Details About Generic Salt ::  Buprenor

Main Medicine Class:: Narcotic agonist-antagonist analgesic   

BYOO-preh-NAHR-feen HIGH-droe-KLOR-ide
Buprenex
Subutex
Class: Narcotic agonist-antagonist analgesic

 

Drugs Class ::

 Action Analgesic effect caused by binding to opiate receptors in the CNS. Antagonist effects decrease abuse potential.

Absorption: Cmax is approximately 5.47 ng/mL (16 mg SL dose). AUC is approximately 32.63 hr•ng/mL (16 mg SL dose).

Distribution: Approximately 96% protein bound.

Metabolism: Undergoes CYP3A4-mediated N-dealkylation to norbuprenorphine (active) and glucuronidation.

Elimination: 30% is exctreted in the urine and 69% in the feces. The t1/2 is 37 hr.

Onset of Action: 15 min (IM).

Time to peak effect: 1 hr (IM).

Duration: At least 6 hr (IM).

Indications for Drugs ::

 Indications

Tablet: Treatment of opioid dependence.

Injection: Relief of moderate to severe pain.

Drug Dose ::

 Route/Dosage

Tablets

Adults: SL (Use limited to health care providers who meet certain qualifications and have notified the Health and Human Services of their intent to prescribe.) 12 to 16 mg/day.

Injection

Adults and children (13 yr and older): IM/IV 0.3 mg deep IM or slow IV (over at least 2 min) at up to 6 hr intervals, as needed. May repeat once (up to 0.3 mg) 30 to 60 min after initial dosage, if required.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Safety and efficacy not established in children under 13 yr. Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions. Dependency: Buprenorphine has abuse potential. Psychological and physical dependence as well as tolerance may occur. Head injury or increased intracranial pressure: Use with caution; drug can increase CSF pressure. Narcotic dependent patients: Use in physically dependent individuals may result in withdrawal effects. Special risk patients: Use with caution in elderly or debilitated patients; use with caution in patients with impaired hepatic, renal or pulmonary function, myxedema or hypothyroidism, adrenal cortical insufficiency (eg, Addison disease), CNS depression or coma, toxic psychoses, prostatic hypertrophy or urethral stricture, acute alcoholism, delirium tremens or kyphoscoliosis, biliary tract dysfunction.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: Hypotension; hypertension; tachycardia; bradycardia. CNS: Sedation; dizziness/vertigo; headache; confusion; dreaming; psychosis; euphoria; weakness/fatigue; malaise; hallucinations; depersonalization; coma; tremor; dysphoria; agitation; convulsions; lack of muscle coordination; insomnia. DERMATOLOGIC: Sweating; pruritus; injections site reaction; rash; pallor; urticaria. EENT: Miosis. GI: Nausea; vomiting; constipation; dry mouth; dyspepsia; flatulence; loss of appetite; diarrhea; abdominal pain. HEPATIC: Hepatitis and hepatitis with jaundice. RESPIRATORY: Hypoventilation. OTHER: Chronic and acute hypersensitivity; infection.

Drug Mode of Action ::  

 Action Analgesic effect caused by binding to opiate receptors in the CNS. Antagonist effects decrease abuse potential.

Absorption: Cmax is approximately 5.47 ng/mL (16 mg SL dose). AUC is approximately 32.63 hr•ng/mL (16 mg SL dose).

Distribution: Approximately 96% protein bound.

Metabolism: Undergoes CYP3A4-mediated N-dealkylation to norbuprenorphine (active) and glucuronidation.

Elimination: 30% is exctreted in the urine and 69% in the feces. The t1/2 is 37 hr.

Onset of Action: 15 min (IM).

Time to peak effect: 1 hr (IM).

Duration: At least 6 hr (IM).

Drug Interactions ::

 Interactions

Barbiturate anesthetics: May have additive effects with buprenorphine, increasing the respiratory and CNS effects. Benzodiazepines (eg, diazepam): Coma and death have been associated with misuse of buprenorphine and benzodiazepines. CNS depressants (eg, alcohol, phenothiazines, sedative-hypnotics): Increased CNS depression may occur. CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin): May reduce buprenorphine plasma levels, decreasing the efficacy. CYP3A4 inhibitors (eg, erythromycin, ketoconazole, ritonavir): May elevate buprenorphine plasma levels, increasing the risk of side effects.

