Tizaro
Generic Name
Tizanidine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tizaro 25 mg injection | ৳ 1,200.00 | N/A |
Description
Overview of the medicine
Tizaro 25 mg Injection contains Tizanidine, a centrally acting alpha-2 adrenergic agonist. It is used for the symptomatic treatment of spasticity associated with multiple sclerosis, spinal cord injury, or other neurological disorders. It helps to relax muscles and reduce muscle tone and involuntary spasms.
Uses & Indications
Dosage
Adults
Initial dose is usually 5 mg administered once daily by injection. Dosage may be gradually increased by 2.5-5 mg at 3-7 day intervals, based on patient response and tolerability, up to a maximum of 36 mg/day in divided doses. Administer as directed by a physician.
Elderly
Lower initial doses and slower titration are recommended due to potential for decreased renal clearance and increased sensitivity to adverse effects.
Renal_impairment
For patients with creatinine clearance <25 mL/min, a lower starting dose (e.g., 2.5 mg) and slower titration with careful monitoring are necessary.
How to Take
Tizaro 25 mg Injection is for intramuscular (IM) or intravenous (IV) administration only. It must be administered by a qualified healthcare professional. Do not administer intrathecally. Do not discontinue treatment abruptly.
Mechanism of Action
Tizanidine is an alpha-2 adrenergic receptor agonist that acts centrally. It primarily exerts its muscle relaxant effect at the spinal cord level by increasing presynaptic inhibition of motor neurons. This leads to a reduction in the release of excitatory amino acids, thereby decreasing muscle tone and frequency of spasms.
Pharmacokinetics
Onset
Onset of action typically occurs within 1-2 hours after injection.
Excretion
Mainly excreted by the kidneys (approximately 60% of a dose is excreted in urine, largely as metabolites).
Half life
Plasma half-life is approximately 2.5 hours (range 2-4 hours).
Absorption
Rapidly absorbed following intramuscular or intravenous administration. Bioavailability of parenteral tizanidine is generally higher than oral.
Metabolism
Extensively metabolized in the liver, primarily by the CYP1A2 isoenzyme.
Side Effects
Contraindications
- Known hypersensitivity to tizanidine or any component of the formulation
- Concomitant use with potent CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin
Drug Interactions
Antihypertensives
Increased risk of hypotension due to additive hypotensive effects. Monitor blood pressure closely.
Oral Contraceptives
May decrease the clearance of tizanidine, potentially leading to higher plasma levels and increased adverse effects. Dose adjustment may be necessary.
Fluvoxamine, Ciprofloxacin
Potent CYP1A2 inhibitors; significantly increase tizanidine plasma concentrations, leading to enhanced adverse effects (e.g., severe hypotension, bradycardia, drowsiness). Concomitant use is contraindicated.
Other CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Increased risk of additive CNS depression (e.g., increased drowsiness, sedation, respiratory depression). Use with caution.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children. Diluted solutions should be used immediately.
Overdose
Symptoms of overdose include severe hypotension, bradycardia, dizziness, drowsiness, agitation, respiratory depression, and coma. Management is primarily supportive: maintain airway, monitor vital signs, and initiate symptomatic treatment. Gastric lavage may be considered if oral ingestion occurred recently. Hemodialysis is not expected to enhance elimination significantly.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies of tizanidine in pregnant women. Tizanidine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether tizanidine is excreted in human milk. Caution should be exercised when tizanidine is administered to a nursing woman.
Side Effects
Contraindications
- Known hypersensitivity to tizanidine or any component of the formulation
- Concomitant use with potent CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin
Drug Interactions
Antihypertensives
Increased risk of hypotension due to additive hypotensive effects. Monitor blood pressure closely.
Oral Contraceptives
May decrease the clearance of tizanidine, potentially leading to higher plasma levels and increased adverse effects. Dose adjustment may be necessary.
Fluvoxamine, Ciprofloxacin
Potent CYP1A2 inhibitors; significantly increase tizanidine plasma concentrations, leading to enhanced adverse effects (e.g., severe hypotension, bradycardia, drowsiness). Concomitant use is contraindicated.
Other CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Increased risk of additive CNS depression (e.g., increased drowsiness, sedation, respiratory depression). Use with caution.
Storage
Store at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children. Diluted solutions should be used immediately.
Overdose
Symptoms of overdose include severe hypotension, bradycardia, dizziness, drowsiness, agitation, respiratory depression, and coma. Management is primarily supportive: maintain airway, monitor vital signs, and initiate symptomatic treatment. Gastric lavage may be considered if oral ingestion occurred recently. Hemodialysis is not expected to enhance elimination significantly.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies of tizanidine in pregnant women. Tizanidine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether tizanidine is excreted in human milk. Caution should be exercised when tizanidine is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 24 to 36 months from the date of manufacture, depending on specific formulation and packaging. Refer to product labeling for exact details.
Availability
Hospitals, retail pharmacies (requires prescription)
Approval Status
Approved by regulatory bodies for specific indications (e.g., DGDA)
Patent Status
Generic available
Clinical Trials
While tizanidine has undergone extensive clinical trials for oral formulations, specific trials for a 25 mg injectable formulation may be limited or conducted for niche indications. Efficacy and safety data are extrapolated from oral data, with consideration for pharmacokinetic differences in injectable forms.
Lab Monitoring
- Liver function tests (ALT, AST) should be monitored at baseline, 1, 3, 6 months, and periodically thereafter, especially during dose escalation or if liver injury is suspected.
- Blood pressure monitoring regularly, especially during initiation and dose adjustments.
Doctor Notes
- Emphasize the importance of gradual dose tapering to prevent withdrawal symptoms upon discontinuation.
- Strictly monitor liver function tests (ALT, AST) at baseline and periodically due to the risk of hepatotoxicity, especially during dose adjustments.
- Advise patients about the potential for hypotension and CNS depression (drowsiness, dizziness) and to avoid activities requiring mental alertness until effects are known.
- Avoid concomitant use with potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) due to significant interaction risk.
Patient Guidelines
- Do not stop Tizaro Injection abruptly. Abrupt discontinuation can lead to withdrawal symptoms such as rebound spasticity, rapid heart rate, and high blood pressure. Consult your doctor for safe tapering.
- Avoid alcohol and other central nervous system depressants while using this medication, as they can increase drowsiness and sedation.
- Be cautious when driving or operating heavy machinery until you know how Tizaro affects you, as it may cause drowsiness, dizziness, or blurred vision.
- Report any signs of liver injury immediately to your doctor (e.g., unexplained nausea, loss of appetite, dark urine, yellowing of skin/eyes, abdominal pain).
Missed Dose Advice
If a dose of Tizaro Injection is missed, administer it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. Consult your physician for specific guidance.
Driving Precautions
Tizaro can cause drowsiness, dizziness, and blurred vision, which may impair your ability to drive or operate machinery. It is advisable to avoid these activities until you are certain how this medicine affects your capabilities.
Lifestyle Advice
- Incorporate regular physical therapy and rehabilitation exercises as recommended by your physician to maximize therapeutic benefits and improve mobility.
- Maintain a balanced diet and adequate hydration to support overall health and recovery.
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