Bacben 10mg

Tablet
Baclofen
BENHAM pharmaceuticals

Other Strength:

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



Bacben
Presentation:
Bacben 10 : Each film coated tablet contains Baclofen BP 10 mg.
Pharmacology:
Baclofen is an effective muscle relaxant and antispastic agent with a spinal site of action. 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. Neuromuscular transmission is not affected by Baclofen. Baclofen also exerts an antinoceptive effect.

Indication:
Bacben is indicated for:
► Spasm & Spasticity
► Low Back Pain
► Prevention of Migraine
► HICCUPS
► Dysfunctional Voiding
► Trigeminal Neuralgia
► GERD
► Stiffness

Dosage & Administration:
Adults :
For the management of spasticity, the initial oral dosage of baclofen is 5 mg 3 times daily.
Oral daily dosage may be increased by 10 mg at 3-day intervals, until optimum effect is achieved (usually at dosages of 40-80 mg daily).
In patients with psychiatric or brain disorders and in geriatric patients, oral dosage should be increased more gradually.
In some patients, a smoother antispastic effect is obtained by administering the oral daily dosage in 4 divided doses.
Max:
80 mg daily.

Children : Treatment should be started at a very low dose e.g. 0.3 mg/kg per day in divided doses.
The dosage should be raised cautiously at 1-2 week intervals until it is sufficient for the child's individual needs.
The usual dosage range for maintenance therapy is 0.75 to 2 mg/kg body weight per day.
In children aged over 10 years a maximum daily dose of 2.5mg/kg body weight may be given.

Use in Pregnancy & Lactation:
Pregnancy Catagory:
Pregnancy Catagory-C The safety of baclofen in women who are or who may become pregnant has not been established. Potential benefits should be weighed against possible hazards.

Lactation:
use of baclofen in lactating women is not recommended. If therapy is considered essential, alternative feeding arrangement should be made

Hepatic Insufficiency:
In patients with mild hepatic insufficiency, liver function should be monitored.

Renal Insufficiency:
Because baclofen is excreted principally in urine as unchanged drug, it may be necessary to reduce either oral or intrathecal dosage in patients with impaired renal function.

Side Effects:
The most common side-effects include drowsiness, nausea, dizziness, lassitude, light eadedness, confusion, fatigue, Abdominal pain, Headache, muscular pain and weakness and hypotension.

Drug Interactions:
Alcohol and other CNS depressants may exacerbate the CNS effects of baclofen and should be avoided, severe aggravation of hyperkinetic symptoms may possibly occur in patients taking lithium. There may be increased weakness if baclofen is given to patients taking a tricyclic antidepressant and there may be an increased hypotensive effect if it is given to patients receiving antihypertensive therapy. Ibuprofen and other drugs that produce renal insufficiency may reduce baclofen excretion leading to toxicity.

Precaution:
Baclofen stimulates gastric acid secretion and should be used with caution in patients with a history of peptic ulcer and avoided in those with active peptic ulcer disease. Liver function should be monitored in patients with liver disease, patients with renal impairment need a reduced dose. Baclofen should be used with caution in patients with respiratory impairment. Observations of increased blood sugar concentrations suggest caution in patients with diabetes mellitus. Care is also required in the elderly, in whom adverse effects may be more common, and in patients with cerebrovascular disease (who tolerate baclofen poorly). Baclofen may cause drowsiness, patients affected should not drive or operate machinery. Abrupt withdrawal of baclofen may result in a withdrawal syndrome and exacerbation of spasticity; dosage should be reduced gradually over at least 1 to 2 weeks, or longer if symptoms occur.

Contraindication:
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pharmaceutical Precaution:
Store in a cool and dry place and away from light. Keep out of the reach of children



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