Drug Info
- Brand Name: Baclofen;
- Active Ingredient: Baclofen;
- Manufacturer: Polpharma, Sigma-Aldrich, Supelco.
Baclofen and its active ingredient
Baclofen is a muscle relaxant, the active ingredient of which is a derivative of gamma-aminobutyric acid (GABA). This organic compound is the most important inhibitory neurotransmitter of the human central nervous system (CNS). Thanks to this, Baclofen reduces the increased muscle tone caused by damage to the spinal cord.
The benefits of using Baclofen are related with the ability to reduce painful flexor spasms and spontaneous muscle contractions, which improves patient mobility and reduces dependence on the help of other people, improves rehabilitation.
Indications for use
Baclofen tablets are approved for the treatment of reversible spasticity, specifically for the relief of body flexor spasms, spontaneous convulsions, associated pain, general effects of spinal cord injuries, and multiple sclerosis.
The drug is used for trigeminal neuralgia, gastroesophageal reflux disease and hiccups, as well as:
- tumors of the spinal cord;
- syringomyelia;
- disease of motor neurons;
- transverse myelitis;
- traumatic partial dissection of the spinal cord.
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Treatment regimens and dosages
At the beginning of treatment, it is recommended to take the lowest dose of the drug, which provides an adequate therapeutic response. If you are taking the maximum recommended dose, but do not feel the result of treatment, you should consult your doctor and reconsider your treatment regimen. It may be necessary to change the dosage, or switch to other drugs with a similar effect.
Adult patients
Treatment should be started with one dose of Baclofen 15 mg per day, preferably with multiple doses. If a gradually increasing drug dose is prescribed, it should be adjusted according to the individual needs of the patient.
- Baclofen 5 mg three times a day, for three days;
- Baclofen 10 mg three times a day, for three days;
- Baclofen 15 mg three times a day, for three days;
- Baclofen 25 mg three times a day, for three days.
If necessary, the dose can be gradually increased, but the maximum daily dose should not exceed 100 mg.
Taking the medication only at night to counter painful flexor spasm also helps, and a single dose taken about an hour before specific tasks such as washing, dressing, shaving, physical therapy often improves body mobility.
Elderly patients of 65 years and older
Elderly patients may be more susceptible to side effects in the early stages of Baclofen use. So, at the beginning of treatment, you should use minimum doses gradually selecting the dosage of the drug depending on the physiological response, under the close supervision of a doctor.
Children and teenagers
Baclofen tablets are contraindicated for children with the weight of less than 33 kg!
Usually, treatment is started with the lowest dosage of 0.3 mg per kilogram of the child weight divided into 3-4 doses per day. Then the dosage is gradually increased until it becomes sufficient for the child.
The total daily dose for children should not exceed:
- 40 mg/day for children under 8 years of age;
- 60 mg/day for children over 8 years of age.
Recommendations for use
Take this drug with a small amount of liquid before or after meals. It is recommended to take the medicine with milk to reduce stomach irritation. Avoid increasing the dose or taking it more often than your doctor has told you.
The drug withdrawal should always be gradual. Decrease the dose consistently over a period of about 1–2 weeks, except in cases of overdose or severe side effects.
Missed dose
Take the missed dose as soon as you remember about it. If it's time to take the next dose of the drug, then take it and skip the missed one, and then return to the usual dosing schedule. Do not take two doses at once to make up for the missed one.
Precautions
It is necessary to carefully observe the dosage of the drug, especially for the elderly patients, until their condition stabilizes. Taking a very high dose or increasing the dose too fast can cause side effects in people of all ages.
Precautions
- Baclofen should be used with extreme caution in obese patients with high blood pressure;
- Baclofen should be used with caution in patients with cerebral circulatory disorders, respiratory or hepatic impairment;
- It is contraindicated to take Baclofen for patients with hypersensitivity to the drug or any component of its composition;
- With caution, the drug is prescribed for patients with urinary retention or respiratory diseases, gastrointestinal disorders.
Because of the risk of sedative effect, you should refrain from driving a car or running other dangerous mechanisms, as well as from activities that may be dangerous because of reduced alertness. In addition, the action of Baclofen on the central nervous system may be increased by the use of alcohol and other drugs that depress CNS.
Use of Baclofen during pregnancy
During pregnancy, especially in the first three months, the drug should be used only if absolutely necessary. The benefits of treatment for the mother should be carefully weighed against the possible risks to the baby.
When breastfeeding, Baclofen does not cause any side effects due to the low level of the drug in breast milk. However, infants should be monitored for signs of sedation.
Possible side effects
Side effects manifest mainly at the beginning of treatment, when the dose is increased too quickly, when using high doses, or in elderly patients. They are often of temporary nature and can be reduced or removed by dosage reduction.
Possible side effects:
- Severe dizziness or fainting, clouded consciousness;
- Change in urination frequency;
- The appearance or worsening of psychiatric disorders, mood swings, or behavioral changes;
- Signs of an allergic reaction, labored respiration, unusual hoarseness, swelling in the face or throat.
Sudden drug withdrawal may cause convulsions and hallucinations. In case of abrupt withdrawal of Baclofen, especially after long-term use, symptoms of anxiety and clouded consciousness, psychotic disorders, mania or paranoia, seizures and a temporary increase in spasticity may manifest.
It is recommended to gradually reduce the drug dose.
Baclofen: interaction with other drugs
Levodopa, Carbidopa
When taken with Baclofen for treatment of Parkinson's disease, manifestations of clouded consciousness, hallucinations, nausea and agitation are possible. Simultaneous use worsens the symptoms of Parkinson's disease, as well.
Drugs that cause depression of the central nervous system
When taken with muscle relaxants, with synthetic opiates or alcohol, a strong sedative effect may manifest.
The risks of respiratory depression and a sharp drop in blood pressure also increase.
Antidepressants
When taken with antidepressants, the action of Baclofen can increase, which leads to a decrease in muscle tone.
Storage
Store Baclofen tablets in a dry place at room temperature. Store all medicines out of the reach of children and pets.
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