Tizanidine-teva
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)
tab. 4 mg: 20, 30, 50 or 100 pcs. Reg. No.: LP-001812
Clinical and pharmacological group:
Centrally acting muscle relaxant
Release form, composition and packaging
Pills
round, biconvex, white or off-white, with a cross-shaped mark on one side and “T4” engraving on the other.
| 1 tab. | |
| tizanidine | 4 mg |
Excipients:
lactose anhydrous 115.82 mg, prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) SMCC 50 45.15 mg, stearic acid 4.3 mg, prosolv (microcrystalline cellulose 98%, colloidal silicon dioxide 2%) SMCC 90 45.15 mg.
10 pieces. - blisters (2) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs. 10 pieces. - blisters (5) - cardboard packs. 10 pieces. - blisters (10) - cardboard packs.
Description of the active components of the drug "Tizanidine"
pharmachologic effect
Centrally acting muscle relaxant. Reduces increased tone of skeletal muscles, relieves their spasm; reduces muscle resistance during passive movements, increases the strength of voluntary contractions. The muscle-relaxing effect of tizanidine is probably due to inhibition of spinal polysynaptic reflexes, which is associated with a decrease in the release of excitatory amino acids from the presynaptic terminals of spinal interneurons, as well as stimulation of α2-adrenergic receptors. Tizanidine does not affect the transmission of excitation at neuromuscular synapses.
Indications
Spastic condition of skeletal muscles caused by neurological diseases (multiple sclerosis, chronic myelopathy, stroke, degenerative diseases of the spinal cord). Painful spasm of skeletal muscles caused by damage to the spine (cervical and lumbar syndromes) or occurring after surgery (for a herniated disc or osteoarthritis of the hip).
Dosage regimen
To stop painful spasms of skeletal muscles, use 2-4 mg 3 times a day; in severe cases, it is additionally recommended to take 2-4 mg at night. For spastic muscle conditions caused by neurological diseases, the initial dose is 6 mg/day in 3 divided doses. The dose is gradually increased by 2-4 mg/day every 3-7 days. The optimal therapeutic effect is usually achieved at a dose of 12-24 mg/day, divided into 3-4 doses. The dose should not exceed 36 mg/day.
Side effect
When using tizanidine in relatively small doses in rare cases
drowsiness, a feeling of fatigue, dizziness, dry mouth, nausea, and a slight decrease in blood pressure are observed;
in higher doses
- these effects occur more often and are more pronounced, in addition, insomnia, muscle weakness, bradycardia, and increased transaminase activity in the serum are possible.
Contraindications
Hypersensitivity to tizanidine.
Use for liver dysfunction
Use with caution in patients with impaired liver function.
Use for renal impairment
Use with caution in patients with impaired renal function.
special instructions
Use with caution in patients with impaired liver and kidney function.
Impact on the ability to drive vehicles and operate machinery
At the beginning of treatment, if drowsiness occurs, activities that require a high concentration of attention and rapid psychomotor reactions should be avoided.
Drug interactions
When used simultaneously with antihypertensive drugs (including diuretics), severe arterial hypotension and bradycardia may develop.
With the simultaneous use of ethanol and drugs with a sedative effect, the sedative effect increases.
Drug interactions
When used simultaneously with antihypertensive drugs (including diuretics), severe arterial hypotension and bradycardia may develop.
With the simultaneous use of ethanol and drugs with a sedative effect, the sedative effect increases.
Tizanidine-Teva tablet 4 mg x30
Tizanidine-Teva tablet 4 mg x30, ATX code: M03BX02 (Tizanidine) Active substance: tizanidine (tizanidine) Rec.INN registered by WHO
Dosage form
TIZANIDINE-TEVA
tab. 4 mg: 20, 30, 50 or 100 pcs.reg. No.: LP-001812 dated 08/27/12 - Valid
Release form, composition and packaging
Tablets 1 tab.
tizanidine 4 mg, Clinical-pharmacological group: Central-acting muscle relaxant Pharmaco-therapeutic group: Peripheral-acting muscle relaxant The scientific information provided is general and cannot be used to make a decision about the possibility of using a specific drug.
Pharmacological action Centrally acting muscle relaxant. Reduces increased skeletal muscle tone, relieves spasm, reduces muscle resistance during passive movements, and increases the strength of voluntary contractions. The muscle-relaxing effect of tizanidine is probably due to inhibition of spinal polysynaptic reflexes, which is associated with a decrease in the release of excitatory amino acids from the presynaptic terminals of spinal interneurons, as well as stimulation of α2-adrenergic receptors. Tizanidine does not affect the transmission of excitation at neuromuscular synapses.
Indications Spastic condition of skeletal muscles caused by neurological diseases (multiple sclerosis, chronic myelopathy, stroke, degenerative diseases of the spinal cord). Painful spasm of skeletal muscles caused by damage to the spine (cervical and lumbar syndromes) or occurring after surgery (for a herniated disc or osteoarthritis of the hip). ICD-10 codes
Dosage regimen To stop painful spasms of skeletal muscles, use 2-4 mg 3 times a day; in severe cases, it is additionally recommended to take 2-4 mg at night. For spastic muscle conditions caused by neurological diseases, the initial dose is 6 mg/day in 3 divided doses. The dose is gradually increased by 2-4 mg/day every 3-7 days. The optimal therapeutic effect is usually achieved at a dose of 12-24 mg/day, divided into 3-4 doses. The dose should not exceed 36 mg/day.
Side effects When using tizanidine in relatively small doses, in rare cases, drowsiness, a feeling of fatigue, dizziness, dry mouth, nausea, a slight decrease in blood pressure are observed, in higher doses - these effects occur more often and are more pronounced, in addition, insomnia, muscle pain are possible weakness, bradycardia, increased transaminase activity in the serum.
