Pantocas tablets

Pantocas

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

The active ingredient of Pantocas 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

Pantocas 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 Pantocas include: large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; unpleasant breath odor; red skin lesions, often with a purple center; cough; increased hunger.

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Pregnancy Category C

Reproduction studies have been performed in rats at oral Pantocas doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of Pantocas sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to Pantocas.

A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Pantocas sodium. Oral Pantocas doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg). There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

DESCRIPTION

The active ingredient in PROTONIX (Pantocas sodium) For Delayed-Release Oral Suspension and PROTONIX (Pantocas sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2- sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:

Pantocas sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantocas has weakly basic and acidic properties. Pantocas sodium sesquihydrate 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.

PROTONIX is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength (40 mg) Pantocas, (equivalent to 45.1 mg of Pantocas sodium), and as a delayed-release tablet, available in two strengths 20 mg Pantocas (equivalent to 22.56 mg of Pantocas sodium) and 40 mg Pantocas (equivalent to 45.1 mg of Pantocas sodium).

PROTONIX Delayed-Release Tablets contain the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.

PROTONIX For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

Storage And Handling

PROTONIX (Pantocas sodium) Delayed-Release Tablets are supplied as yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side containing 40 mg Pantocas and are available as follows:

PROTONIX (Pantocas sodium) Delayed-Release Tablets are supplied as yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side containing 20 mg Pantocas and are available as follows:

PROTONIX (Pantocas sodium) For Delayed-Release Oral Suspension contains pale yellowish to dark brownish, enteric-coated granules containing 40 mg Pantocas in a 40 mg unit-dose packet and are available as follows:

  • NDC 0008-0844-02, unit-dose carton of 30

How it works

Pantocas 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.

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

Before taking this medicine

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not use this medicine if:

you also take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey); or

you are allergic to Pantocas or similar medicines (lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, and others).

Tell your doctor if you have ever had:

low levels of magnesium in your blood;

osteoporosis or low bone mineral density.

You may be more likely to have a broken bone while using Pantocas long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy, especially if you are an adult over 50.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using this medicine.

Pantocas is not approved for use by anyone younger than 5 years old.

Lactation

Pantocas and metabolites are excreted in milk of rats. Pantocas excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of Pantocas sodium; clinical relevance of this finding not known; many drugs excreted in human milk have potential for serious adverse reactions in nursing infants; based on potential for tumorigenicity shown for Pantocas sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account benefit of drug to mother

7. Pregnancy and breastfeeding

Pantocas isn't usually recommended during pregnancy as there's no firm evidence it's safe.

A medicine called omeprazole, which is similar to Pantocas, is safe in pregnancy.

However, if you're pregnant, it's better to try to treat your symptoms without taking a medicine.

Your doctor or midwife may suggest eating smaller meals more often and avoiding fatty and spicy foods.

They may also suggest that you raise the head of your bed 10 to 20cm by putting something under your bed or mattress, so that your chest and head are above your waist. This helps stop stomach acid travelling up towards your throat.

If these lifestyle changes don't work, you may be recommended omeprazole, which is safe to take during pregnancy.

What is Pantocas (Protonix, Protonix IV)?

Pantocas is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Pantocas is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Pantocas is usually given for up to 8 weeks at a time while your esophagus heals.

Pantocas is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.

Pantocas is not for immediate relief of heartburn.

Pantocas may also be used for purposes not listed in this medication guide.

Pantocas dosing information

Usual Adult Dose for Erosive Esophagitis:

Treatment of Erosive Esophagitis: 40 mg orally once a day for up to 8 weeks; however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Maintenance of Healing of Erosive Esophagitis: 40 mg orally once a day. Controlled studies have been limited to 12 months of Pantocas therapy.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Parenteral: 40 mg once a day for 7 to 10 days, administered via intravenous infusion over a period of 15 minutes. Intravenous therapy should be discontinued as soon as the patient is able to resume oral therapy.

