Buprenorphine Hydrochloride

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Overview

What is Buprenorphine Hydrochloride?

Buprenorphine hydrochloride injection is a partial opioid agonist.

The chemical name of buprenorphine hydrochloride is 1 7-(cyclopropylmethyl)-a-(1, 1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-a-methyl-6, 14-ethenomorphinan-7-methanol, hydrochloride [5α, 7α(S)].

Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water.

Buprenorphine hydrochloride injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of buprenorphine hydrochloride injection contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection and HCl to adjust pH between 3.0 and 7.0.

Buprenorphine hydrochloride has the molecular formula, CHNOHCl, and the following structure:

Molecular weight:504.11

What does Buprenorphine Hydrochloride look like?

What are the available doses of Buprenorphine Hydrochloride?

Sorry No records found.

What should I talk to my health care provider before I take Buprenorphine Hydrochloride?

Sorry No records found

How should I use Buprenorphine Hydrochloride?

Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses reserve buprenorphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Use the lowest effective dosage for the shortest duration consistent with individual patients treatment goals

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with buprenorphine hydrochloride injection and adjust the dosage accordingly

What interacts with Buprenorphine Hydrochloride?

Sorry No Records found

What are the warnings of Buprenorphine Hydrochloride?

Sorry No Records found

What are the precautions of Buprenorphine Hydrochloride?

Sorry No Records found

What are the side effects of Buprenorphine Hydrochloride?

Sorry No records found

What should I look out for while using Buprenorphine Hydrochloride?

Buprenorphine hydrochloride injection is contraindicated in patients with:

Clinically significant drug interactions with

Buprenorphine Hydrochloride Injection

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What might happen if I take too much Buprenorphine Hydrochloride?

How should I store and handle Buprenorphine Hydrochloride?

TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018Buprenorphine hydrochloride injection, 0.3 mg (Base)/mL, is supplied in amber glass vials of 1 mL. NDC 0517-0725-05Store at 20°C to 25°C (68°F to 77°F) [USP Controlled Room Temperature]. Protect from prolonged exposure to light. AMERICAN REGENT, INC. SHIRLEY, NY 11967Revised March 2018

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa- opioid receptor. One unusual property of buprenorphine hydrochloride injection observed studies is its very slow rate of dissociation from its receptor. This could account for its longer duration of action than morphine, the unpredictability of its reversal by opioid antagonists, and its low level of manifest physical dependence.

Non-Clinical Toxicology

Buprenorphine hydrochloride injection is contraindicated in patients with:

Array

Buprenorphine hydrochloride injection should be administered with caution in the elderly, debilitated patients, in children and those with severe impairment of hepatic, pulmonary, or renal function; myxedema or hypothyroidism; adrenal cortical insufficiency (e.g., Addison's disease); CNS depression or coma; toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis.

Because buprenorphine hydrochloride injection is metabolized by the liver, the activity of buprenorphine hydrochloride injection may be increased and/or extended in those individuals with impaired hepatic function or those receiving other agents known to decrease hepatic clearance.

Buprenorphine hydrochloride injection has been shown to increase intracholedochal pressure to a similar degree as other opioid analgesics, and thus should be administered with caution to patients with dysfunction of the biliary tract.

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

Other less frequent adverse reactions occurring in 5% to 10% of the patients were:

Nausea                  Dizziness/Vertigo

Occurring in 1% to 5% of the patients:

Sweating                Headache

Hypotension           Nausea/Vomiting

Vomiting                 Hypoventilation

Miosis

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect:

Cardiovascular:

Gastrointestinal:

Respiratory:

Dermatological:

Ophthalmological:

Miscellaneous:

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions:

In the United Kingdom, buprenorphine hydrochloride was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to buprenorphine hydrochloride were observed.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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