Suboxone Film - FDA prescribing information, side effects and uses. SUBOXONE sublingual film is indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 2. U. S. C. 8. 23(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Suboxone Film Dosage and Administration. To avoid precipitating an opioid withdrawal syndrome, the first dose of buprenorphine/naloxone should be started only when objective signs of moderate withdrawal appear. Clinicians should start with an initial dose of 2 mg/0. Provision of multiple refills is not advised early in treatment or without appropriate patient follow- up visits. SUBUTEX sublingual tablet is administered sublingually as a single daily dose. SUBUTEX sublingual tablet contains no naloxone and is preferred for use only during induction. Following induction, SUBOXONE sublingual film or SUBOXONE sublingual tablet is. SUBOXONE sublingual film is indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the. Buprenorphine/naloxone combination products have not been evaluated in adequate and well- controlled studies for induction in patients on long- acting opioid products, and contain naloxone, which is absorbed in small amounts by the sublingual route and could cause worse precipitated and prolonged withdrawal. For this reason, buprenorphine monotherapy is recommended in patients taking long- acting opioids when used according to approved administration instructions. Following induction, the patient may then be transitioned to once- daily SUBOXONE sublingual film. The first dose of SUBOXONE sublingual film or buprenorphine should be administered when objective signs of moderate opioid withdrawal appear, and not less than 6 hours after the patient last used an opioid. It is recommended that an adequate maintenance dose, titrated to clinical effectiveness, be achieved as rapidly as possible. In some studies, a too- gradual induction over several days led to a high rate of drop- out of buprenorphine patients during the induction period. Maintenance. For maintenance, SUBOXONE sublingual film may be administered buccally or sublingually. The dosage of SUBOXONE sublingual film from Day 3 onwards should be progressively adjusted in increments/decrements of 2 mg/0. After treatment induction and stabilization, the maintenance dose of SUBOXONE sublingual film is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 2. The recommended target dosage of SUBOXONE sublingual film during maintenance is 1. Dosages higher than 2. Method of Administration. SUBOXONE sublingual film must be administered whole.
Do not cut, chew, or swallow SUBOXONE sublingual film. Sublingual Administration. Place one film under the tongue, close to the base on the left or right side. If an additional film is necessary to achieve the prescribed dose, place an additional film sublingually on the opposite side from the first film. Place the film in a manner to minimize overlapping as much as possible. The film must be kept under the tongue until the film is completely dissolved. If a third film is necessary to achieve the prescribed dose, place it under the tongue on either side after the first 2 films have dissolved. Buccal Administration. Place one film on the inside of the right or left cheek. If an additional film is necessary to achieve the prescribed dose, place an additional film on the inside of the opposite cheek. The film must be kept on the inside of the cheek until the film is completely dissolved. If a third film is necessary to achieve the prescribed dose, place it on the inside of the right or left cheek after the first two films have dissolved. SUBOXONE sublingual film should NOT be moved after placement. Proper administration technique should be demonstrated to the patient. Clinical Supervision. Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient's clinical stability permits. Medication should be prescribed in consideration of the frequency of visits. A once- monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the physician's evaluation of treatment outcomes and objectives such as: Absence of medication toxicity. Absence of medical or behavioral adverse effects. Responsible handling of medications by the patient. Patient's compliance with all elements of the treatment plan (including recovery- oriented activities, psychotherapy, and/or other psychosocial modalities). Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use). If treatment goals are not being achieved, the physician should re- evaluate the appropriateness of continuing the current treatment. Patients With Hepatic Impairment. Because the doses of this fixed combination product cannot be individually titrated, the combination product should generally be avoided in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment . For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the physician does not feel that he/she has the expertise to manage the patient. In such cases, the physician may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment. Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment. Stopping Treatment. The decision to discontinue therapy with SUBOXONE sublingual film after a period of maintenance should be made as part of a comprehensive treatment plan. Taper patients to avoid opioid withdrawal signs and symptoms. