Sirdalud – composition, action, indications, contraindications, interactions

Proven content

Sirdalud is an analgesic and antispasmodic drug that is used to relieve muscle tension in neurology and general surgery. Sirdalud has an effect on the musculoskeletal system, incl. eliminating painful muscle spasms.

Sirdalud – characteristics

Action of the drug Sirdalud

Sirdalud is a preparation whose active substance is tizanidine. It acts on neurons in the spinal cord, activates alpha2 adrenergic receptors located presynaptically on the surface of the spinal cord insertion neurons. This kind of activation affects the inhibition of the impulses that cause excessive muscle tension. Tizanidine also has an analgesic effect.

Sirdalud is great for acute / painful spasms as well as chronic spasticity of spinal or spinal origin. The drug is very quickly absorbed from the gastrointestinal tract and metabolized in the liver (the maximum concentration of tizanidine in the blood is obtained about 1 hour after taking the preparation).

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Sirdalud – composition

Active substance: 5-chloro-4- (2-imidazolino-2-ylamino) -2,1,3-benzothiadiazole (tizanidine) The tablets contain 4 mg tizanidine (Tizanidinum) (as tizanidine hydrochloride 4,576 mg).

Indications for the use of the drug Sirdalud

Sirdalud is a prescription-only preparation. The active substance is tizanidine, an organic chemical compound used to relax skeletal muscles. Sirdalud is prescribed to patients suffering from:

1. painful muscle spasms associated with static and functional diseases of the spine (cervical and lumbar syndromes);
2. following surgery, for example for a testicular hernia or inflammation of the hip joint;
3. increased muscle tension caused by neurological diseases such as multiple sclerosis;
4. chronic diseases of the spinal cord;
5. degenerative diseases of the spinal cord;
6. cerebrovascular accident;
7. cerebral palsy (in adults with previously diagnosed cerebral palsy).

In the case of ailments related to the kidney disease, supportive use of dietary supplements for the nervous system may be recommended. If in doubt, consult your doctor about the recommended preparations.

Sirdalud – contraindications to use

Contraindications to the use of Sirdalud are:

1. hypersensitivity to any of its ingredients,
2. disturbance of liver function (liver enzymes exceeding 3 times the upper limit of normal),
3. simultaneous use with inhibitors of the isoenzyme 1A2 cytochrome P450 (hypotension may occur),
4. pregnant women,
5. the period of breastfeeding,
6. age: under 18.

The drug is available on prescription. To receive or extend it, the patient can sign up for an e-consultation with an e-prescription in order to inform the doctor about the need for a drug.

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Sirdalud – dosage

Characteristic for Sirdalud is a narrow therapeutic index and a large inter-individual variability in the plasma concentration of tizanidine, which means that the dose should be adjusted to the patient’s needs.

1. Painful muscle spasms: 2-4 mg three times a day. In severe cases, the doctor may additionally recommend 2-4 mg at bedtime.
2. Increased muscle tension caused by neurological diseases: – initially no more than 6 mg per day in three divided doses; – then, your doctor may increase the dose gradually every 3-7 days by 2-4 mg per day. The usual dose is 12-24 mg daily in 3-4 divided doses. The maximum dose is 36 mg daily.
3. It is recommended to start treatment with the lowest dose in elderly patients and in those with moderate hepatic impairment. The dose is then increased gradually, with caution, and depending on the patient’s tolerance and individual needs.
4. In patients with renal insufficiency (creatinine clearance less than 25 ml / min) initially 2 mg once a day, then the dose is gradually increased depending on the tolerance and effectiveness of the preparation.

Sirdalud – warnings

1. Before taking Sirdalud, consult your doctor if: you have hypotension, liver or kidney problems.

2. Do not suddenly stop the treatment with the preparation, gradually reduce the dose as recommended by your doctor. Abrupt discontinuation of the drug may result in the side effects of high blood pressure and heart rate, which may result in a stroke.

