Methadone (injection): Difference between revisions
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|indicationType=treatment | |indicationType=treatment | ||
|adverseReactions=<!--Black Box Warning--> | |adverseReactions=<!--Black Box Warning--> | ||
|blackBoxWarningTitle= | |blackBoxWarningTitle=CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS | ||
FOR THE TREATMENT OF OPIOID ADDICTION | |||
|blackBoxWarningBody=Code of Federal Regulations, Title 42, Sec 8 | |||
* METHADONE PRODUCTS WHEN USED FOR THE TREATMENT OF OPIOID ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY OPIOID TREATMENT PROGRAMS (AND AGENCIES, PRACTITIONERS OR INSTITUTIONS BY FORMAL AGREEMENT WITH THE PROGRAM SPONSOR) CERTIFIED BY THE SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION AND APPROVED BY THE DESIGNATED STATE AUTHORITY. CERTIFIED TREATMENT PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL OPIOID TREATMENT STANDARDS (42 CFR 8.12). '''See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment'''. | |||
* | * 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. | ||
|fdaLIADAdult===Indications== | |||
| | |||
* | * For the treatment of moderate to severe [[pain]] not responsive to non-narcotic analgesics. | ||
* For use in temporary treatment of opioid dependence in patients unable to take oral medication. | |||
* | * Outpatient maintenance and outpatient detoxification treatment may be provided only by opioid treatment programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of hospitalization, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone. | ||
* | * '''NOTE: INJECTABLE METHADONE PRODUCTS ARE NOT APPROVED FOR THE OUTPATIENT TREATMENT OF OPIOID DEPENDENCE. IN THIS PATIENT POPULATION, PARENTERAL METHADONE IS TO BE USED ONLY FOR PATIENTS UNABLE TO TAKE ORAL MEDICATION, SUCH AS HOSPITALIZED PATIENTS.''' | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
There is limited information regarding <i>Off-Label | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
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|brandNames=* METHADONE®<ref>{{Cite web | title =methadone hydrochloride injection, solution | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9bbe219f-3bf1-44f4-a709-cd108c4fa9ef}}</ref> | |brandNames=* METHADONE®<ref>{{Cite web | title =methadone hydrochloride injection, solution | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9bbe219f-3bf1-44f4-a709-cd108c4fa9ef}}</ref> | ||
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | ||
|drugShortage= | |drugShortage= | ||
}} | }} |
Revision as of 17:13, 14 May 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
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Overview
Methadone (injection) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.
- For use in temporary treatment of opioid dependence in patients unable to take oral medication.
- Outpatient maintenance and outpatient detoxification treatment may be provided only by opioid treatment programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of hospitalization, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
- NOTE: INJECTABLE METHADONE PRODUCTS ARE NOT APPROVED FOR THE OUTPATIENT TREATMENT OF OPIOID DEPENDENCE. IN THIS PATIENT POPULATION, PARENTERAL METHADONE IS TO BE USED ONLY FOR PATIENTS UNABLE TO TAKE ORAL MEDICATION, SUCH AS HOSPITALIZED PATIENTS.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Methadone (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Methadone (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Methadone (injection) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Methadone (injection) in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Methadone (injection) in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Methadone (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Methadone (injection) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methadone (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Methadone (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Methadone (injection) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Methadone (injection) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Methadone (injection) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Methadone (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Methadone (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Methadone (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Methadone (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Methadone (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Methadone (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Methadone (injection) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Methadone (injection) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Methadone (injection) in the drug label.
Pharmacology
There is limited information regarding Methadone (injection) Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Methadone (injection) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Methadone (injection) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Methadone (injection) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Methadone (injection) in the drug label.
How Supplied
Storage
There is limited information regarding Methadone (injection) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Methadone (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Methadone (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Methadone (injection) in the drug label.
Precautions with Alcohol
- Alcohol-Methadone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- METHADONE®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "methadone hydrochloride injection, solution".
- ↑ "http://www.ismp.org". External link in
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