Neurological

BACLOTAS-10 TAB

Prescription Required

SALT COMPOSITION

TYPE

TABLET

STORAGE

Store BACLOTAS-10 TAB below 30°C in a cool, dry place, protected from direct sunlight and moisture. Keep out of reach of children and pets. Do not use after the expiry date printed on the pack.

PRODUCT INTRODUCTION

BACLOTAS-10 TAB, containing Baclofen 10mg, is a highly effective medication designed to alleviate muscle spasticity resulting from various neurological conditions. This medication is a central nervous system depressant that works by relaxing muscles, thereby reducing stiffness, pain, and improving muscle movement. It is widely prescribed in India for patients suffering from conditions like multiple sclerosis, spinal cord injuries, and cerebral palsy, where involuntary muscle spasms significantly impair daily life. By offering relief from debilitating muscle rigidity, BACLOTAS-10 TAB helps patients regain better control over their movements and enhances their overall quality of life. Always consult a healthcare professional for proper diagnosis and dosage.

Uses of BACLOTAS-10 TAB

BACLOTAS-10 TAB is primarily used to treat muscle spasticity caused by a range of neurological disorders.

Multiple Sclerosis (MS)
It is used to relieve the muscle spasms, cramping, and stiffness associated with multiple sclerosis. By reducing spasticity, BACLOTAS-10 TAB helps improve mobility and comfort for individuals living with MS, making daily activities easier to perform. It targets the involuntary muscle contractions that are common in this progressive neurological condition.
Spinal Cord Injuries
BACLOTAS-10 TAB is effective in managing severe spasticity that often follows spinal cord injuries. It helps in reducing the intensity and frequency of muscle spasms, which can be painful and interfere with rehabilitation efforts. This allows patients to participate more effectively in physical therapy and improves their functional independence.
Cerebral Palsy
For individuals with cerebral palsy, BACLOTAS-10 TAB can help alleviate the chronic muscle stiffness and involuntary movements. It aids in improving muscle control and reducing discomfort, which can significantly enhance the quality of life and facilitate better motor development and daily functioning in both children and adults with cerebral palsy.

Side Effects of BACLOTAS-10 TAB

Like all medications, BACLOTAS-10 TAB can cause side effects, although not everybody gets them. Most side effects are mild to moderate and often diminish with continued use.

Common side effects

Drowsiness
Dizziness
Nausea
Weakness
Headache

Less common or rare side effects may occur and require immediate medical attention if experienced:

Seizures
Hallucinations
Confusion

If any side effect persists or worsens, or if you experience any severe reactions, consult your doctor immediately. Do not stop taking the medication abruptly without medical advice.

How to use BACLOTAS-10 TAB

Adults:
Typically, treatment is initiated with a low dose, such as 5mg three times daily, and gradually increased over several weeks based on patient response and tolerability. The usual maintenance dose ranges from 30mg to 75mg daily, divided into 3-4 doses. Do not exceed 100mg per day. It should be taken with food or milk to minimize gastrointestinal upset. Always follow your doctor's instructions carefully.
Children:
Dosage for children must be carefully determined by a pediatrician, starting with a very low dose and titrating upwards. The initial dose is usually 0.3mg/kg/day in 2-4 divided doses, not exceeding 10mg/day. The maximum daily dose for children aged 2-7 years is 40mg, and for children over 8 years, it is 60mg. Regular monitoring is essential.
Elderly:
Elderly patients may be more sensitive to the effects of Baclofen. A lower initial dose and slower titration are recommended to minimize side effects such as drowsiness and confusion. Close monitoring for adverse reactions is crucial, and dose adjustments should be made under medical supervision.
Missed Dose:
If you miss a dose of BACLOTAS-10 TAB, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one, as this can increase the risk of side effects.

How BACLOTAS-10 TAB works

Baclofen, the active ingredient in BACLOTAS-10 TAB, functions as a gamma-aminobutyric acid (GABA) analogue, specifically acting as an agonist at GABA-B receptors. These receptors are found throughout the central nervous system, particularly in the spinal cord. When Baclofen binds to these receptors, it inhibits the release of excitatory neurotransmitters, leading to hyperpolarization of neurons and a reduction in neuronal excitability. This action effectively dampens the excessive reflex activity that causes muscle spasticity. By modulating nerve impulses, Baclofen helps to decrease the frequency and severity of muscle spasms, allowing for improved muscle tone and reduced stiffness. The overall effect is a significant reduction in muscle rigidity and associated pain, facilitating better motor function and comfort for the patient. Its central action makes it a potent agent in managing chronic spasticity.

Precautions

Do not stop BACLOTAS-10 TAB abruptly; gradual dose reduction is necessary to avoid withdrawal symptoms.
Use with caution in patients with impaired kidney function, as dose adjustment may be required.
Patients with a history of epilepsy or psychiatric disorders should be closely monitored.
Avoid driving or operating heavy machinery until you know how the medication affects you, due to potential drowsiness.
Inform your doctor about all other medications you are taking to avoid potential drug interactions.
Use with caution in patients with peptic ulcer disease or pre-existing cerebrovascular disease.

