Adult Dosing
Opioid dependency
Maintenance therapy
- Recommended target dosage: 16 mg/4 mg (buprenorphine/naloxone)/day (tabs or film) PO qd
- Adjust the dose progressively in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
- Maintenance dose is generally between 4 mg/1 mg to 24 mg/6 mg per day depending on the individual patient
Maintenance therapy (Zubsolv)
- Recommended target dosage: 11.4 mg/2.8 mg (buprenorphine/naloxone)/day PO qd
- Adjust the dose progressively in increments/decrements of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
- Maintenance dose is generally between 2.8 mg/0.72 mg to 17.1 mg/4.2 mg per day depending on the individual patient
Note:
- One 5.7 mg/1.4 mg SL Zubsolv provides equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg SL
- While switching between sublingual tabs and films, patients should be started on the same dose as the previously administered product
- Dose modifications may be essential when switching between products
- Due to potentially greater relative bioavailability of films compared to tabs, consider monitoring for over-medication in patients switching from tabs to film. However, patients switching from film to tablets should be observed for withdrawal or other indications of under-dosing
- The sublingual film/tab should be placed under the tongue until it completely dissolves; do not chew, swallow, or move after placement
- If an additional film is necessary to achieve the necessary dose, place the other film sublingually on the opposite side from the first film
- Patients requiring more than 2 tabs to achieve the necessary dose may place all the tablets under the tongue; if they cannot fit in more than 2 tabs, then two tabs should be placed at a time
Pediatric Dosing
- SL films: Safety and effectiveness in pediatric patients have not been established
- SL tabs:
- <16 yrs: Safety and effectiveness in these patients have not been established
- >16 yrs: Dosage as recommended for adult patients
[Outline]
See Supplemental Patient Information
- To avoid misuse, abuse, or diversion and ensure appropriate protection from theft, prescribe and dispense buprenorphine with appropriate precautions. Clinical monitoring according to the patient’s level of stability is essential. Do not prescribe multiple refills early in treatment or without appropriate follow-up visits
- Buprenorphine can cause significant respiratory depression and death, particularly when taken by the IV route, in combination with benzodiazepines or other CNS depressants (including alcohol). Warn patients not to self-administer benzodiazepines or other depressants during therapy. If overdose occurs, the primary management should include re-establishment of adequate ventilation with mechanical assistance of respiration (if required). Naloxone may be of use in the management of buprenorphine overdose; higher than normal doses and repeated administration may be necessary
- Patients receiving buprenorphine in combination with other opioid analgesics, phenothiazines, general anesthetics, sedative/hypnotics, or other CNS depressants (including alcohol) may experience increased CNS depression. Consider lowering the dose of either of the drugs or both in situations of concomitant prescription
- Severe, possibly fatal, respiratory depression may result in children, accidentally exposed to buprenorphine. Store these medications safely out of reach and sight of children and dispose any unused medications appropriately
- Chronic administration of buprenorphine produces physical dependence of the opioid type, which is characterized by withdrawal signs and symptoms upon abrupt discontinuation or on rapid tapering. These withdrawal symptoms are usually milder than seen with full agonists and may be delayed in onset. Physicians should consider this while prescribing or dispensing buprenorphine in situations where there is an increased risk of misuse, abuse, or diversion
- Cases of cytolytic hepatitis and hepatitis with jaundice have been observed in patients taking buprenorphine. Abnormalities ranging from transient asymptomatic elevations in hepatic transaminases to reports of death, hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy have been reported. Buprenorphine may have had a role in the development of such hepatic abnormalities. Therefore, baseline liver function tests prior to initiation of treatment along with periodic monitoring during treatment are recommended. Depending on the case, therapy may need to be carefully discontinued to prevent withdrawal signs and symptoms and a return by the patient to illicit drug use, and strict monitoring of the patient should be initiated
- Hypersensitivity to buprenorphine and naloxone has been reported in clinical trials and post-marketing studies, including cases of bronchospasm, angioneurotic edema, and anaphylactic shock. Common signs and symptoms include rashes, hives, and pruritus. Do not prescribe this drug to patients with a history of hypersensitivity to either of the drug
