Naltrexone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Naltrexone hydrochloride 50mg equivalent to 45.2 mg Naltrexone

Available from:

Max Health Limited

Dosage:

50 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Naltrexone hydrochloride 50mg equivalent to 45.2 mg Naltrexone Excipient: Cellactose 80 Colloidal silicon dioxide Crospovidone Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry beige 31F27245

Prescription type:

Prescription

Therapeutic indications:

Naltrexone is indicated for use within a comprehensive treatment programme for alcohol dependence.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C. Keep the tablets stored in the original carton until use.

Authorization date:

2020-03-04

Summary of Product characteristics

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1.
NAME OF THE MEDICINE
Naltrexone 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg of naltrexone hydrochloride.
Excipients with known effect: Lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Naltrexone is presented as beige, film-coated, capsule-shaped tablets,
with a score on each
side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naltrexone is indicated for use within a comprehensive treatment
programme for alcohol
dependence.
Naltrexone is also indicated as adjunctive therapy in the maintenance
of formally opioid-
dependent patients who have ceased the use of opioids such as
diamorphine (heroin) and
morphine.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy may only be initiated by a specialist with experience in
alcohol and drug dependence
management.
Do not attempt treatment with naltrexone hydrochloride unless, in the
medical judgement of
the prescribing physician, there is no reasonable possibility of
opioid use within the past 7-10
days. If there is any question of occult opioid dependence, perform a
NARCAN challenge test
and do not initiate naltrexone hydrochloride therapy until the NARCAN
challenge is negative.
TREATMENT OF ALCOHOL DEPENDENCE
A dose of 50 mg once daily is recommended for most patients. The
placebo-controlled studies
that demonstrated the efficacy of naltrexone hydrochloride as an
adjunctive treatment of
alcoholism used a dose regimen of naltrexone hydrochloride 50 mg once
daily for up to 12
weeks. Other dose regimens or durations of therapy were not evaluated
in these trials.
A patient is a candidate for treatment with naltrexone hydrochloride
if:
•
the patient is willing to take a medicine to help with alcohol
dependence
•
the patients is opioid free for 7-10 days
•
the patient does not have severe or active liver or kidney problems
(typical guidelines
suggest liver function tests no greate