pantrol 40

pantrol 40

pantrol 40

Anti-Ulcer/Acid/Flatulence

 Pantoprazole is gastric acid pump inhibitor and antiulcer agent. It is a 
  specific inhibitor of the proton pump of H+/K+ ATPase, the enzyme 
  responsible for the secretion of acid by the gastric partial cells. By 
  virtue of its mechanism of action on the terminal phase of secretion. 
  Pantoprazole provokes  a durable inhibition of basal & stimulated 
  gastric acid secretion.
- 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

Indecation

Pantrol®  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.
    

Dosage & Administration

 Pantrol® should be swallowed whole with water 1hour before 
  breakfast.
- Gastro-esophageal reflux disease: one tablet  of Pantrol® 40 mg daily 
  in the  morning for 4 weeks, followed  by further 4 weeks if not fully 
  healed.
- Benign gastric  ulcer :one tablet of Pantrol® 40 mg daily  in the 
  morning  for 4 weeks, followed  by further 4 weeks if not fully healed.
- Duodenal ulcer: One tablet of Pantrol® 40 daily in the morning for 
  2 weeks, followed by further 2 weeks if not fully healed.
- Duodenal ulcer associated with H. pylori: one tablet 40 mg twice daily 
  along  with Clarithromycin 500 mg and Amoxicillin  1000 mg  twice 
  daily or Metronidazol 500 mg twice daily for 10-14 days.
- Zollinger Ellison syndrome and other hypersecretory conditions: 
  initially, 80 mg once daily adjusted according to response (Elderly, 
  maximum 40 mg 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 Pantrol® 20 daily.
  

 Each enteric coated  tablet of Pantrol®  40 contain:
  Pantoprazole sodium sesquihydrate        40 mg.
- Each enteric coated  tablet of Pantrol® 20 contain:
  Pantoprazole sodium sesquihydrate        20 mg

Hypersensitivity to Pantrol®  product.

 Pantrol® 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 Pantrol® 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. 
 

Pantrol® should be used with caution in pregnancy and breastfeeding 
 and should only be used when the potential benefits outweighs 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.
Over dose:-
- If  you have taken too little Pantrol® or have forgotten to take it, don’t 
  take the dose late, but continue with the next regular dose on your dosing 
  schedule .
-Talk to your doctor if  you want to interrupt or prematurely discontinue 
  treatment with Pantrol®. 
-There are no known symptoms of overdosing  in human, in any case, the 
  doctor must be consulted.

Pantrol® 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, Pantrol® 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.
 

Pantrol® 40   :   Strips of 7 Tablets, pack of 2 strips .  
 Pantrol® 20   :   Strips of 10 Tablets, pack of 5 or10 strips.  
- Hospital packs of different sizes.

Store in a cool dry place below 30° C, protect form light.