__________________ ______________ _____________ ___________________ HIGHLIGHTS OF PRESCRIBING INFORMATION The highlights do not include all the information needed to u BUNAVAIL safely and effectively. See full prescribing information for BUNAVAIL. BUNAVAIL (buprenorphine and naloxone) buccal film, CIII Initial U.S. Approval: 2002 INDICATIONS AND USAGE
BUNAVAIL is a partial opioid agonist indicated for the maintenance treatment of opioid dependence. Prescription u of this product is limited under the Drug Addiction Treatment Act. (1) _______________DOSAGE AND ADMINISTRATION Apply BUNAVAIL buccal film as a single daily do. (2) The recommended daily do for maintenance is 8.4 mg/1.4 mg. DOSAGE FORMS AND STRENGTHS Buccal film: BUNAVAIL 2.1 mg buprenorphine/0.3 mg naloxone; BUNAVAIL 4.2 mg buprenorphine/0.7 mg naloxone and BUNAVAIL 6.3 mg buprenorphine/1 mg naloxone. (3) CONTRAINDICATIONS Hypernsitivity to buprenorphine or naloxone. (4) _______________ WARNINGS AND PRECAUTIONS _______________ •
本科怎么考
Buprenorphine can be abud in a similar manner to other opioids. Clinical monitoring appropriate to the patient’s level of stability is esntial. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. (5.1) • Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in co
mbination with benzodiazepines or other CNS depressants (including alcohol). (5.2) • Consider do reduction of CNS depressants, BUNAVAIL buccal film, or both in situations of concomitant prescription. (5.3) • Store BUNAVAIL buccal film safely and out of the sight and reach of children. Buprenorphine can cau vere, possibly fatal, respiratory depression in children. (5.4) • Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid do taper may result in opioid withdrawal syndrome. (5.5) • Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events. (5.6) • Do not administer BUNAVAIL buccal film to patients with known hypernsitivity to buprenorphine or naloxone. (5.7) • An opioid withdrawal syndrome is likely to occur with parenteral misu of BUNAVAIL buccal film by individuals physically dependent on full opioid agonists or by buccal administration before the agonist effects of other opioids have subsided. (5.8) • Neonatal withdrawal has been reported following u of buprenorphine by the mother during pregnancy. (5.9) • BUNAVAIL buccal film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a buprenorphine do smaller than the lowest available BUNAVAIL strength. (5.10) • Buprenorphine/naloxone products are not recommended in patients with vere hepatic impairment and may not be appropriate for patients with moderate hepatic impairment (5.11) • Caution patients about the risk of driving or operating hazardous machinery. (5.12) ___________________ ADVERS
E REACTIONS ___________________ Adver events commonly obrved with administration of BUNAVAIL buccal films during clinical trials are headache, naua, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia and pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact (BioDelivery Sciences International) at 1-800-469-0261 or FDA at 1-800-FDA-1088 or v/medwatch . ___________________ DRUG INTERACTIONS ____________________ • Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing. (7.1) • U caution in prescribing BUNAVAIL buccal film for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant lf-administration/misu. (7.3) USE IN SPECIFIC POPULATIONS • Pregnancy: Bad on animal data, may cau fetal harm. (8.1) • Nursing mothers: Caution should be exercid when administered to a nursing woman. (8.3) • Safety and effectiveness of BUNAVAIL buccal film in patients below the age of 16 has not been established. (8.4) • Administer BUNAVAIL buccal film with caution to elderly or debilitated patients. (8.5) • Buprenorphine/naloxone products are not recommended in patients with vere hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. (8.6) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 6/ 2014 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Maintenance 2.2 Method of Administration 2.
3 Clinical Supervision 2.4 Patients With Hepatic Impairment 2.5 Unstable Patients 2.6 Stopping Treatment 2.7 Switching between SUBOXONE Sublingual Tablets or Films and BUNAVAIL buccal film 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Abu Potential 5.2 Respiratory Depression 5.3 CNS Depression 5.4 Unintentional Pediatric Exposure 5.5 Dependence 5.6 Hepatitis, Hepatic Events 5.7 Allergic Reactions 5.8 Precipitation of Opioid Withdrawal Signs and Symptoms 5.9 Neonatal Withdrawal 5.10 U in Opioid Naïve Patients 5.11 U in Patients with Impaired Hepatic Function 5.12
Impairment of Ability to Drive or Operate Machinery 5.13 Orthostatic Hypotension 5.14 Elevation of Cerebrospinal Fluid Pressure 5.15 Elevation of Intracholedochal Pressure 5.16 Effects in Acute Abdominal Conditions 5.17 General Precautions 6 ADVERSE REACTIONS 6.1 Adver Events in Clinical Trials 7 DRUG INTERACTIONS 7.1 Cytochrome P-450 3A4 (CYP3A4) Inhibitors and Inducers 7.2 Antiretrovirals 7.3 Benzodiazepines 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3hire
Nursing Mothers 8.4
Pediatric U 8.5
Geriatric U
8.6 Hepatic Impairment
8.7 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abu
闺蜜的英文
9.3 Dependence
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
cheers是什么意思12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
手榴弹英文17 PATIENT COUNSELING INFORMATION
17.1 Safe U
17.2 Disposal of Unud
*Sections or subctions omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
宾语从句引导词
BUNAVAIL buccal film is indicated for the maintenance treatment of opioid dependence and should be ud as part of a complete treatment plan to include counling and psychosocial support.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription u 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.