Safety Advice

Alcohol

UNSAFE

Consumption of alcohol while taking BACLOTAS-10 TAB is unsafe. Alcohol can significantly increase the sedative effects of Baclofen, leading to severe drowsiness, dizziness, and impaired coordination. It is strongly advised to avoid alcohol entirely during treatment.

Pregnancy

CONSULT YOUR DOCTOR

BACLOTAS-10 TAB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data are available, and animal studies have shown adverse effects. Always consult your doctor to discuss the risks and benefits before taking this medication if you are pregnant or planning to conceive.

Breastfeeding

CONSULT YOUR DOCTOR

Baclofen is excreted in breast milk in small amounts. While the effects on a breastfed infant are generally considered minimal, it's crucial to consult your doctor before using BACLOTAS-10 TAB if you are breastfeeding. Your doctor will weigh the potential risks to the infant against the benefits of treatment for the mother.

Driving

UNSAFE

BACLOTAS-10 TAB can cause drowsiness, dizziness, and impaired concentration, especially at the start of treatment or after a dose increase. It is unsafe to drive or operate heavy machinery until you are certain how this medication affects your ability to perform such tasks safely. Exercise extreme caution.

Kidney

CAUTION

BACLOTAS-10 TAB should be used with caution in patients with kidney disease. Baclofen is primarily excreted unchanged by the kidneys, and impaired renal function can lead to accumulation and increased risk of side effects. Dose adjustments are often necessary under strict medical supervision.

Liver

CAUTION

While Baclofen is minimally metabolized by the liver, caution is advised in patients with severe liver impairment. Regular monitoring of liver function tests may be recommended by your doctor. Always inform your healthcare provider about any pre-existing liver conditions before starting treatment.

Fact Box

Chemical Class

GABA derivative

Habit Forming

Therapeutic Class

Skeletal Muscle Relaxant

Action Class

Centrally acting GABA-B receptor agonist

Frequently asked questions by patients

Q: How long does it take for BACLOTAS-10 TAB to start working?

A: The effects of BACLOTAS-10 TAB typically begin within 1 to 2 hours after taking a dose. However, it may take several days to weeks of consistent use and dose titration to achieve the full therapeutic benefits and significant reduction in muscle spasticity.

Q: Can I stop taking BACLOTAS-10 TAB if I feel better?

A: No, you should never stop taking BACLOTAS-10 TAB abruptly, even if your symptoms improve. Abrupt discontinuation can lead to severe withdrawal symptoms, including hallucinations, seizures, and rebound spasticity. Always consult your doctor, who will guide you on a gradual dose reduction schedule.

Q: Is BACLOTAS-10 TAB addictive?

A: BACLOTAS-10 TAB is not considered habit-forming in the same way as opioids or benzodiazepines. However, physical dependence can develop with prolonged use, leading to withdrawal symptoms if the medication is stopped suddenly. Therefore, it should always be tapered off under medical supervision.

Q: What should I do if I experience severe drowsiness?

A: If you experience severe drowsiness while taking BACLOTAS-10 TAB, avoid driving or operating heavy machinery. Inform your doctor, as your dosage may need to be adjusted. Taking the medication with food or at bedtime might help manage this side effect.

Frequently Asked Questions

Q: What is BACLOTAS-10 TAB used for?

BACLOTAS-10 TAB is primarily used to treat muscle spasticity, a condition characterized by muscle stiffness, tightness, and involuntary spasms. It is commonly prescribed for spasticity associated with neurological conditions such as multiple sclerosis, spinal cord injuries, and certain types of cerebral palsy. Its action helps to improve muscle movement and reduce associated pain.

Q: How should I take BACLOTAS-10 TAB?

BACLOTAS-10 TAB should be taken orally, usually with food or milk to minimize stomach upset. The dosage is highly individualized and typically starts low, gradually increasing under medical supervision. It is crucial to follow your doctor's exact instructions regarding dose and frequency and not to exceed the prescribed amount.

Q: Are there any specific dietary restrictions while on this medication?

There are no specific dietary restrictions for BACLOTAS-10 TAB. However, it is generally recommended to take it with food or milk to reduce the likelihood of gastrointestinal discomfort. Avoiding alcohol is crucial due to increased sedative effects. Maintain a balanced diet as advised by your healthcare provider.

Q: Can BACLOTAS-10 TAB interact with other medications?

Yes, BACLOTAS-10 TAB can interact with other medications. It can enhance the sedative effects of other CNS depressants like benzodiazepines, opioids, and antihistamines. It may also interact with antihypertensive drugs, potentially causing a drop in blood pressure. Always inform your doctor about all prescription, non-prescription, and herbal supplements you are taking to prevent adverse interactions.

Q: What are the long-term effects of using BACLOTAS-10 TAB?

Long-term use of BACLOTAS-10 TAB is generally well-tolerated for managing chronic spasticity. However, physical dependence can develop, necessitating gradual withdrawal to avoid adverse effects. Regular monitoring by a healthcare professional is important to assess its continued efficacy and manage any potential long-term side effects or complications, especially concerning kidney function.