Patients should be cautioned about driving or operating hazardous machinery until they are reasonably certain that Suboxone sublingual film therapy does not adversely affect his or her ability to engage in such activities.Like other opioids, Suboxone sublingual film may produce orthostatic hypotension in ambulatory patients.Buprenorphine, like other opioids, may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. However, there was not evidence to suggest that any of the four subjects experienced precipitated withdrawal secondary to the administration of buprenorphine or buprenorphine/naloxone sublingual films.The following adverse reactions have been identified during post-approval use of Suboxone sublingual film. For all measures for which the drugs produced an effect, buprenorphine produced a dose-related response. Do not take Suboxone for a condition for which it was not prescribed. Clinical guidelines: Buprenorphine Containing Products Buprenorphine containing products reduce or eliminate opioid withdrawal symptoms and opioid cravings. Talk to your doctor or pharmacist if you have questions about Suboxone.Share the important information in this Medication Guide with members of your household.These can be signs of an overdose or other serious problems.Do not take Suboxone if you are allergic to buprenorphine or naloxone.Sometimes the doses of certain medicines and Suboxone may need to be changed if used together. Other adverse events were constipation, glossodynia, oral mucosal erythema, vomiting, intoxication, disturbance in attention, palpitations, insomnia, withdrawal syndrome, hyperhidrosis, and blurred vision.The most common adverse events associated with the buccal administration were similar to those observed with sublingual administration of the film.Other adverse event data were derived from larger, controlled studies of Suboxone (buprenorphine and naloxone) sublingual tablets and SUBUTEX (buprenorphine) tablets and of buprenorphine sublingual solution. Therefore, once induction is complete, patients can switch between buccal and sublingual administration without significant risk of under or overdosing.Suboxone sublingual film is supplied as an orange rectangular film with a white printed logo in four dosage strengths:Suboxone sublingual film should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported Buprenorphine can be abused in a manner similar to other opioids, legal or illicit. Embryofetal death was also observed in both rats and rabbits.Suboxone sublingual film should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. Results were negative in yeast (Results were equivocal in the Ames test: negative in studies in two laboratories, but positive for frame shift mutation at a high dose (5 mg/plate) in a third study. When Suboxone sublingual film is administered sublingually or buccally, buprenorphine has a mean elimination half-life ranging from 24 to 42 hours and naloxone has a mean elimination half-life ranging from 2 to 12 hours.Buprenorphine undergoes both N-dealkylation to norbuprenorphine and glucuronidation. 2. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. In the rabbit, increased post-implantation losses occurred at an oral dose of 40 mg/kg/day. Higher than normal doses and repeated administration may be necessary.Suboxone (buprenorphine and naloxone) sublingual tabletsUnder the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. Buprenorphine may be prescribed to women who are pregnant and have an OUD. When respiratory or cardiac functions are depressed, primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation.