Spakem 10mg

Tablet
Baclofen
Unimed Unihealth MFG. Ltd

Other Strength:
- Spakem 5mg

Alternative:
- Lospan 10mg
- Flexilax® 10mg
- Myorel 10mg
- Mylofen 10mg
- Liorel 10mg
- Baclomax 10mg
- Zerolent 10mg
- SMR 10mg
- Beclovan 10mg
- Baclodol 10mg
- Bacben 10mg
- Relofen 10mg
- Maxolax 10mg



Spakem
Presentation
Spakem 5 tablet: White, round-shaped tablet; each tablet contains Baclofen BP 5mg.

Spakem 10 tablet: White, shield-shaped tablet; each tablet contains Baclofen BP 10mg.

Indication
Spakem (Baclofen) is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, e.g. tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. Spakem (Baclofen) is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury. Patient selection is important when initiating Spakem
(Baclofen) therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has become stablished.

Paediatric population: Spakem (Baclofen) is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity 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. Spakem (Baclofen) is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.

Dosage and administration
Adults: Treatment should be started with a dosage of Baclofen 15 mg daily, preferably in divided doses. The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements. 5mg (One Spakem 5 tablet) three times a day for three days, 10mg (One Spakem 10 tablet) three times a day for three days, 15mg (One Spakem 5 & one Spakem 10 tablet) three times a day for three days, 20mg (Two Spakem 10 tablet) three times a day for three days. Satisfactory control of symptoms is usually obtained with doses of up to 60mg daily, but a careful adjustment is often necessary to meet the requirements of each individual patient. The dose may be increased slowly if required, but a maximum daily dose of more than 100mg is not advised unless the patient is in hospital under careful medical supervision. Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Spakem (Baclofen) only at night to counteract painful flexor spasm. Similarly a single dose given approximately 1 hour prior to performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.

Elderly: Elderly patients may be more susceptible to side effects, particularly in the early stages of introducing Spakem (Baclofen). Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response, under careful supervision.

Paediatric population (0 to < 18 years): Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses, preferably in 4 divided doses. The dosage should be cautiously raised at about 1 week intervals, until it becomes sufficient for the child’s individual requirements. The usual daily dosage for maintenance therapy ranges between 0.75 and 2mg/kg body weight. The total daily dose should not exceed a maximum of 40mg/day in children below 8 years of age. In children over 8 years of age, a maximum daily dosage of 60mg/day may be given. Spakem (Baclofen) tablets are not suitable for use in children below 33 kg body weight.

Patients with impaired renal function: In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of Spakem (Baclofen) should be selected i.e. approx. Baclofen 5mg (1 Spakem 5 tablet) daily. Spakem (Baclofen) should only be administered to end stage renal failure patients when benefit outweighs risk. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity (e.g. somnolence, lethargy).

Patients with spastic states of cerebral origin: Unwanted effects are more likely to occur in these patients. It is therefore recommended that a very cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.

Contra-indications, warnings etc.
Contra-indications: Baclofen tablet is contraindicated in patients with hypersensitivity to Baclofen and peptic ulceration.

Warnings and precautions: Psychiatric and nervous system disorders: Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson’s disease may be exacerbated by treatment with Baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.

Epilepsy: Baclofen may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained. Others: Baclofen should be used with extreme care in patients already receiving antihypertensive therapy. Baclofen should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment. Renal impairment: Signs of overdose have been observed in patients with renal impairment taking oral Baclofen at doses of more than 5mg per day. Baclofen should be used with caution in patients with renal insufficiency and should only be administered to patients with end-stage renal failure (CKD stage 5, GFR < 15mL/min) when benefit outweighs risk. Cases of Baclofen toxicity have been reported in patients with acute renal failure. Particular caution is required when combining Baclofen to drugs or medicinal products that can significantly affect renal function. Renal function should be closely monitored and Baclofen daily dosage adjusted accordingly to prevent Baclofen toxicity. Besides discontinuing treatment, unscheduled haemodialysis might be considered as a treatment alternative in patients with severe Baclofen toxicity. Haemodialysis effectively removes Baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients.

Urinary disorders: Under treatment with Baclofen neurogenic disturbances affecting emptying of the bladder may show an improvement. In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such cases.

Use in pregnancy and lactation: During pregnancy, especially in the first 3 months, Baclofen should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child. Baclofen crosses the placental barrier. One case of suspected withdrawal reaction (generalised convulsions) has been reported in a week-old infant whose mother had taken oral Baclofen 80 mg daily throughout her pregnancy. The convulsions, which were refractory to standard anticonvulsant treatment, ceased within 30 minutes of giving Baclofen to the infant. In mothers taking Baclofen in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

Side effect: Unwanted effects occur mainly at the start of treatment (e.g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication. Should nausea persist following a reduction in dosage, it is recommended that Baclofen be ingested with food or a milk beverage. In patients with a history of psychiatric illness or with cerebrovascular disorders (e.g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients. Nervous system disorders: Very common- Sedation, somnolence; Common- Respiratory depression, lassitude, exhaustion, confusional state, dizziness, headache, insomnia, euphoric mood, depression, muscular weakness, ataxia, tremor, hallucinations, nightmares, myalgia, nystagmus, dry mouth; Rare- Paraesthesia, dysarthria, dysgeusia; Very rare- Hypothermia. Eye disorders: Common- Accommodation disorders, visual disturbances. Cardiac disorders: Common- Cardiac output decreased. Vascular disorders: Common- Hypotension. Gastrointestinal disorders- Very common: Nausea; Common- Gastrointestinal disturbance, retching, vomiting, constipation, diarrhea; Rare- Abdominal pain. Hepatobiliary disorders: Rare- Hepatic function abnormal. Skin and subcutaneous tissue disorders- Common- Hyperhidrosis, rash; Not known- Urticaria. Renal and urinary

disorders- Common- Polyuria, enuresis, dysuria; Rare- Urinary retention. Reproductive system and breast disorders: Rare- Erectile dysfunction. Certain patients have shown increased spasticity as a paradoxical reaction to the medication. An undesirable degree of muscular hypotonia – making it more difficult for patients to walk or fend for themselves – may occur and can usually be relieved by re-adjusting the dosage (i.e. by reducing the doses given during the day and possibly increasing the evening dose).

Drug interactions: Where Baclofen is taken concomitantly with other drugs acting on the CNS, with synthetic opiates or with alcohol, increased sedation may occur. The risk of respiratory depression is also increased. Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness. During concurrent treatment with tricyclic antidepressants, the effect of Baclofen may be potentiated, resulting in pronounced muscular hypotonia. Since concomitant treatment with Baclofen and anti-hypertensives is likely to increase the fall in blood pressure, the dosage of antihypertensive medication should be adjusted accordingly. Hypotension has been reported in one patient receiving morphine and intrathecal Baclofen. In patients with Parkinson’s disease receiving treatment with Baclofen and levodopa plus carbidopa, there have been reports of mental confusion, hallucinations, nausea and agitation. Drugs or medicinal products that can significantly affect renal function may reduce Baclofen excretion leading to toxic effects.

Overdose: Symptoms: Prominent features are signs of central nervous depression: drowsiness, impairment of consciousness, respiratory depression, coma. Also liable to occur are: confusion, hallucinations, agitation, accommodation disorders, absent pupillary reflex, generalised muscular hypotonia, myoclonia, hyporeflexia or areflexia, convulsions, EEG changes (burst suppression pattern and triphasic waves), peripheral vasodilatation, hypotension or hypertension, bradycardia, tachycardia or cardiac arrhythmias, hypothermia, nausea, vomiting, diarrhoea, hypersalivation, elevated LDH, AST and ALP values. Patients with renal impairment can develop signs of overdose even on low doses of oral Baclofen. A deterioration in the condition may occur if various substances or drugs acting on the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) have been taken at the same time.

Treatment: No specific antidote is known. Supportive measures and symptomatic treatment should be given for complications such as hypotension, hypertension, convulsions, respiratory or cardiovascular depression. After ingestion of a potentially toxic amount, activated charcoal should be considered. In the early period after ingestion charcoal should be considered in adults who ingested more than 100mg Baclofen within 1 hour, and in children who have ingested more than 5mg/kg Baclofen within 1 hour. Gastric decontamination (e.g. gastric lavage) should be considered in individual cases, especially in the early period (60 minutes) after ingestion of a potentially life-threatening overdose. Comatose or convulsing patients should be intubated prior to the initiation of gastric decontamination. Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. Haemodialysis (sometimes unscheduled) may be useful in severe poisoning associated with renal failure. In the event of convulsions diazepam should be administered cautiously i.v.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Spakem 5 tablet: Cartons containing 30 tablets in blister pack.
Spakem 10 tablet: Cartons containing 30 tablets in blister pack.

এই পাতাটি ১৭৪ বার দেখা হয়েছে