Pantodone L Capsule

Description

Pantodone L Capsule

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1. Pharmacokinetics

Pantoprazole 40mg ER

Absorption: Rapid; peak plasma concentration in 2–3 hours.

Distribution: Widely distributed; plasma protein binding ~98%.

Metabolism: Hepatic via CYP2C19.

Excretion: Mainly urine (~71%) and feces (~18%).

Half-life: 1–2 hours (prolonged effect due to enteric coating).

Levosulpiride 75mg SR

Absorption: Well absorbed; peak plasma concentration in 3–4 hours (sustained release).

Distribution: Plasma protein binding 30%.

Metabolism: Liver metabolism.

Excretion: Urine and feces; unchanged and as metabolites.

Half-life: ~6–8 hours (sustained release formulation).

 

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2. Pharmacodynamics

Class: Proton pump inhibitor (Pantoprazole) + Prokinetic, dopamine antagonist (Levosulpiride)

Action:

Pantoprazole: Inhibits gastric acid secretion by blocking H+/K+ ATPase in parietal cells.

Levosulpiride: Enhances gastrointestinal motility, improves gastric emptying, and has antiemetic effects.

Effect: Reduces acid-related symptoms, relieves nausea, bloating, and dyspepsia, and promotes gastric motility.

 

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3. Mechanism of Action

Pantoprazole: Suppresses basal and stimulated gastric acid secretion by irreversibly binding to gastric proton pumps.

Levosulpiride: Blocks dopamine D2 receptors in the gut and central nervous system, increasing motility and controlling nausea/vomiting.

 

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4. Specification

Form: Capsule, Extended/Sustained Release

Strength: Pantoprazole 40mg ER + Levosulpiride 75mg SR

Route: Oral

 

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5. Clinical Indications

Gastroesophageal reflux disease (GERD)

Functional dyspepsia

Gastritis and peptic ulcer disease

Nausea, vomiting, and bloating associated with delayed gastric emptying

Acid-related gastrointestinal disorders with motility dysfunction

 

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6. Dosage and Administration

Adults: 1 capsule once daily, 30 minutes before meals, or as prescribed by a physician

Administration: Swallow whole; do not crush or chew

Duration: As advised by a healthcare professional

 

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7. Precautions

Caution in patients with liver or kidney impairment

Not recommended in children under 18 years without medical supervision

Avoid in patients with known hypersensitivity to Pantoprazole or Levosulpiride

 

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8. Warnings

Long-term PPI therapy may cause vitamin B12 deficiency, hypomagnesemia, or bone fractures

Rare risk of extrapyramidal symptoms with Levosulpiride

May mask symptoms of serious GI conditions; rule out malignancy if symptoms persist

 

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9. Side Effects

Common:

Headache, dizziness

Abdominal pain, nausea, diarrhea

Flatulence, bloating

Serious (rare):

Extrapyramidal symptoms (tremor, rigidity)

Liver enzyme elevation

Allergic reactions (rash, swelling, anaphylaxis)

Cardiac arrhythmias

 

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10. Drug Interactions

Pantoprazole may reduce absorption of drugs requiring acidic pH (e.g., ketoconazole, atazanavir)

Levosulpiride may interact with CNS depressants or antipsychotics

Avoid concurrent use with QT-prolonging drugs

 

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11. Storage and Stability

Store below 25°C

Protect from light and moisture

Keep out of reach of children

Shelf-life: 2–3 years

 

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12. Additional Notes

Take 30 minutes before meals for maximum effect

Do not exceed prescribed dose; consult physician for persistent symptoms

Patient Advice: Report severe abdominal pain, persistent vomiting, involuntary movements, or jaundice immediately