Pol

Pol Uses, Dosage, Side Effects, Food Interaction and all others data.

Pol 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.

Pol is quantitatively absorbed and its bioavailability does not change upon multiple dosing. Pol is extensively metabolized in the liver. Almost 80% of an oral dose is excreted as metabolites in urine; the remainder is found in feces.

This drug acts to decrease gastric acid secretion, which reduces stomach acidity. Pol administration leads to long-lasting inhibition of gastric acid secretion.

General Effects

Pol has been shown to reduce acid reflux-related symptoms, heal inflammation of the esophagus, and improve patient quality of life more effectively than histamine-2 receptor antagonists (H2 blockers). This drug has an excellent safety profile and a low incidence of drug interactions. It can be used safely in various high-risk patient populations, including the elderly and those with renal failure or moderate hepatic dysfunction.

Trade Name Pol
Availability Prescription only
Generic Pantoprazole
Pantoprazole Other Names Pantoprazol, Pantoprazole, Pantoprazolum
Related Drugs amoxicillin, omeprazole, famotidine, metronidazole, Nexium, Pepcid, Protonix, esomeprazole, sucralfate, Prilosec
Weight 500mg, 120mg/5ml
Type Tablet, Oral Suspension
Formula C16H15F2N3O4S
Weight Average: 383.37
Monoisotopic: 383.075133083
Protein binding

Approximately 98%

Groups Approved
Therapeutic Class Proton Pump Inhibitor
Manufacturer Malar Health Care, Globe Pharmaceuticals Limited
Available Country India, Bangladesh
Last Updated: September 19, 2023 at 7:00 am
Pol
Pol

Uses

Pol is used where suppression of acid secretion is of therapeutic benefit. Pol 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

Pol is also used to associated treatment for these conditions: Erosive Esophagitis, GERD With Erosive Esophagitis, Gastro-esophageal Reflux Disease (GERD), Healing, Heartburn, Helicobacter Pylori Infection, Stress Ulcers, Zollinger-Ellison Syndrome, Conditions where a reduction of gastric acid secretion is required, Pathological hypersecretory conditions

How Pol works

Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K(+)-ATPase of the proton pump, expressed in high quantities by the parietal cells of the stomach. ATPase is an enzyme on the parietal cell membrane that facilitates hydrogen and potassium exchange through the cell, which normally results in the extrusion of potassium and formation of HCl (gastric acid).

Proton pump inhibitors such as pantoprazole are substituted benzimidazole derivatives, weak bases, which accumulate in the acidic space of the parietal cell before being converted in the canaliculi (small canal) of the gastric parietal cell, an acidic environment, to active sulfenamide derivatives. This active form then makes disulfide bonds with important cysteines on the gastric acid pump, inhibiting its function. Specifically, pantoprazole binds to the sulfhydryl group of H+, K+-ATPase, which is an enzyme implicated in accelerating the final step in the acid secretion pathway. The enzyme is inactivated, inhibiting gastric acid secretion. The inhibition of gastric acid secretion is stronger with proton pump inhibitors such as pantoprazole and lasts longer than with the H(2) antagonists.

Dosage

Pol dosage

Tablet:

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: Pol 40 mg tablet once daily for 2-4 weeks.
  • Gastric ulcer: Pol 40 mg tablet once daily for 4-8 weeks.
  • Reflux esophagitis: Pol 40 mg tabletonce daily for 4-8 weeks.
  • Ulcers induced by NSAIDs: Pol 40 mg tablet once daily.
  • Maintenance therapy: Maintenance therapy should involve the lowest effective dose of the drug. Pol both 20 mg & 40 mg doses are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.

IV Injection:

  • Duodenal ulcer and gastric ulcer:40 mg once daily for 7-10 days
  • Gastroesophageal reflux disease associatedwith 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 hoursif needed, may titrate to higher doses depending on acid output.

DIRECTION FOR USE OF IV INJECTION: Pol lyophilized powder and 0.9% Sodium Chloride Injection is for intravenous administration only and must not be given by any other route. Pol 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: Pol IV infusion should be given as an intravenous infusion over a period of approximately 15 minutes. Pol 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.

Side Effects

No potentially life-threatening effects have been reported with Pol. 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.

Toxicity

Rat Oral LD 50 747 mg/kg

Tumorigenicity

Because of the chronic nature of GERD, there may be a potential for long-term administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and its administration lead to rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown at this time.

