Pantopaz tablets

Pantopaz

  • Active Ingredient: Pantoprazole
  • 40 mg, 20 mg
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What is Pantopaz?

The active ingredient of Pantopaz brand is pantoprazole. Pantoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg Pantoprazole (equivalent to 22.56 mg of Pantoprazole sodium USP) and 40 mg Pantoprazole (equivalent to 45.1 mg of Pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contain the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.

Used for

Pantopaz is used to treat diseases such as: Barrett's Esophagus, Dumping Syndrome, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Peptic Ulcer, Stomach Ulcer, Stress Ulcer Prophylaxis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Pantopaz include: cough; drowsiness; general feeling of tiredness or weakness; fever; sweating; sores, ulcers, or white spots on the lips or in the mouth; continuous ringing or buzzing or other unexplained noise in the ears.

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Will my dose go up or down?

Sometimes your doctor will increase your dose of Pantopaz if it isn't working well enough.

Depending on the reason you take Pantopaz, you may take a higher dose to begin with, usually for a month or two. After this, your doctor may recommend that you take a lower dose.

What other drugs will affect Pantopaz (Protonix, Protonix IV)?

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may affect Pantopaz, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Clinical Trials Experience

The adverse reaction profiles for PROTONIX (Pantopaz sodium) For Delayed-Release Oral Suspension and PROTONIX (Pantopaz sodium) Delayed-Release Tablets are similar.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

On this page

  1. About Pantopaz
  2. Key facts
  3. Who can and can't take Pantopaz
  4. How and when to take it
  5. Side effects
  6. How to cope with side effects
  7. Pregnancy and breastfeeding
  8. Cautions with other medicines
  9. Common questions

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Pantopaz.

Warnings

This medication contains Pantopaz. Do not take Protonix if you are allergic to Pantopaz or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

What Other Drugs Interact with Pantopaz?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Pantopaz include:

Serious Interactions of Pantopaz include:

  • afatinib
  • atazanavir
  • dasatinib
  • delavirdine
  • digoxin
  • edoxaban
  • indinavir
  • itraconazole
  • ivacaftor
  • ketoconazole
  • mesalamine
  • nilotinib
  • nisoldipine
  • pazopanib
  • pomalidomide
  • ponatinib
  • riociguat
  • sofosbuvir/velpatasvir
  • venetoclax

Pantopaz has moderate interactions with at least 52 different drugs.

Pantopaz has mild interactions with at least 27 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Pantopaz and Magnesium

Low magnesium levels can also occur in people on Pantopaz for at least three months.

Tell your doctor if you have ever had low magnesium in your blood or if you have ever tested positive for the bacteria H. pylori.

Low magnesium levels can result in serious adverse events such as:

  • Muscle spasms
  • Irregular heartbeat
  • Seizures

If you have low magnesium levels while using Pantopaz, your doctor may advise you to take a magnesium supplement or discontinue treatment.

What to do about:

  • headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches usually go away after the first week of taking Pantopaz. Talk to your doctor if they last longer than a week or are severe.
  • diarrhoea - drink plenty of water by having small, frequent sips to avoid dehydration. Signs of dehydration include peeing less than usual or having strong-smelling pee. Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.
  • feeling sick or being sick (nausea or vomiting) - stick to simple meals and do not eat rich or spicy food. If you're vomiting, try small frequent sips of water. Do not take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
  • constipation - get more fibre into your diet such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise, for example, by going for a daily walk or run. If this doesn't help, talk to your pharmacist or doctor.
  • stomach pain or wind - steer clear of foods that cause wind, such as lentils, beans and onions. It might also help to eat smaller and more frequent meals, eat and drink slowly, and exercise regularly. Some pharmacy remedies, such as simethicone, may relieve the symptoms of wind.

Pantopaz Dosage

Pantopaz is supplied as a granule for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg).

It's also available in an intravenous (IV) solution for hospital use.

Typically, your doctor will prescribe 40 mg daily for four to eight weeks of treatment. The medication should be taken around the same time each day.

Take Pantopaz for the full prescribed length of time as your symptoms may improve before your condition is completely treated.

How it works

Pantopaz belongs to a class of drugs called proton pump inhibitors. It works to shut off the acid-pumping cells in your stomach. It reduces the amount of stomach acid and helps to reduce painful symptoms related to conditions such as GERD.

Pantopaz oral tablet does not cause drowsiness. However, it can cause other side effects.

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How to use Pantopaz SODIUM

Read the Medication Guide provided by your pharmacist before you start taking Pantopaz and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Dosage and length of treatment are based on your medical condition and response to treatment.

If you are taking the tablets, you may take them with or without food. Swallow the tablets whole. Do not split, crush, or chew the medication. Doing so may destroy the drug.

If you are taking the granules, take your dose 30 minutes before a meal. To take it by mouth, open the packet and mix the granules in applesauce or apple juice. Do not mix with other foods or liquids. Do not crush or chew the granules. Sprinkle the granules on 1 teaspoon (5 milliliters) of applesauce and swallow all of the mixture right away (within 10 minutes). Follow with sips of water. Or you can mix the granules with 1 teaspoon (5 milliliters) of apple juice in a small cup, stir for 5 seconds, and swallow all of the mixture right away. To make sure you take the entire dose, rinse the cup once or twice with apple juice to mix any remaining granules, and swallow the juice. Do not prepare the mixture ahead of time for later use.

If you are giving the granules through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.

If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Pantopaz at least 30 minutes before sucralfate.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.

Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with Pantopaz doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed with 40 mg/day. In the gastric fundus, treatment at 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas. Rare gastrointestinal tumors associated with Pantopaz treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment at 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.

In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of Pantopaz, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of Pantopaz.

In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of Pantopaz, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.

A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive.

Pantopaz was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay. Pantopaz was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay.

There were no effects on fertility or reproductive performance when Pantopaz was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).


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