3. Taking the drug may lead to liver dysfunction, therefore its parameters should be monitored during the first months, especially if the patient uses a dose exceeding 12 mg per day. Attention! If you develop nausea, anorexia and constant fatigue – your doctor will advise you to discontinue the drug.

4. Patients who have impaired kidney function excrete the drug longer. They should initially use lower doses, and then may gradually increase them under the supervision of a doctor.

5. People with galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Sirdalud because it contains lactose.

6. The drug may cause drowsiness, dizziness – if you experience these symptoms, refrain from driving or operating machinery / equipment.

7. Long-term use of Sirdalud in smokers may suggest increasing the dose. Do not drink alcohol while taking this medicine as it increases the risk of side effects (e.g. sedation or hypotension). Alcohol may increase the CNS depressant effect of Sirdalud.

8. Due to the presence of tizanidine, hypersensitivity reactions including anaphylaxis, angioedema, dermatitis, rash, urticaria, pruritus and erythema may occur. If anaphylaxis or angioedema with anaphylactic shock or difficulty breathing occurs, treatment with Sirdalud should be discontinued immediately and appropriate therapy instituted.

Sirdalud – interactions with other drugs

Sirdalud may interact with other drugs and active substances. Belong to them:

1. strong inhibitors of the cytochrome P1A2 isoenzyme, such as e.g. fluvoxamine or ciprofloxacin (may lead to coma, rebound tachycardia or severe hypotension);
2. antiarrhythmic drugs (e.g. mexiletine, propafenone), oral contraceptives (the QT interval may be prolonged on the ECG);
3. drugs that prolong the QT interval, e.g. amitriptyline, azithromycin;
4. antihypertensive drugs (including diuretics) may cause hypotension. It happens that if we suddenly stop taking these drugs together with Sirdalud, the pressure will increase and in some cases even cause a stroke;
5. rifampicin reduces the effectiveness of the drug Sirdalud (causes a 50% reduction in the concentration of tizanidine);
6. hypnotics, sedatives and antihistamines inhibit the effects of Sirdalud on the central nervous system;
7. drugs with a similar effect (the effects of antihypertensive drugs may be additive).

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Side effect of the drug Sirdalud

Like all medicines, Sirdalud can cause side effects, although they will not occur in all patients using this preparation. It should be realized that the expected benefits of using the drug are usually greater than the harm resulting from the occurrence of side effects.

Very often: drowsiness and dizziness, dry mouth, gastrointestinal disturbances, muscle weakness, tiredness.

Often: insomnia, sleep disorders, fatigue, decreased heart rate (bradycardia), decreased blood pressure, nausea, transient increases in serum transaminases (AST, ALT).

In addition, possible side effects for which their frequency has not been established: hallucinations, confusional state, balance disorder, visual disturbance (blurred vision), fainting, inflammation or liver failure, weakness.

Hypertension and an increased heart rate, which may lead to a stroke, may occur upon sudden discontinuation of long-term high doses of tizanidine.

At higher doses for treating high muscle tension, side effects are more frequent and more pronounced, and there may also be QT prolongation on the ECG and life-threatening torsades de pointes, very rarely acute hepatitis.

If you experience other, not mentioned side effects, you should inform your doctor about them.

See also: Adverse drug reactions

Sirdalud in pregnancy and lactation

During pregnancy, you shouldn’t take any medication without consulting your doctor!

Due to the limited experience with the use of Sirdalud in pregnant women, the preparation should not be used during pregnancy, unless the therapeutic benefits clearly outweigh the risks. Sexually active women of child-bearing age are advised to undergo a pregnancy test before starting treatment with Sirdalud.

According to the results of animal studies, Sirdalud has been shown to be harmful to the developing fetus. Therefore, it is recommended that sexually active women of childbearing age use effective contraception (with a conception rate of less than 1%) while taking Sirdalud and for 1 day after stopping treatment.

In the case of breastfeeding, the component of Sirdalud, tizanidine, was reported to pass into the milk of female rats to a small extent. Due to the lack of available data in humans, Sirdalud should not be administered to women who are breastfeeding.