INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NORTON-BACLOFEN TABLETS

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

NORTON-BACLOFEN TABLETS

COMPOSITION:
Each tablet contains: 10 mg
Baclofen.

PHARMACOLOGICAL CLASSIFICATION
A 2.10 Centrally active muscle relaxants.

PHARMACOLOGICAL ACTION
NORTON-BACLOFEN is a derivative of the inhibitory neurotransmitter gama-aminobutyric acid (GABA). NORTON-BACLOFEN is useful in reducing the frequency of flexor or extensor spasms, and in reducing increased flexor tone. NORTON-BACLOFEN exerts its antispastic effects by depressing monosynaptic and polysynaptic transmission in the spinal cord. It reduces excitatory postsynaptic potentials in motoneurons in the ventral horn without affecting their membrane potential or input resistance. These effects superficially resemble those of GABA, which is released by interneutrons in the spinal cord and depolarizes the axonal terminals of primary afferent fibres. This results in presynaptic inhibition of motoneurons. NORTON-BACLOFEN does not cause depolarization of primary afferent nerve terminals.
NORTON-BACLOFEN is absorbed rapidly after oral administration and its plasma half-life is about 3 to 4 hours. It is excreted largely unchanged by the kidney.

INDICATIONS
NORTON-BACLOFEN is effective in the symptomatic treatment of spasticity caused by multiple sclerosis or other diseases of the spinal cord, such as traumatic lesions.

CONTRA-INDICATIONS
Patients with a history of epilepsy or convulsive disorders. NORTON-BACLOFEN is teratogenic in animals and should therefore not be administered to pregnant and lactating women.

WARNINGS
Extreme caution is needed if NORTON-BACLOFEN is combined with anti-hypertensive therapy because of the risk of potentiating the hypotensive effect.
The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients taking NORTON-BACLOFEN should not take charge of vehicles, or operate machinery when loss of attention may result in accidents.
Patients with stroke tolerate NORTON-BACLOFEN poorly. Withdrawal of NORTON-BACLOFEN should be gradual. Sudden withdrawal of NORTON-BACLOFEN after chronic administration may cause auditory and visual hallucinations, anxiety and tachycardia.

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be initiated with an oral dose of 5 mg, given two or three times daily. After three days the individual dose is increased to 10 mg. The maximum dosage is 20 mg four times daily. Do not exceed 80 mg daily.
ABRUPT WITHDRAWAL OF THIS MEDICINE SHOULD BE AVOIDED.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, drowsiness, confusion, dizziness, fatigue and hypotonia may occur. Other side-effects include giddiness, hypotension, euphoria, hallucinations, depression, headache, diarrhoea or constipation, tremors, insomnia, visual disturbances, allergic skin reactions, pruritus, urinary disturbances and hepatic impairment.
NORTON-BACLOFEN should be used with caution in patients in whom spasticity is used to maintain posture or increase functional capacity. NORTON-BACLOFEN should be used with caution in patients with a history of gastric and duodenal ulcer, severe psychiatric disorders, or impaired cerebrovascular system, in pulmonary insufficiency, renal impairment and in patients receiving anti-hypertensive therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Coma, respiratory depression and seizures have been reported. Convulsions occur mainly in patients with a history of epilepsy. Treatment is symptomatic and supportive.

IDENTIFICATION:
A white, flat, bevelled edge tablet embossed "BCN 10" and breakline on one side, with a twin triangle logo on the reverse.

PRESENTATION:
Securitainers containing 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
W/2.10/433

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NORTON HEALTHCARE (PTY) LIMITED
59 Greenfield Road
Greenside
2193

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26 January 1993

                Davbar

Updated on this site: November 2000
Current: September 2004
Source: Community Pharmacy

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