Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

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Overview

What is Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

Buprenorphine and naloxone sublingual tablet, 2 mg/0.5 mg is an orange, mottled, hexagonal tablet debossed “2N” on one side and “M” in a box on the other side. Buprenorphine and naloxone sublingual tablet, 8 mg/2 mg is an orange, mottled, hexagonal tablet debossed “8N” on one side and “M” in a box on the other side. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and naloxone HCl dihydrate, 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 anhydrous, 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 Hydrochloride and Naloxone Hydrochloride Dihydrate look like?

What are the available doses of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

Sublingual tablets: 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. ()

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

How should I use Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence and 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.

Buprenorphine and naloxone sublingual tablets are administered sublingually as a single daily dose. Buprenorphine and naloxone sublingual tablets should be used in patients who have been initially inducted using buprenorphine sublingual tablets.

Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.

What interacts with Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

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What are the warnings of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

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What are the precautions of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

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What are the side effects of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate?

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

Buprenorphine and naloxone sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported .

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

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

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 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 Hydrochloride and Naloxone Hydrochloride Dihydrate?

ArrayBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx onlyBuprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “2N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8005-03Buprenorphine and naloxone sublingual tablets, are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP.Bottles of 30……………NDC 0406-8020-03Store 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.Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children.[see ]Rx only

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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 should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported .

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.

The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.

Buprenorphine 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

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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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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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