Soforal-LP
Generic Name
Venlafaxine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soforal lp 90 mg tablet | ৳ 1,000.00 | N/A |
Description
Overview of the medicine
Soforal-LP 90 mg Tablet contains Venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant. It is primarily used to treat major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder. The prolonged-release formulation allows for once-daily dosing, improving patient compliance.
Uses & Indications
Dosage
Adults
For Major Depressive Disorder (MDD), usual initial dose is 75 mg once daily, titrating up to 225 mg once daily if needed. For Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD), initial dose is typically 37.5 mg once daily, escalating gradually. Soforal-LP 90 mg is often used as an intermediate or maintenance dose, as directed by a physician.
Elderly
No specific dose adjustment is recommended for elderly patients based on age alone, but caution is advised due to potential age-related decrease in renal or hepatic function. Initiate at a lower dose and monitor closely.
Renal_impairment
For moderate renal impairment (GFR 10-70 mL/min), a 25-50% reduction in total daily dose is recommended. For severe renal impairment (GFR < 10 mL/min) or hemodialysis patients, a 50% reduction in total daily dose is recommended.
How to Take
Soforal-LP 90 mg Tablet should be taken orally once daily, preferably with food, at approximately the same time each day. Tablets should be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
Mechanism of Action
Venlafaxine works by selectively inhibiting the reuptake of serotonin and norepinephrine, and weakly dopamine, in the central nervous system. This action increases the availability of these neurotransmitters in the synaptic cleft, leading to improved mood, reduced anxiety, and alleviation of depression symptoms.
Pharmacokinetics
Onset
Initial antidepressant effects may be observed within 1-2 weeks, with full therapeutic effects often seen after 4-6 weeks of consistent treatment.
Excretion
Approximately 87% of a venlafaxine dose is excreted in the urine within 48 hours, predominantly as ODV and its conjugates, and to a lesser extent as unconjugated venlafaxine.
Half life
Venlafaxine has a half-life of approximately 5 hours, while its major active metabolite, O-desmethylvenlafaxine (ODV), has a half-life of about 11 hours.
Absorption
Well absorbed from the gastrointestinal tract; absorption is not significantly affected by food. Peak plasma concentrations of venlafaxine XR are reached in approximately 5.5 hours for venlafaxine and 9 hours for its active metabolite ODV.
Metabolism
Extensively metabolized in the liver, primarily to its active metabolite O-desmethylvenlafaxine (ODV) by CYP2D6, and to a lesser extent by other CYP isoenzymes.
Side Effects
Contraindications
- Hypersensitivity to venlafaxine or any component of the formulation
- Concomitant use or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs) due to risk of serious, potentially fatal serotonin syndrome
- Concomitant use with linezolid or intravenous methylene blue
Drug Interactions
MAOIs
Concomitant use is contraindicated due to the risk of serotonin syndrome, which can be fatal.
Warfarin
Increased risk of bleeding due to potential alteration of platelet aggregation or prothrombin time.
CNS Depressants (e.g., Alcohol, Benzodiazepines)
May potentiate CNS depressant effects; use with caution.
CYP2D6 Inhibitors (e.g., Quinidine, Paroxetine, Fluoxetine)
May increase venlafaxine and decrease ODV plasma concentrations, potentially requiring dose adjustments.
Other Serotonergic Drugs (e.g., SSRIs, SNRIs, Triptans, Tramadol, Linezolid, Lithium, St. John's Wort)
Increased risk of serotonin syndrome; monitor patients closely.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, convulsions, and serotonin syndrome. There is no specific antidote. Treatment should be supportive and symptomatic, involving maintaining a clear airway, monitoring cardiac rhythm, and vital signs. Activated charcoal may be useful if administered soon after ingestion.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications. Venlafaxine and its active metabolite are excreted in breast milk; therefore, caution is advised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to venlafaxine or any component of the formulation
- Concomitant use or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs) due to risk of serious, potentially fatal serotonin syndrome
- Concomitant use with linezolid or intravenous methylene blue
Drug Interactions
MAOIs
Concomitant use is contraindicated due to the risk of serotonin syndrome, which can be fatal.
Warfarin
Increased risk of bleeding due to potential alteration of platelet aggregation or prothrombin time.
CNS Depressants (e.g., Alcohol, Benzodiazepines)
May potentiate CNS depressant effects; use with caution.
CYP2D6 Inhibitors (e.g., Quinidine, Paroxetine, Fluoxetine)
May increase venlafaxine and decrease ODV plasma concentrations, potentially requiring dose adjustments.
Other Serotonergic Drugs (e.g., SSRIs, SNRIs, Triptans, Tramadol, Linezolid, Lithium, St. John's Wort)
Increased risk of serotonin syndrome; monitor patients closely.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, vomiting, tachycardia, convulsions, and serotonin syndrome. There is no specific antidote. Treatment should be supportive and symptomatic, involving maintaining a clear airway, monitoring cardiac rhythm, and vital signs. Activated charcoal may be useful if administered soon after ingestion.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications. Venlafaxine and its active metabolite are excreted in breast milk; therefore, caution is advised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Patent expired, generics available
Clinical Trials
Venlafaxine has undergone numerous placebo-controlled and active-comparator clinical trials demonstrating its efficacy and safety in the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder, and panic disorder across diverse patient populations. Long-term studies have supported its sustained efficacy and tolerability.
Lab Monitoring
- Monitor blood pressure and heart rate regularly, especially during dose escalation and at higher doses.
- Periodically monitor serum sodium levels, especially in elderly patients or those on diuretics.
- Consider periodic liver function tests for patients with pre-existing hepatic impairment or during long-term therapy.
- Monitor cholesterol levels periodically.
Doctor Notes
- Regularly monitor blood pressure, especially at higher doses, due to the dose-related risk of hypertension associated with venlafaxine.
- Educate patients thoroughly about the importance of not discontinuing the medication abruptly to avoid withdrawal symptoms, and provide a clear tapering schedule if discontinuation is planned.
- Be vigilant for signs of clinical worsening or suicidality, particularly during the initial phases of treatment or dose adjustments, and ensure close follow-up.
- Consider ECG monitoring in patients with pre-existing cardiac conditions or those at risk of cardiovascular events.
Patient Guidelines
- Take this medication exactly as prescribed by your doctor and do not stop taking it suddenly without consulting your doctor, as this can lead to severe withdrawal symptoms.
- Swallow the tablet whole; do not crush, chew, or dissolve it to maintain its prolonged-release properties.
- Report any new or worsening symptoms of depression, suicidal thoughts, or unusual changes in behavior to your doctor immediately.
- Avoid alcohol while on this medication as it can increase CNS depression and other side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next scheduled 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
Soforal-LP may cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Engage in regular physical activity, which can help improve mood and reduce anxiety.
- Maintain a balanced diet and adequate sleep hygiene to support overall mental well-being.
- Practice stress-reduction techniques such as meditation or yoga to manage stress levels.
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