Restobac Tablet 10 mg

Restobac Tablet 10 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Restobac Tablet 10 mg is a centrally acting skeletal muscle relaxant and an antispastic agent with a spinal site of action.

In neurological diseases associated with spasm of the skeletal muscles, the clinical effects of baclofen occur due to baclofen action on reflex muscle contractions and of significant relief from painful spasm, automatism, as well as clonus. Restobac Tablet 10 mg, when used as indicated, improves mobility, increasing levels of independence, and facilitates both passive and active physiotherapy. Restobac Tablet 10 mg also stimulates gastric acid secretion .

GABA-B receptor activation by baclofen may produce protective neurological effects. Restobac Tablet 10 mg also possesses anti-inflammatory properties that may be of interest in the study of addiction treatment . Preclinical studies have shown that GABA-B receptors have roles in memory storage and retrieval, reward, motivation, mood, as well as anxiety. Neuroimaging studies in humans indicate that baclofen produces region-specific alterations in brain activity.

Trade Name Restobac Tablet 10 mg
Availability Prescription only
Generic Baclofen
Baclofen Other Names Baclofen, Baclofène, Baclofeno, Baclofenum, DL-Baclofen
Related Drugs Botox, dantrolene, trihexyphenidyl, Artane, Lioresal, onabotulinumtoxinA, Lyvispah, Gablofen, Dantrium, Fleqsuvy
Weight 10 mg
Type Tablet
Formula C10H12ClNO2
Weight Average: 213.661
Monoisotopic: 213.05565634
Protein binding

30%

Groups Approved
Therapeutic Class Centrally acting Skeletal Muscle Relaxants
Manufacturer General Pharmaceuticals Ltd.
Available Country Bangladesh
Last Updated: October 19, 2023 at 6:27 am
Restobac Tablet 10 mg
Restobac Tablet 10 mg

Uses

Restobac Tablet 10 mg is used for:

  • Spasm.
  • Spinal cord diseases.
  • Cerebrovascular accidents or neoplastic or degenerative brain disease.
  • Muscle spasm of cerebral origin especially infantile cerebral palsy.
  • The alleviation of spasticity resulting from multiple sclerosis

Restobac Tablet 10 mg is also used to associated treatment for these conditions: Joint Pain, Soreness, Muscle, Flexor spasm, Reversible Spasticity, Severe cerebral origin Spasticity, Severe spinal cord origin Spasticity

How Restobac Tablet 10 mg works

The exact mechanism of action of baclofen is not fully understood at this time , . Many studies indicate that baclofen is a GABA-B receptor agonist , , , , . Despite this, there is no conclusive evidence that the effects of baclofen on GABA systems are involved in the production of its clinical effects .

Restobac Tablet 10 mg is an effective and widely used antispastic agent with a spinal site of action. Its mechanism of action and pharmacological properties are different from the effects of other antispastic agents. In addition, baclofen has central sites of action, shown by its adverse event profile and general CNS depressant properties . GABA-B receptors interact with signal transduction pathways and neurotransmitter systems. Restobac Tablet 10 mg exerts an antinociceptive effect. The clinical significance of this warrants further research data for clarification.

Restobac Tablet 10 mg depresses monosynaptic and polysynaptic reflex transmission, by various actions, and possibly including the stimulation of GABAβ-receptors. This stimulation results in the inhibition of excitatory neurotransmitter (glutamate and aspartate) release, which may normally contribute to pain and spasticity. Although baclofen is an analog of the inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there are no conclusive data indicating GABA systems are involved in its clinical effects .

Dosage

Restobac Tablet 10 mg dosage

Adults:

Treatment should be started with low dose and increased gradually until optimum effect is achieved. The following dosage titration schedule is suggested:

5 mg 3 times daily for 3 days,

10 mg 3 times daily for 3 days,

15 mg 3 times daily for 3 days,

20 mg 3 times daily for 3 days,

25 mg 3 times daily for 3 days.

Thereafter, additional increases may be necessary. The optimum dosage generally ranges from 30 - 80 mg daily in 3 - 4 divided doses. Daily doses of 100 - 120 mg may be given to carefully supervised patients in hospitals.

Children:

Treatment should be started at a very low dose, e.g., 0.3 mg/kg per day in divided (preferably 4) 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 2.5 mg/kg body weight may be given.