- Because of naloxone component in the combination drug, there exists a high risk of marked and intense withdrawal signs and symptoms if misused parenterally by individuals dependent on full opioid agonists such as heroin, morphine, or methadone. Also, due to partial agonist properties of buprenorphine, this drug may precipitate opioid withdrawal signs and symptoms in such persons if administered sublingually before the agonist effects of the opioid have subsided
- Neonatal withdrawal syndrome has been reported in infants of women treated with buprenorphine during pregnancy. The time of onset of these withdrawal signs ranged from day 1 to day 8 of life with most cases occurring on day 1. Hypertonia, neonatal tremor, neonatal agitation, and myoclonus are some of the adverse events associated with neonatal withdrawal syndrome
- Patients should be cautioned about driving a car or operating hazardous machinery (especially during treatment induction and dose adjustment) as the mental or physical abilities required for the performance of such tasks may be impaired while on therapy
- Buprenorphine/naloxone is not recommended for analgesia, as there have been reports of deaths in opioid naive individuals treated with buprenorphine for analgesia
- Treatment with buprenorphine/naloxone may cause orthostatic hypotension in ambulatory patients
- Buprenorphine may increase CSF pressure and should be used with caution in patients with head injury, intracranial lesions, and other such circumstances. It can also produce miosis and changes in the level of consciousness thus interfering with patient evaluation
- Buprenorphine has been reported, like other opioids, to increase intracholedochal pressure and hence caution is advised while administering to patients with dysfunction of the biliary tract
- Buprenorphine (like other opioids) may obscure the diagnosis or clinical course of patients with acute abdominal conditions
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Pulmonary impairment
- Seizure disorder
- Chronic obstructive pulmonary disease
- Cor pulmonale
- Decreased respiratory reserve
- Hypoxia
- Hypercapnia
- Preexisting respiratory depression
- CNS depression or coma
- Toxic psychoses
- Prostatic hypertrophy
- Urethral stricture
- Myxedema or hypothyroidism
- Adrenal cortical insufficiency (e.g., Addison's disease)
- Acute alcoholism
- Delirium tremens
- Kyphoscoliosis
- Debilitated or elderly patients
Supplemental Patient Information
- Instruct patients to inform their family members that, in the event of emergency, the emergency room staff should be informed that the patient is physically dependent on narcotics and that the patient is being treated with buprenorphine/naloxone
- Caution patients that a serious overdose and death may occur if benzodiazepines, tranquilizers, antidepressants, sedatives, or alcohol are taken concomitantly with buprenorphine/naloxone
- Advise patients to refrain from driving a car or operating machinery until they are reasonably certain that buprenorphine therapy does not adversely affect their ability to engage in such activities
Pregnancy Category:C
Breastfeeding: Buprenorphine is excreted in low levels into breastmilk. Because of its poor oral bioavailability in infants and low drug concentrations found in serum and urine of breastfed infants, its use is acceptable in nursing mothers. However, monitor infants for drowsiness, adequate weight gain, and developmental milestones (especially in younger and exclusively nursed infants). Contact a physician immediately if the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Whether naloxone is excreted into breastmilk is not known; however, it is unlikely to affect the breastfed infant as it is not orally bioavailable. Studies have shown that naloxone does not affect lactation hormone levels in nursing mothers and breastfeeding can be continued by nursing mothers requiring naloxone. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed on 29 Jun 2011). As per manufacturer's data, buprenorphine is excreted into breast milk and thus breastfeeding is not advised in mothers treated with buprenorphine products.
US Trade Name(s)
US Availability
buprenorphine/naloxone (generic)
Suboxone (buprenorphine/naloxone)
- SL FILM:
- 2 mg/0.5 mg
- 8 mg/2 mg
- 4 mg/1 mg
- 12 mg/3 mg
Zubsolv (buprenorphine/naloxone)
- SL TABS:
- 1.4 mg/0.36 mg
- 5.7 mg/1.4 mg
Canadian Trade Name(s)
Canadian Availability
Suboxone (buprenorphine/naloxone)
UK Trade Name(s)
UK Availability
Suboxone (buprenorphine/naloxone)
Australian Trade Name(s)
Australian Availability
Suboxone (buprenorphine/naloxone)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Suboxone 2-0.5 MG SUBL [Bottle] (RECKITT BENCKISER)
30 mg = $141.93
90 mg = $390.59 - Suboxone 8-2 MG SUBL [Bottle] (RECKITT BENCKISER)
30 mg = $238
90 mg = $678.96 - Suboxone 8-2 MG FILM [Box] (RECKITT BENCKISER)
30 mg = $226.81
90 mg = $654.53
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.