Methadone Hydrochloride concentrate for oral solution

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

methadone (methadone hydrochloride)

Saadav alates:

Rusan Pharma Ltd.

ATC kood:

N07BC02

INN (Rahvusvaheline Nimetus):

methadone (methadone hydrochloride)

Annus:

25mg/ml

Ravimvorm:

concentrate for oral solution

Ühikuid pakis:

150ml glass bottle

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2016-08-23

Toote omadused

4.
Clinical
particulars
4.1 Therapeutic
indications
For
use in the
treatment
of
opioid
drug
addiction
(as
a
narcotic
abstinence
syndrome
suppressant)
4.2 Posology
and method of
administration
For oral
administration only.
This product
may be used with a diluent.
Dosage Recommendations:
,
Adults:
Initially 10-20mg per
day,
increasing by 10-20mg per
day until
there are no signs of
withdrawal
or intoxication.
The usual
dose is 40-60mg per day.
The dose is adjusted according
to the degree of dependence with the aim of gradual
reduction.
Elderly:
In the case of
elderly or
ill
patients repeated doses should only be given with extreme
caution.
Children:
Not recommended for children.
This product is intended to be used with a diluent.
4.3 Contra indications
Respiratory depression,
obstructive airway disease Use during an acute asthma attack is not
recommended.
Concurrent
administration
with
MAO inhibitors
or
within
two
weeks
of
discontinuation
of
treatment
with them.
Patients dependent
on non opioid drugs.
Use during labour
is not
recommended,
the prolonged duration of
action increases the risk of
neonatal
depression.
Methadone is not suitable for children.
Known hypersensitivity to hydroxybenzoates or methadone.
Raised intracranial
pressure or head injury.
Phaeochromocytoma.
Risk of paralytic ileus (including drug induced gastrOintestinal
hypotonia).
4.4 Special
warnings
and precautions
for
use
Caution should be exercised in patients with hepatic dysfunction or
renal
dysfunction.
In the case of elderly or ill
patients,
repeated doses should only be given with extreme caution.
Add ictionltolera nee/dependence
Methadone is a drug of
addiction
and is controlled under
the
Misuse of
Drugs Act
1971
(Schedule 2).
It
has a long half-life and can therefore accumulate.
A single dose which will
relieve symptoms may,
if repeated on a daily basis, lead to accumulation and possible
death.-
Tolerance and dependence may occur as with morphine.
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Methadone can produce drowsiness
and re