Renal Insufficiency:

Restobac Tablet 10 mg is excreted principally in urine as unchanged drug. So it may be necessary to reduce the dosage in patients with impaired renal function.

Side Effects

The most common side effects include drowsiness, nausea, dizziness, lassitude, lightheadedness, confusion, fatigue, muscular pain & weakness and hypotension.

Toxicity

LD50 after oral administration in rats: 145 mg/kg

Overdosage: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures may occur with overdosage .

Pregnancy: This drug is a pregnancy category C drug. There are no adequate and well-controlled studies that have been performed with pregnant women. Restobac Tablet 10 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus .

Excretion in breastmilk: It is unknown whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution is warranted when baclofen is administered to a nursing woman .

Precaution

Patients suffering from psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson\'s disease, should be treated cautiously with Restobac Tablet 10 mg. Restobac Tablet 10 mg 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. Restobac Tablet 10 mg 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 Restobac Tablet 10 mg poorly). Restobac Tablet 10 mg may cause drowsiness; patients affected should not drive or operate machinery. Abrupt withdrawal of Restobac Tablet 10 mg 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.

Interaction

Alcohol and other CNS depressants may exacerbate the CNS effects of Restobac Tablet 10 mg and should be avoided. There may be increased weakness if Restobac Tablet 10 mg is given to patients taking a tricyclic antidepressant and an increased hypotensive effect if it is given to patients receiving antihypertensive therapy.

Food Interaction

  • Avoid alcohol.
  • Take with food. Take with food or milk to reduce gastric irritation.

[Moderate] GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents.

Use in combination may result in additive central nervous system depression and
MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol.

Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

Volume of Distribution

Apparent volume of distribution: 59 liters .

Restobac Tablet 10 mg does not readily cross the blood-brain barrier .

Elimination Route

Rapidly and almost completely absorbed from the gastrointestinal tract. Absorption may be dose-dependent, being reduced with increased doses .

Restobac Tablet 10 mg, when introduced directly into the intrathecal space, allows for effective CSF concentrations to be achieved with resulting plasma concentrations 100 times less than concentrations occurring with oral administration , .

Half Life

Elimination half-life: Approximately 5.5 hours .

Clearance

Total systemic clearance: 180 mL/min Renal clearance: 103 mL/min

Restobac Tablet 10 mg is primarily excreted unchanged by the kidneys. It should be administered cautiously, and it may be necessary to reduce the dosage in patients with reduced renal function .

Elimination Route

Restobac Tablet 10 mg is rapidly and extensively eliminated from the body. There is significant intersubject variation in elimination rates. Restobac Tablet 10 mg is excreted mainly by the kidney as unchanged drug. Seventy to eighty (70 - 80%) of a dose is measured in the urine as unchanged drug. The remainder of the dose is excreted as unchanged drug in the feces or as metabolites in the urine and feces. Excretion is complete within 72 hours after administration .

Pregnancy & Breastfeeding use

There are no adequate and well controlled studies of Restobac Tablet 10 mg in pregnant women. So it should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Restobac Tablet 10 mg is excreted in breast milk. However, evidence suggests that the quantities are so small that no undesirable effect on the infant would be expected.

Contraindication

Restobac Tablet 10 mg is contraindicated in patients with hypersensitivity to any component of this product.

Special Warning

Renal Insufficiency: Restobac Tablet 10 mg is excreted principally in urine as unchanged drug. So it may be necessary to reduce the dosage in patients with impaired renal function.

Acute Overdose

Prominent features are signs of central nervous system depression. No specific antidote of Restobac Tablet 10 mg is known. Elimination of the agent from GI tract, artificial respiration, administration of fluid with a diuretic and dialysis should be considered.

Interaction with other Medicine

Alcohol and other CNS depressants may exacerbate the CNS effects of Restobac Tablet 10 mg and should be avoided. There may be increased weakness if Restobac Tablet 10 mg is given to patients taking a tricyclic antidepressant and an increased hypotensive effect if it is given to patients receiving antihypertensive therapy.

Storage Condition

Store in cool & dry place, away from children.

