Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ), NALOXONE HYDROCHLORIDE DIHYDRATE (UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)
Almatica Pharma Inc.
SUBLINGUAL
PRESCRIPTION DRUG
Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone 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 [see Warnings and Precautions (5.9) ] . The data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual film, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. There are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see Data] . Observational studies have reported on congenital malformations among buprenorphine-
Buprenorphine and naloxone sublingual film is supplied as an orange rectangular film with white printing in child-resistant polyester/foil laminated pouches: Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store buprenorphine and naloxone sublingual film securely and dispose of properly [see Patient Counseling Information (17)] .
Abbreviated New Drug Application
Almatica Pharma Inc. ---------- MEDICATION GUIDE Buprenorphine and Naloxone (bue'' pre nor' feen and nal ox' one) Sublingual Film for sublingual or buccal administration (CIII) IMPORTANT: Keep buprenorphine and naloxone sublingual film in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses buprenorphine and naloxone sublingual film, get emergency help right away. Read this Medication Guide that comes with buprenorphine and naloxone sublingual film before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor. Talk to your doctor or pharmacist if you have questions about buprenorphine and naloxone sublingual film. Share the important information in this Medication Guide with members of your household. What is the most important information I should know about buprenorphine and naloxone sublingual film? • Buprenorphine is a medicine in buprenorphine and naloxone sublingual film that can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you: • feel faint or dizzy • have mental changes such as confusion • have slower breathing than you normally have • have severe sleepiness • have blurred vision • have problems with coordination • have slurred speech • cannot think well or clearly • have slowed reflexes • have a high body temperature • feel agitated • have stiff muscles • have trouble walking • Do not switch from buprenorphine and naloxone sublingual film to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of buprenorphine and naloxone sublingual film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine and naloxone sub Baca dokumen lengkapnya
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM- BUPRENORPHINE AND NALOXONE FILM ALMATICA PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM, FOR SUBLINGUAL OR BUCCAL USE CIII INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 10/2019 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. (1) Buprenorphine and naloxone sublingual film should be used as a part of a complete treatment plan that includes counseling and psychosocial support. (1) DOSAGE AND ADMINISTRATION • • • • • • • • • DOSAGE FORMS AND STRENGTHS Sublingual film: (3) buprenorphine 2 mg and naloxone 0.5 mg, buprenorphine 4 mg and naloxone 1 mg, buprenorphine 8 mg and naloxone 2 mg and buprenorphine 12 mg and naloxone 3 mg. CONTRAINDICATIONS Hypersensitivity to buprenorphine or naloxone. (4) WARNINGS AND PRECAUTIONS • • • Prescription use of this product is limited under the Drug Addiction Treatment Act. (2.1) Administer buprenorphine and naloxone sublingual film as a single daily dose. (2.2) To avoid precipitating withdrawal, induction with buprenorphine and naloxone sublingual film should be undertaken when objective and clear signs of withdrawal are evident and buprenorphine and naloxone sublingual film should be administered in divided doses when used as initial treatment. (2.3) For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 8 mg/2 mg buprenorphine and naloxone sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of buprenorphine and naloxone sublingual film as a single dose. (2.3) For patients dependent on Baca dokumen lengkapnya