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII. Approval: 2002 SUBOXONE sublingual film. This guideline applies to Tufts Health Together and Tufts Health Direct members who meet specific coverage criteria. Suboxone Sublingual Film, Suboxone Sublingual Tablets, Subutex AMCP Dossier (2010). Reckitt Benckiser Pharmaceuticals. Learning to cut Suboxone strips for use in Rehab and Opiate Withdrawals. Buprenorphine comes as a sublingual tablet. The combination of buprenorphine and naloxone comes as a sublingual tablet (Zubsolv) and as a sublingual film (Suboxone) to take under the tongue and as a buccal film (Bunavail) to apply between the gum and cheek. Switching Between Buprenorphine or Buprenorphine and Naloxone Sublingual Tablets and SUBOXONE Sublingual Film. Patients being switched between buprenorphine and naloxone or buprenorphine only sublingual tablets and SUBOXONE sublingual film should be started on the corresponding dosage of the previously administered product. However, dosage adjustments may be necessary when switching between buprenorphine products. Not all strengths and combinations of the SUBOXONE sublingual films are bioequivalent to the SUBOXONE (buprenorphine and naloxone) sublingual tablets as observed in pharmacokinetic studies . Therefore, systemic exposures of buprenorphine and naloxone may be different when patients are switched from tablets to film or vice- versa. Patients should be monitored for symptoms related to over- dosing or under- dosing. Switching Between SUBOXONE Sublingual Film Strengths. As indicated in Table 1, the sizes and the compositions of the four units of SUBOXONE sublingual films, i. If patients switch between various combinations of lower and higher strength units of SUBOXONE sublingual films to obtain the same total dose, (e. For this reason, pharmacist should not substitute one or more film strengths for another without approval of the prescriber. Table 1. Comparison of Available SUBOXONE Sublingual Film Strengths by Dimensions and Drug Concentrations. SUBOXONE sublingual film unit strength (buprenorphine/naloxone)SUBOXONE sublingual film unit dimensions. Buprenorphine Concentration% (w/w)Naloxone Concentration% (w/w)2 mg/0. X 1. 9. 2 mm. 17. Switching Between Sublingual and Buccal Sites of Administration. The systemic exposure of buprenorphine between buccal and sublingual administration of SUBOXONE sublingual film is similar. Therefore, once induction is complete, patients can switch between buccal and sublingual administration without significant risk of under or overdosing. Dosage Forms and Strengths. SUBOXONE sublingual film is supplied as an orange rectangular film with a white printed logo in four dosage strengths: buprenorphine/naloxone 2 mg/0. Contraindications. SUBOXONE sublingual film should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported . Prescribe and dispense buprenorphine with appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft, including in the home. Clinical monitoring appropriate to the patient's level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow- up visits . Many, but not all, post- marketing reports regarding coma and death associated with the concomitant use of buprenorphine and benzodiazepines involved misuse by self- injection. Deaths have also been reported in association with concomitant administration of buprenorphine with other depressants such as alcohol or other CNS depressant drugs. Patients should be warned of the potential danger of self- administration of benzodiazepines or other depressants while under treatment with SUBOXONE sublingual film . Naloxone may be of value for the management of buprenorphine overdose. Higher than normal doses and repeated administration may be necessary. SUBOXONE sublingual film should be used with caution in patients with compromised respiratory function (e. CNS Depression. Patients receiving buprenorphine in the presence of opioid analgesics, general anesthetics, benzodiazepines, phenothiazines, other tranquilizers, sedative/hypnotics, or other CNS depressants (including alcohol) may exhibit increased CNS depression. Consider dose reduction of CNS depressants, SUBOXONE sublingual film, or both in situations of concomitant prescription . Store buprenorphine- containing medications safely out of the sight and reach of children. Buprenorphine/naloxone - Wikipedia. Buprenorphine/naloxone (trade name Suboxone) is a combination drugformulation of buprenorphine, a . The Suboxone formulation still has potential to produce an opioid agonist . Published data show that the . In addition, opioids and especially benzodiazepines increase the risk for potentially lethal respiratory depression. Aschenbrenner; Samantha J. Drug Therapy in Nursing. Lippincott Williams & Wilkins. ISBN 9. 78- 0- 7. Roget (1. 1 November 2. Encyclopedia of Substance Abuse Prevention, Treatment, and Recovery. ISBN 9. 78- 1- 4. Iqbal Choudhary (1 January 2. Frontiers in CNS Drug Discovery. Bentham Science Publishers. ISBN 9. 78- 1- 6. Mc. Cuistion; Joyce Le. Fever Kee; Evelyn R. Hayes (2. 5 March 2. Pharmacology: A Patient- Centered Nursing Process Approach. Elsevier Health Sciences. ISBN 9. 78- 0- 3. Austria- Codex (in German). Clinical Pharmacology & Therapeutics. Drug and Alcohol Dependence. The Journal of Pharmacology and Experimental Therapeutics. Drug and Alcohol Dependence. Treatment Improvement Protocol (TIP) 4. US Department of Health and Human Services.^Volpe DA, Mc. Mahon Tobin GA, Mellon RD, Katki AG, Parker RJ, Colatsky T, Kropp TJ, Verbois SL (2. Regulatory Toxicology and Pharmacology. MORDORKORAgonists: 6'- GNTI8- CAC1. MC1. 4- Methoxymetopon.
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