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These brands contain the same active ingredient (Tizanidine Hydrochloride). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Tizanidine Hydrochloride is used to treat painful muscle spasms. This includes spasms linked with static and functional disorders of the spine (cervical and lumbar syndromes), and spasms after surgery, for example for a herniated intervertebral disc or osteoarthritis of the hip. Tizanidine Hydrochloride is also used to treat spasticity caused by neurological disorders. These are multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, cerebrovascular accidents and cerebral palsy.
Pharmacology
Tizanidine is a centrally acting skeletal muscle relaxant. It works mainly in the spinal cord. The evidence suggests that it stimulates presynaptic alpha2 receptors, and this stops the release of excitatory amino acids that would otherwise stimulate N-methyl-D aspartate (NMDA) receptors. Polysynaptic signal transmission at the spinal interneuron level is responsible for excessive muscle tone, so blocking it brings the muscle tone down. Besides relaxing muscle, the medicine also has a moderate central analgesic effect.
In terms of its pharmacodynamic action, tizanidine is effective in both acute painful muscle spasms and chronic spasticity of spinal and cerebral origin. It reduces resistance to passive movements, eases spasms and clonus, and may improve voluntary strength. The antispastic activity (measured by the Ashworth score and pendulum test) and the adverse effects (heart rate and blood pressure) are both related to plasma tizanidine concentrations.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Tizanidine has a narrow therapeutic index, and tizanidine plasma concentrations vary a lot from one patient to another, so the dose has to be adjusted for each person. Starting low, at 2 mg three times daily, can reduce the risk of adverse effects. The dose should then be raised carefully, according to what the individual patient needs.
Relief of painful muscle spasms: The usual dose is 2 to 4 mg three times daily, in tablet form. In severe cases, an extra dose of 2 or 4 mg may be taken, preferably at night to keep sedation down.
Spasticity due to neurological disorders: The starting daily dose should not go above 6 mg, given in 3 divided doses. It can be increased step by step at half-weekly or weekly intervals, by 2 to 4 mg each time. The best response is generally reached with a daily dose of between 12 and 24 mg, given in 3 or 4 equally spaced doses. The daily dose of 36 mg should not be exceeded.
Pediatrics patients: Experience in patients below 18 years of age is limited, so Tizanidine is not recommended for this group.
Geriatric patients (65 years of age or older): Experience with Tizanidine in the elderly is limited. Because of this, treatment should begin at the lowest dose, and any increase should be made in small steps, depending on how well the patient tolerates it and how well it works.
Renal impairment: In patients with renal impairment (creatinine clearance <25 mL/min), treatment should start at 2 mg once daily. Increase the dose in small steps, according to tolerability and efficacy. If the effect needs to be improved, it is advisable to first increase the strength of the daily dose before increasing the frequency of administration.
Hepatic impairment: Tizanidine is contraindicated in patients with severe hepatic impairment. It is extensively metabolized in the liver, but limited data are available for this group. Its use has been linked to a reversible abnormality in liver function tests. In moderate hepatic impairment, Tizanidine should be used with caution and treatment should start at the lowest dose. After that, any increase should be made carefully, according to how well the patient tolerates it.
Discontinuation of treatment: If Tizanidine has to be stopped, the dose should be brought down slowly, particularly in patients who have taken high doses for a longer period. This helps avoid or reduce the risk of rebound hypertension and tachycardia.
Side Effects
With low doses, such as those recommended for the relief of painful muscle spasms, somnolence, fatigue, dizziness, dry mouth, blood pressure decrease, nausea, gastrointestinal disorder and transaminase increase have been reported. These reactions were usually mild and passed quickly. With the higher doses recommended for the treatment of spasticity, the reactions seen at low doses are more frequent and more pronounced, but they are seldom severe enough to make stopping treatment necessary. The following reactions may also occur: hypotension, bradycardia, muscular weakness, insomnia, sleep disorder, hallucination and hepatitis. Psychiatric disorders: insomnia and sleep disorder are common. Nervous system disorders: somnolence and dizziness are very common. Cardiac disorders: bradycardia is uncommon. Vascular disorders: hypotension is common. Gastrointestinal disorders: gastrointestinal disorder and dry mouth are very common; nausea is common. Musculoskeletal and connective tissue disorders: muscular weakness is very common. General disorders and administration site conditions: fatigue is very common. Investigations: blood pressure decreased and transaminases increased are common.
