LIORESAL TABLET 10 MG

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

BACLOFEN

Available from:

NOVARTIS INDONESIA - Indonesia

INN (International Name):

BACLOFEN

Dosage:

10 MG

Pharmaceutical form:

TABLET

Units in package:

DUS, 5 BLISTER @ 10 TABLET

Manufactured by:

NOVARTIS INDONESIA - Indonesia

Authorization date:

2015-03-03

Summary of Product characteristics

1
LIORESAL

Antispastic with spinal site of attack; gamma-aminobutytric acid
(GABA) derivatives.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Tablet
ACTIVE SUBSTANCE
Baclofen
EXCIPIENTS
Aerosil 200 – Colloidal silicon dioxide, magnesium stearate,
polyvinylpyrollidone,
microcrystalline cellulose (Avicel PH101, Avicel PH 102), corn starch,
purified water.
INDICATIONS
ADULTS
Treatment of spasticity of the skeletal muscles in multiple sclerosis.
Treatment of spastic conditions occur in spinal-cord diseases of
infections, degenerative,
traumatic, neoplastic, or unknown origin: e.g. spastic spinal
paralysis, amyotrophic
lateral sclerosis, syringo-myelia, transverse myelitis, traumatic
paraplegia or paraparesis,
and compression of the spinal cord; muscle spasm of cerebral origin,
especially where
due to infantile cerebral palsy, as well as following cerebrovascular
accidents or in the
presence of neoplastic or degenerative brain disease.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Before starting treatment with Lioresal it is prudent to realistically
assess the overall
extent of clinical improvement that the patient may be expected to
achieve. Careful
titration of dosage is essential (particularly in the elderly) until
the patient is stabilized.
If too high a dose is initiated or if the dosage is increased too
rapidly side effects may
occur. This is particularly relevant if the patients is ambulant in
order to minimize muscle
weakness in the unaffected limbs or where spasticity is necessary for
support.
ADULTS
The following gradually increasing dosage regimen is suggested, but
should be adjusted
to suit individual patient requirements.
5 mg three times a day for three days
10 mg three times a day for three days
15 mg three times a day for three days
20 mg three times a day for three days
Satisfactory control of symptoms is usually obtained with doses of up
to 60 mg daily,
but a careful adjustment is often necessary to meet the requirements
of each individual
patient. The dose may be increased slowly if req