AUP-20 Tablet is manufactured by Decent Pharma Laboratories Ltd. AUP-20 Tablet contains 20 mg Pantoprazole. It is Proton Pump Inhibitor class drug.
AUP-20 is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of H+/K+ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric effect that persists longer than 24 hours.
AUP-20 is quantitatively absorbed and its bioavailability does not change upon multiple dosing. AUP-20 is extensively metabolized in the liver. Almost 80% of an oral dose is excreted as metabolites in urine; the remainder is found in feces.
AUP-20 is used where suppression of acid secretion is of therapeutic benefit. AUP-20 Is registered in the foltawing indications:
- Peptic ulcer diseases (PUD)
- Gastro-esophageal reflux diseases
- Treatment of ulcer resistant to M2 blocker
- Treatment of ulcer induced by NSAIDs
- Gl bleeding from stress or acid peptic diseases
- Eradication of Helicobacter pylori
- Zollinger-Ellison syndrome
- Prophylaxis for acid aspiration syndrome during induction of anesthesia
|Therapeutic Class:||Proton Pump Inhibitor|
|Manufacturer:||Decent Pharma Laboratories Ltd|
|Last Updated:||June 9, 2021 at 4:28 pm|
Table Of contents
AUP-20 contains Pantoprazole 20 mg. AUP-20 Dosage:
The usual recommended adult oral dose is 40 mg given once daily, preferably in the morning with or without food. The duration of therapy is ranging from 2-8 weeks.
- Duodenal ulcers: AUP-20 40 mg tablet once daily for 2-4 weeks.
- Gastric ulcer: AUP-20 40 mg tablet once daily for 4-8 weeks.
- Reflux esophagitis: AUP-20 40 mg tablet once daily for 4-8 weeks.
- Ulcers induced by NSAIDs: AUP-20 40 mg tablet once daily.
- Maintenance therapy: Maintenance therapy should involve the lowest effective dose of the drug. AUP-20 both 20 mg & 40 mg doses are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.
- Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
- Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
- Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
- Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 h
- Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.
DIRECTION FOR USE OF IV INJECTION: AUP-20 lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. AUP-20 IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml 0.9% Sodium Chloride Injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes. Use only freshly prepared solution. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours.
DIRECTION FOR USE OF IV INFUSION: AUP-20 IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. AUP-20 IV infusion should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection and further diluted (admixed) with 0.9% Sodium Chloride Injection or 5% Dextrose or Lactated Ringer's Injection to a final volume of 100 ml. The reconstituted solution may be stored at room temperature (up to 30° C) for a maximum 4 hours prior to further dilution. The admixed solution may be stored at room temperature (up to 30° C) and must be used within 24 hours from the time of initial reconstitution.
No potentially life-threatening effects have been reported with AUP-20. Symptomatic adverse effects include headache and diarrhoea are two common reported adverse effects. Peripheral edema has been occasionally reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc.
Patients should be cautioned that AUP-20 tablet should not be split, crushed or chewed. The tablet should be swallowed whole, with or without food in the stomach. Concomitant administration of antacid does not affect the absorption of AUP-20.
There is no interaction with concomitantly administered antacids. No dosage adjustment is needed with combination use of the following drugs: Theophylline, Caffeine, Diazepam, Digoxin, Ethanol, Metoprolol, Nifedipine or Warfarin.
Pregnancy Lactation use
There are no adequate or well-controlled studies in pregnant women. AUP-20 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether AUP-20 is excreted in human breast milk. AUP-20 should be used during lactation only if the potential benefit justifies the potential risk.
It is contraindicated in patients with known hypersensitivity to AUP-20.
There are no known symptoms of overdosage in humans. Since AUP-20 is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.
Interaction with other Medicine
Store in a cool, dry place and away from light. Keep out of the reach of children.
What is AUP-20 used for?
AUP-20 is used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older.
How does AUP-20 work?