Contraindications for use: Hypersensitivity to tizanidine.
Use for liver dysfunction Use with caution in patients with liver dysfunction.
Use for impaired renal function Use with caution in patients with impaired renal function.
special instructions
Use with caution in patients with impaired liver and kidney function.
Impact on the ability to drive vehicles and operate machinery
At the beginning of treatment, if drowsiness occurs, activities that require a high concentration of attention and rapid psychomotor reactions should be avoided.
Drug interactions
When used simultaneously with antihypertensive drugs (including diuretics), severe arterial hypotension and bradycardia may develop.
With the simultaneous use of ethanol and drugs with a sedative effect, the sedative effect increases.
Tizanidine-teva 2 mg 30 pcs. Teva tablets pharmaceutical plant private co.ltd
pharmachologic effect
Tizanidine is an agonist of alpha2-adrenergic receptors located in the central nervous system at the supraspinal and spinal levels.
By stimulating presynaptic alpha2-adrenergic receptors, tizanidine inhibits the release of excitatory amino acids that stimulate N-methyl-D-aspartate-sensitive receptors (NMDA receptors). As a result, polysynaptic transmission of excitation is suppressed at the level of interneurons of the spinal cord. Tizanidine has no direct effect on skeletal muscle, neuromuscular junctions, or monosynaptic reflexes.
Tizanidine reduces spasticity and clonic convulsions, as a result of which muscle resistance to passive movements in the joints decreases and the range of active movements increases.
Composition and release form Tizanidin-teva 2 mg 30 pcs. Teva tablets pharmaceutical plant private co.ltd
Tablet - 1 tablet:
- Active substance: tizanidine hydrochloride (tizanidine) 2.0 mg;
- Excipients: lactose (lactose anhydrous); proSolv SMCC 50 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%); proSolv SMCC 90 (microcrystalline cellulose 98%, colloidal silicon dioxide 2%); stearic acid.
30 pcs. packaged.
Description of the dosage form
The tablets are round, biconvex, white or almost white, scored on one side and engraved “T2” on the other.
Directions for use and doses
The initial dose is 2 mg, followed by increasing the dose by 2 mg at intervals of at least 3-4 days.
The maximum daily dose is 36 mg.
The dosage regimen should be set individually, the daily dose is divided into several doses (up to 3-4) depending on the patient’s needs. Usually no more than 24 mg/day is required.
Treatment of patients with renal failure (creatinine clearance less than 25 ml/min) is recommended to begin with a dose of 2 mg once a day. The dose should be increased gradually, taking into account tolerability and effectiveness: first increase the dose, then increase the frequency of use.
In patients over 65 years of age, Tizanidine-Teva should be used under close monitoring of renal function due to a possible decrease in glomerular filtration rate.
Pharmacokinetics
Suction:
Tizanidine absorption is high, the time to reach maximum plasma concentration (TCmax) is 1-2 hours. Bioavailability is 34%. Food intake does not affect pharmacokinetics.
Distribution and metabolism:
Volume of distribution - 2.6 l/kg. Communication with plasma proteins - 30%.
In the dose range from 4 to 20 mg, pharmacokinetics are linear. Tizanidine is rapidly metabolized to a large extent in the liver (95%) with the formation of inactive metabolites.
Removal:
The half-life (T1/2) is 3-5 hours. It is excreted mainly by the kidneys (70% unchanged, 2.7% in the form of metabolites) and excreted in the feces (20%).
In patients with renal failure (creatinine clearance (CC) less than 25 ml/min), the maximum plasma concentration (Cmax) increases 2 times, T1/2 - 14 hours, the area under the curve of hepatic transaminases is 3 times higher than the upper limit of normal or more, use of the drug Tizanidine should be discontinued.
With simultaneous use of the drug Tizanidine with inhibitors of the CYP1A2 isoenzyme, it is possible to increase the concentration of tizanidine in the blood plasma, which in turn may cause the development of overdose symptoms, in particular prolongation of the QT(c) interval. Concomitant use of Tizanidine with inhibitors of the CYP1A2 isoenzyme and other drugs that can lead to prolongation of the QT(c) interval is not recommended.
When treating patients with cardiovascular diseases and coronary heart disease with tizanidine, caution should be exercised. It is necessary to regularly monitor laboratory indicators of the functional state of the heart and monitor ECG indicators.
Tizanidine should be discontinued gradually due to the risk of developing hepatic transaminase syndrome, hepatitis, and liver failure.
From the musculoskeletal system: rarely - muscle weakness.
Other: very often - increased fatigue; often - withdrawal syndrome*.
With abrupt withdrawal after prolonged treatment and/or taking high doses of the drug (as well as after use together with antihypertensive drugs), the risk of developing tachycardia, increased blood pressure, and, in some cases, acute cerebrovascular accident increases.
Drug interactions
Concomitant use with potent inhibitors of the CYP1A2 isoenzyme (fluvoxamine, ciprofloxacin) significantly increases the concentration of tizanidine in the blood plasma and increases the likelihood of adverse reactions.
Antihypertensive drugs, including diuretics, when used simultaneously with tizanidine, increase the risk of developing a pronounced decrease in blood pressure and bradycardia.
When used simultaneously with oral contraceptives, antiarrhythmic drugs, cimetidine, norfloxacin, rofecoxib, ticlopidine, the clearance of tizanidine is significantly reduced.
When sedatives and ethanol are used simultaneously with tizanidine, the risk of central nervous system depression increases.
Paracetamol increases TCmax by 16 minutes (no clinical significance).
