METHADOSE Tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

SpecGx LLC

Λέξεις κλειδιά

0406-0540 0406-2540

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BOXED WARNING SECTION

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES and TREATMENT ...

1. Indications and Usage

Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). Maintenance ...

2. Dosage and Administration

2.1 Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid Addiction Code of Federal Regulations, Title 42, Sec 8: Methadone products when used for the treatment of ...

3. Dosage Forms and Strengths

METHADOSE Dispersible Tablet for oral administration following dispersion in a liquid: 40 mg of methadone hydrochloride and is a white, round, cross-scored dispersible tablet. Methadone Hydrochloride Tablets ...

4. Contraindications

Methadone hydrochloride tablets for oral suspension are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.1)]. Acute or severe bronchial asthma ...

5. Warnings and Precautions

5.1 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of methadone, even when used as recommended. Respiratory depression, ...

6. Adverse Reactions

The following serious adverse reactions and/or conditions are described, or described in greater detail, in other sections: Respiratory Depression [see Warnings and Precautions (5.1)] Interactions ...

7. Drug Interactions

Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including ...

8.1. Pregnancy

Risk Summary Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see Warnings and Precautions (5.6)]. Pregnant women in ...

8.2. Lactation

Risk Summary Based on two studies in 22 breastfeeding women maintained on methadone treatment, methadone was present in low levels in human milk, and did not show adverse reactions in breastfed infants. ...

8.3. Females and Males of Reproductive Potential

Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions ...

8.4. Pediatric Use

The safety, effectiveness, and pharmacokinetics of methadone in pediatric patients below the age of 18 years have not been established.

8.5. Geriatric Use

Clinical studies of methadone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently compared to younger subjects. Other reported clinical experience ...

8.6. Hepatic Impairment

Methadone pharmacokinetics have not been extensively evaluated in patients with hepatic insufficiency. Methadone is metabolized by hepatic pathways; therefore, patients with liver impairment may be at ...

8.7. Renal Impairment

Methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency. Since unmetabolized methadone and its metabolites are excreted in urine to a variable degree, start ...

9.1. Controlled Substance

Methadone hydrochloride tablets for oral suspension contain methadone, a Schedule II controlled substance.

9.2. Abuse

Methadone hydrochloride tablets for oral suspension contain methadone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, ...

9.3. Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect (in the absence of disease progression ...

10. Overdosage

Clinical Symptoms Acute overdosage with methadone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal-muscle flaccidity, cold and clammy skin, constricted pupils, ...

11. Description

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 ...

12.1. Mechanism of Action

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 ...

12.2. Pharmacodynamics

Effects on the Central Nervous System Methadone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness ...

12.3. Pharmacokinetics

Absorption Following oral administration the bioavailability of methadone ranges between 36 to 100% and peak plasma concentrations are achieved between 1 to 7.5 hours. Dose proportionality of methadone ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis The results of carcinogenicity assessment in B6C2F1 mice and Fischer 344 rats following dietary administration of two doses of methadone HCl have been published. Mice consumed 15 mg/kg/day ...

16.1. How Supplied

METHADOSE Dispersible Tablets, 40 mg: Available as a white, round tablet, debossed with METHADOSE 40 on one side, a quadrisect on the other. Bottles of 100 NDC 0406-0540-34. Methadone Hydrochloride ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store methadone hydrochloride tablets for oral suspension securely and dispose of properly ...

17. Patient Counseling Information

Provide the following information to patients receiving methadone hydrochloride tablets for oral suspension or to their caregivers: Life-Threatening Respiratory Depression Discuss the risk of respiratory ...