METHADONE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

METHADONE HYDROCHLORIDE

Composition:

METHADONE HYDROCHLORIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methadone Hydrochloride Oral Solution is indicated for the: Limitations of Use: Limitations of Use: Methadone Hydrochloride Oral Solution is contraindicated in patients with: Risk Summary The majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. Pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. Several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy. Information is limited regarding dose and duration of methadone use during pregnancy, and most maternal exposure in these studies appear

Product summary:

Methadone is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone may be targeted for theft and diversion by criminals [see Warnings and Precautions ( 5.2)]. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25ºC (68º to 77°F), with excursions permitted between 15° to 30°C (59° to 86° F). [See USP Controlled Room Temperature.] Store Methadone Hydrochloride Oral Solution securely and dispose of properly [see Patient Counseling Information (17)]. Methadone Hydrochloride Oral Solution USP 5 mg per 5 mL (1 mg/mL) is supplied as a clear or nearly clear, orange-colored, citrus-flavored solution. NDC 0054-3555-63: Bottle of 500 mL 10 mg per 5 mL (2 mg/mL) is supplied as a clear or nearly clear, orange-colored, citrus-flavored solution. NDC 0054-3556-63: Bottle of 500 mL DEA order form required.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Methadone Hydrochloride (meth’ a done hye” droe klor’ ide) Oral
Solution USP, CII
Rx only
Methadone Hydrochloride Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily around-the-clock, long-term treatment
with an opioid, when other
pain treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not
treat your pain well enough or you cannot tolerate them.
•
A long-acting opioid pain medicine that can put you at risk for
overdose and death. Even if you
take your dose correctly as prescribed you are at risk for opioid
addiction, abuse, and misuse than
can lead to death.
•
Not for use to treat pain that is not around-the-clock
•
Also used to manage drug addiction.
Important information about Methadone Hydrochloride Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Methadone Hydrochloride Oral
Solution (overdose). When you first start taking Methadone
Hydrochloride Oral Solution, when
your dose is changed, or if you take too much (overdose), serious or
life-threatening breathing
problems that can lead to death may occur. Talk to your healthcare
provider about naloxone, a
medicine for the emergency treatment of an opioid overdose.
•
Taking Methadone Hydrochloride Oral Solution with other opioid
medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your Methadone Hydrochloride Oral Solution.
They could die from taking
it. Selling or giving away Methadone Hydrochloride Oral Solution is
against the law.
•
Store Methadone Hydrochloride Oral Solution securely, out of sight and
reach of children, and in
a location not accessible by others, including visitors to the home.
Do not take Methadone Hydrochloride Oral Solution if you have:

Summary of Product characteristics

METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHADONE
HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR METHADONE HYDROCHLORIDE ORAL SOLUTION.
METHADONE HYDROCHLORIDE ORAL SOLUTION, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1947
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING
CYTOCHROME P450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; AND TREATMENT FOR OPIOID
ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Methadone Hydrochloride Oral Solution is an opioid agonist indicated
for the:
•
•
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
METHADONE
HYDROCHLORIDE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG
AND ML,
AND OTHER METHADONE HYDROCHLORIDE ORAL SOLUTIONS OF DIFFERENT
CONCENTRATIONS CAN
RESULT IN ACCIDENTAL OVERDOSE AND DEATH. (2.2, 5.1)
METHADONE HYDROCHLORIDE ORAL SOLUTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE,
AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH
PATIENT’S RISK
BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR DEVELOPMENT OF THESE
BEHAVIORS AND
CONDITIONS. (5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
THE PEAK
RESPIRATORY DEPRESSION EFFECT OF METHADONE OCCURS LATER, AND PERSISTS
LONGER THAN
THE PEAK ANALGESIC EFFECT. MONITOR CLOSELY, ESPECIALLY UP