Pantoflux® 40
Pantoflux® 40
Antacid/AntiUlcerant & AntiFlatulent

Indication

Pantoflux® tablet is indicated in the following cases:

  • In combination with two appropriate antibiotics for the eradication of helicobacter pylori in patients with peptic ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
  •  For short term treatment (up to 8weeks) In the healing and symptomatic relieve of erosive esophagitis associated with gastro esophageal reflux disease( GERD).
  •  For long term treatment of pathological hypersecretory conditions, including Zollinger Ellison syndrome.
  •  For prophylaxis of NSAID associated gastric or duodenal ulcer, in patients with increased risk.

Composition

Each enteric coated  tablet of Pantoflux® 40 contain:

  • Pantoprazole sodium sesquihydrate 40 mg.

Each enteric coated tablet of Pantoflux® 20 contain:

  • Pantoprazole sodium sesquihydrate 20 mg.

Dosage

Pantoflux ® should be swallowed whole with water 1 hour before breakfast.

  • Gastro-esophageal reflux disease: one tablet  of Pantoprazole 40 mg daily in the  morning  for  4 weeks ,followed  by further 4 weeks if not fully healed.
  • Benign gastric ulcer: one tablet 40 mg daily in the morning for 4 weeks, followed by further 4 weeks if not fully healed.
  • Duodenal ulcer: One tablet of Pantoprazole 40 daily in the morning for 2weeks, followed by further 2weeks if not fully healed.
  • Duodenal ulcer associated with H. pylori: one tablet of Pantoprazole 40mg twice daily along with Clarithromycin 500mg and Amoxicillin 1000 mg twice daily or Metronidazole 500mg   twice daily for 10-14 days.
  • Zollinger Ellison syndrome and other hyper-secretory conditions: Initially, 80 mg once daily adjusted according to response (Elderly, maximum 40mg daily).
  • Prophylaxis of  NSAID associated gastric or duodenal ulcer in patients with increased risk of gastro-duodenal complications who require continued NSAID treatment: one tablet of Pantoprazole  20 daily.
     
  • Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)- ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.
  • Pantoprazole is rapidly absorbed , oral bioavailability is 77%. It is highly bound to plasma proteins (98%) and undergoes extensive hepatic metabolism by CYP2C19 & excreted mainly renally.
  • Pantoprazole absorption is not affected by concomitant administration of antacids & administration of Pantoprazole with food may delay its absorption up to 2 hours or longer, but C max & extent of Pantoprazole absorption are not affected.

Each enteric coated  tablet of Pantoflux® 40 contain:

  • Pantoprazole sodium sesquihydrate 40 mg.

Each enteric coated tablet of Pantoflux® 20 contain:

  • Pantoprazole sodium sesquihydrate 20 mg.

Pantoflux® tablet is indicated in the following cases:

  • In combination with two appropriate antibiotics for the eradication of helicobacter pylori in patients with peptic ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
  •  For short term treatment (up to 8weeks) In the healing and symptomatic relieve of erosive esophagitis associated with gastro esophageal reflux disease( GERD).
  •  For long term treatment of pathological hypersecretory conditions, including Zollinger Ellison syndrome.
  •  For prophylaxis of NSAID associated gastric or duodenal ulcer, in patients with increased risk.
  • Hypersensitivity to Pantoflux® product.
  •  Pantoflux® may reduce the absorption of drugs whose bioavailability is pH–dependent e.g( Ketoconazole, Itraconazole and other Azole antifungals, Ampicillin, Esters, and Iron salts).
  • Interaction of Pantoflux® with other drugs which are metabolized by cytochrome P450 enzyme system cannot be excluded noteworthy plasma concentration, of digoxin possibly increased.
  • No clinical significant interactions were observed, studies have been carried out on Carbamazepine, Caffeine, Diazepam, Diclofenac, Ethanol, Glibenclamide, Metoprolol, Nifiedipine, Phynetoin, Theophylline, Warfarin and oral contraceptives.
  • No clinically relevant interactions were observed with concomitantly administered antacids, Clarithromycin, Metronidazole and Amoxicillin.
  • Pantoflux® should be used with caution in pregnancy and breastfeeding and should only be used when the potential benefits outweigh risks.
  • Gastrointestinal tract disturbances including: nausea, vomiting, abdominal pain, flatulence, diarrhea or constipation, and dizziness
  • Rarely: dry mouth ,insomnia, drowsiness, malaise, blurred vision.
  • Very rarely: taste disturbances, liver dysfunction, hypersensitive reactions including, urticaria,peripheral edema, angioedema, bronchospasm, sweating, anaphylaxis, fever, photosensitivity, depression, intestinal nephritis, blood disorders, arthralgia, myalgia and skin reactions.
  • May increase the risk of gastro-intestinal tract infections.
  • Also reported raised triglycerides in some case.

Overdose:

  • There are no known symptoms of overdosing in human, in any case, the doctor must be consulted.

Pantoflux ® should be swallowed whole with water 1 hour before breakfast.

  • Gastro-esophageal reflux disease: one tablet  of Pantoprazole 40 mg daily in the  morning  for  4 weeks ,followed  by further 4 weeks if not fully healed.
  • Benign gastric ulcer: one tablet 40 mg daily in the morning for 4 weeks, followed by further 4 weeks if not fully healed.
  • Duodenal ulcer: One tablet of Pantoprazole 40 daily in the morning for 2weeks, followed by further 2weeks if not fully healed.
  • Duodenal ulcer associated with H. pylori: one tablet of Pantoprazole 40mg twice daily along with Clarithromycin 500mg and Amoxicillin 1000 mg twice daily or Metronidazole 500mg   twice daily for 10-14 days.
  • Zollinger Ellison syndrome and other hyper-secretory conditions: Initially, 80 mg once daily adjusted according to response (Elderly, maximum 40mg daily).
  • Prophylaxis of  NSAID associated gastric or duodenal ulcer in patients with increased risk of gastro-duodenal complications who require continued NSAID treatment: one tablet of Pantoprazole  20 daily.
     
  • Pantoflux® should be used with caution in patient with severe liver impairment. The dose has to be reduced to 1 tablet (40 mg) every 48 hours. Also the liver enzymes should be monitored during therapy. In case of a raise of the liver enzymes, Pantoflux® should be discontinued.
  • Before treatment, the presence of gastric or esophageal malignancy should be excluded.
  • There has no experience with treatment in children.
  • There are no known effects on the ability to drive and use machines.
  • Pantoflux® 40 : (Strips of 7 Tablets, pack of 2 strips).
  • Pantoflux® 20 : (Strips of 10 Tablets, pack of 5 or10 strips).
  • Store in a cool dry place below 30° C, protect form light.