Baclofen Tablets

Pharmacological action Baclofen tablets are a muscle relaxant that acts on the spinal cord. Baclofen inhibits the release of excitatory amino acids glutamate and aspartate by stimulating GABAB receptors, thereby inhibiting monosynaptic and polysynaptic reflexes in the spinal cord. Baclofen has no effect on impulse transmission between nerves and muscles and has analgesic effects. For neurological diseases related to skeletal muscle spasms, the clinical effects of baclofen are mainly manifested in the relief of reflex muscle spasms, as well as significant relief of painful spasms, automatisms and clonus. Baclofen can effectively improve mobility, facilitate daily life, catheterization and physical therapy. The indirect effects of taking baclofen also include: preventing and promoting the healing of bedsores, improving sleep conditions (due to the elimination of painful muscle spasms), and improving the function of bladder and anal sphincter. This can significantly improve the patient's quality of life. Baclofen can stimulate the secretion of gastric acid. Preclinical safety data The test data so far show that baclofen is not carcinogenic or mutagenic. In female rats treated with baclofen for two years, a dose-related increase in the incidence of ovarian cysts and enlarged and/or hemorrhagic adrenal glands was observed after the highest doses (50-100 mg/kg).

Active ingredient: Baclofen. Chemical name: β-(aminomethyl)-4-chlorophenylpropionic acid Molecular weight: C10H12CINO2

This product is white or slightly yellowish tablets.

Proven indications: Severe but reversible muscle spasticity caused by multiple sclerosis. Other possible indications: Spinal cord spasticity caused by infection, degeneration, trauma or tumor.

Recommended dosage: Normally, the optimal daily dose of baclofen for adults is 30-75 mg, taken in 3-5 divided doses. In individual cases, the daily dose can be as high as 100 mg/day. The starting dose for children is generally 0.3 mg/kg/day. In special cases, stroke patients usually have poor tolerance to baclofen, so special attention needs to be paid to such patients. Conventional/maximum dose (single and daily)/dosage interval: The initial dose for adult treatment should be 5 mg each time, three times a day. Then, based on the patient's response, the single dose can be gradually increased by 5 mg each time, with an interval of three days. In general, the average daily dose is 30-75 mg, and in individual cases, the daily dose can be as high as 100 mg/day as needed. For children, please refer to [Pediatric Use] for special dosage instructions during treatment.

Adverse reactions (Table 1) are ranked according to frequency of occurrence. First are very common adverse reactions, with the corresponding classification criteria: very common (≥1/10), common (≥1/100, <1/10). Uncommon (≥1/1,000, [1/100), rare (≥1/10,000, <1/1,000), very rare ([1/10,000), including case reports. Adverse reactions mainly occur in the initial stage of medication (e.g., sedation, drowsiness), and may occur if the dose is increased too quickly or a large dose is taken. Adverse reactions are mostly temporary and can be alleviated or eliminated by reducing the dose. Severe adverse reactions that require discontinuation of medication rarely occur. Adverse reactions may be more severe in patients with a history of mental illness or cerebrovascular disease (such as stroke), or in the elderly. It can lower the threshold for seizures and may cause seizures, especially in patients with epilepsy. As an abnormal reaction to medication, muscle spasms may worsen in some patients. (See the inner package insert for details)

Patients with known hypersensitivity to baclofen or any other excipients.

Precautions for children: In general, treatment should be started at a very low dose, such as 0.3 mg/kg/day, divided into 2-4 doses. Therefore, this product is not suitable for children weighing less than 33 kg. In about 1-2 weeks, the dosage is increased cautiously. Until the individual treatment requirements of the child are met, the daily dose for maintenance treatment is 0.75-2 mg/kg body weight. The maximum daily dose for children under 8 years old should not exceed 40 mg/day. For children over 8 years old, the maximum daily dose can reach 60 mg/day. Precautions for pregnancy and lactation: In rats that took baclofen orally at 13 times the recommended human dose (calculated in mg/kg), an increased incidence of fetal umbilical hernia (abdominal wall hernia) was found. However, this abnormality did not occur in experiments with mice or rabbits. There are currently no adequate and well-matched controlled studies on the use of this drug in pregnant women. Baclofen can cross the placental barrier and should not be used in pregnant women unless the benefits of the medication outweigh the possible risks to the fetus. For lactating women who take baclofen at clinical doses, a small amount of baclofen can enter breast milk, but the dose is too small to have any adverse effects on the baby. Elderly precautions: See [Usage and Dosage] and other items, or follow the doctor's advice.

When levofloxacin is used simultaneously with other drugs that act on the central nervous system (containing opiates or alcohol), a stronger sedative effect may occur (see [Precautions]). The risk of respiratory depression will also increase accordingly. Respiratory and cardiovascular function need to be closely monitored, especially for patients with cardiopulmonary disease or respiratory muscle weakness. Concomitant use of tricyclic antidepressants may enhance the effects of baclofen. Causes a significant decrease in muscle tension. Because use with antihypertensive agents may lead to a drop in blood pressure, the dosage of antihypertensive agents must be adjusted accordingly. One patient who used morphine and intrathecal baclofen simultaneously developed hypotension. When Parkinson's patients take baclofen and levodopa simultaneously, there have been reports of confusion, hallucinations, headaches, nausea, and other symptoms.

Keep away from light and store in a sealed container.

10 mg x 30 tablets

48 months