Buprenorphine and Naloxone

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Overview

What is Buprenorphine and Naloxone?

Buprenorphine and Naloxone Sublingual Tablets are uncoated white to off-white, round tablets, debossed with on one side and a numeric imprint identifying the product and strength on the other side. They contain buprenorphine HCl USP, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate USP, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). They are intended for sublingual administration and are available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains citric acid anhydrous, crospovidone, lactose monohydrate, magnesium stearate, mannitol, N&A lemon FL, pregelatinized starch (maize), povidone, sodium citrate, and sucralose micronized.

Chemically, buprenorphine HCl, USP is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6- methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:

Buprenorphine HCl, USP

CHNO • HCl M.W. 504.10

It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.

Chemically, naloxone HCl dihydrate, USP is 17-Allyl-4, 5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:

Naloxone hydrochloride dihydrate, USP

CHNO • HCl • 2H0 399.87

It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.

What does Buprenorphine and Naloxone look like?

What are the available doses of Buprenorphine and Naloxone?

Sublingual tablet:

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

How should I use Buprenorphine and Naloxone?

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes 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 and Naloxone?

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What are the warnings of Buprenorphine and Naloxone?

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What are the precautions of Buprenorphine and Naloxone?

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What are the side effects of Buprenorphine and Naloxone?

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What should I look out for while using Buprenorphine and Naloxone?

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

What might happen if I take too much Buprenorphine and Naloxone?

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 and naloxone sublingual tablets 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 and Naloxone?

Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] The reconstituted solution of TYGACIL may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) .Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].Buprenorphine and Naloxone Sublingual Tablets are available as follows:2 mg/0.5 mg –White to off-white, round, unscored tablet debossed with on one side and 154 on the other side supplied in a blister pack of 30 tablets (NDC 0228-3154-73).8 mg/2 mg – White to off-white, round, unscored tablet debossed with on one side and 155 on the other side supplied as 1 carton of 30 tablets (NDC 0228-3155-73). Each carton contains 2 blister packs of 15 tablets each.Store 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 and to destroy any unused medication appropriately[see Patient Counseling Information (17)].

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Buprenorphine and naloxone sublingual tablets contain buprenorphine and naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.

Non-Clinical Toxicology

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

Although the pressor activity of DDAVP is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of DDAVP with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.

DDAVP has been used with epsilon aminocaproic acid without adverse effects.

Buprenorphine and naloxone 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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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