White Subutex 8 mg (buprenorphine) sublingual tablet is an uncoated oval white flat beveled edged tablet, debossed with an alphanumeric word identifying the product and strength on one side. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Subutex 8mg white pill tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate.
Prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression). Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for continuing opioid substitution therapy should be reviewed regularly.
Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit. Some risks of misuse and abuse include overdose, spread of blood borne viral or localized infections, respiratory depression and hepatic injury. Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicine is not safeguarded against theft.
Sub-optimal treatment with buprenorphine may prompt medication misuse by the patient, leading to overdose or treatment dropout. A patient who is under-dosed with buprenorphine may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
To minimize the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient’s level of stability.
At treatment initiation, the first dose of SUBUTEX should be administered only when objective and clear signs of moderate opioid withdrawal appear, and not less than 4 hours after the patient last used an opioid.
It is recommended that an adequate treatment dose, titrated to clinical effectiveness, should be achieved as rapidly as possible. The dosing on the initial day of treatment may be given in 2 mg to 4 mg increments if preferred. In some studies, gradual induction over several days led to a high rate of dropout of buprenorphine patients during the induction period.
In a one-month study, patients received 8 mg of SUBUTEX on Day 1 and 16 mg SUBUTEX on Day 2. From Day 3 onward, patients received either SUBOXONE sublingual tablet or SUBUTEX at the same buprenorphine dose as Day 2 based on their assigned treatment. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose.
Patients dependent upon methadone or other long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction than those on short-acting opioid products; therefore, the first dose of SUBUTEX should only be administered when objective and clear signs of moderate opioid withdrawal appear, and generally not less than 24 hours after the patient last used a long-acting opioid product.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
- Do not place the medicine on areas of the mouth with sores or lesions.
- Use your tongue to wet the inside of your cheek or rinse your mouth with water before placing the film in your mouth.
- Place the yellow side of the film against the inside of your cheek.
- Press against the film and hold it there with clean, dry fingers for 5 seconds.
- Leave the film in place until it dissolves and do not touch or move it. Do not chew or swallow the film.
- Do not eat or drink anything until the film is completely dissolved, which is usually within 30 minutes.
Do not crush or swallow the sublingual tablet. Place the tablet under the tongue until it is dissolved. If you take 2 or more tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken. Do not chew or swallow the sublingual tablet.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
Direction for Intake:
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For buccal dosage form :7
- For Adults—At first, 75 micrograms (mcg) as a single dose once a day or every 12 hours for at least 4 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 900 mcg every 12 hours.
- For azChildren—Use and dose must be determined by your doctor.
- For sublingual dosage form (tablets):
- For maintenance treatment of opioid dependence:
- Adults—4 to 24 milligrams (mg) as a single dose once a day.
- Children—Use and dose must be determined by your doctor.
- For maintenance treatment of opioid dependence:
