Trilin B
Generic Name
Nortriptyline + Fluphenazine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| trilin b 100 mg tablet | ৳ 11.00 | N/A |
Description
Overview of the medicine
Trilin B is a combination medication containing a tricyclic antidepressant (Nortriptyline) and a phenothiazine antipsychotic (Fluphenazine). It is primarily used to treat mixed anxiety-depressive neuroses, psychosomatic disorders, and certain anxiety states with depression.
Uses & Indications
Dosage
Adults
Initial dose typically 1 tablet (10 mg Nortriptyline / 0.5 mg Fluphenazine) 1 to 3 times daily. Dosage should be individualized based on patient response and tolerability, not exceeding recommended maximums.
Elderly
Lower starting doses are recommended (e.g., half an adult dose), with slow and careful titration due to increased sensitivity to side effects.
Renal_impairment
Use with caution. Dose adjustment may be necessary in severe renal impairment, though primarily hepatically metabolized.
How to Take
Administer orally, with or without food. It is recommended to take doses at regular intervals.
Mechanism of Action
Nortriptyline, a tricyclic antidepressant, inhibits the reuptake of norepinephrine and serotonin in the central nervous system, thereby increasing their concentrations in the synaptic cleft. Fluphenazine, a phenothiazine derivative, acts as a dopamine D2 receptor antagonist in the brain.
Pharmacokinetics
Onset
Clinical effects for anxiety may be seen within a few days, but full antidepressant effects of Nortriptyline may take 2-4 weeks. Antipsychotic effects of Fluphenazine can be observed sooner.
Excretion
Primarily excreted in urine as metabolites, with a small portion excreted in feces.
Half life
Nortriptyline has a half-life ranging from 15 to 90 hours. Fluphenazine has a half-life of 13-58 hours (oral).
Absorption
Both Nortriptyline and Fluphenazine are well absorbed orally. Peak plasma concentrations for Nortriptyline are reached within 7-8 hours, and for Fluphenazine within 2-4 hours.
Metabolism
Both components undergo extensive hepatic metabolism, primarily via the cytochrome P450 (CYP) enzyme system (e.g., CYP2D6 for Nortriptyline).
Side Effects
Contraindications
- Hypersensitivity to Nortriptyline, Fluphenazine, or any component of the formulation
- Acute recovery phase after myocardial infarction
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Narrow-angle glaucoma
- Urinary retention
- Severe liver disease
- Bone marrow depression
Drug Interactions
MAOIs
Can lead to severe, potentially fatal reactions (serotonin syndrome).
Antihypertensives
May antagonize the hypotensive effects of certain drugs (e.g., guanethidine).
Anticholinergic drugs
Increased anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention).
CNS Depressants (alcohol, benzodiazepines, opioids)
Enhanced sedative effects and CNS depression.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
Can increase Nortriptyline plasma levels, leading to toxicity.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe drowsiness, confusion, agitation, seizures, cardiac arrhythmias (tachycardia, QT prolongation), hypotension, respiratory depression, coma, and anticholinergic effects. Management: Symptomatic and supportive treatment. Maintain airway, monitor cardiac function, and correct electrolyte imbalances. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C/D (Nortriptyline). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both Nortriptyline and Fluphenazine are excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to Nortriptyline, Fluphenazine, or any component of the formulation
- Acute recovery phase after myocardial infarction
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Narrow-angle glaucoma
- Urinary retention
- Severe liver disease
- Bone marrow depression
Drug Interactions
MAOIs
Can lead to severe, potentially fatal reactions (serotonin syndrome).
Antihypertensives
May antagonize the hypotensive effects of certain drugs (e.g., guanethidine).
Anticholinergic drugs
Increased anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention).
CNS Depressants (alcohol, benzodiazepines, opioids)
Enhanced sedative effects and CNS depression.
CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine)
Can increase Nortriptyline plasma levels, leading to toxicity.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe drowsiness, confusion, agitation, seizures, cardiac arrhythmias (tachycardia, QT prolongation), hypotension, respiratory depression, coma, and anticholinergic effects. Management: Symptomatic and supportive treatment. Maintain airway, monitor cardiac function, and correct electrolyte imbalances. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C/D (Nortriptyline). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both Nortriptyline and Fluphenazine are excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture when stored under recommended conditions.
Availability
Available in pharmacies and hospitals in Bangladesh
Approval Status
Approved
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
The combination of Nortriptyline and Fluphenazine has been studied in various clinical trials for its efficacy in treating anxiety-depressive states. It is a well-established combination, although newer agents are also available.
Lab Monitoring
- Baseline and periodic ECG (due to cardiac effects, especially Nortriptyline)
- Liver function tests (LFTs) due to hepatic metabolism
- Complete Blood Count (CBC) for possible blood dyscrasias
- Serum electrolyte levels (especially in patients at risk of cardiac arrhythmias)
- Plasma drug levels (Nortriptyline) if clinical response is poor or toxicity is suspected
Doctor Notes
- Monitor for signs of Neuroleptic Malignant Syndrome (NMS) and Tardive Dyskinesia (TD), especially with Fluphenazine component.
- Assess for suicidal ideation, particularly in younger patients, at the start of treatment and during dose changes.
- Gradual dose reduction is essential upon discontinuation to avoid withdrawal symptoms.
Patient Guidelines
- Do not stop taking this medication abruptly; gradual withdrawal under medical supervision is necessary to avoid withdrawal symptoms.
- Avoid alcohol consumption as it can increase drowsiness and other side effects.
- Report any unusual symptoms, especially changes in mood, suicidal thoughts, or uncontrolled movements (tardive dyskinesia).
- Be aware of orthostatic hypotension (dizziness upon standing) and rise slowly.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medication may cause drowsiness, dizziness, or blurred vision, which can impair your ability to drive or operate machinery safely. Exercise caution and avoid such activities until you are certain you can perform them safely.
Lifestyle Advice
- Avoid driving or operating heavy machinery until you know how this medication affects you, due to potential drowsiness or blurred vision.
- Maintain adequate hydration to help manage dry mouth and constipation.
- Regular exercise and a balanced diet can help manage potential weight gain.
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