Methadose dispersible tablets USP

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

methadone (methadone hydrochloride)

Available from:

SpecGx LLC

INN (International Name):

methadone (methadone hydrochloride)

Dosage:

40mg

Pharmaceutical form:

tablets for oral suspension

Prescription type:

Prescription

Patient Information leaflet

Page 1 of 37
022018-2
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHADOSE
™ DISPERSIBLE TABLETS AND METHADONE HYDROCHLORIDE
TABLETS
FOR
ORAL
SUSPENSION
SAFELY
AND
EFFECTIVELY.
SEE
FULL
PRESCRIBING INFORMATION FOR METHADOSE DISPERSIBLE TABLETS AND
METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION.
METHADOSE
™ DISPERSIBLE TABLETS, 40 MG
(METHADONE HYDROCHLORIDE TABLETS FOR ORAL SUSPENSION)
AND METHADONE HYDROCHLORIDE TABLETS, 40 MG
(DISPERSIBLE, ORANGE FLAVORED) (METHADONE HYDROCHLORIDE TABLETS
FOR ORAL SUSPENSION), CII
INITIAL U.S. APPROVAL: 1947
----------------------------RECENT MAJOR
CHANGES--------------------------
Boxed Warning
02/2018
Warnings and Precautions (5.2, 5.6)
02/2018
----------------------------INDICATIONS AND USAGE
----------------------------
Methadone hydrochloride tablets for oral suspension are an opioid
agonist indicated for the:
•
Detoxification treatment of opioid addiction (heroin or other
morphine-like drugs). (1)
•
Maintenance treatment of opioid addiction (heroin or other
morphine-like drugs), in conjunction with appropriate social and
medical services. (1)
_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 21 CFR, Title
42, Sec 8. (1, 2.1) _ _
------------------------DOSAGE AND ADMINISTRATION
-----------------------
•
Initiation of Detoxification and Maintenance Treatment: A single
dose of 20 to 30 mg may be sufficient to suppress withdrawal
syndrome. (2.4)
•
Do not abruptly discontinue methadone hydrochloride tablets
for oral suspension in a physically dependent patient. (2.6,
5.15)
•
Maintenance Treatment: Clinical stability is most commonly
achieved at doses between 80 to 120 mg/day. (2.5)
-----------------------DOSAGE FORMS AND STRENGTHS --------------------
Tablets intended for dispersion in a liquid immediately prior to oral
administration: 40 mg. (3)
---

Summary of Product characteristics

Methadose™ Dispersible Tablets USP, 40mg
SpecGx LLC • 385 Marshall Avenue • Webster Groves, MO 63119 •
314.654.2000 T • www.mallinckrodt.com
Appendix 1.9 Summary of Product Characteristics
1.
NAME OF MEDICINAL PRODUCT:
Methadose™ Dispersible Tablets USP, 40mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Active Ingredient:

Methadone Hydrochloride, USP 40.00 mg
Excipients:

Microcrystalline Cellulose, NF 1,243.14 mg

Colloidal Silicon Dioxide, NP 4.000mg

Pregelatinized Starch, NF 262.87 mg

Stearic Acid, NF 12.000 mg

Magnesium Stearate, NF 5.090 mg

Dibasic Calcium Phosphate, USP 82.90 mg
3.
PHARMACEUTICAL FORM:
tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
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 treatment of opioid addiction (heroin or other
morphine-like drugs), in
conjunction with appropriate social and medical services.
_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.
4.2
METHOD OF ADMINISTRATION:
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 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
Methadose™ Dispersible Tablets USP, 40mg
SpecGx LLC • 385 Marshall Avenue • Webster Gr