Adult Dosing
Opioid dependence
- Usual dose: 12-16 mg SL qd
- Induction: 8 mg SL on day 1, then 16 mg SL on day 2, followed by buprenorphine and naloxone HCl sublingual tablets from day 3 onwards
- Administer shortly after the patient last used long-acting opioids (methadone) or 4 hrs after the use of short-acting opioids (heroin) or when early withdrawal signs occur
- Not preferred for maintenance treatment
Pediatric Dosing
- The safety and effectiveness in pediatric patients <16 yrs of age have not been established
Opioid dependence (16-18 yrs)
- Usual dose: 12-16 mg SL qd
- Induction: 8 mg SL on day 1, then 16 mg SL on day 2, followed by buprenorphine and naloxone HCl sublingual tablets from day 3 onwards
- Administer shortly or when withdrawal symptoms are present, after the patient last used long acting opioids (Methadone) or 4 hrs after short acting opioids (Heroin)
[Outline]
See Supplemental Patient Information
- Buprenorphine causes significant respiratory depression and can even cause death when administered concomitantly with other depressants such as alcohol or other opioids. Patients should be warned against self-administration of benzodiazepines or other depressants while receiving buprenorphine HCl sublingual tablets
- In case of overdosage of buprenorphine, re-establish adequate ventilation with mechanical assistance of respiration. Use cautiously in patients with compromised respiratory function
- Buprenorphine causes CNS depression when administered concomitantly with other narcotic analgesics, general anesthetics, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics or other CNS depressants. In such case, reduce the dose of one or both agents
- Chronic administration of buprenorphine produces dependence of the opioid type, as it is a partial agonist at the mu-opiate receptor. The withdrawal syndrome is seen upon abrupt discontinuation or rapid taper
- Hepatotoxicity ranging from transient asymptomatic elevations in hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy have been reported in addicted population receiving buprenorphine. Measure LFT prior to initiation of treatment and periodically during the treatment. In case of severe hepatotoxicity, discontinue the drug carefully to prevent withdrawal symptoms and monitor the patient
- Acute and chronic hypersensitivity reaction including rashes, hives, pruritus and severe reactions like bronchospasm, angioneurotic edema, and anaphylactic shock have been reported with buprenorphine. Do not use in patients with history of hypersensitivity to buprenorphine
- Buprenorphine may produce orthostatic hypotension and can impair the mental or physical abilities, especially during drug induction and dose adjustment. Caution patients against operating hazardous machinery, including automobiles
- Buprenorphine HCl sublingual tablets may elevate cerebrospinal fluid pressure and can produce miosis and changes in the level of consciousness. Use cautiously in patients with head injury, intracranial lesions and other circumstances where cerebrospinal pressure may be increased
- Use cautiously in patients with dysfunction of the biliary tract as it increases intracholedochal pressure
- Buprenorphine HCl sublingual tablets can obscure the diagnosis or clinical course of patients with acute abdominal conditions
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Myxedema or hypothyroidism
- Adrenal cortical insufficiency
- Compromised respiratory function
- CNS depression
- Coma
- Increased intracranial pressure
- Head injury
- Intracranial lesion
- Concomitant CNS depressant
- Toxic psychosis
- Prostatic hypertrophy
- Urethral stricture
- Acute alcoholism
- Delirium tremens
- Kyphoscoliosis
- Biliary tract dysfunction
- Elderly or debilitated patients
- Pulmonary impairment
- Cor pulmonale
- Seizure disorder
- Biliary surgery
Supplemental Patient Information
- Patients should be warned against the self-administration of benzodiazepines, tranquilizers, sedatives, alcohol, or narcotic drugs during treatment with buprenorphine as it may cause a serious overdose and death
- Caution patients against operating hazardous machinery, including automobiles
- In case of emergency, caution family members to inform the treating physician or emergency room staff that the patient is physically dependent on narcotics and is being treated with buprenorphine HCl sublingual tablets
Pregnancy Category:C
Breastfeeding: Buprenorphine use is acceptable in nursing mothers because low levels are excreted in breastmilk, and they have poor oral bioavailability in infants and low drug concentration is found in serum and urine of breastfed infants. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones in exclusively breastfed infants. If any signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness are seen, immediately contact a physician. Mothers taking buprenorphine for opiate addiction have lower rate of breastfeeding than in other mothers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 26 February 2011).As per the manufacturer's data, breastfeeding is not advised in mothers receiving buprenorphine HCl sublingual tablets.
Pricing data from www.DrugStore.com in U.S.A.
- Subutex 2 MG SUBL [Bottle] (RECKITT BENCKISER)
30 mg = $193.99
90 mg = $553.97 - Subutex 8 MG SUBL [Bottle] (RECKITT BENCKISER)
30 mg = $357.01
90 mg = $1039
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Subutex (as buprenorphine hydrochloride) 2 MG Sublingual Tablet
Ingredient(s): Buprenorphine
Imprint: B2
Color(s): White
Shape: Oval
Size (mm): 10.00
Score: 1
Inactive Ingredient(s): lactose / mannitol / cornstarch / povidone k30 / citric acid anhydrous / sodium citrate / magnesium stearate
Drug Label Author:
Reckitt Benckiser Pharmaceuticals, Inc.
DEA Schedule:
CIII
Drug Name: Subutex (as buprenorphine hydrochloride) 8 MG Sublingual Tablet
Ingredient(s): Buprenorphine
Imprint: B8
Color(s): White
Shape: Oval
Size (mm): 14.00
Score: 1
Inactive Ingredient(s): lactose / mannitol / cornstarch / povidone k30 / citric acid anhydrous / sodium citrate / magnesium stearate
Drug Label Author:
Reckitt Benckiser Pharmaceuticals, Inc.
DEA Schedule:
CIII
