Buprenorphine HCl

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Overview

What is Buprenorphine HCl?

Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in two dosage strengths, 2 mg buprenorphine free base and 8 mg buprenorphine free base. Each tablet also contains citric acid anhydrous, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, povidone, purified water and sodium citrate.

Chemically, buprenorphine hydrochloride USP is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O-methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure:

Buprenorphine hydrochloride USP has the molecular formula CHNO • HCl and the molecular weight is 504.12. It is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

What does Buprenorphine HCl look like?

What are the available doses of Buprenorphine HCl?

Sublingual Tablet: 2 mg buprenorphine and 8 mg buprenorphine. ()

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

How should I use Buprenorphine HCl?

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

What interacts with Buprenorphine HCl?

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What are the warnings of Buprenorphine HCl?

Sorry No Records found

What are the precautions of Buprenorphine HCl?

Sorry No Records found

What are the side effects of Buprenorphine HCl?

Sorry No records found

What should I look out for while using Buprenorphine HCl?

Buprenorphine Sublingual Tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported .

What might happen if I take too much Buprenorphine HCl?

Clinical Presentation

The manifestations of acute overdose include pinpoint pupils, sedation, hypotension, respiratory depression, and death.

Treatment of Overdose

In the event of overdose, the respiratory and cardiac status of the patient should be monitored carefully. 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. Oxygen, IV fluids, vasopressors, and other supportive measures should be employed as indicated.

In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required. Naloxone may be of value for the management of buprenorphine overdose. Higher than normal doses and repeated administration may be necessary. The long duration of action of buprenorphine should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose. Insufficient duration of monitoring may put patients at risk.

How should I store and handle Buprenorphine HCl?

Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].Buprenorphine Sublingual Tablets 2 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “775" on one side and plain on the other side. NDC 0054-0176-13: Bottle of 30 Sublingual Tablets8 mg, supplied as white, flat faced, beveled edge tablets with product identification "54” over “411" on one side and plain on the other side. NDC 0054-0177-13: Bottle of 30 Sublingual TabletsStorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in USP.CAUTION: DEA Order Form Required.Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children[see Patient Counseling Information ()].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Buprenorphine Sublingual Tablets contain buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Non-Clinical Toxicology

Buprenorphine Sublingual Tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported .

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.

Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure [see ], as well as to assure diuretic efficacy.

Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

Buprenorphine Sublingual Tablets contain buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids, legal or illicit. Prescribe and dispense buprenorphine with appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft, including in the home. Clinical monitoring 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

The following serious adverse reactions are described elsewhere in the labeling:

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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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