Teratogenic Effects

This drug falls under pregnancy category B category. Reproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose (RHD), as well as in rabbits at oral doses up to 16 times the RHD, and have shown no evidence of impaired fertility or harm to the fetus caused by pantoprazole. No adequate and well-controlled studies in pregnant women have been completed. Because animal reproduction studies are not always predictive of human response, this drug should only be used during pregnancy if clearly required.

Nursing Mothers

Pol and its metabolites have been found to be excreted in the milk of rats. Pol excretion in human milk has been found in a study performed with a single nursing mother after one 40 mg oral dose. The clinical relevance of this finding is not known, however, it is advisable to take note of this finding when considering pantoprazole use during nursing. Many drugs excreted in human breastmilk have a risk for serious adverse effects in nursing infants.

Precaution

Patients should be cautioned that Pol 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 Pol.

Interaction

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.

Food Interaction

  • Take with or without food. The absorption is unaffected by food.

Volume of Distribution

The apparent volume of distribution of pantoprazole is approximately 11.0-23.6 L, distributing mainly in the extracellular fluid.

Elimination Route

Pol is absorbed after oral administration as an enteric-coated tablet with maximum plasma concentrations attained within 2 – 3 hours and a bioavailability of 77% that does not change with multiple dosing . Following an oral dose of 40mg, the Cmax is approximately 2.5 μg/mL with a tmax of 2 to 3 hours. The AUC is approximately 5 μg.h/mL. There is no food effect on AUC (bioavailability) and Cmax.

Delayed-release tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach.

Half Life

About 1 hour

Clearance

Adults: With intravenous administration of pantoprazole to extensive metabolizers, total clearance is 7.6-14.0 L/h. In a population pharmacokinetic analysis, the total clearance increased with increasing body weight in a non-linear fashion.

Children: clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h.

Elimination Route

After a single oral or intravenous (IV) dose of 14C-labeled pantoprazole to healthy, normal metabolizing subjects, about 71% of the dose was excreted in the urine, with 18% excreted in the feces by biliary excretion. There was no kidney excretion of unchanged pantoprazole.

Pregnancy & Breastfeeding use

There are no adequate or well-controlled studies in pregnant women. Pol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Pol is excreted in human breast milk. Pol should be used during lactation only if the potential benefit justifies the potential risk.

Contraindication

It is contraindicated in patients with known hypersensitivity to Pol.

Acute Overdose

There are no known symptoms of overdosage in humans. Since Pol is highly protein bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Storage Condition

Store in a cool, dry place and away from light. Keep out of the reach of children.

Innovators Monograph

You find simplified version here Pol

Pol contains Pantoprazole see full prescribing information from innovator Pol Monograph, Pol MSDS, Pol FDA label

FAQ

What is Pol used for?

Pol 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 Pol work?

Pol 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. Pol prevents proton pumps from working properly. This reduces the amount of acid the stomach makes.

When will I feel better after taking Pol?

You should start to feel better within 2 to 3 days. It may take up to 4 weeks for Pol to work properly so you may still have some symptoms during this time. If you bought Pol 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 Pol for a long time?

If you take Pol 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 Pol 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 Pol 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 Pol?

Taking Pol long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

Common side effects of Pol include

  • injection site reactions (redness, pain, swelling),
  • headache,
  • nausea,
  • vomiting,
  • abdominal or stomach pain,
  • diarrhea,
  • gas,
  • dizziness,
  • joint pain,
  • weight changes,
  • drowsiness,
  • tired feeling, or
  • sleep problems (insomnia).

Does Pol work immediately?

Pol 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 Pol?

PPI have minimal side effects and few slight drug interactions and are considered safe for long term treatment. Pol 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 Pol 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 Pol to leave the body?

Pol 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 Pol?

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 Pol can I eat?

Pol 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 Pol safe in pregnancy?

Usually, Pol is safe to take during pregnancy.

Is Pol safe during breastfeeding?

Usually, Pol is safe to take during breastfeeding.

Are there other medicines like Pol?

There are 4 other medicines that are similar to Pantoprazole. They are:

  • lansoprazole
  • esomeprazole
  • omeprazole
  • rabeprazole

Can I take Pol with an antacid?

You can take Pol with an antacid (for example, Gaviscon) if you need to, but leave a gap of 2 hours between them.

Will Pol affect my fertility?

There's no clear evidence to suggest that taking Pol 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 Pol affect my contraception?

Pol does not affect any type of regular contraception, including the combined pill. But if Pol 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.

*** Taking medicines without doctor's advice can cause long-term problems.
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