Cautions & Contraindications
Warnings & Precautions
CYP inhibitors Tizanidine Hydrochloride should not be used together with moderate CYP1A2 inhibitors. Take care when it is given with drugs known to increase the QT interval. Hypotension Blood pressure may fall during treatment with Tizanidine Hydrochloride. It can also happen because of interactions with CYP1A2 inhibitors and/or antihypertensive drugs. Severe hypotension, including loss of consciousness and circulatory collapse, has also been observed. Withdrawal syndrome Rebound hypertension and tachycardia have been seen after sudden withdrawal of Tizanidine Hydrochloride, when it had been used for a long time, and/or in high daily doses, and/or together with antihypertensive drugs. In extreme cases, rebound hypertension might lead to cerebrovascular accident. So the medicine should not be stopped abruptly. The dose should be brought down gradually. Hepatic dysfunction Hepatic dysfunction has been reported with tizanidine, though rarely at daily doses up to 12 mg. For this reason, liver function tests should be checked monthly for the first four months in patients taking 12 mg and higher. The same applies to patients who develop clinical symptoms suggestive of hepatic dysfunction, such as unexplained nausea, anorexia or tiredness. Treatment with Tizanidine Hydrochloride should be stopped if serum SGPT or SGOT levels stay above three times the upper limit of the normal range. Patients with renal impairment In patients with renal impairment (creatinine clearance <25 mL/min), exposure to tizanidine in the body may rise up to 6 times compared with patients who have normal kidney function. Because of this, treatment should start at 2 mg once daily. Hypersensitivity reactions Hypersensitivity reactions have been reported with tizanidine. These include anaphylaxis, angioedema, dermatitis, rash, urticaria, pruritus and erythema. The patient should be watched carefully for one to two days after the first dose. If anaphylaxis, or angioedema with anaphylactic shock or difficulty in breathing, is seen, Tizanidine Hydrochloride should be stopped immediately and proper medical treatment started. Driving and using machines Patients who feel sleepy or dizzy, or who have any signs or symptoms of hypotension, should avoid activities that need a high degree of alertness, for example driving a vehicle or operating machines.
Contraindications
Tizanidine Hydrochloride must not be given to anyone with a known hypersensitivity to tizanidine or to any of the excipients in the product. It is also contraindicated in people with severely impaired hepatic function. Tizanidine must not be used together with strong inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin.
Pregnancy & Breastfeeding
There isn't much experience with Tizanidine in pregnant women, so it should not be used during pregnancy unless the benefit clearly outweighs the risk.
Animal data: Reproduction studies in rats and rabbits did not show evidence of teratogenicity. In rats, dose levels of 10 and 30 mg/kg/day increased the length of gestation. Pup loss went up before and after birth, and development was retarded. At these doses, the dams showed marked signs of muscle relaxation and sedation. Based on body surface area, these doses were 2.2 and 6.7 times the maximum recommended human dose of 0.72 mg/kg/day.
Lactation: Small amounts of tizanidine pass into rat milk. No human data are available, so Tizanidine should not be given to women who are breast-feeding.
Females and males of reproductive potential:
Pregnancy testing: Sexually-active females of reproductive potential are recommended to have a pregnancy test before starting treatment with Tizanidine.
Contraception: Females of reproductive potential should be told that animal studies have shown Tizanidine to be harmful to the developing fetus. Sexually-active females of reproductive potential are recommended to use effective contraception (methods that result in less than 1 % pregnancy rates) during treatment with Tizanidine and for 1 day after stopping it.
