Regitine Side Effects

Generic Name: phentolamine

Note: This page contains side effects data for the generic drug phentolamine. It is possible that some of the dosage forms included below may not apply to the brand name Regitine.

It is possible that some side effects of Regitine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to phentolamine: injection injectable, injection powder for solution, injection solution

As well as its needed effects, phentolamine (the active ingredient contained in Regitine) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking phentolamine, check with your doctor immediately:

Rare
  • Dizziness
  • erection continuing for more than 4 hours, or painful erection
  • lumps in the penis

Some phentolamine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare
  • Bruising or bleeding at place of injection
  • burning (mild) along penis
  • difficulty in ejaculating
  • swelling at place of injection

Phentolamine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.

For Healthcare Professionals

Applies to phentolamine: compounding powder, injectable powder for injection, injectable solution

Cardiovascular

Cardiovascular side effects have included hypotension due to reduced peripheral vascular resistance. This has been a significant cardiovascular complication of phentolamine (the active ingredient contained in Regitine) therapy in some cases. Acute and prolonged hypotensive episodes with reflex tachycardia and cardiac arrhythmias have been reported. Overdosage has been characterized primarily by cardiac arrhythmias, tachycardia and severe hypotension or shock.[Ref]

If severe hypotension develops, prompt elevation of the patient's legs, infusion of IV fluids and/or volume expanders, and, if necessary, an infusion of norepinephrine (titrated to an acceptable blood pressure) is recommended. Epinephrine should not be used since it may cause a paradoxical reduction in BP.

While limited data have shown that phentolamine can attenuate the marked increases in pulmonary artery pressure and vascular resistance associated with exercise in some patients with primary pulmonary hypertension (PPH), its role in this disease is not clear. A single case of severe, worsened pulmonary hypertension has been reported after the administration of phentolamine to a young woman with PPH. Theoretically, the drug was expected to cause pulmonary arterial vasodilation and an improvement of her condition. Apparently, in patients with PPH, the pulmonary vessels become progressively unresponsive to vasodilator therapy. Phentolamine did induce decreased systemic peripheral vascular resistance in this case, which was associated with increased cardiac output, increased pulmonary blood flow, and, because of a constant pulmonary vascular resistance, increased pulmonary artery blood pressure.[Ref]

Nervous system

Nervous system side effects have included weakness and dizziness. Anxiety, headache, pupillary contraction and visual disturbances are signs of toxicity.[Ref]

Respiratory

Respiratory system side effects have included nasal stuffiness, probably due to peripheral vasodilation.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea.[Ref]

Genitourinary

Genitourinary side effects among male patients who directly inject the penile cavernous body have included prolonged erections/priapism, fibrous plaque formation, severe local pain, cavernositis, urethritis, ecchymosis with hematoma, gross hematuria, and hematospermia. Urinary incompetence has not been reported, although the drug has been used to successfully treat urinary obstruction due to benign prostatic hypertrophy.[Ref]

Hepatic

Hepatic side effects have included transient hepatic abnormalities, manifested as elevations in liver function tests, with direct injection of phentolamine (the active ingredient contained in Regitine) and papaverine in 0.4% to 40% of men with erectile impotence.[Ref]

Metabolic

Metabolic side effects have included hypoglycemia. This was probably due to stimulation of insulin as a result of alpha-adrenergic blockade.[Ref]

References

1. "Product Information. Regitine (phentolamine)." Ciba Pharmaceuticals, Summit, NJ.

2. Van Way CW 3d, Faraci RP, Cleveland HC, Foster JF, Scott HW Jr "Hemorrhagic necrosis of pheochromocytoma associated with phentolamine administration." Ann Surg 184 (1976): 26-30

3. Diagnostic and Therapeutic Technology Assissment (DATTA) "Vasoactive intracavernous pharmacotherapy for impotence: papaverine and phentolamime." JAMA 264 (1990): 752-4

4. Se Do Cha, Kirschbaum M, Maranhao V, Paine E, Gooch AS "Phentolamine for primary pulmonary hypertension." Ann Intern Med 91 (1979): 927-8

5. Zentgraf M, Baccouche M, Junemann KP "Diagnosis and therapy of erectile dysfunction using papaverine and phentolamine." Urol Int 43 (1988): 65-75