Drug Assesment ::

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note presence of hepatic or renal impairment, compromised respiratory function (eg, COPD), biliary tract dysfunction, acute abdominal condition, hypothyroidism, adrenal cortical insufficiency (Addison disease), CNS depression, toxic psychosis, prostatic hypertrophy or urethral stricture, acute alcoholism, delerium tremens, kyphoscoliosis, intracranial lesion, or history of recent head injury.
  • Ensure that liver enzymes and hepatic function are evaluated prior to starting therapy and periodically during treatment.
  • Document type of opioid dependence (eg, long-, short-acting), time since last opioid use, and degree of opioid dependence prior to starting sublingual tablets.
  • Monitor patient for respiratory depression. If noted, re-establish adequate ventilation with mechanical assistance and notify health care provider immediately. Naloxone may not be effective in reversing respiratory depression caused by this drug.
  • Monitor patient for narcotic withdrawal symptoms, CNS, GI, and general body side effects. Report to health care provider if noted and significant.
OVERDOSAGE: SIGNS & SYMPTOMS
  Respiratory depression, pinpoint pupils, sedation, hypotension, death

Drug Storage/Management ::

 Administration/Storage

Sublingual tablets:

  • For sublingual use only. Do not chew, crush, or swallow tablets.
  • Buprenorphine and buprenorphine/naloxone tablets are interchangeable.
  • Do not initiate therapy until objective signs of opioid withdrawal are evident.
  • Administer prescribed dose once daily.
  • Place tablets under the tongue until they are dissolved. Swallowing tablets reduces effectiveness.
  • For dose requiring more than 2 tablets, place all tablets under the tongue and allow to dissolve. If patient cannot fit more than 2 tablets under the tongue at one time, then place 2 tablets under the tongue at a time.
  • Store tablets at controlled room temperature (59° to 86°F).

Injection:

  • For deep IM or slow IV (over at least 2 min) administration only. Not for intradermal, SC, or intra-arterial administration.
  • Prescribed dose may be given at up to q 6 hr, as needed for pain relief. May repeat dose once, if required for pain relief, 30 to 60 min after first dose.
  • Administer reduced dose to high-risk patient (eg, elderly, debilitated, impaired respiratory function) or in patient receiving other CNS depressants (eg, postoperative).
  • Store injection at controlled room temperature (59° to 86°F). Avoid freezing or exposure to excessive heat (over 104°F). Protect from prolonged exposure to light.

Drug Notes ::

 Patient/Family Education

  • Explain name, dose, action, and potential side effects of drug.

Injection:

  • Advise patient, family, or caregiver that medication is used to control pain and will be prepared and administered by a health care provider in a medical setting.

Sublingual tablets:

  • Advise patient to take prescribed dose once daily by placing tablet under the tongue until dissolved. For dose requiring more than 2 tablets, advise patient to place all tablets under the tongue and allow to dissolve. If patient cannot fit more than 2 tablets under the tongue at one time, then advise patient to place 2 tablets under the tongue at a time and repeat until entire dose has been taken.
  • Caution patient that swallowing tablets reduces effectiveness.
  • Advise patient to not change the dose or stop taking unless advised by the health care provider.
  • Caution patient to avoid alcoholic beverages and other CNS depressants (eg, narcotics, benzodiazepines) while taking this drug. Combined use may result in a serious overdose and possibly death.
  • Advise patient to inform family members that, in the event of an emergency, the treating emergency personnel should be informed that the patient is physically dependent on narcotics and is being treated with buprenorphine.
  • Advise patient that drug may impair mental or physical abilities required for the performance of potentially hazardous tasks and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
  • Instruct patient to lie or sit down if they experience dizziness or lightheadedness when standing.
  • Advise patient to contact health care provider if experiencing the following side effects: headache, insomnia, nausea, vomiting, or abdominal pain.
  • Instruct patient not to take prescription or OTC drugs or dietary supplements without consulting health care provider.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Advise patient that follow-up visits may be required to monitor therapy and to keep appointments.

Disclaimer ::

The Information available on this site is for only Informational Purpose , before any use of this information please consult your Doctor .Price of the drugs indicated above may not match to real price due to many possible reasons may , including local taxes etc.. These are only approximate indicative prices of the drug.

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