Tadalafil / Phentolamine Mesylate Capsules ek compounded dual-drug formulation hai jo generally erectile dysfunction (ED) aur enhanced penile hemodynamics ke management ke liye diya jaata hai.

Tadalafil: Long-acting PDE5 inhibitor – promotes sustained erection by improving blood flow.

Combination therapy synergistically enhances penile vasodilation by acting through two complementary pathways.

Tadalafil:

• Inhibits Phosphodiesterase type 5 (PDE5) enzyme
• Increases cGMP levels in smooth muscle cells
• Helps in achieving and maintaining erection
• Phentolamine Mesylate:
• Non-selective alpha-1 and alpha-2 adrenergic antagonist
• Blocks sympathetic vasoconstriction
• Leads to peripheral vasodilation and smooth muscle relaxation
• Enhances the erectile effect of tadalafil

Synergistic effect:

• Tadalafil maintains erection, while Phentolamine improves initiation and rapid onset of erection via vascular dilation.

Contraindications:

• Nitrate medications use (e.g., nitroglycerin) → risk of severe hypotension

• Known hypersensitivity to tadalafil or phentolamine

• Severe hypotension or uncontrolled hypertension

• History of cardiovascular disorders (e.g., MI, stroke within last 6 months)

• Retinitis pigmentosa or vision disorders

• Peptic ulcer or GI bleeding risk (due to phentolamine’s alpha-blockade)

Precautions:

• Cardiovascular disease – monitor BP closely

• Postural hypotension risk – especially in elderly

• Prostate hyperplasia patients on alpha-blockers – additive hypotensive effect

• Caution in patients with hepatic or renal impairment

• Avoid driving or operating machinery after use (due to dizziness risk)

Tadalafil-related:

• Headache

• Flushing

• Back/muscle pain

• Nasal congestion

• Dyspepsia

• Rare: Priapism, vision or hearing loss

Phentolamine-related:

• Nasal stuffiness or congestion

• Tachycardia or palpitations

• Dizziness, postural hypotension

• GI disturbances (nausea, abdominal cramping)

• Sweating, flushing

• Rare: Reflex tachycardia, angina exacerbation

Combination-specific risks:

• Enhanced risk of hypotension and dizziness

• Rapid onset of erection, may not be suitable for all patients

• Mild transient blurred vision or flushing more likely

Pregnancy:

• Tadalafil: Category B (animal studies show no harm; no adequate human data)

• Phentolamine: Limited data; use in pregnancy not established

• Not recommended during pregnancy except under physician-supervised off-label use (very rare)

Breastfeeding:

• Unknown whether either drug is excreted in human milk

• Use not recommended in lactating women

• Avoid use during breastfeeding unless specifically prescribed for off-label female use (extremely rare)

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

1. Montague DK, Jarow JP, Broderick GA, et al. Chapter 1: The management of erectile dysfunction: an AUA update. J Urol 2005;174:230-9.
2. Phentolamine mesylate injection. Bedford, OH: Bedford Laboratories; 1999 May.
3. OraVerse (phentolamine mesylate) injection package insert. Louisville, CO: Septodont, Inc.; 2016 Mar.
4. Cialis (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Oct.
5. Adcirca (tadalafil) package insert. Indianapolis, IN: Lilly ICOS, LLC; 2011 Apr.
6. Robertson D, Biaggioni I. Chapter 10. Adrenoceptor Antagonist Drugs. In: Katzung BG, Masters SB, Trevor AJ, eds. Basic & Clinical Pharmacology. 12nd ed. New York: McGraw-Hill; 2012. http://www.accesspharmacy.com/content.aspx?aID=55821437.– LinkOpens in New Tab Accessed December 5, 2012.
7. Westfall TC, Westfall DP. Chapter 12. Adrenergic Agonists and Antagonists. In: Chabner BA, Brunton LL, Knollmann BC, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16661344.– LinkOpens in New Tab Accessed Sept 25, 2017.
8. Burnett AL, Bivalacqua TJ. Priapism: current principles and practice. Urol Clin N Am 2007;34:631-642.
9. Bortolotti M, Mari C, Giovannini M, et al. Effects of sildenafil on esophageal motility of normal subjects. Dig Dis Sci 2001;46:2301-2306.
10. Phentolamine mesylate injection (Sandoz). Quebec, Canada: Sandoz, Inc., 2012 May.
11. Padma-Nathan H, McMurray JG, Pullman WE, et al. On-demand IC351 (Tadalafil) enhances erectile function in patients with erectile dysfunction. Int J Impot Res 2001;13:2-9.
12. Pomeranz HD, Bhavsar AR. Nonarteritic ischemic optic neuropathy developing soon after use of sildenafil (Viagra): a report of seven new cases. J Neuroophthalmol 2005;25:9-13.
13. Escaravage GK Jr, Wright JD Jr, Givre SJ. Tadalafil associated with anterior ischemic optic neuropathy. Arch Ophthalmol 2005;123(3):399-400.
14. Bollinger K, Lee MS. Recurrent visual field defect and ischemic optic neuropathy associated with tadalafil rechallenge. Arch Ophthalmol 2005;123(3):400-1.
15. Peter NM, Singh MV, Fox PD. Tadalafil-associated anterior ischaemic optic neuropathy. Eye 2005;19(6):715-7.