DOLOPHINE- methadone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceuticals Corp.

INN (International Name):

METHADONE HYDROCHLORIDE

Composition:

METHADONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DOLOPHINE Tablets are indicated for the: Limitations of Use 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 [see Dosage and Administration (2.1)]. DOLOPHINE Tablets are 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 childr

Product summary:

DOLOPHINE (methadone hydrochloride USP) Tablets 5 mg tablets are round, white biconvex tablets debossed with tablet identifier 54 162 on one side and scored on the other side. NDC 0054-4218-25: Bottle of 100 Tablets The 10 mg tablets are round, white biconvex tablets debossed with tablet identifier 54 549 on one side and scored on the other side. NDC 0054-4219-25: Bottle of 100 Tablets Store at 20º to 25ºC (68º to 77ºF), with excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Store DOLOPHINE securely and dispose of properly [see Patient Counseling Information (17)] .

Authorization status:

New Drug Application

Patient Information leaflet

West-Ward Pharmaceuticals Corp.
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Medication Guide
DOLOPHINE®
(DOL-o-feen)
(methadone hydrochloride USP) Tablets CII
Rx only
DOLOPHINE Tablets are:
•
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 DOLOPHINE Tablets:
•
Get emergency help or call 911 right away if you take too much
DOLOPHINE Tablets (overdose).
When you first start taking DOLOPHINE, 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 emergency
treatment of opioid overdose.
•
Taking DOLOPHINE Tablets 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 DOLOPHINE. They could die from taking it.
Selling or giving away
DOLOPHINE is against the law.
•
Store DOLOPHINE securely, out of sight and reach of children, and in a
location not accessible by
others, including visitors to the home.
Do not take DOLOPHINE Tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
Before taking DOLOPHINE Tablets, tell your healthcare provider if you
have a history of:
•
head injury,

Summary of Product characteristics

DOLOPHINE- METHADONE HYDROCHLORIDE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOLOPHINE® TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOLOPHINE® TABLETS.
DOLOPHINE® (METHADONE HYDROCHLORIDE) TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1947
WARNING: 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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RECENT MAJOR CHANGES
Dosage and Administration (2.3) 03/2021
Warnings and Precautions (5.1, 5.3, 5.7) 03/2021
INDICATIONS AND USAGE
DOLOPHINE is an opioid agonist indicated for the:
4.
DOLOPHINE TABLETS EXPOSE 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. (5.1)
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. (5.2)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
THE PEAK
RESPIRATORY DEPRESSANT EFFECT OF METHADONE OCCURS LATER, AND PERSISTS
LONGER THAN
THE PEAK ANALGESIC EFFECT. MONITOR CLOSELY, ESPECIALLY UPON INITIATION
OR FOLLOWING A
DOSE INCREASE. (5.3)
ACCIDENTAL INGESTION OF DOLOPHINE, ESPECIALLY BY CHILDREN, CAN RESULT
IN FATAL
OVERDOSE OF METHADONE. (5.3)
QT INTERVAL PROLONGATION AND SERIOUS ARRHYTHMIA (TORSADES DE POINTES)
HAVE
OCCURRED DURING TREATMENT WITH METHADONE. CLOSELY MONITOR PATIENTS
WITH