Buprenorphine HCl and Naloxone HCl

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Overview

What is Buprenorphine HCl and Naloxone HCl?

Buprenorphine and naloxone sublingual tablet, 2 mg/0.5 mg is an orange, round, biconvex tablet debossed “A” on one side and “14” on the other side. Buprenorphine and naloxone sublingual tablet, 8 mg/2 mg is an orange, round, biconvex tablet debossed “AN 415” on one side and plain 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). It is intended for sublingual administration and is 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 the following inactive ingredients: acesulfame potassium, anhydrous citric acid, artificial lemon flavor, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, mannitol, povidone, sodium citrate and starch (corn starch).

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 has the molecular formula CHNO • HCl and the molecular weight is 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 has the molecular formula CHNO • HCl • 2HO and the molecular weight is 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 HCl and Naloxone HCl look like?

What are the available doses of Buprenorphine HCl and Naloxone HCl?

Sublingual tablet:

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

How should I use Buprenorphine HCl and Naloxone HCl?

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 HCl and Naloxone HCl?

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What are the warnings of Buprenorphine HCl and Naloxone HCl?

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What are the precautions of Buprenorphine HCl and Naloxone HCl?

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What are the side effects of Buprenorphine HCl and Naloxone HCl?

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

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 HCl and Naloxone 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 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 HCl and Naloxone HCl?

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Do not freeze.Protect from light.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Do not freeze.Protect from light.Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet, debossed “A” on one side and “14” on the other side. They are available as follows:Bottles of 30 NDC 65162-416-03Bottles of 90 NDC 65162-416-09Buprenorphine and Naloxone Sublingual Tablets, are supplied as orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They are available as follows:Bottles of 30 NDC 65162-415-03Bottles of 90 NDC 65162-415-09Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Advise patients to store buprenorphine-containing medications safely and out of sight and reach of children and to destroy any unused medication appropriately [see ]

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Clinical Information

Chemical Structure

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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 .

See Table 1 for clinically significant drug interactions with naproxen.

Drug/Laboratory Test Interactions

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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Tips

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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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