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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for use
medicine for experts
of TIZANIL
the Trade name
of TIZANIL
the International unlicensed
name Tizanidin Lekarstvennaya a form
of the Tablet of 2 mg and 4 mg
Structure
One tablet contains
active agent – tizanidin 2 mg 4 mg
excipients:
microcrystalline cellulose 74.412 mg 101.024 mg
of lactose monohydrate 80.00 mg 110.00 mg
stearic acid 3.00 mg 4.00 mg
of silicon dioxide anhydrous 0.30 mg 0.40 mg
Description
White, round, biconvex tablets
Pharmacotherapeutic group
Other muscle relaxants of the central action.
The code of automatic telephone exchange M03BX02
the Pharmacological
Pharmacokinetics At properties intake is soaked up quickly and almost completely (for 90%). The maximum concentration (Cmax) in blood plasma is reached in 1-2 hours after administration of drug. Gets through a blood-brain barrier. Because of intensive metabolism at the first passing through a liver the average value of bioavailability is about 34%. The average value of volume of distribution (Vd) in the period of an equilibrium state is 2.6 l/kg. In the range of doses from 4 to 20 mg the pharmacokinetics of drug has linear character. Linking with proteins of plasma makes 30%. The sex of the patient and a concomitant use of food do not influence clinically significantly the pharmacokinetic Tizanila parameters. Metabolism is quickly and substantially carried out in a liver. Metabolites have no pharmacological activity. Elimination half-life (T1/2) from a system blood-groove – 2-5 h. Drug is removed by kidneys (about 70% of the entered dose) in the form of metabolites, and with stool, in not changed look 2.7 – 5% are removed. At patients with a renal failure (at clearance of creatinine less than 25 ml/min.) the average Cmax value in plasma exceeds this indicator at healthy volunteers twice, and final T1/2 can increase to 14 h therefore AUC increases on average 6 times.
The pharmacodynamics
Stimulates presynaptic alfa2-adrenoceptors that leads to slowing down of release of the exciting amino acids which are endogenous agonists of receptors of NMDA type. Thereof polisinaptichesky transfer of excitement is suppressed (at the level of interneuronels of a spinal cord), the excess muscle tone decreases, and the central analgeziruyushchy effect develops.
Tizanil is effective both at a sharp painful muscular spasm, and at chronic spasticity of spinal and cerebral genesis. Reduces muscle tension at passive movements, reduces spasms and clonic spasms and also increases force of any reductions of skeletal muscles.
Indications
– the painful muscular spasms caused by organic and functional disturbances of a backbone (cervical and lumbar syndromes, osteochondrosis, a spondylosis, a myelosyringosis, a hemiplegia, etc.) and also arising after surgeries (including concerning a protruded disk or an osteoarthrosis of a hip joint)
– spasticity of skeletal muscles in neurologic diseases (including in multiple sclerosis, a chronic myelipathy, degenerative diseases of a spinal cord, at the residual phenomena of the had stroke, a craniocereberal injury, cerebral palsy, etc.).
Route of administration and doses
Stopping of a painful muscular spasm: inside, on 2-4 mg 3 times a day, in hard cases – in addition appoint 2-4 mg to night.
Treatment of the spasticity of skeletal muscles caused by neurologic diseases: the dose is established individually. An initial dose – on 2 mg 3 times a day, then gradually increase a daily dose by 2-4 mg with intervals from 3-4 to 7 days. Usually optimum therapeutic effect is reached at the daily dose from 12 to 24 mg distributed on 3 or 4 receptions at regular intervals.
The maximum daily dose – 36 mg.
To patients with a renal failure (clearance of creatinine less than 25 ml/min.) the recommended initial dose – 2 mg of 1 times a day. Increase in a dose is carried out gradually, slowly, taking into account shipping and efficiency. If it is necessary to gain more significant effect, it is recommended to increase at first the dose appointed 1 time a day then increase frequency rate of appointment.
Side effects
– drowsiness, weakness, dizziness, muscle weakness, insomnia,
sleep disorders, hallucinations
– bradycardia, insignificant decrease in the ABP
– dryness in a mouth, nausea, gastrointestinal disorders, passing increase in activity of hepatic transaminases (AlAT and AsAT), an acute hepatitis.
Contraindications
– hypersensitivity to a tizanidin or to other component of drug
– the significant disturbance of functions of a liver (a liver failure with permanent exceeding level of the upper bound of norm of hepatic transaminases in blood serum by 3 times and more)
– children’s and teenage age up to 18 years.
Medicinal interaction
At simultaneous use of Tizanil with antihypertensive drugs (including diuretics) is possible development of arterial hypotension and bradycardia.
The combination to other alfa2-adrenostimulyator is not recommended.
Sedative drugs and alcohol can strengthen sedative action of Tizanil.
Paracetamol increases TCmax for 16 min. (has no clinical value). Oral contraceptive means reduce clearance of a tizanidin by 50%.
Special instructions
patients Should appoint with care Tizanil with the profound renal failure (a renal failure with clearance of creatinine less than 25 ml/min.).
It is recommended to control functional hepatic trials in the first 4 months of treatment once a month at those patients to whom it is appointed tizanidin in a daily dose of 12 mg and above and also when the clinical signs allowing to assume an abnormal liver function (inexplicable nausea, anorexia, fatigue) are observed In case levels of hepatic transaminases in serum with firmness exceed the upper bound of norm by 3 times and more, Tizanil’s use should be stopped.
Use in gerontological to practice
Because at patients of advanced age the renal clearance can be reduced it is necessary to be careful at Tizanil’s use.
Pregnancy and a lactation
Tizanil it is not necessary to apply during pregnancy and a lactation unless the potential advantage for mother exceeds possible risk for a fruit or the child.
Influence on ability to control of motor transport and mechanisms.
Patients at whom drowsiness is noted should recommend to refrain from types of the works demanding high concentration of attention and fast reaction, for example, of driving of vehicles or work with cars and mechanisms.
Overdose
Symptoms: nausea, vomiting, arterial hypotension, dizziness,
drowsiness, miosis, concern, disturbance of breath, lump.
Treatment: Gastric lavage, purpose of sorbents, (activated carbon), artificial diuresis, symptomatic therapy.
A form of release and packing
On 10 tablets in the blister from PVH/PE/PVDH/alyum.
On 1 or 3 or 10 blisters in a cardboard box together with the instruction for use.
To Store storage conditions in the cool, dry and protected from light place at a temperature not above 25ºС.
To store out of children’s reach!
An expiration date
of 3 years
not to use drug after the expiration date specified on packing.
Prescription status
According to the prescription
the Producer:
Simpex Pharm Pvt. Ltd. ., India
B4/160, Safdardzhung the Enclave,
New Delhi – 110029, India.
Additional information
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