Buprenorphine hydrochloride

490.07

503.28000

258-396-8

56W8MW3EN1

9064

DTXSID2048905

C47424

N07BC01|N07BC51

2939110000

62.2

4.98

1.26g/cm3

279-281 °C

51.8 °F

Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96 per cent), practically insoluble in cyclohexane.

-0°C

Intravenous-rat LD50: 62 mg/kg; Oral-mouse LD50: 800 mg/kg

Thermal decomposition releases toxic nitrogen oxides and hydrogen chloride fumes

NONH for all modes of transport

3

22-62-63-39/23/24/25-23/24/25-11

26-36-45-36/37-16-7

KM7758000

Xn,T,F

Warehouse ventilated, low temperature and dry

P281

H302-H361

|Danger|H301 (87.64%): Toxic if swallowed [Danger Acute toxicity, oral]|P201, P202, P260, P261, P263, P264, P270, P271, P280, P281, P285, P301+P310, P301+P312, P302+P352, P304+P340, P304+P341, P305+P351+P338, P308+P313, P312, P321, P330, P332+P313, P337+P313, P342+P311, P362, P403+P233, P405, and P501|Aggregated GHS information provided by 89 companies from 6 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|H302 (96.23%): Harmful if swallowed [Warning Acute toxicity, oral]|P201, P202, P260, P261, P263, P264, P270, P271, P272, P280, P281, P285, P301+P312, P302+P352, P304+P340, P304+P341, P307+P311, P308+P313, P312, P321, P330, P333+P313, P342+P311, P363, P403+P233, P405, and P501|Aggregated GHS information provided by 53 companies from 8 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

moderately toxic

Buprenorphine therapy has been associated with a low rate of serum enzyme elevations during treatment, although the populations studied (opioid dependent) often have coexisting chronic liver diseases which complicate such assessments. Nevertheless, rates of ALT elevations during treatment with buprenorphine (with or without naloxone) have been minimally or no greater than with comparator arms (methadone).

Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.,|Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.|Treatment of opioid dependence

Buprenorphine is a sublingually and transdermally available, semisynthetic opioid analgesic, which is used as an analgesic and for management of opioid dependence. Therapy with buprenorphine is associated with mild and transient serum enzyme elevations, and with moderate-to-severe clinically apparent liver injury when abused by intravenous administration or the sublingual formations.

Substance Abuse Treatment Agents

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)|Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)|Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)

6029 M

Buprenorphine|Buprenex, Temgesic, Subutex, Suboxone|9064|Schedule III - Substances in the DEA Schedule III have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.|Yes

Human drugs -> Sixmo -> EMA Drug Category|Other nervous system drugs -> Human pharmacotherapeutic group|Human drugs -> Zubsolv -> EMA Drug Category|Human Drugs -> EU pediatric investigation plans|Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients