NV-Line  10/0.5mg Tablet

Description

NV-Line  10/0.5mg Tablet –

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1. Pharmacokinetics

Nortriptyline (10mg)

Absorption: Well absorbed orally; peak plasma levels occur in 6–8 hours.

Distribution: Widely distributed; ~95% plasma protein binding.

Metabolism: Metabolized in the liver via CYP2D6 to active metabolites.

Excretion: Mainly in urine as metabolites.

Half-life: Approximately 18–44 hours.

Fluphenazine (0.5mg)

Absorption: Rapid oral absorption; peak plasma concentration in 1–6 hours.

Distribution: Highly protein-bound; accumulates in tissues including brain and liver.

Metabolism: Extensively metabolized in the liver.

Excretion: Primarily via urine and bile.

Half-life: 15–30 hours.

 

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2. Pharmacodynamics

Class: Combination of a tricyclic antidepressant (Nortriptyline) and a typical antipsychotic (Fluphenazine).

Action:

Nortriptyline: Inhibits reuptake of norepinephrine and serotonin, improving mood and emotional balance.

Fluphenazine: Dopamine D2 receptor antagonist, reducing psychotic symptoms like hallucinations and delusions.

Effect: Controls depressive symptoms with psychotic features or agitation.

 

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3. Mechanism of Action

Nortriptyline: Enhances noradrenaline and serotonin levels in synaptic clefts to improve mood.

Fluphenazine: Blocks dopamine receptors in the brain to manage psychosis.

 

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4. Specification

Form: Film-coated tablet

Strength: Nortriptyline 10mg + Fluphenazine 0.5mg

Appearance: Round/oval tablet

Route: Oral

 

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5. Clinical Indications

Depressive episodes with psychotic features

Schizoaffective disorder

Psychotic depression

Chronic depression with agitation or psychomotor disturbances

 

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6. Dosage and Administration

Adults: Usually 1 tablet once or twice daily; dose adjusted according to clinical response.

Elderly: Start with lower dose due to increased sensitivity and slower metabolism.

Administration: Take orally, preferably after meals to reduce gastrointestinal upset.

 

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7. Precautions

Cardiac conditions (arrhythmias, prolonged QT interval)

Epilepsy or seizure disorders

Glaucoma or urinary retention

Hepatic or renal impairment

Caution in elderly due to anticholinergic effects

 

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8. Warnings

Suicidal Risk: Monitor in young adults and depressive patients.

Extrapyramidal Symptoms (EPS): Fluphenazine may cause tremors, rigidity, or tardive dyskinesia.

Serotonin Syndrome: Rare, if combined with other serotonergic drugs.

Withdrawal: Do not stop abruptly; taper under medical supervision.

 

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9. Side Effects

Common:

Dry mouth, constipation, blurred vision

Drowsiness or sedation

Weight gain

Orthostatic hypotension

Serious (rare):

Extrapyramidal symptoms (tremor, dystonia)

Neuroleptic malignant syndrome

Cardiac arrhythmias

Seizures

 

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10. Drug Interactions

Other CNS depressants or alcohol (increased sedation)

MAO inhibitors (risk of hypertensive crisis or serotonin syndrome)

Anticholinergic drugs (enhanced anticholinergic effects)

CYP2D6 inhibitors may increase Nortriptyline levels

 

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11. Storage and Stability

Store below 30°C

Protect from moisture and light

Keep out of reach of children

Shelf-life: 2–3 years

 

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12. Additional Notes

Monitor mood, psychotic symptoms, blood pressure, and ECG during therapy.

Regular follow-up is essential for dosage adjustment and side-effect management.

Patient Advice: Report involuntary movements, palpitations, severe sedation, or mood worsening immediately