ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 0 مورد

Phenoxybenzamine: Pediatric drug information

Phenoxybenzamine: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Phenoxybenzamine: Drug information" and "Phenoxybenzamine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Dibenzyline
Therapeutic Category
  • Alpha-Adrenergic Blocking Agent, Oral;
  • Antihypertensive Agent;
  • Vasodilator
Dosing: Pediatric
Pheochromocytoma, preoperative management

Pheochromocytoma, preoperative management: Limited data available: Children and Adolescents: Oral: Initial: 0.2 to 0.25 mg/kg/dose once or twice daily; maximum dose: 10 mg/dose; slowly titrate (eg, every 4 days) to effect; increments of 0.2 mg/kg/day have been reported; reported maintenance dose range: 0.4 to 3 mg/kg/day in divided doses every 6 to 8 hours; maximum single maintenance dose: 40 mg/dose; maximum daily dose: 4 mg/kg/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Adult

(For additional information see "Phenoxybenzamine: Drug information")

Pheochromocytoma

Pheochromocytoma: Oral: Initial: 10 mg twice daily; may increase slowly every other day until optimal blood pressure response is achieved; usual dosage range: 20 to 40 mg 2 to 3 times daily. Doses up to 240 mg daily have been reported (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Edema (van der Zee 2014), orthostatic hypotension (van der Zee 2014), tachycardia (van der Zee 2014)

Gastrointestinal: Gastrointestinal irritation

Genitourinary: Inhibited ejaculation

Nervous system: Drowsiness, fatigue

Ophthalmic: Miosis

Respiratory: Nasal congestion (van der Zee 2014)

Contraindications

Hypersensitivity to drug or any component of the formulation; conditions in which a fall in blood pressure may be undesirable.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: An exaggerated hypotensive response and tachycardia may occur when administered concurrently with compounds that stimulate both alpha- and beta-adrenergic receptors.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with marked cerebral or coronary atherosclerosis.

• Renal impairment: Use with caution in patients with renal impairment.

• Respiratory infection: May aggravate symptoms of respiratory infections.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Long-term use: Not recommended for long-term use due to case reports of cancer in humans; carefully weigh the risk and benefits before use.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Dibenzyline: 10 mg [contains fd&c yellow #6 (sunset yellow)]

Generic: 10 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Dibenzyline Oral)

10 mg (per each): $24.00

Capsules (Phenoxybenzamine HCl Oral)

10 mg (per each): $129.45 - $134.99

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Extemporaneous Preparations

A 2 mg/mL oral suspension may be made with capsules, propylene glycol 1%, and citric acid 0.15% in distilled water. Prepare the vehicle by dissolving 150 mg citric acid in a minimal amount of distilled water. Add 1 mL propylene glycol and mix well; add quantity of distilled water sufficient to make 100 mL (only a small portion of this vehicle will be used to make the final product). Grind the contents of two phenoxybenzamine 10 mg capsules in a mortar and reduce to a fine powder. Add a small portion of the vehicle and mix to a uniform paste; transfer to a graduated cylinder, rinse mortar with vehicle, and add quantity of prepared vehicle sufficient to make 10 mL. Transfer to an amber glass prescription bottle with tight-fitting cap; label "shake well" and "refrigerate". Stable for 7 days when stored in amber glass prescription bottles and refrigerated.

A stock solution of 10 mg/mL in propylene glycol was stable for 30 days refrigerated. When this stock solution was diluted 1:4 (v/v) with syrup (66.7% sucrose) to 2 mg/mL, the preparation was stable for 1 hour refrigerated. Note: Although the stock solution is stable for 30 days, it must be diluted before administration to decrease the amount of propylene glycol delivered to the patient.

Lim LY, Tan LL, Chan EW, et al, "Stability of Phenoxybenzamine Hydrochloride in Various Vehicles," Am J Health Syst Pharm, 1997, 54(18):2073-8.9377206
Administration: Pediatric

Oral: Administer without regard to meals; may administer with milk to decrease GI upset

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Use

Treatment of hypertension and sweating in patients with pheochromocytoma (FDA approved in adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Phenoxybenzamine may be confused with phenazopyridine

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Alpha-/Beta-Agonists: Alpha1-Blockers may decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor

Alpha1-Blockers: May increase antihypertensive effects of Alpha1-Blockers. Risk X: Avoid

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Dapoxetine: May increase orthostatic hypotensive effects of Alpha1-Blockers. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Levomethadone: May increase hypotensive effects of Alpha1-Blockers (Nonselective). Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Midodrine: Alpha1-Blockers (Nonselective) may decrease therapeutic effects of Midodrine. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Phenylephrine (Systemic): Alpha1-Blockers may decrease vasoconstricting effects of Phenylephrine (Systemic). Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Alpha1-Blockers (Nonselective). Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider Therapy Modification

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Rilmenidine: Alpha1-Blockers may increase hypotensive effects of Rilmenidine. Risk C: Monitor

Reproductive Considerations

It is not known whether phenoxybenzamine can affect reproduction capacity.

