Buprenomorphine and Naloxone 8mg/2mg30 tabs
Buprenomorphine and Naloxone sublingual tablet is an uncoated hexagonal orange tablet, debossed with an alphanumeric word identifying the product and strength. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, acesulfame K sweetener and a lemon / lime flavor.
Method Of Administration
Buprenomorphine and Naloxone sublingual tablets must be administered whole. Do not cut, chew, or swallow Buprenomorphine and Naloxone sublingual tablets. Advise patients not to eat or drink anything until the tablet is completely dissolved. Buprenomorphine and Naloxone sublingual tablet should be placed under the tongue until it is dissolved. For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably), place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.
Proper administration technique should be demonstrated to the patient.
Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient’s clinical stability permits. Buprenomorphine and Naloxone 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 healthcare provider’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 healthcare provider should re-evaluate the appropriateness of continuing the current treatment.
-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg
-Maximum dose: 17.2 mg/4.2 mg per day
Renal Dose Adjustments
Use with caution; no dose adjustments recommended
Liver Dose Adjustments
Mild hepatic impairment: Use with caution; no dose adjustments recommended
Moderate Hepatic Impairment: Not recommended for induction due to increased risk of precipitated withdrawal; may be used cautiously for maintenance treatment; monitor for opioid withdrawal.
Severe Hepatic impairment: Use not recommended
Elderly: Clinical studies have not included a sufficient number of subjects 65 years or older to determine whether they respond differently than younger subjects; use caution and monitor for signs and symptoms of toxicity or overdose.
Patients switching between buprenorphine-naloxone products must be monitored for over-medication or under-dosing, i.e., signs of withdrawal.
Side effects :
Many medications can cause side effects. A side effect is an undesirable response to a drug when taken at normal doses. It can be mild or severe, temporary or permanent.
The side effects listed below are not felt by everyone who takes this medicine. If you are worried about side effects, discuss the risks and benefits of this medicine with your doctor.
At least 1% of people taking this medicine have reported the following side effects. A lot of these side effects can be taken care of and a few can go away on their own with time.
Consult your doctor if you experience these side effects and if they are serious or bothersome. Your pharmacist may be able to give you advice on what to do if these side effects occur:
a state of general weakness or drowsiness;
dizziness when moving from a sitting or lying position to a standing position;
loss of appetite
Most of the side effects listed below do not occur very often, but they could cause serious problems if you do not receive medical care.
Check with your doctor as soon as possible if any of the following side effects occur:
a drop in blood pressure;
swelling of hands or feet
hallucinations (eg the illusion of hearing, seeing or feeling something that does not really exist);
signs of depression (eg, lack of concentration, weight fluctuations, changes in sleep, disinterest in many activities, suicidal thoughts)
symptoms of low blood sugar (eg cold sweats, pallor and freshness of the skin, headache, fast heartbeat, weakness)
symptoms of liver problems (such as yellowing of the whites of the eyes or skin, abdominal pain, loss of appetite, pale stools, itchy skin, or dark urine)
symptoms of high blood sugar (eg, frequent urination, increased thirst, excessive appetite, unexplained weight loss, poor healing wounds, infections, fruity breath)
Stop taking the medication and seek immediate medical attention if there is an answer such as:
feeling unconscious, dizziness, mental confusion, or unusual symptoms;
signs of overdose (eg, cold, clammy skin, confusion, tremors, nausea, low and rapid pulse, gait disturbances, breathing difficulties, flaccidity (softness) ) muscles);
slower than normal breathing or difficulty breathing
symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, wheezing or difficulty breathing)