Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Methadone Hcl 28-05-2009
5mg/10mg per ml syrup
5mg/10mg/20mg/40mg tablet
For the treatment of opiod dependence and in maintenence treatment
of opiod dependence
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Methandienone BP 25mg + April 1970
Benzyl alcohol in sterile solution 9%
Moderate to severe pain
PROPOXYPHENE- NARCOTIC ANALGESIS- INFORMATION ALSO APPLIES TO
BUPRENORPHINE, BUTORPHANOL, CODIENE, HYDROCODONE, HYDROMORPHONE,
LEVOMETHADYL ACETATE, LEVORPHANOL TARTARATE, MEPERIDINE, METHADONE, MORPHINE,
NALBUPHINE, OPIUM INJECTION, OXYCODONE, OXYMORPHONE, PENTOZOCINE,
PROPOXYPHENE,DEXTROPROPOXYPHENE -
- REFER DEXTROPROPOXYPHENE
Adverse Reaction:
WARNINGS-
Deaths have been reported during initiation of methadone treatment for Opiod
dependence. In some cases drug interactions with other drugs both lieit and
ilieit have been suspected. However in other cases deaths appear to have
occured because of respiratory or cardiac effects of methadone and too-rapid
titration without appreciation of accumulation of methadone over time.
It is critical to understand the pharmocokinetics of methadone and to excercise
vigilance during initiation and dose titration. Patients must also be strongly
cautioned against self-medication with CNS depressants during initiation of
methadone treatment.
Respiratory depression is chief hazard asociated with methadone administration.
Methadones peak respiratory depressant effects typically occur later and persist
longer than than its peak analgesic effects ,particularly in the early dosing period.
These characteristics can contribute to the case of iatrogenic overdose,particularly
during the treatment initiation and dose titration
Ref- Drug Facts and Comparisons (2010)
Dosages/ Overdosage Etc:
Indication-
For the relief of severe pain, detoxification and temporary maintenance
treatment of narcotic addition .
Methodone is ineffective for the relief of general anxiety
Dosage-
Pain- Adults- 2.5 to 10mg IM.SC or orally every 3 to 4 hours as necesary.
Individulalize the dose.
For exceptionally severe pain, or in those tolerant of narcotic analgesia,
it may be necessary to exceed the usual recommended dosage.
Injection of IM is preferred for repeated dosage.
SC may cause local irritation.
Children- Not for analgesia use, due to insufficient documentation
Detoxification treatment- should not exceed 21 days and may not be repeated
earlier than 4 weeks after completion of the preceeding dose.
Oral administration is preferred . However, if patient is unable to ingest oral
methadone the parentral form may be used.
Initially 15 to 20mg will often supress withdrawal symptoms. Provide additional
methadone if withdrwal symptoms are not supressed or if symptoms reappear.
When patients are physically dependent on high doses. 40mg/day in single or
divided doses is usually adequate an stabilizing dose.
Continue stabilization for 2 to 3 days, then gradually decrease the dose on a daily
basis or at 2 day intervals.
Provide a sufficient amount to keep withdrawal symptoms at a tolerable level.
In hospitalized patients a daily reduction of 20% of total daily dose may be tolerated
Maintenance treatment- Individualize dosage. Initial dosage should control abstinence
symptoms following narcotic withdrawal, but should not cause sedation , respiratory
depression or other effects of acute intoxification.
If patients have been heavy heroin users up to admission day, they may be given
20mg methadone 4 to 8 hours after heroin is stopped or 40mg in a single dose.
If they enter treatment with little or no narcotic tolerance, initial dosage may be
halved. When in doubt use smaller dose. If abstinence symptoms are depressing,
give additional 10mg doses as needed.
Adjust dosage as tolerated and required, upto 120mg/day
Methadone Regulation Regulations- Maintenace therapy-
If used to treat heroin dependence for > 3 weeks, the procedure passes from
treatment acute withdrawal syndrome(detoxification) to maintenance therapy
Maintenance may be undertaken only by approved methadone programs,
This does not preclude maintenance of addict hospitalized for other conditions.
Distribution- To treat additiction in detoxification or maintenance programs,
methadone may be dispensed only by pharmacies and maintenance programs
approved by FDA and designated state authorities according to treatment
requirements stipulated in Federal Methadone Regulations (21 CFR 291.505)
Failure to abide by these regulations may result in criminal prosecution,
seizure of drug, revocation of program approval and injuction precluding
program operation.
Methadone used as an analgesic, may be dispensed in any licensed pharmacy
