Zosectra DSR

Domperidone (30mg) + Pantoprazole (40mg)
Price: ₹110 - ₹170 for 10 tablets strip (MRP)
Mfr: Zydus Cadila | Form: Tablet

📋 Clinical Overview

A fixed-dose combination (FDC) of a prokinetic antiemetic (Domperidone) and a proton pump inhibitor (Pantoprazole). Domperidone enhances gastric motility and acts as an antiemetic via peripheral dopamine D2 receptor antagonism. Pantoprazole provides potent, long-lasting suppression of gastric acid secretion by irreversibly inhibiting the H+/K+ ATPase enzyme system (proton pump) of the gastric parietal cell. This combination is primarily used for the management of gastroesophageal reflux disease (GERD) and other acid-peptic disorders where delayed gastric emptying and nausea/vomiting are significant components.

💊 Dosage & Administration

Adult: One tablet (Domperidone 30mg + Pantoprazole 40mg) once daily, preferably 30-60 minutes before a meal (typically breakfast). The maximum recommended duration of Domperidone use is usually 1 week for nausea/vomiting. For GERD, Pantoprazole may be continued for 4-8 weeks as per clinical need. Do NOT exceed one tablet per day.

Note: Swallow the tablet whole with a glass of water. Do NOT crush, chew, or break. Should be taken on an empty stomach, at least 30-60 minutes before a meal (ideally before breakfast) for optimal absorption and effect. If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose.

⚠️ Contraindications

  • Known hypersensitivity to Domperidone, Pantoprazole, or any substituted benzimidazole
  • Prolactin-releasing pituitary tumor (prolactinoma)
  • Conditions where gastrointestinal stimulation might be dangerous (e.g., gastrointestinal hemorrhage, mechanical obstruction, perforation)
  • Moderate to severe hepatic impairment (Child-Pugh B & C) for this FDC
  • Concomitant use with potent CYP3A4 inhibitors (e.g., Ketoconazole, Fluconazole, Voriconazole, Clarithromycin, Ritonavir, Nelfinavir) due to increased risk of Domperidone toxicity
  • Existing or history of significant cardiac conditions (e.g., congestive heart failure, clinically significant bradycardia, existing QTc prolongation >450ms in men/470ms in women, electrolyte disturbances)

🔬 Mechanism of Action

Domperidone acts as a selective peripheral dopamine D2 and D3 receptor antagonist. It blocks dopamine receptors in the chemoreceptor trigger zone (CTZ) and the gastric wall. Blockade in the CTZ produces an antiemetic effect. Blockade in the upper GI tract increases lower esophageal sphincter pressure, enhances gastric peristalsis and antral contractions, and improves gastroduodenal coordination, thereby accelerating gastric emptying. Pantoprazole is a substituted benzimidazole prodrug. It is activated in the acidic environment of the parietal cell canaliculus to a sulfenamide derivative. This active form covalently binds to cysteine residues on the luminal surface of the H+/K+ ATPase enzyme (proton pump), irreversibly inhibiting its function, thereby suppressing the final step of gastric acid secretion.

🤕 Side Effects

  • Headache
  • Dry mouth
  • Diarrhea
  • Abdominal pain/cramps
  • Flatulence
  • Constipation
  • Dizziness
  • Fatigue
  • Itching/Rash

🤰 Special Populations

Pregnancy: Category B (US FDA) for Pantoprazole. Domperidone: Data limited. Use during pregnancy only if clearly needed. Domperidone is secreted in breast milk and may affect infant. Avoid in the first trimester unless absolutely necessary.

Driving: Domperidone may rarely cause dizziness, drowsiness, or visual disturbances. Patients should be cautioned about operating machinery or driving until they are sure they are not affected.

🔄 Drug Interactions

Ketoconazole, Itraconazole, Posaconazole, VoriconazolePotent CYP3A4 inhibitors. Significantly increase Domperidone plasma levels, raising the risk of QTc prolongation and serious cardiac arrhythmias. CONTRAINDICATED.High
Clarithromycin, Erythromycin, TelithromycinCYP3A4 inhibitors and also prolong QTc. Synergistic risk of life-threatening arrhythmias with Domperidone. CONTRAINDICATED.High
Protease Inhibitors (Ritonavir, Saquinavir, Nelfinavir)Potent CYP3A4 inhibitors. Increase Domperidone levels. CONTRAINDICATED.High
Amiodarone, Dronedarone, Quinidine, Procainamide, SotalolOther QTc-prolonging drugs. Additive risk of arrhythmias with Domperidone. Avoid combination.High
AntacidsMay interfere with the absorption of Pantoprazole. Administer Pantoprazole at least 2 hours before or after antacids.Moderate
Warfarin, AcenocoumarolPantoprazole may interact with CYP2C19, potentially altering INR. Monitor INR closely when starting or stopping Pantoprazole.Moderate
Methotrexate (especially high-dose)PPIs like Pantoprazole may decrease renal clearance of methotrexate, leading to increased toxicity. Monitor closely.Moderate
DigoxinDomperidone may increase the absorption of Digoxin by accelerating gastric emptying. Monitor Digoxin levels.Moderate
FluconazoleModerate CYP3A4/CYP2C19 inhibitor. May increase levels of both drugs. Use with extreme caution and monitor for Domperidone toxicity.Moderate
Phenytoin, Phenobarbital, RifampicinCYP450 inducers. May decrease plasma levels of Pantoprazole and Domperidone, reducing efficacy.Moderate
Atazanavir, NelfinavirPPIs like Pantoprazole significantly reduce their absorption and plasma concentration, leading to loss of virologic response. Avoid concomitant use.High
ClopidogrelPantoprazole, a CYP2C19 inhibitor, may reduce the antiplatelet effect of Clopidogrel (a prodrug activated by CYP2C19). Consider using an alternative PPI like Pantoprazole (controversial, but considered lower risk) or H2RA, or monitor therapy. The clinical significance is debated.Moderate

🔁 Alternatives to Zosectra DSR

Same composition (Domperidone (30mg) + Pantoprazole (40mg)), different brands:

Pantop DSR Pansec DSR Pantafol DSR Pentab DSR Panto-D