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Prescription use of this product is limited under the Drug Addiction Treatment Act.
Administer SUBOXONE sublingual film as a single daily dose.
To avoid precipitating withdrawal, induction with SUBOXONE sublingual film should be undertaken when objective and clear signs of withdrawal are evident and SUBOXONE sublingual film should be administered in divided doses when used as initial treatment.
For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 8 mg/2 mg SUBOXONE sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of SUBOXONE sublingual film as a single dose.
For patients dependent on methadone or long‐acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment.
For maintenance treatment, the target dosage of SUBOXONE sublingual film is usually 16 mg/4 mg as a single daily dose.
Sublingual Administration: Place one film under the tongue, close to the base on the left or right side, and allow to completely dissolve. Buccal Administration: Place one film on the inside of the left or right cheek and allow to completely dissolve.
SUBOXONE sublingual film must be administered whole. Do not cut, chew, or swallow SUBOXONE sublingual film.
When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal.
Possible Side Effects
What are the possible side effects of SUBOXONEsublingual film?
SUBOXONE sublingual film can cause serious side effects, including: ·
Respiratory problems. You have a higher risk of death and coma if you take SUBOXONE sublingual film with other medicines, such as benzodiazepines. Sleepiness, dizziness, and problems with coordination
Dependency or abuse Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take SUBOXONE sublingual film.
Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or a loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches. Tell your doctor if you develop any of these symptoms.
Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
Some Common side effects of SUBOXONE sublingual film include:
Nausea , Vomiting , Drug withdrawal syndrome , Headache , Sweating , Numb mouth ,Constipation , Swollen and/or painful tongue , The inside of your mouth is more red than normal , Intoxication (feeling lightheaded or drunk) , Disturbance in attention , Irregular heart beat (palpitations) , Decrease in sleep (insomnia) , Blurred vision , Back pain , Fainting , Dizziness , Sleepiness
SUBOXONE sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.
Warnings and Precautions
SUBOXONE sublingual film contains buprenorphine, a schedule III controlled substance that can be abused in a manner similar to other opioids, legal or illicit. 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