Indications
Skelofen is indicated in-
spasticity resulting from
multiple sclerosis
flexor spasms and concomitant
pain, clonus and muscular rigidity
skeletal muscle spasm resulting
from rheumatic disorders
spinal cord injuries and other
spinal cord diseases
cerebrovascular accidents or
neoplastic or degenerative brain disease
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Baclofen inhibits both
monosynaptic and polysynaptic reflexes at the spinal level by stimulating the
GABAB receptors, which inhibits the release of glutamate and aspartate. It may
also act at intraspinal sites producing CNS depression. Baclofen also exerts an
antinociceptive effect.
Dosage & Administration
Adult & children over 10
years: 5 mg 3 times daily, preferably with or after food, gradually increased;
max. 100 mg daily.
Children <10 years: Treatment is
usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according
to requirement. Daily maintenance dose-
12 month-2 years: 10-20 mg (10-20
ml)
2 years-6 years: 20-30 mg (20-30
ml)
6 years-10 years: 30-60 mg (30-60
ml)
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Increased sedation may occur if
Skelofen is taken with agents acting on the central nervous system, alcohol or
synthetic opiates. The risk of respiratory depression is also increased.
Combined treatment with Skelofen
and antihypertensives is likely to increase the fall in blood pressure;
therefore the dosage of antihypertensive medication should be adjusted
accordingly.
The concomitant administration of
Skelofen and tricyclic antidepressants may potentiate the pharmacological
effects of Skelofen resulting in pronounced muscular hypotonia.
In patients with Parkinsons
disease receiving treatment with Skelofen and levodopa and carbidopa, there
have been several reports of mental confusion, hallucinations, headaches,
nausea and agitation.
The concurrent use of MAO
inhibitors and Skelofen may result in increased CNS depressant effects. Caution
is advised and the dosage of one or both agents should be adjusted accordingly.
Caution should be exercised when
administering Skelofen and magnesium sulphate or other neuromuscular blocking
agents since a synergistic effect may theoretically occur.
Contraindications
Baclofen is contraindicated in
patients with hypersensitivity to any component of this product.
Side Effects
The most common adverse reactions
associated with Skelofen are transient drowsiness, daytime sedation, dizziness,
weakness and fatigue.
Central Nervous System: Headache
(<10%), insomnia (<10%), and rarely, euphoria, excitement, depression,
confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus,
slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia,
blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria,
epileptic seizures, respiratory depression.
Cardiovascular: Hypotension
(<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
Gastrointestinal: Nausea
(approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia,
taste disorder, abdominal pain, vomiting, diarrhoea and positive test for
occult blood in stool.
Genitourinary: Urinary frequency
(<10%) and rarely, enuresis, urinary retention, dysuria, impotence,
inability to ejaculate, nocturia, haematuria.
Other: Instances of rash,
pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion,
visual disturbances, hepatic function disorders and paradoxical increase in
spasticity. Muscular hypotonia of a degree sufficient to make walking or
movement difficult may occur but is usually relieved by readjusting the dosage.
For this purpose, the daytime dosage may be reduced and the evening dosage
increased.
Pregnancy & Lactation
Pregnancy category B3. Safe use
of Baclofen during pregnancy has not been established. Baclofen crosses the
placental barrier. Baclofen should only be administered to pregnant women when
in the judgement of the physician concludes that the potential benefits
outweigh the possible hazards. Baclofen is excreted in breast milk however
evidence to date suggests that the quantities are so small that no undesirable
effects on the infant would be expected.
Precautions & Warnings
Lower doses (approximately 5 mg
per day) should be used for patients with impaired renal function or those
undergoing chronic haemodialysis.
Patients suffering not only from
spasticity but also from psychotic disorders, schizophrenia, depressive or
manic disorders or confusional states should be treated cautiously and closely
monitored as exacerbations of these disorders may occur.
In patients with epilepsy and
muscle spasticity, Skelofen may be used under appropriate supervision and
provided that adequate anticonvulsive therapy is continued. Lowering of the
convulsion threshold may occur and seizures have been reported after the
cessation of Skelofen therapy or with overdose.
Skelofen should be used with
caution in patients with or with a history of peptic ulcers, cerebrovascular
diseases, or hepatic, renal or respiratory failure.
Careful monitoring of respiratory
and cardiovascular function is essential especially in patients with
cardiopulmonary disease and respiratory muscle weakness.
During treatment with Skelofen,
neurogenic disturbances affecting emptying of the bladder may improve. However
in patients with preexisting sphincter hypertonia, acute retention of urine may
occur. Skelofen should be used with caution in these circumstances.
Skelofen has not significantly
benefited patients with stroke. These patients have also shown poor tolerance
to the medicine.
Appropriate laboratory tests
should be performed periodically in patients with hepatic diseases or diabetes
mellitus to ensure that no medicine induced changes in these underlying
diseases have occurred.
Overdose Effects
Gastric lavage is important in
case of severe overdose.
Therapeutic Class
Centrally acting Skeletal Muscle
Relaxants
Storage Conditions
Keep below 30°C temperature, away
from light & moisture. Keep out of the reach of children.
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