Orexo Us, Inc.

Orexo Us, Inc. Drugs

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  Seasonal Allergy Formula

  

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  ZUBSOLV sublingual tablet is administered sublingually as a single daily dose. ZUBSOLV sublingual tablets should be used in patients who have been initially inducted using buprenorphine sublingual tablets.

  The difference in bioavailability of ZUBSOLV compared to Suboxone tablet requires a different tablet strength to be given to the patient. One ZUBSOLV 5.7/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one SUBOXONE 8/2 mg sublingual tablet.

  The corresponding doses going from induction to maintenance treatment are:

  Induction phase: Final sublingual buprenorphine dose Maintenance phase: Corresponding sublingual ZUBSOLV dose 8 mg buprenorphine, taken as: 5.7 mg/1.4 mg ZUBSOLV, taken as: One 8 mg buprenorphine tablet One 5.7 mg/1.4 mg ZUBSOLV tablet 12 mg buprenorphine, taken as: 8.6 mg/2.1 mg ZUBSOLV, taken as: One 8 mg buprenorphine tablet AND Two 2 mg buprenorphine tablets One 8.6 mg/2.1 mg ZUBSOLV tablet 16 mg buprenorphine, taken as: 11.4 mg/2.9 mg ZUBSOLV, taken as: Two 8 mg buprenorphine tablets One 11.4/2.9 mg ZUBSOLV tablet

  2.1 Maintenance

  ZUBSOLV sublingual tablet is indicated for maintenance treatment. The recommended target dosage of ZUBSOLV sublingual tablet is 11.4 mg/2.9 mg buprenorphine/naloxone/day as a single daily dose.

  The dosage of ZUBSOLV sublingual tablet should be progressively adjusted 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.

  The maintenance dose of ZUBSOLV sublingual tablet is generally in the range of 2.8 mg/0.72 mg buprenorphine/naloxone to 17.2 mg/4.2 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage

  When determining the prescription quantity for unsupervised administration, consider the patient's level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication.

  2.2 Method of Administration

  Do not cut, chew, or swallow ZUBSOLV sublingual tablets. ZUBSOLV sublingual tablet should be placed under the tongue until dissolved. The dissolve time for ZUBSOLV varies between individuals, and the median dissolve time observed was 5 minutes. For dosages requiring more than one sublingual tablet, place all tablets in different places under the tongue at the same time. Patients should keep the tablets under the tongue until dissolved; swallowing the tablets reduces the bioavailability of the drug. Advise patients not to eat or drink anything until the tablet is completely dissolved. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.

  If a sequential mode of administration is preferred, patients should follow the same manner of dosing with continued use of the product, to ensure consistency in bioavailability.

  Proper administration technique should be demonstrated to the patient.

  2.3 Clinical Supervision

  Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient's clinical stability permits. ZUBSOLV sublingual tablet is subject to diversion and abuse. When determining the prescription quantity for unsupervised administration, consider the patient's level of stability, the security 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 seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment 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 assessment (e.g., urine drug screening) does not indicate illicit drug use, 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 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.

  2.4 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 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.

  2.5 Patients With Hepatic Impairment

  Because the doses of this fixed combination product cannot be individually titrated, severe 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 severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment [see Warnings and Precautions (5.11)].

  2.6 Stopping Treatment

  The decision to discontinue therapy with ZUBSOLV sublingual tablets after a period of maintenance should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation of buprenorphine has been used, but the data are insufficient to determine the best method of dose taper at the end of treatment.

  2.7 Switching between ZUBSOLV sublingual Tablets and other buprenorphine/naloxone combination products

  For patients being switched between ZUBSOLV sublingual tablets and other buprenorphine/naloxone products dosage adjustments may be necessary. Patients should be monitored for over-medication as well as withdrawal or other signs of under-dosing.

  The differences in bioavailability of ZUBSOLV compared to Suboxone tablet requires that different tablet strengths be given to the patient. One ZUBSOLV 5.7/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one Suboxone 8/2 mg sublingual tablet.

  When switching between Suboxone dosage strengths and ZUBSOLV dosage strengths the corresponding dosage strengths are:

  SUBOXONE sublingual tablets, including generic equivalents Corresponding dosage strength of ZUBSOLV sublingual tablets One 2 mg/0.5 mg buprenorphine/naloxone sublingual tablet One 1.4 mg/0.36 mg ZUBSOLV sublingual tablet One 8 mg/2 mg buprenorphine/naloxone sublingual tablet One 5.7 mg/1.4 mg ZUBSOLV sublingual tablet 12 mg/3 mg buprenorphine/naloxone, taken as: One 8 mg/2 mg sublingual buprenorphine/naloxone tablet AND Two 2 mg/0.5 mg sublingual buprenorphine/naloxone tablets One 8.6 mg/2.1 mg ZUBSOLV sublingual tablet 16 mg/4 mg buprenorphine/naloxone, taken as: Two 8 mg/2 mg sublingual buprenorphine/naloxone tablets One 11.4 mg/2.9 mg ZUBSOLV sublingual tablet

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