Fertility: Animal data: No impairment of fertility was seen in male rats at a dose of 10 mg/kg/day, or in female rats at a dose of 3 mg/kg/day. Fertility was reduced in male rats receiving 30 mg/kg/day and in female rats receiving 10 mg/kg/day. Based on body surface area, these doses were 6.7 and 2.2 times the maximum recommended human dose of 0.72 mg/kg. At these doses, maternal behavioral effects and clinical signs were seen, including marked sedation, weight loss and ataxia.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal impairment (creatinine clearance <25 mL/min): in people with this level of kidney function, the highest mean plasma levels of tizanidine were twice as high as in normal volunteers. The terminal half-life was also longer, at approximately 14 hours, and this led to much higher AUC values (approximately 6-fold on average).
Hepatic impairment: No specific studies were done in this group. Tizanidine is broken down extensively in the liver by the CYP1A2 enzyme, so liver impairment may raise its systemic exposure. Tizanidine Hydrochloride is contraindicated in patients with severe hepatic impairment.
Geriatrics (65 years of age and older): The pharmacokinetic data for this age group are limited.
Gender: Gender has no clinically significant effect on the pharmacokinetics of tizanidine.
Ethnicity: The effect of ethnic sensitivity and race on the pharmacokinetics of tizanidine has not been studied.
Overdose
Only a few overdose reports for Tizanidine Hydrochloride have been received, and recovery was uneventful in them. This includes one patient who had taken 400 mg. The symptoms listed are nausea, vomiting, hypotension, QT(c) prolongation, dizziness, somnolence, miosis, restlessness, respiratory distress and coma. To remove the swallowed drug, repeated high doses of activated charcoal are recommended. Forced diuresis is expected to speed up the elimination of Tizanidine Hydrochloride. Any further treatment should be symptomatic.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Tizanidine Hydrochloride in a dry place, below 30°C. Make sure children can neither reach it nor see it.
Drug Interactions
Common questions about Sirdalud 2 mg
What is Sirdalud 2 mg Tablet?
Sirdalud 2 mg Tablet is a medicine that contains Tizanidine Hydrochloride. It is made by Nevian Lifescience PLC. It belongs to the Centrally acting Skeletal Muscle Relaxants group of medicines.
What is Sirdalud used for?
Tizanidine Hydrochloride is used to treat painful muscle spasms. This includes spasms linked with static and functional disorders of the spine (cervical and lumbar syndromes), and spasms after surgery, for example for a herniated intervertebral disc or osteoarthritis of the hip.
What are the side effects of Sirdalud?
With low doses, such as those recommended for the relief of painful muscle spasms, somnolence, fatigue, dizziness, dry mouth, blood pressure decrease, nausea, gastrointestinal disorder and transaminase increase have been reported. These reactions were usually mild and passed quickly.
Can I take Sirdalud during pregnancy or while breastfeeding?
There isn't much experience with Tizanidine in pregnant women, so it should not be used during pregnancy unless the benefit clearly outweighs the risk. Animal data: Reproduction studies in rats and rabbits did not show evidence of teratogenicity. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Sirdalud?
Only a few overdose reports for Tizanidine Hydrochloride have been received, and recovery was uneventful in them. This includes one patient who had taken 400 mg. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Sirdalud?
Keep Tizanidine Hydrochloride in a dry place, below 30°C. Make sure children can neither reach it nor see it.
Can I take other medicines with Sirdalud?
Some medicines can interact with Tizanidine Hydrochloride, for example: Clonidine Hydrochloride, Azithromycin, Ciprofloxacin, Amiodarone Hydrochloride, Pefloxacin, Fluvoxamine Maleate. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Tizalex by Apex Pharma Ltd. has the same ingredient and strength for ৳5.00 per unit, compared with ৳11.53 for Sirdalud. Ask your doctor or pharmacist before switching.
Do I need a prescription for Sirdalud?
Sirdalud is a prescription (Rx) medicine. Take it as your doctor advises.