2 DOSAGE AND ADMINISTRATION
BUNAVAIL buccal film is applied to the buccal mucosa as a single daily do. BUNAVAIL buccal film should be ud in patients who have been initially inducted using buprenorphine sublingual tablets.
The difference in bioavailability of BUNAVAIL compared to SUBOXONE sublingual tablet requires a different dosage strength to be administered to the patient. A BUNAVAIL 4.2/0.7 mg buccal film provides equivalent buprenorphine exposure to a SUBOXONE 8/2 mg sublingual tablet.
Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advid early in treatment or without appropriate patient follow-up visits.
2.1 Maintenance
• BUNAVAIL buccal film is indicated for maintenance treatment. The recommended target dosage of BUNAVAIL buccal film is 8.4/1.4 mg per day as a single daily do.
• The dosage of BUNAVAIL buccal film should be progressively adjusted in increments/decrements of 2.1/0.3 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppress opioid withdrawal signs and symptoms.
safe hou• The maintenance do of BUNAVAIL buccal film is generally in the range of 2.1/0.3 mg buprenorphine/naloxone to 12.6/2.1 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage.
2.2 Method of Administration
The patient should:
• u the tongue to wet the inside of the cheek or rin the mouth with water to moisten the area immediately before placement of BUNAVAIL;
• open the BUNAVAIL package immediately prior to u as indicated by the instructions; • hold the BUNAVAIL film with clean, dry fingers with the text (BN2, BN4, or BN6) facing up;
• place the side of the BUNAVAIL film with the text (BN2, BN4, or BN6) against the inside of the cheek;
• press and hold the film in place for 5 conds.
BUNAVAIL film(s) adhere to the moist buccal mucosa and should stay in place after this period. If multiple films need to be administered, the patient should immediately apply the next film according to the steps above. Note that when two films are required for one do, the patient should place one film on the inside of one cheek and the other film on the inside of the other cheek. For dos requiring multiple films, no more than two films should be applied to the inside of one cheek at a time.
BUNAVAIL film(s) completely dissolve after application. The patient should be instructed to avoid ma
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nipulating the film(s) with the tongue or finger(s) and avoid drinking or eating food until the film(s) dissolve. BUNAVAIL film should not be chewed or swallowed as this may result in lower peak concentrations and lower bioavailability [e Clinical Pharmacology (12.3)]. Instruct the patient to u the entire film. BUNAVAIL should not be cut or torn.
Proper administration technique should be demonstrated to the patient.
2.3 Clinical Supervision
resistantTreatment should be initiated with supervid administration, progressing to unsupervid administration as the patient’s clinical stability permits. BUNAVAIL buccal film is subject to diversion and abu. When determining the prescription quantity for unsupervid administration, consider the patient’s level of stability, the curity of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication. Ideally patients should be en at reasonable intervals (e.g., at least weekly during the first month of treatment) bad upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advid early in treatment or without appropriate patient follow-up visits. Periodic asssment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress.
Once a stable dosage has been achieved and patient asssment (e.g., urine drug screening) does not indicate illicit drug u, less frequent follow-up visits may be appropriate. 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 bad on the physician’s evaluation of treatment outcomes and objectives such as: 1. Abnce of medication toxicity
2. Abnce of medical or behavioral adver effects
3. Responsible handling of medications by the patient
4. Patient’s compliance with all elements of the treatment plan (including recovery-orientedfuga
activities, psychotherapy, and/or other psychosocial modalities)
5. Abstinence from illicit drug u (including problematic alcohol and/or benzodiazepine u) If treatment goals are not being achieved, the physician should re-evaluate the appropriateness of continuing the current treatment.
2.4 Patients With Hepatic Impairment
Becau the dos of this fixed combination product cannot be individually titrated, vere hepatic impairment results in a reduced clearance of naloxone to a much greater extent than buprenorphine, and moderate hepatic impairment also results in a reduced clearance of naloxone to a greater extent than buprenorphine, the combination product should generally be avoided in patients with vere hepatic impairment and may not be appropriate for patients with moderate hepatic impairment [e Warnings and Precautions (5.11)].
2.5 Unstable Patients
Physicians will need to decide when they cannot appropriately provide further management for particular patients. 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 experti to manage the patient. In such cas, the physician may want to asss whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be bad on a treatment plan established and agreed upon with the patient at the beginning of treatment. Patients who continue to misu, abu, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.
2.6 Stopping Treatment
The decision to discontinue therapy with BUNAVAIL buccal 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.
2.7 Switching between SUBOXONE Sublingual Tablets or Films and
BUNAVAIL buccal film
The difference in bioavailability of BUNAVAIL compared to SUBOXONE sublingual tablet requires a different dosage strength to be administered to the patient. A BUNAVAIL 4.2/0.7 mg
