Zonor (Buprenorphine) 0.2mg

Zonor 0.2mg Tablet

Product Description
Brand Name:

Zonor 0.2mg Tablet By Pharmatec

HIGHLIGHTS OF PRESCRIBING INFORMATION:

These highlights do not include all the information needed to use Buprenor-phine HCl Sublingual Tablets safely and effectively. See full prescribing informa-tion for Buprenorphine HCl Sublingual Tablets.

INDICATIONS AND USAGE:

Buprenorphine HCl Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction.

DOSAGE AND ADMINISTRATION:

Administer Buprenorphine HCl sublingual tablets sublingually as a single daily dose.

To avoid precipitating withdrawal, induction with buprenorphine HCl sublingual tab-lets should be undertaken when objective and clear signs of withdrawal are evident. Buprenorphine and naloxone sublingual film CIII or buprenorphine and naloxone sublingual tablets CIII are generally initiated after two days of buprenorphine HCl sub-lingual tablet titration.

DOSAGE FORMS AND STRENGTHS:

Sublingual tablet: 2 mg buprenorphine and 8 mg buprenorphine.

CONTRAINDICATIONS:

Hypersensitivity to buprenorphine. 

WARNINGS AND PRECAUTIONS:

•    Buprenorphine can be abused in a similar manner to other opioids. Clinical monitor-ing 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 visits.

•    Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol).

•    Consider dose reduction of CNS depressants, Buprenorphine HCl Sublingual Tab-lets, or both in situations of concomitant prescription.

•    Store Buprenorphine HCl Sublingual Tablets safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.

•    Chronic administration produces opioid-type physical dependence. Abrupt discon-tinuation or rapid dose taper may result in opioid withdrawal syndrome.

•    Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

•    Do not administer Buprenorphine HCl Sublingual Tablets to patients with known hypersensitivity to buprenorphine.

•    Buprenorphine HCl Sublingual Tablets may precipitate opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists if adminis-tered sublingually or parenterally before the agonist effects of other opioids have subsided.

•    Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy.

•    Buprenorphine HCl Sublingual Tablets are NOT appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublin-gual dose of buprenorphine.

•    Caution patients about the risk of driving or operating hazardous machinery.

ADVERSE REACTIONS:

Adverse events most commonly observed during clinical trials and post-marketing experience for buprenorphine HCl sublingual tablets are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, and pain.

DRUG INTERACTIONS:

•    Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.

•    Use caution in prescribing buprenorphine HCl sublingual tablets for patients receiv-ing benzodiazepines or other CNS depressants and warn patients against concomi-tant self-administration/misuse.

USE IN SPECIFIC POPULATIONS:

•    Buprenorphine HCl sublingual tablets are not indicated for use during pregnancy unless potential benefit justifies potential risk.

•    Buprenorphine passes into the mother’s milk. Breast-feeding is not advised while taking buprenorphine HCl sublingual tablets.

•    Safety and effectiveness of buprenorphine HCl sublingual tablets in patients below the age of 16 have not been established.

•    Administer buprenorphine HCl sublingual tablets with caution to elderly or debili-tated patients.

•    Administer buprenorphine HCl sublingual tablets with caution to patients with liver dysfunction.