Midita
Generic Name
Sertraline
Manufacturer
Hypothetical Pharma Co.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| midita 50 mg tablet | ৳ 42.00 | ৳ 168.00 |
Description
Overview of the medicine
Midita 50 mg tablet contains Sertraline, which is an antidepressant medication belonging to the Selective Serotonin Reuptake Inhibitor (SSRI) class. It is primarily used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder.
Uses & Indications
Dosage
Adults
Initial dose is usually 50 mg once daily. Dosage may be increased gradually, typically at weekly intervals, up to a maximum of 200 mg/day depending on clinical response and tolerability.
Elderly
Lower initial doses (e.g., 25 mg/day) may be considered, and dosage should be titrated carefully due to potential for reduced clearance and increased sensitivity.
Renal_impairment
No dosage adjustment is generally required for mild to moderate renal impairment. Caution is advised in severe renal impairment as sertraline has not been extensively studied in this population.
How to Take
Midita tablets should be taken orally, once daily, either in the morning or evening. It can be taken with or without food. Swallow the tablet whole with water; do not chew or crush.
Mechanism of Action
Sertraline selectively inhibits the reuptake of serotonin by the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft. This leads to enhanced serotonergic neurotransmission in the central nervous system, contributing to its antidepressant and anxiolytic effects.
Pharmacokinetics
Onset
Clinical effects typically begin within 2-4 weeks, but full therapeutic benefits may take longer (6-8 weeks).
Excretion
Excreted almost equally in feces (approximately 40-45%) and urine (approximately 40-45%) as metabolites. Less than 0.2% is excreted unchanged in urine.
Half life
Approximately 26 hours for sertraline itself, and 62 to 104 hours for its active metabolite, N-desmethylsertraline.
Absorption
Well absorbed orally; peak plasma concentrations reached 4.5 to 8.4 hours after administration. Bioavailability is approximately 44%. Food has a minimal effect on absorption.
Metabolism
Extensively metabolized in the liver, primarily via CYP2B6, CYP2C19, CYP2D6, and CYP3A4 enzymes, to its major active metabolite, N-desmethylsertraline.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy (risk of serotonin syndrome).
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Alcohol
Avoid concomitant use due to potential for increased central nervous system (CNS) depressant effects.
Pimozide
Significantly increased plasma levels of pimozide, leading to QT prolongation and potential for serious cardiac events.
Warfarin
May enhance the anticoagulant effect of warfarin, leading to increased bleeding risk. Monitor INR closely.
NSAIDs (e.g., Ibuprofen, Aspirin)
Increased risk of bleeding, especially gastrointestinal bleeding.
MAOIs (e.g., Selegiline, Phenelzine)
Increased risk of serotonin syndrome, which can be life-threatening.
Other Serotonergic Drugs (e.g., Triptans, Fentanyl, Lithium, Tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C, in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely coma. Management is supportive and symptomatic, including maintaining a clear airway, monitoring cardiac and vital signs, and standard measures for gastric emptying (e.g., activated charcoal). There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline is excreted in breast milk in small amounts; caution should be exercised when administered to a nursing woman. Consult a doctor before use during pregnancy or lactation.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy (risk of serotonin syndrome).
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Alcohol
Avoid concomitant use due to potential for increased central nervous system (CNS) depressant effects.
Pimozide
Significantly increased plasma levels of pimozide, leading to QT prolongation and potential for serious cardiac events.
Warfarin
May enhance the anticoagulant effect of warfarin, leading to increased bleeding risk. Monitor INR closely.
NSAIDs (e.g., Ibuprofen, Aspirin)
Increased risk of bleeding, especially gastrointestinal bleeding.
MAOIs (e.g., Selegiline, Phenelzine)
Increased risk of serotonin syndrome, which can be life-threatening.
Other Serotonergic Drugs (e.g., Triptans, Fentanyl, Lithium, Tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C, in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, tremor, agitation, dizziness, and rarely coma. Management is supportive and symptomatic, including maintaining a clear airway, monitoring cardiac and vital signs, and standard measures for gastric emptying (e.g., activated charcoal). There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline is excreted in breast milk in small amounts; caution should be exercised when administered to a nursing woman. Consult a doctor before use during pregnancy or lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, when stored under recommended conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved (FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Sertraline has undergone extensive clinical trials demonstrating its efficacy and safety in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, and other anxiety-related conditions across various populations.
Lab Monitoring
- No specific routine lab monitoring is required. However, liver function tests may be considered in patients with hepatic impairment. Serum sodium levels should be monitored in elderly patients or those taking diuretics due to the risk of hyponatremia.
Doctor Notes
- Gradual dose titration is recommended to minimize initial side effects.
- Monitor patients for clinical worsening and suicidality, especially at the beginning of treatment or after dose changes.
- Be aware of potential drug-drug interactions, particularly with other serotonergic agents and MAOIs.
Patient Guidelines
- Take Midita regularly as prescribed by your doctor, do not stop abruptly without consulting your doctor.
- It may take several weeks to feel the full benefits; continue treatment even if you don't see immediate improvement.
- Report any worsening of depression, suicidal thoughts, or unusual changes in behavior to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Midita may cause dizziness, drowsiness, or blurred vision. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that sertraline therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Avoid alcohol consumption while taking Midita, as it can worsen side effects. Maintain a healthy lifestyle, including regular exercise and a balanced diet, which can complement your treatment. Consider psychotherapy in conjunction with medication.
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