METHADOSE DISPERSIBLE

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Overview

What is METHADOSE DISPERSIBLE?

Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist, available as 40 mg dispersible tablets for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride is a white, essentially odorless, bitter-tasting crystalline powder. It is very soluble in water, soluble in isopropranol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride tablets for oral suspension as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and it has the following structural formula:

Each METHADOSE Dispersible Tablet contains 40 mg of methadone hydrochloride, USP and the following inactive ingredients: dibasic calcium phosphate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, pregelatinized starch, stearic acid.

Each Methadone Hydrochloride Tablet USP (dispersible, orange flavored) contains 40 mg of methadone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide; monobasic potassium phosphate; magnesium stearate; microcrystalline cellulose; pregelatinized starch; stearic acid; orange blend: FD&C yellow #6, FD&C yellow #6 lake, and FD&C yellow #5 lake; orange flavor.

Methadone hydrochloride tablets for oral suspension are cross-scored, allowing for flexible dosage adjustment. Each tablet may be broken or cut in half to yield two 20-mg doses, or in quarters to yield four 10-mg doses.

Methadone hydrochloride tablets for oral suspension are for oral administration following dispersion in a liquid.

Methadone hydrochloride tablets for oral suspension contain insoluble excipients and must not be injected.

What does METHADOSE DISPERSIBLE look like?

What are the available doses of METHADOSE DISPERSIBLE?

Tablets intended for dispersion in a liquid immediately prior to oral administration: 40 mg. ()

What should I talk to my health care provider before I take METHADOSE DISPERSIBLE?

How should I use METHADOSE DISPERSIBLE?

Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist indicated for the:

Limitations of Use

Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 .

Code of Federal Regulations, Title 42, Sec 8

Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program.

Regulatory Exceptions to the General Requirement for Certification to Provide Opioid Agonist Treatment

What interacts with METHADOSE DISPERSIBLE?

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What are the warnings of METHADOSE DISPERSIBLE?

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What are the precautions of METHADOSE DISPERSIBLE?

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What are the side effects of METHADOSE DISPERSIBLE?

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What should I look out for while using METHADOSE DISPERSIBLE?

Methadone hydrochloride tablets for oral suspension are contraindicated in patients with:

What might happen if I take too much METHADOSE DISPERSIBLE?

[see Clinical Pharmacology ()]

Treatment of Overdose

The opioid antagonists, such as naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to methadone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to methadone overdose.

Because the duration of reversal would be expected to be less than the duration of action of methadone, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to opioid antagonists is suboptimal or not sustained, administer additional antagonist as directed in the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

How should I store and handle METHADOSE DISPERSIBLE?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].METHADOSE Dispersible Tablets, 40 mg:Bottles of 100……NDC 0406-0540-34Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg:Bottles of 100……NDC 0406-2540-01Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers and kept out of reach of children to prevent accidental ingestion. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Methadone hydrochloride is a mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and organs composed of smooth muscle. The methadone withdrawal syndrome, although qualitatively similar to that of morphine, differs in that the onset is slower, the course is more prolonged, and the symptoms are less severe.

Some data also indicate that methadone acts as an antagonist at the N-methyl-D-aspartate (NMDA) receptor. The contribution of NMDA receptor antagonism to methadone’s efficacy is unknown.

Non-Clinical Toxicology

Methadone hydrochloride tablets for oral suspension are contraindicated in patients with:

(Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets)

Furosemide

Nifedipine

Drugs that reduce metformin clearance

In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.

Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.

Other

Carbonic anhydrase inhibitors

Alcohol

Serious, life-threatening, or fatal respiratory depression has been reported with the use of methadone, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide (CO) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status .

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of methadone hydrochloride tablets for oral suspension, the risk is greatest during the initiation of therapy or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period. Monitor patients closely for respiratory depression, when initiating therapy with methadone hydrochloride tablets for oral suspension and following dose increases.

Instruct patients against use by individuals other than the patient for whom methadone was prescribed and to keep methadone out of the reach of children, as such inappropriate use may result in fatal respiratory depression.

To reduce the risk of respiratory depression, proper dosing and titration of methadone are essential . Overestimating the methadone dosage when initiating treatment can result in fatal overdose with the first dose.

To further reduce the risk of respiratory depression, consider the following:

The following serious adverse reactions and/or conditions are described, or described in greater detail, in other sections:

The following adverse reactions have been identified during post-approval use of methadone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred.

The most frequently observed adverse reactions included lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seemed to be more prominent in ambulatory patients and in those who are not suffering severe pain.

Other adverse reactions include the following:

Body as a Whole:

Cardiovascular:

torsades de pointes

Central Nervous System:

Endocrine:

Gastrointestinal:

Hematologic:

Metabolic:

Musculoskeletal:

Renal:

Reproductive:

Respiratory:

Skin and Subcutaneous Tissue:

Hypersensitivity:

Serotonin Syndrome:

Adrenal Insufficiency:

Anaphylaxis:

Androgen Deficiency:

[see Clinical Pharmacology ()]

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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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