AUP-20 is a type of medicine called a proton pump inhibitor (PPI). Proton pumps are tiny substances in the lining of the stomach that help it make acid to digest your food. AUP-20 prevents proton pumps from working properly. This reduces the amount of acid the stomach makes.
When will I feel better after taking AUP-20?
You should start to feel better within 2 to 3 days. It may take up to 4 weeks for AUP-20 to work properly so you may still have some symptoms during this time. If you bought AUP-20 without a prescription, and feel no better after 2 weeks, tell your doctor. They may want to do tests or change you to a different medicine.
Is it safe to take AUP-20 for a long time?
If you take AUP-20 for more than 3 months, the levels of magnesium in your blood may fall. This can make you feel tired, confused and dizzy and cause muscle twitches, shakiness and an irregular heartbeat. If you get any of these symptoms, tell your doctor.
Taking AUP-20 for more than a year may increase your chances of certain side effects, including:
- bone fractures
- gut infections
- vitamin B12 deficiency - symptoms include feeling very tired, a sore and red tongue, mouth ulcers, and pins and needles
If you take AUP-20 for longer than 1 year your doctor will regularly check your health to see if you should carry on taking it.
What are the side effects of taking AUP-20?
Taking AUP-20 long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.
Common side effects of AUP-20 include
- injection site reactions (redness, pain, swelling),
- abdominal or stomach pain,
- joint pain,
- weight changes,
- tired feeling, or
- sleep problems (insomnia).
Does AUP-20 work immediately?
AUP-20 takes approximately two and a half hours to begin working, so it won't be effective for current symptoms. However, patients who need immediate relief from their acid reflux symptoms can combine pantoprazole with fast-acting Tums or Maalox to reduce the amount of acid.
Is drinking water good for acid reflux?
Frequently consuming water can make the digestion process better and curb GERD symptoms.
How safe is AUP-20?
PPI have minimal side effects and few slight drug interactions and are considered safe for long term treatment. AUP-20 is significantly effective both for acute and long-term treatment with excellent control of relapse and symptoms. It is well tolerated even for long-term therapy and its tolerability is optimal.
Does AUP-20 work better than omeprazole?
Generally, pantoprazole and omeprazole are equally effective. Studies comparing pantoprazole and omeprazole have found pantoprazole as effective as omeprazole in treating GERD as well as treating stomach ulcers.
How long does it take for AUP-20 to leave the body?
AUP-20 is extensively metabolized in the liver through the cytochrome P-450 system, predominantly by CYP2C19 demethylation with subsequent sulfation and has a serum elimination half-life of about 1.1 hours.
What are the side effects of stopping AUP-20?
Most patients have difficulty discontinuing their PPI's because the amount of acid in their digestive system surges when they stop taking the drug, and they're often left with symptoms like excruciating stomach pain and increased heartburn.
How long after taking AUP-20 can I eat?
AUP-20 oral granules should be taken 30 minutes before a meal.
How long does it take for stomach acid to return to normal?
For most people acid levels return to normal within one to two weeks.
Is AUP-20 safe in pregnancy?
Usually, AUP-20 is safe to take during pregnancy.
Is AUP-20 safe during breastfeeding?
Usually, AUP-20 is safe to take during breastfeeding.
Are there other medicines like AUP-20?
There are 4 other medicines that are similar to Pantoprazole. They are:
Can I take AUP-20 with an antacid?
You can take AUP-20 with an antacid (for example, Gaviscon) if you need to, but leave a gap of 2 hours between them.
Will AUP-20 affect my fertility?
There's no clear evidence to suggest that taking AUP-20 will reduce fertility in either men or women. But speak to a pharmacist or your doctor if you're trying to get pregnant. They may want to review your treatment.
Will AUP-20 affect my contraception?
AUP-20 does not affect any type of regular contraception, including the combined pill. But if AUP-20 makes you sick (vomit), your contraceptive pills may not protect you from pregnancy. If this happens, follow the instructions in the leaflet that comes with your contraceptive pills.