Baclof Od 30 Mg Tablet (10 Tab)

BACLOF OD 30 MG TABLET (10 TAB) by INTAS PHARMACEUTICALS LTD.

BACLOF OD 30 MG TABLET is a muscle relaxant prescribed for the symptomatic treatment of various conditions causing muscle spasticity.

• Name

  • Brand Name: BACLOF OD 30 MG TABLET
  • Common Name: Baclofen (extended-release, ER)
  • Manufacturer: Intas Pharmaceuticals Ltd.

• Composition

  • Each extended-release (ER) tablet contains 30 mg of Baclofen as the active ingredient.

• Uses BACLOF OD 30 MG TABLET is primarily used to reduce and relieve muscle spasms, cramping, rigidity, tension, and tightness (spasticity) that can result from various medical conditions, including:

  • Multiple sclerosis
  • Spinal cord injuries or diseases
  • Stroke
  • Cerebral palsy
  • Other nerve-related disorders or injuries to the brain or spine

• Dosage and Administration BACLOF OD 30 MG TABLET is an extended-release formulation and should be taken as directed by a healthcare professional.

  • Initial dosage for Baclofen ER may begin with 20 mg once daily. The dose can be gradually increased every 3 days based on patient tolerance and desired effect.
  • The maximum dose for oral baclofen is typically 80 mg per day, though for the OD formulation, it should not exceed 100 mg once daily.
  • It can be taken with or after food or with a little liquid to avoid stomach upset.
  • Do not break, crush, or chew the extended-release tablet; it should be swallowed whole.
  • It is crucial not to suddenly stop taking this medicine, especially if taken for a long time. The dosage should be slowly decreased under medical supervision to avoid severe withdrawal symptoms.

• Side Effects

  • Common Side Effects: Drowsiness, dizziness, weakness, tiredness, headache, nausea, constipation, difficulty falling asleep or staying asleep, frequent urination, dry mouth, blurred vision, rapid eye movements, excessive sweating, or a mild rash.
  • Serious Side Effects (Report immediately to your doctor): Allergic reactions (skin rash, itching, hives, swelling of the face, lips, tongue, or throat), CNS depression (slow or shallow breathing, shortness of breath, confusion, trouble staying awake), hallucinations, seizures, high fever, rhabdomyolysis (if stopped suddenly), yellowing of the eyes or skin (liver problems), or an increase in muscle spasms.

• Precautions

  • Abrupt Discontinuation: Never stop taking BACLOF OD suddenly. Abrupt discontinuation can lead to serious adverse reactions, including seizures, high fever, confusion, muscle stiffness, hallucinations, and even death. Doses must be gradually reduced under medical guidance.
  • Central Nervous System Effects: This medicine may cause dizziness, drowsiness, vision problems, clumsiness, or unsteadiness. Patients should not drive, operate machinery, or engage in activities requiring alertness until they know how the medication affects them.
  • Alcohol and CNS Depressants: Avoid consuming alcohol and other central nervous system depressants (such as antihistamines, sedatives, tranquilizers, or prescription pain medicines) as they can enhance the sedative effects of Baclofen, leading to increased drowsiness and dizziness.
  • Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Baclofen may cause fetal harm based on animal data and is present in human milk. Neonatal withdrawal symptoms can occur if the medication is abruptly discontinued before delivery.
  • Underlying Medical Conditions: Use with caution in patients with a history of stroke, kidney disease, epilepsy or other seizure disorders, mental health conditions (e.g., psychotic disorders, schizophrenia), Parkinson's disease, diabetes, or autonomic dysreflexia. Elderly patients may be more sensitive to the effects of this medicine.
  • Allergies: Contraindicated in individuals with known hypersensitivity to baclofen or any components of the product.

• Storage

  • Store BACLOF OD 30 MG TABLET in its closed container at room temperature.
  • Keep it away from excessive heat, moisture, and direct light.
  • Specifically, store below 25°C.
  • Keep out of the reach of children.
  • Do not keep outdated medicine or medicine no longer needed.

BACLOF OD 30 MG TABLET is a muscle relaxant containing Baclofen as its active ingredient. It is primarily used to relieve muscle spasms, stiffness, and pain caused by various neurological conditions.

What is BACLOF OD 30 MG TABLET used for?