Pregnancy Considerations

Adequate animal reproduction studies have not been conducted. It is not known whether phenoxybenzamine can cause fetal harm when administered to a pregnant woman.

Monitoring Parameters

Blood pressure, orthostasis, heart rate

Mechanism of Action

Produces long-lasting noncompetitive alpha-adrenergic blockade of postganglionic synapses in exocrine glands and smooth muscle; relaxes urethra and increases opening of the bladder

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Within 2 hours; Maximum effect: Within 4 to 6 hours

Duration: IV: ≥3 to 4 days

Distribution: Distributes to and may accumulate in adipose tissues

Bioavailability: 20% to 30%

Half-life elimination: IV: ~24 hours

Excretion: Primarily in urine and bile

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Dibenzyran;
  • (AU) Australia: Dibenyline | Dibenzyline;
  • (BE) Belgium: Dibenyline;
  • (CH) Switzerland: Dibenzyline;
  • (CN) China: Dibenyline;
  • (DE) Germany: Dibenzyran;
  • (FR) France: Dibenyline | Dibenzyran;
  • (GB) United Kingdom: Dibenyline;
  • (GR) Greece: Dibenyline | Phenoxybenzamine;
  • (HK) Hong Kong: Dibeline | Dibenyline | Phenoxybenzamine;
  • (HU) Hungary: Dibenyline;
  • (IE) Ireland: Dibenyline;
  • (IL) Israel: Dibenyline;
  • (IN) India: Fenoxene;
  • (KR) Korea, Republic of: Dibenylin | Dibenzyline;
  • (LT) Lithuania: Dibenyline | Dibenzyran;
  • (LV) Latvia: Dibenyline | Dibenzyran;
  • (MY) Malaysia: Dibenyline | Dibenzyline | Dibenzyran | Fenoxene;
  • (NL) Netherlands: Dibenyline;
  • (NO) Norway: Dibenzyran;
  • (NZ) New Zealand: Dibenyline | Phenoxybenzamine;
  • (PL) Poland: Dibenyline | Dibenzyran;
  • (PR) Puerto Rico: Dibenzyline | Phenoxybenzamine;
  • (SI) Slovenia: Dibenzyran;
  • (TW) Taiwan: Dibecine | Dibenyline | Feromine | Limycin | Lition | Phenculin | Seton
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  3. Dibenzyline (phenoxybenzamine) [prescribing information]. St. Michael, Barbados: Concordia Pharmaceuticals Inc; April 2020.
  4. Gal P, Reed M. Medications. In: Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007: 2955-2999.
  5. Hack HA. The perioperative management of children with phaeochromocytoma. Paediatr Anaesth. 2000.10(5):463-476. [PubMed 11012949]
  6. Hack HA, Brown TC. Preoperative management of phaeochromocytoma--a paediatric perspective. Anaesth Intensive Care. 1999;27(1):112-113. [PubMed 10050231]
  7. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  8. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  9. Kinney MA, Narr BJ, and Warner MA, “Perioperative Management of Pheochromocytoma,” J Cardiothorac Vasc Anesth, 2002, 16(3):359-69. [PubMed 12073213]
  10. Kinney MA, Warner ME, vanHeerden JA, et al. Perianesthetic risks and outcomes of pheochromocytoma and paraganglioma resection. Anesth Analg. 2000;91(5):1118-1123. [PubMed 11049893]
  11. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  12. Romero M, Kapur G, Baracco R, Valentini RP, Mattoo TK, Jain A. Treatment of hypertension in children with catecholamine-secreting tumors: a systematic approach. J Clin Hypertens (Greenwich). 2015;17(9):720-725. doi: 10.1111/jch.12571 [PubMed 26010736]
  13. Sperling MA, ed. Pediatric Endocrinology. 4th ed. Philadelphia, PA: Elsevier; 2014.
  14. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  15. van der Zee PA, de Boer A. Pheochromocytoma: a review on preoperative treatment with phenoxybenzamine or doxazosin. Neth J Med. 2014;72(4):190-201. [PubMed 24829175]
Topic 12699 Version 246.0