Sirdalud, Novartis Saglic, Tizanidine, 4 mg, 30 Tablets
| Composition: | ||
| Serving Size: 1 tablet | ||
| Servings Per Container: 30 | ||
| One serving: | % of Daily Value | |
| Tizanidine Hydrochloride (tizanidine) | 4.576mg |
Tizanidine belongs to a group of medicines called muscle relaxants. Muscle relaxants are medications that are used to prevent or reduce muscle spasms and spasticity. Spasticity occurs when the muscles contract tightly and become stiff and become more difficult to use. This often causes pain and discomfort.
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Contraindications:
- Hypersensitivity to tizanidine or any other component of the drug;
- Severe liver dysfunction;
- Simultaneous use with strong inhibitors of cytochrome P450 1A2 ( CYP1A2) such as fluvoxamine or ciprofloxacin.
Experience with the drug in patients under 18 years of age is limited. The use of Sirdalud® in this population is not recommended.
With caution: age over 65 years, impaired renal function, moderately severe impaired liver function.
Suggested usage:
Inside. The dosage regimen should be selected individually.
Sirdalud® has a narrow therapeutic index and high variability in the concentration of tizanidine in the blood plasma of patients, so careful dose selection is necessary.
Initial dose of 2 mg 3 times a day able to minimize the risk of adverse reactions. The dose should be carefully selected according to the individual needs of the patient. In severe cases, an additional 2 or 4 mg can be taken (preferably at bedtime due to a possible increase in drowsiness).
The 2 and 4 mg tablets can be divided into 2 equal parts.
When spasticity of skeletal muscles due to neurological diseases, the initial daily dose should not exceed 6 mg, divided into 3 doses. Do not exceed a dose of 36 mg / day. Upon termination of therapy with Sirdalud®, in order to reduce the risk of developing rebound hypertension and tachycardia, the dose should be slowly reduced until the drug is completely discontinued, especially in patients receiving high doses of the drug for a long time.
Warning:
Because no controlled studies have been conducted on the use of tizanidine in pregnant women, it should not be used during pregnancy unless the potential benefit outweighs the potential risk. Women who are breastfeeding children should not use the drug, because. there is no data on the penetration of Sirdalud® into breast milk.
The use of Sirdalud® in patients with severely impaired liver function is contraindicated.
Experience with the use of Sirdalud® in patients aged 65 years and older limited.
Hypotension may occur during the use of the drug Sirdalud®, as well as as a result of drug interactions with CYP1A2 inhibitors and / or antihypertensive drugs. A pronounced decrease in blood pressure can lead to loss of consciousness and collapse.
Cases of liver dysfunction associated with tizanidine have been reported, however, when using a daily dose of up to 12 mg, these cases were rare. In the case when the levels of ALT and ACT in serum persistently exceed the ULN by 3 times or more, the use of the drug Sirdalud® should be discontinued.
Since the composition of the tablets of the drug Sirdalud® contains lactose, it is not recommended to use the drug in patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose/galactose malabsorption.
Overdose:
To date, there have been several reports of overdose of Sirdalud®, including the case when the accepted dose was 400 mg. In all cases, recovery was uneventful.
Symptoms: nausea, vomiting, decreased blood pressure, prolongation of the QT(c) interval, dizziness, drowsiness, miosis, anxiety, respiratory failure, coma. Forced diuresis may also accelerate the elimination of Sirdalud®.
Do not use after the expiry date stated on the package.
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