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Phenoxybenzamine: Drug information

Phenoxybenzamine: Drug information
(For additional information see "Phenoxybenzamine: Patient drug information" and see "Phenoxybenzamine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Dibenzyline
Pharmacologic Category
  • Alpha 1 Blocker;
  • Antidote
Dosing: Adult
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: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Phenoxybenzamine: Pediatric drug information")

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: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in 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.

Administration: Pediatric

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

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends single gloving for administration of intact tablets or capsules. If manipulating tablets/capsules (eg, to prepare an oral suspension), NIOSH recommends double gloving, a protective gown, and preparation in a controlled device; if not prepared in a controlled device, respiratory and eye/face protection as well as ventilated engineering controls are recommended. NIOSH recommends double gloving, a protective gown, and (if there is a potential for vomit or spit up) eye/face protection for administration of an oral liquid/feeding tube administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Pheochromocytoma: Treatment of sweating and hypertension associated with pheochromocytoma.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpha-/Beta-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Alpha1-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Risk X: Avoid combination

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect 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 diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Dapoxetine: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Flunarizine: May enhance the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

Loop Diuretics: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect 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 enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect 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 enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Rilmenidine: Alpha1-Blockers may enhance the hypotensive effect of Rilmenidine. Risk C: Monitor therapy

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.

Breastfeeding Considerations

It is not known if phenoxybenzamine is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.

Monitoring Parameters

Blood pressure, pulse, orthostatics

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
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