milk. M/P ratio unknown. Potential for infant exposure; caution advised. Use only if clearly needed. |
| Teratogenic Risk | TADLIQ is not FDA-approved; no human pregnancy data. Animal studies suggest developmental toxicity only at maternally toxic doses. Theoretical risk of teratogenicity cannot be excluded; avoid in first trimester unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Concomitant use with any form of nitrate (e.g., nitroglycerin, isosorbide mononitrate)","Concomitant use with guanylate cyclase stimulators (e.g., riociguat)","Hypersensitivity to tadalafil or any component","Patients with loss of vision in one eye due to NAION","Severe hepatic impairment (Child-Pugh class C) for once-daily dosing"]
| Precautions | ["Cardiovascular risk: Use not recommended in patients with unstable angina, recent MI, stroke, or uncontrolled hypertension.","Priapism: Prolonged erection (>4 hours) requires immediate medical attention.","Hearing loss: Sudden decrease or loss of hearing has been reported.","Vision loss: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported.","Avoid use with nitrates due to risk of severe hypotension.","Caution in patients with severe renal or hepatic impairment.","Not recommended for use with alpha-blockers (except for PAH indication) due to risk of hypotension."] |
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| Monitor liver function tests, renal function, and complete blood count periodically. Fetal ultrasound if used in pregnancy. |
| Fertility Effects | No human fertility studies. Animal studies show no impairment at clinically relevant doses. |