Serolux
Generic Name
Sertraline Hydrochloride
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| serolux 25 mg tablet | ৳ 4.10 | ৳ 41.00 |
Description
Overview of the medicine
Serolux 25 mg Tablet is an antidepressant belonging to the Selective Serotonin Reuptake Inhibitor (SSRI) class of medicines. It is primarily used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). It helps improve mood, sleep, appetite, and energy levels, and can help restore interest in daily living.
Uses & Indications
Dosage
Adults
Initial dose of 25 mg or 50 mg once daily, depending on the indication. Dosage may be increased gradually, typically by 25 mg increments at weekly intervals, up to a maximum of 200 mg once daily.
Elderly
Elderly patients may be more sensitive to the effects of sertraline. Initial doses should be at the lower end of the adult range (e.g., 25 mg once daily) and titrated cautiously.
Renal_impairment
No dosage adjustment is generally required for patients with mild to moderate renal impairment. Caution is advised in severe renal impairment due to limited data.
How to Take
Take Serolux 25 mg Tablet orally, once daily, with or without food. It is recommended to take it at the same time each day to maintain consistent drug levels. Do not crush, chew, or break the tablet; swallow it whole.
Mechanism of Action
Sertraline, the active ingredient in Serolux, selectively inhibits the reuptake of serotonin (5-HT) by the presynaptic neuron. This leads to an increase in serotonin concentration in the synaptic cleft, enhancing serotonergic neurotransmission in the central nervous system, which is believed to be responsible for its antidepressant and anxiolytic effects.
Pharmacokinetics
Onset
Therapeutic effects typically begin within 2 to 4 weeks of regular treatment, although some patients may experience benefits sooner.
Excretion
Approximately 40-45% of the dose is excreted in the feces, and about 12-14% is excreted in the urine as metabolites. Only a small amount of unchanged sertraline is excreted.
Half life
The mean elimination half-life of sertraline is approximately 26 hours (range 22-36 hours). The half-life of its major active metabolite, N-desmethylsertraline, is longer, around 62-104 hours.
Absorption
Sertraline is well absorbed after oral administration, with peak plasma concentrations occurring between 4.5 to 8.4 hours after dosing. Food slightly increases the absorption rate and AUC.
Metabolism
Sertraline undergoes extensive first-pass metabolism in the liver by multiple cytochrome P450 (CYP) isoforms, primarily CYP2D6, CYP2B6, CYP2C19, CYP3A4, and CYP2C9, to form its primary metabolite, N-desmethylsertraline, which is less active.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping an MAOI.
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Alcohol
Enhances CNS depressant effects; concomitant use is not recommended.
Pimozide
Increased pimozide levels and QT prolongation due to CYP3A4 inhibition.
Warfarin
May increase prothrombin time/INR, leading to increased bleeding risk.
Triptans (e.g., Sumatriptan)
Increased risk of Serotonin Syndrome.
NSAIDs (e.g., Aspirin, Ibuprofen)
Increased risk of bleeding, especially gastrointestinal bleeding.
Monoamine Oxidase Inhibitors (MAOIs)
Concomitant use can lead to serious, sometimes fatal, reactions including Serotonin Syndrome.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, nausea, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, seizures or coma. There is no specific antidote. Treatment should be supportive and symptomatic. Gastric lavage and activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown adverse effects on the fetus; there are no adequate and well-controlled studies in pregnant women. Serolux should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline and its metabolite are excreted in human breast milk. Caution should be exercised when Serolux is administered to a nursing mother. Consult your doctor before use during pregnancy or lactation.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping an MAOI.
- Concomitant use with pimozide.
- Known hypersensitivity to sertraline or any component of the formulation.
Drug Interactions
Alcohol
Enhances CNS depressant effects; concomitant use is not recommended.
Pimozide
Increased pimozide levels and QT prolongation due to CYP3A4 inhibition.
Warfarin
May increase prothrombin time/INR, leading to increased bleeding risk.
Triptans (e.g., Sumatriptan)
Increased risk of Serotonin Syndrome.
NSAIDs (e.g., Aspirin, Ibuprofen)
Increased risk of bleeding, especially gastrointestinal bleeding.
Monoamine Oxidase Inhibitors (MAOIs)
Concomitant use can lead to serious, sometimes fatal, reactions including Serotonin Syndrome.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, nausea, vomiting, tachycardia, tremor, agitation, dizziness, and rarely, seizures or coma. There is no specific antidote. Treatment should be supportive and symptomatic. Gastric lavage and activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown adverse effects on the fetus; there are no adequate and well-controlled studies in pregnant women. Serolux should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sertraline and its metabolite are excreted in human breast milk. Caution should be exercised when Serolux is administered to a nursing mother. Consult your doctor before use during pregnancy or lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies nationwide
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Sertraline has undergone extensive clinical trials supporting its efficacy and safety for various indications. Ongoing post-marketing surveillance and studies continue to monitor its long-term effects and potential new uses.
Lab Monitoring
- Liver function tests (periodically, especially in patients with pre-existing hepatic impairment)
- Serum sodium levels (especially in elderly patients, those on diuretics, or volume-depleted patients, due to risk of hyponatremia)
- Thyroid function tests (if clinically indicated)
Doctor Notes
- Monitor patients for clinical worsening and suicidality, especially at the beginning of treatment or after dose changes.
- Counsel patients regarding potential sexual dysfunction and weight changes.
- Caution advised when prescribing with other serotonergic agents due to the risk of Serotonin Syndrome.
- Consider baseline and periodic liver function tests in patients with hepatic impairment.
Patient Guidelines
- Take Serolux exactly as prescribed by your doctor. Do not change the dose or stop taking it without consulting your doctor, as abrupt discontinuation can lead to withdrawal symptoms.
- It may take 2-4 weeks to feel the full effects of the medicine. Continue taking it even if you don't feel better immediately.
- Report any unusual mood changes, worsening depression, or suicidal thoughts to your doctor immediately.
- Avoid alcohol while taking this medicine.
Missed Dose Advice
If you miss a dose of Serolux, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Serolux may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Serolux therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Engage in regular physical activity to help manage mood and stress.
- Maintain a balanced diet and ensure adequate sleep.
- Consider psychotherapy or counseling in conjunction with medication for better outcomes.
- Practice stress-reduction techniques like meditation or yoga.
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