Buprenorphine Hydrochloride Sublingual

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Overview

What is Buprenorphine Hydrochloride Sublingual?

Buprenorphine hydrochloride sublingual tablets are white, round, unscored tablets, debossed with over (2 mg) or over (8 mg) on one side of the tablet and blank on the other side. They contain buprenorphine hydrochloride, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.156 mg buprenorphine hydrochloride, USP and 8.624 mg buprenorphine hydrochloride, USP). Each tablet also contains anhydrous citric acid, anhydrous lactose, colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and sodium citrate.

Chemically, buprenorphine hydrochloride is 21-Cyclopropyl-7α-[( )-1-hydroxy-1,2,2-trimethylpropyl]-6,14- -ethano-6,7,8,14-tetrahydrooripavine hydrochloride. It has the following chemical structure:

Buprenorphine hydrochloride, USP has the molecular formula C H NO •HCl and the molecular weight is 504.10. It is a white or off-white powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

What does Buprenorphine Hydrochloride Sublingual look like?

What are the available doses of Buprenorphine Hydrochloride Sublingual?

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

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

How should I use Buprenorphine Hydrochloride Sublingual?

Buprenorphine hydrochloride sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine hydrochloride 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.

Buprenorphine hydrochloride sublingual tablets are administered sublingually as a single daily dose. Buprenorphine hydrochloride sublingual tablets contain no naloxone hydrochloride and are preferred for use only during induction. Following induction, buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets are preferred due to the presence of naloxone when clinical use includes unsupervised administration. The use of buprenorphine hydrochloride sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablets; for example, those patients who have been shown to be hypersensitive to naloxone.

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 Sublingual?

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What are the warnings of Buprenorphine Hydrochloride Sublingual?

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What are the precautions of Buprenorphine Hydrochloride Sublingual?

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What are the side effects of Buprenorphine Hydrochloride Sublingual?

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What should I look out for while using Buprenorphine Hydrochloride Sublingual?

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

What might happen if I take too much Buprenorphine Hydrochloride Sublingual?

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 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 Sublingual?

Buprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. [see ].Rx onlyBuprenorphine Hydrochloride Sublingual Tablets are available containing buprenorphine hydrochloride, USP equivalent to 2 mg or 8 mg of buprenorphine.The 2 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0923-93 bottles of 30 tablets The 8 mg sublingual tablets are white, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0924-93 bottles of 30 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST: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 hydrochloride sublingual tablets contain buprenorphine, a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Non-Clinical Toxicology

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

If phenytoin or other hepatic enzyme inducers are taken concurrently with disopyramide, lower plasma levels of disopyramide may occur. Monitoring of disopyramide plasma levels is recommended in such concurrent use to avoid ineffective therapy. Other antiarrhythmic drugs (e.g., quinidine, procainamide, lidocaine, propranolol) have occasionally been used concurrently with disopyramide. Excessive widening of the QRS complex and/or prolongation of the Q-T interval may occur in these situations (see ). In healthy subjects, no significant drug-drug interaction was observed when disopyramide was coadministered with either propranolol or diazepam. Concomitant administration of disopyramide and quinidine resulted in slight increases in plasma disopyramide levels and slight decreases in plasma quinidine levels. Disopyramide does not increase serum digoxin levels.

Until data on possible interactions between verapamil and disopyramide phosphate are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration.

Although potent inhibitors of CYP3A4 (e.g., ketoconazole) have not been studied clinically, studies have shown that erythromycin and oleandomycin inhibit the metabolism of disopyramide. Cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin indicating that co-administration of disopyramide with inhibitors of CYP3A4 could result in potentially fatal interaction.

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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