6. Suzuki T, Mori C, Asakage H, Akaza H, Kawabe K, Ueno A, Koiso K, Niijima T "Pheochromocytoma with remission following phentolamine-induced shock." Urology 23 (1984): 582-4

7. Ruskin JN, Hutter AM Jr "Primary pulmonary hypertension treated with oral phentolamine." Ann Intern Med 90 (1979): 772-4

8. Cohen ML, Kronzon I "Adverse hemodynamic effects of phentolamine in primary pulmonary hypertension." Ann Intern Med 95 (1981): 591-2

9. Gould L, Reddy CV, Gomprecht RF "The effect of phentolamine on conduction in the bundle of His." Angiology 26 (1975): 507-10

10. Gould L, Reddy CV, Oh KC, Kim SG, Becker W "The effect of phentolamine on intra-Hisian conduction." J Electrocardiol 11 (1978): 391-4

11. Romankiewicz JA "Pharmacology and clinical use of drugs in hypertensive emergencies." Am J Hosp Pharm 34 (1977): 185-93

12. Hauptman JB, Modlinger RS, Ertel NH "Pheochromocytoma resistant to alpha-adrenergic blockade." Arch Intern Med 143 (1983): 2321-3

13. Stief CG, Gall H, Scherb W, Bahren W "Mid-term results of autoinjection therapy for erectile dysfunction." Urology 31 (1988): 483-5

14. Moriel EZ, Rajfer J "Sodium bicarbonate alleviates penile pain induced by intracavernous injections for erectile dysfunction." J Urol 149 (1993): 1299-300

15. Watters GR, Keogh EJ, Carati CJ, Earle CM, Wisniewski ZS, Tulloch AG, Lord DJ "Prolonged erections following intracorporeal injection of medications to overcome impotence." Br J Urol 62 (1988): 173-5

16. Kerfoot WW, Carson CC "Pharmacologically induced erections among geriatric men." J Urol 146 (1991): 1022-4

17. Bodner DR, Leffler B, Frost F "The role of intracavernous injection of vasoactive medications for the restoration of erection in spinal cord injured males: a three year follow up." Paraplegia 30 (1992): 118-20

18. Althof SE, Turner LA, Levine SB, Risen CB, Bodner D, Kursh ED, Resnick MI "Sexual, psychological, and marital impact of self-injection of papaverine and phentolamine: a long-term prospective study." J Sex Marital Ther 17 (1991): 101-12

19. Levine SB, Althof SE, Turner LA, Risen CB, Bodner DR, Kursh ED, Resnick MI "Side effects of self-administration of intracavernous papaverine and phentolamine for the treatment of impotence." J Urol 141 (1989): 54-7

20. Kursh ED, Bodner DR, Resnick MI, Althof SE, Turner L, Risen C, Levine SB "Injection therapy for impotence." Urol Clin North Am 15 (1988): 625-9

21. Fernandez JA, Basha MA, Wilson GC "Emergency treatment of papaverine priapism." J Emerg Med 5 (1987): 289-91

22. Sidi AA "Vasoactive intracavernous pharmacotherapy." Urol Clin North Am 15 (1988): 95-101

23. Fouda A, Hassouna M, Beddoe E, Kalogeropoulos D, Binik YM, Elhilali MM "Priapism: an avoidable complication of pharmacologically induced erection." J Urol 142 (1989): 995-7

24. Wyndaele JJ, de Meyer JM, de Sy WA, Claessens H "Intracavernous injection of vasoactive drugs, an alternative for treating impotence in spinal cord injury patients." Paraplegia 24 (1986): 271-5

25. Larsen EH, Gasser TC, Bruskewitz RC "Fibrosis of corpus cavernosum after intracavernous injection of phentolamine/papaverine." J Urol 137 (1987): 292-3

26. Kiruluta HG, Andrews K "Urinary incontinence secondary to drugs." Urology 22 (1983): 88-90

27. Caine M, Pfau A, Perlberg S "The use of alpha-adrenergic blockers in benign prostatic obstruction." Br J Urol 48 (1976): 255-63

28. Linde J, Deckert T "Increase of insulin concentration in maturity-onset diabetics by phentolamine (Regitine) infusion." Horm Metab Res 5 (1973): 391-5

29. Persson I, Larsen L "Serum insulin concentration after alpha-adrenergic blockade and secretin in diabetics." Acta Endocrinol (Copenh) 71 (1972): 331-7

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