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Baclofen Tablets

Function and Efficacy

According to literature reports, baclofen is rapidly and completely absorbed in the gastrointestinal tract. After a single oral dose of 10, 20 and 30 mg baclofen, the average peak plasma concentrations were about 180, 340 and 650 mu g/ml, respectively, 0.5 to 1.5 hours later. The corresponding area under the blood concentration curve (AUCS) increased proportionally with the dose, and its values were 1140, 2350 and 3350 mu g/ml, respectively. The distribution volume of baclofen is 0.7 liters/kg. The concentration of active substances in cerebrospinal fluid is about 8.5 times lower than that in plasma. The plasma elimination half-life of baclofen is an average of 3 to 4 hours. Its serum protein binding rate is about 30%. Most of baclofen is excreted in prototype. Within 72 hours, about 75% of the intake is excreted by the kidneys, of which metabolites account for about 5%. The remainder of the intake, including 5%, is excreted in the feces as metabolites, the major metabolite being beta-(p-chlorophenyl)-gamma-hydroxybutyrate, which is pharmacologically inactive.

Ingredients

Main ingredient: Baclofen. Molecular formula: C10H12ClNO2 Molecular weight: 213.66

Name Description Content CAS NO. Manufacturer
BaclofenIngredients

Baclofen is rapidly and completely absorbed in the gastrointestinal tract. After a single oral dose of 10, 20 and 30 mg baclofen, the average peak plasma concentration is about 180, 340 and 650 mu g/ml, respectively, 0.5 to 1.5 hours later. The corresponding area under the blood concentration curve (AUCS) increases proportionally with the dose, and its values are 1140, 2350 and 3350 mu g/ml, respectively. The volume of distribution of baclofen is 0.7 liters/kg. The concentration of active substance in cerebrospinal fluid is about 8.5 times lower than that in plasma. The plasma elimination half-life of baclofen is 3 to 4 hours on average. Its serum protein binding rate is about 30%. Most of baclofen is excreted in the original form. Within 72 hours, about 75% of the intake is excreted by the kidneys, of which metabolites account for about 5%. The rest of the intake, including 5% of metabolites, is excreted in the feces, and the main metabolite is beta-(P-chlorophenyl)-gamma-hydroxybutyric acid, which is pharmacologically inactive.

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1134-47-0 30

Appearance

White or off-white tablets.

Indication

This product is used to relieve skeletal muscle spasms caused by the following diseases: 1. Multiple sclerosis, syringomyelia, spinal cord tumors, transverse myelitis, spinal cord trauma and motor neuron disease. 2. Cerebrovascular disease, cerebral palsy, meningitis, craniocerebral trauma.

Usage and Dosage

Oral adults: The recommended initial dose is 5 mg, three times a day. The dose should be gradually increased, with 5 mg added every 3 days until the required dose is reached, but the dose should be adjusted specifically based on the patient's response. Patients who are sensitive to the effects of this product should have an initial dose of 5-10 mg per day, and the dose should be increased slowly. The usual dose is 30 mg to 75 mg per day, and can reach 100-120 mg per day depending on the condition. Children: The daily dose is 0.75-2 mg/kg body weight. For children over 10 years old, the maximum daily dose can reach 2.5 mg/kg body weight. Treatment usually starts with 2.5 mg each time, 4 times a day. Increase the dose carefully approximately every 3 days until the individual needs of the child are reached. The recommended daily maintenance treatment dose is as follows: Children 12 months to 2 years old: 10-20 mg

Adverse Reactions

Adverse reactions mainly occur at the beginning of treatment, when the dose is increased too quickly, or when the dose is too large. They are generally mild and temporary symptoms. Adverse reactions may be more serious in patients with a history of mental illness, patients with cerebrovascular disease, and elderly patients. 1. Central nervous system: side effects such as daytime sedation, drowsiness, and nausea often occur at the beginning of treatment, and occasionally dry mouth, respiratory depression, dizziness, weakness, mental confusion, vertigo, vomiting, headache, and insomnia occur. 2. Neuropsychiatric manifestations occasionally or rarely reported include: euphoria, depression, paresthesia, myalgia, muscle weakness, ataxia, tremor, nystagmus, accommodation disorders, hallucinations, and nightmares. The above symptoms are often difficult to distinguish from the manifestations of the disease itself. It may lower the seizure threshold and cause seizures. Patients with epilepsy should pay special attention. 3. Gastrointestinal tract: Occasionally

Precautions

The following conditions are contraindicated: 1. Those who are allergic to this product. 2. Patients with epilepsy, Parkinson's disease, and skeletal muscle spasms caused by rheumatic diseases.

Special Population Medication

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Not allowed in the first three months of pregnancy. Use with caution in lactating women. Precautions for the elderly: Not yet clear.

Drug Interactions

1 Alcohol and other central nervous system depressants can increase the central inhibitory effect of this drug. This product combined with other drugs acting on the central nervous system or alcohol can increase the sedative effect. 2 When tricyclic antidepressants are used in combination, the effect of baclofen can be enhanced, causing obvious hypotonia. 3 The combination of baclofen and antihypertensive drugs can enhance the blood pressure lowering effect, so the dose of antihypertensive drugs should be adjusted appropriately. 4 Patients with Parkinson's disease (tremor paralysis) who receive baclofen and levodopa plus carbidopa at the same time have been reported to cause mental confusion, hallucinations and agitation.

Storage

Keep away from light and store in a sealed container.

Packaging Specification

10mg

Validity Period

24 months

Manufacturer

Yunnan Mingding Pharmaceutical Co., Ltd.

  • Founded in:

    2004-05-20
  • Address:

    Zhuangdian Pharmaceutical Park, Chuxiong High-tech Zone, Yunnan Province
  • Tax NO.:

    915323007604330528
  • Registered Funds:

    40 million yuan
  • Website:

  • Email:

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