BACLOF OD 30 MG TABLET is an anti-spastic agent used to reduce and relieve muscle spasms, rigidity, tension, and stiffness (spasticity). These symptoms often occur due to conditions affecting the brain and spinal cord, such as multiple sclerosis, cerebral palsy, stroke, spinal cord injury, and other nerve-related disorders.

How does BACLOF OD 30 MG TABLET work?

This medicine works as a muscle relaxant by acting on the brain and spinal cord. It helps to relax tight or stiff muscles by inhibiting reflexes at the spinal level and reducing the activity of certain nerves that control muscle contraction and relaxation. This action helps to relieve pain and improve muscle movement.

What is the usual dosage for BACLOF OD 30 MG TABLET?

BACLOF OD 30 MG TABLET is an extended-release (once daily) formulation. The initial dosage for extended-release Baclofen typically begins with a 20 mg tablet administered once daily. The dose can be gradually increased by your doctor over periods of every three days until the optimal effect is achieved and well-tolerated. The maximum daily dose should not exceed 100 mg once daily. It should be swallowed whole with a glass of water, with or after food, and not cut, broken, or chewed.

What are the possible side effects of BACLOF OD 30 MG TABLET?

Common side effects include drowsiness, dizziness, weakness, fatigue, headache, nausea, constipation, and dry mouth. Some individuals might experience insomnia, slurred speech, confusion, or a rash. BACLOF OD 30 MG TABLET can also affect vision and may cause excessive daytime urination, a burning sensation during urination, or loss of bladder control. In rare cases, more serious side effects can occur, such as severe muscle stiffness, fast heartbeat, mood changes, mental disorders, fever, hallucinations, or seizures. If you experience any severe or persistent side effects, or any concerning symptoms like thoughts of harming yourself, seek immediate medical attention.

Is BACLOF OD 30 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: BACLOF OD 30 MG TABLET is generally not recommended during pregnancy unless absolutely necessary and prescribed by a doctor, as it may cause fetal harm and neonatal withdrawal syndrome in newborns based on animal data. The potential benefits and risks must be thoroughly discussed with your healthcare provider. Breastfeeding: Baclofen, the active ingredient, is known to pass into breast milk in small amounts. While some sources suggest it may not harm the baby in normal doses, it is crucial to consult your doctor before using this medicine while breastfeeding to weigh the potential benefits against the risks.

Can BACLOF OD 30 MG TABLET be taken with other medications?

It is important to inform your doctor about all prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking.

• Alcohol: Avoid consuming alcohol, as it can significantly increase drowsiness, dizziness, and other central nervous system effects.
• Other Medications: Use with caution when taken with other muscle relaxants (like tizanidine), opioid pain medications, benzodiazepines, lithium, antidepressants (such as amitriptyline), medicines for high blood pressure, NSAIDs (like ibuprofen), and levodopa (for Parkinson's disease). Combining Baclof OD with opioids can increase the risk of serious side effects, including breathing difficulties. Acetaminophen (Tylenol) may be a safer pain reliever option.
• Lab Tests: This medicine may affect the results of certain blood tests, including alkaline phosphatase, AST, glucose, and bilirubin.

What precautions should be taken with BACLOF OD 30 MG TABLET?

Do not stop taking BACLOF OD 30 MG TABLET suddenly, as abrupt discontinuation can lead to severe withdrawal symptoms such as increased muscle stiffness, seizures, hallucinations, high fever, confusion, and changes in mood or behavior. Your doctor will advise on gradually reducing the dose if it needs to be stopped. Due to its potential to cause drowsiness, dizziness, and vision problems, avoid driving or operating heavy machinery until you know how the medication affects you. Inform your doctor if you have kidney or liver problems, mental health conditions (like psychosis or schizophrenia), lung disease, diabetes, difficulty urinating, high blood pressure, Parkinson's disease, a history of stroke, epilepsy, or a history of drug abuse. BACLOF OD 30 MG TABLET is not approved for children under 12 years of age or those weighing less than 33 kg.

What happens if a dose is missed?

If you miss a dose of BACLOF OD 30 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., less than 2 hours until the next dose), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this can increase the risk of side effects. Missing multiple doses can also lead to withdrawal symptoms.

How should BACLOF OD 30 MG TABLET be stored?

Store BACLOF OD 30 MG TABLET at room temperature, protected from moisture and direct light and heat. Keep it out of the reach and sight of children and pets. Do not use expired medicine and dispose of any unused medication appropriately, as advised by your pharmacist or doctor.