Innovators Monograph

You find simplified version here Restobac Tablet 10 mg

Restobac Tablet 10 mg contains Baclofen see full prescribing information from innovator Restobac Tablet 10 mg Monograph, Restobac Tablet 10 mg MSDS, Restobac Tablet 10 mg FDA label

FAQ

What is Restobac Tablet 10 mg used for?

Restobac Tablet 10 mg is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems, such as multiple sclerosis or certain injuries to the spine.

How safe is Restobac Tablet 10 mg?

Restobac Tablet 10 mg can cause a severe allergic reaction. Symptoms can include trouble breathing and swelling of your throat or tongue. If you have an allergic reaction, call your doctor or local poison control center right away.

How does Restobac Tablet 10 mg work?

Restobac Tablet 10 mg is believed to work by activating (or agonizing) GABA receptors, specifically the GABAB receptors.

What are the common side effects of Restobac Tablet 10 mg?

Common side effects of Restobac Tablet 10 mg are include:

  • dizziness
  • weakness
  • confusion
  • headache
  • nausea
  • constipation
  • difficulty falling asleep or staying asleep
  • tiredness
  • frequent urination

Is Restobac Tablet 10 mg safe during pregnancy?

There is no evidence that taking Restobac Tablet 10 mg during pregnancy increases the chance of having a baby with birth defects above the background risk. There are also several case reports of children that were exposed to Restobac Tablet 10 mg during pregnancy and did not have birth defects.

Is Restobac Tablet 10 mg safe during breastfeeding?

Limited information indicates that orally administered Restobac Tablet 10 mg appears in low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.

Can I drink alcohol with Restobac Tablet 10 mg?

If you, or a loved one, have been prescribed Restobac Tablet 10 mg for any condition, refrain from alcohol while taking the Restobac Tablet 10 mg.

Can I drive after taking Restobac Tablet 10 mg?

Some people may feel drowsy and/or dizzy or have problems with their eyes while they are taking Restobac Tablet 10 mg tablets. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until these effects have worn off.

How often can I take Restobac Tablet 10 mg?

It usually is taken 3 times a day at evenly spaced intervals.

What time should I take Restobac Tablet 10 mg?

Take Restobac Tablet 10 mg with a snack or just after eating a meal. Try to take your doses at the same times of day each day, as this will help you to remember to take them.

How long does Restobac Tablet 10 mg take to work?

Most people start to feel the effects within an hour of taking Restobac Tablet 10 mg.

How long does Restobac Tablet 10 mg stay in my system?

Since Restobac Tablet 10 mg is eliminated via urine, it can be detected in a urine screen for up to two days. 

How long can I take Restobac Tablet 10 mg?

The simple answer is as long as it's needed. There's no upper or lower limit on the length of treatment. I generally suggest starting with 12 months of treatment and reviewing from there. Restobac Tablet 10 mg has been used in patients for over 40 years so we know that it's safe over the long term.

What happens if I miss a dose?

Take the Restobac Tablet 10 mg as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention. Overdose symptoms may include muscle weakness, vomiting, severe dizziness or drowsiness, dilated or pinpoint pupils, shallow breathing, seizure, or loss of consciousness.

Who should not take Restobac Tablet 10 mg?

Do not use Restobac Tablet 10 mg at a time when you need muscle tone for safe balance and movement during certain activities. Do not drive or operate heavy machinery until you know how this medicine affects you.

What happen If I stop taking Restobac Tablet 10 mg?

Do not stop using baclofen suddenly, or you could have unpleasant withdrawal symptoms. Withdrawal from Restobac Tablet 10 mg can have clinical manifestations that include agitation, insomnia, confusion, delusions, hallucinations, seizures, visual changes, psychosis, dyskinesia, hyperthermia, and increased spasticity.

Can Restobac Tablet 10 mg affect my kidneys?

Restobac Tablet 10 mg a commonly prescribed muscle relaxant, is primarily excreted via the kidneys; toxicity is a potentially serious adverse outcome in patients with decreased kidney function.

Can Restobac Tablet 10 mg affects my liver?

Restobac Tablet 10 mg is safe to use in patients with liver damage and even cirrhosis because most Restobac Tablet 10 mg simply passes out in the urine and doesn't rely on liver metabolism.

*** Taking medicines without doctor's advice can cause long-term problems.
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