Oral: 40 mg orally once a day, for short-term administration (up to 8 weeks); however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

Usual Adult Dose for Duodenal Ulcer:

Study (n=54) 40 mg orally once a day, dose was increased every 12 weeks by 40 mg increments to a maximum of 120 mg per day, for 28 weeks. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete duodenal ulcer healing in up to 87% and 94% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Gastric Ulcer:

40 mg orally once a day. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete gastric ulcer healing in up to 87% and 97% of patients after 4 weeks and 8 weeks respectively.

Usual Adult Dose for Helicobacter pylori Infection:

Study (n=242) - Triple therapy: 40 mg orally twice daily for 7 days, commonly in conjunction with clarithromycin and either amoxicillin or metronidazole to eradicate Helicobacter pylori, followed with 40 mg Pantocas orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

The QUADRATE Study (n=405) - Quadruple therapy: 40 mg orally twice daily for 7 days, concomitantly with bismuth subcitrate and tetracycline, both four times daily, and metronidazole 200 mg three times daily and 400 mg at bedtime. Helicobacter Pylori eradication was achieved in 82% of patients.

Usual Adult Dose for Zollinger-Ellison Syndrome:

Parenteral: 80 mg every 12 hours, administered by 15-minute infusion. Daily doses higher than 240 mg administered in equally divided doses by 15-minute infusion, or administered for more than 6 days have not been studied.

Oral: 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with Pantocas for more than 2 years.

Usual Adult Dose for Stress Ulcer Prophylaxis:

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting: 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting: 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Usual Adult Dose for Peptic Ulcer:

Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting: 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting: 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

Immediate action required: Call 999 or go to A&E if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you're wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of Pantocas. For a full list see the leaflet inside your medicine packet.

You can report any suspected side effect to the UK safety scheme.

COMMON BRAND(S): Protonix

GENERIC NAME(S): Pantocas

OTHER NAME(S): Pantocas Tablet, Delayed Release (Enteric Coated)

Pantocas is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantocas belongs to a class of drugs known as proton pump inhibitors (PPIs).

How to use Pantocas SODIUM

Read the Medication Guide provided by your pharmacist before you start taking Pantocas 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 Pantocas 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.

  • 40 mg Pantocas, yellow oval biconvex tablets imprinted with PROTONIX (brown ink) on one side
  • 20 mg Pantocas, yellow oval biconvex tablets imprinted with P20 (brown ink) on one side

How much will I take?

Each tablet contains 20mg or 40mg of Pantocas. You can buy Pantocas 20mg tablets from pharmacies. These are suitable for the short-term treatment of heartburn and acid reflux in adults.

Liquid Pantocas can be prescribed for people who cannot swallow tablets. It will come with a syringe or spoon to help you take the right amount. If you don't have a syringe or spoon, ask your pharmacist for one.

The usual dose to treat:

  • heartburn and acid reflux is 20mg a day
  • gastro-oesophageal reflux disease is 20mg to 40mg a day
  • stomach ulcers is 20mg to 40mg a day
  • Zollinger-Ellison syndrome is 40mg to 80mg a day - this can increase to 160mg a day depending on how well it works for you

Delayed-Release Pantocas

The tablet form of Pantocas is released in the intestine to prevent breakdown of the medication by stomach acids.

The tablets are usually taken with or without food one or two times daily.

Swallow the tablets whole. Do not split, chew, or crush them.

3. Who can and can't take Pantocas

Pantocas can be taken by adults and children aged 12 years and over. It is not generally recommended during pregnancy.

Pantocas isn't suitable for some people. To make sure that it is safe for you, tell your doctor if you:

  • have had an allergic reaction to Pantocas or any other medicine in the past
  • have liver problems
  • are due to have an endoscopy

Ask your doctor if you should stop taking Pantocas a few weeks before your endoscopy. This is because Pantocas may hide some of the problems that would usually be spotted during an endoscopy.


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