Ulcotenal tablets

Ulcotenal

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

The active ingredient of Ulcotenal 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

Ulcotenal 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 Ulcotenal include: mood or mental changes; intravenous powder for solution; increased urination; joint pain; dry mouth; hearing loss.

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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 Ulcotenal. For a full list see the leaflet inside your medicine packet.

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

Pregnancy Category C

Reproduction studies have been performed in rats at oral Ulcotenal 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 Ulcotenal sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to Ulcotenal.

A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Ulcotenal sodium. Oral Ulcotenal 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.

How should I use Ulcotenal (Protonix, Protonix IV)?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use the lowest dose for the shortest amount of time needed to treat your condition.

Ulcotenal is taken by mouth (oral) or given as an infusion into a vein (injection). A healthcare provider may teach you how to properly use Ulcotenal injection by yourself.

Ulcotenal tablets are taken by mouth, with or without food. Ulcotenal oral granules should be taken 30 minutes before a meal.

Do not crush, chew, or break the tablet. Swallow it whole.

The oral granules should be mixed with applesauce or apple juice and given either by mouth or through a nasogastric (NG) tube.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve or if they get worse while you are using this medicine.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Ulcotenal.

Ulcotenal may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use this medicine.

Store this medicine at room temperature away from moisture, heat, and light.

Erosive esophagitis

For erosive esophagitis, doctors can prescribe tablets or oral suspension Ulcotenal.

Adults can take 20 mg or 40 mg daily depending on the severity of the condition. Doctors will typically prescribe Ulcotenal for 8 weeks.

If the drug is not effective after 8 weeks, a person can, in some cases, continue taking the lowest effective dosage for another 8 weeks.

How much will I take?

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

Liquid Ulcotenal 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

Ulcotenal side effects

Get emergency medical help if you have signs of an allergic reaction to Ulcotenal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody;

sudden pain or trouble moving your hip, wrist, or back;

bruising or swelling where intravenous Ulcotenal was injected;

kidney problems - urinating less than usual, blood in your urine, swelling, rapid weight gain;

low magnesium - dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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

If you use Ulcotenal for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common Ulcotenal side effects may include:

stomach pain, gas, nausea, vomiting, diarrhea;

fever, rash, or cold symptoms (most common in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

7. Pregnancy and breastfeeding

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

A medicine called omeprazole, which is similar to Ulcotenal, 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.

Zollinger–Ellison syndrome

When treating chronic conditions such as Zollinger–Ellison syndrome, people should take 40 mg of Ulcotenal twice per day.

Most people tolerate Ulcotenal well, but some may experience the following side effects:

When people use Ulcotenal for long periods, they are at an increased risk of the following side effects:

  • Clostridium difficile diarrhea
  • colitis
  • overgrowth of bacteria in the small intestine
  • bone loss
  • kidney disorders

People who take Ulcotenal for an extended period of time are at risk of the drug becoming carcinogenic and causing rare types of gastrointestinal tumors.

Based on a recent major change to its prescribing information, people are also at increased risk of stomach growths called fundic gland polyps when taking PPIs for a long period — especially for longer than 1 year.

Taking Ulcotenal for extended periods can cause vitamin and mineral deficiencies, such as:

  • vitamin B-12 deficiency
  • iron deficiency
  • calcium deficiency
  • magnesium deficiency

Doctors should follow up with people taking Ulcotenal. After completing the treatment, if a person still has symptoms, the doctors should investigate whether or not the diagnosis was indeed accurate.

Sometimes, people may feel much better after the treatment is complete, but their symptoms may quickly return. Doctors may perform further tests, including an endoscopy.

An endoscopy involves passing a flexible tube with a camera attached, called an endoscope, into the stomach through the mouth to see the inside of the body.

Drugs affected by stomach pH

Ulcotenal affects stomach acid levels. As a result, it can reduce your body’s absorption of certain drugs that are sensitive to the effects of decreased stomach acid. This effect can make these drugs less effective.

Examples of these drugs include:

  • ketoconazole
  • ampicillin
  • atazanavir
  • iron salts
  • erlotinib
  • mycophenolate mofetil

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 Ulcotenal. 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.

What are the possible side effects of Ulcotenal (Protonix, Protonix IV)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • sudden pain or trouble moving your hip, wrist, or back;
  • bruising or swelling where intravenous Ulcotenal was injected;
  • kidney problems--urinating less than usual, blood in your urine, swelling, rapid weight gain;
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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

If you use Ulcotenal for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • headache, dizziness;
  • stomach pain, gas, nausea, vomiting, diarrhea;
  • joint pain; or
  • fever, rash, or cold symptoms (most common in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ulcotenal to reduce stomach ac >About Ulcotenal
  • Before taking Ulcotenal
  • How to take Ulcotenal
  • Getting the most from your treatment
  • Can Ulcotenal cause problems?
  • How to store Ulcotenal
  • Important information about all medicines
  • What other drugs will affect Ulcotenal?

    Tell your doctor about all your other medicines. Some may interact with Ulcotenal, especially:

    a diuretic or "water pill."

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

    Ulcotenal Interactions

    Before taking Ulcotenal, tell your doctor and pharmacist about all medications you are taking (including vitamins and herbal supplements).

    Ulcotenal shouldn't be taken with atazanavir (Reyataz) or nelfinavir (Viracept), which are medications used to treat HIV and AIDS.

    Other drugs that may interact with Ulcotenal include:

    • Ampicillin (Omnipen, Principen, Amcill)
    • Warfarin (Coumadin, Jantoven)
    • Digoxin (Lanoxin, Lanoxicaps)
    • Diuretics (water pills)
    • Antifungals such as ketoconazole (Nizoral), itraconazole (Sporanox), and voriconazole (Vfend)
    • Iron supplements/ferrous sulfate (Feosol, Mol-Iron, Fergon, Femiron)
    • Methotrexate (Trexall)
    • Delavirdine (Rescriptor)

    Unless otherwise instructed, you can continue a normal diet and normal activities while taking Ulcotenal.

    • Long-term use warning: Long-term use of Ulcotenal can lead to an increased risk of certain s >

    Ulcotenal oral tablet is a prescription drug that’s available as the brand-name drug Protonix. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

    Ulcotenal comes in three forms: an oral tablet, an oral liquid suspension, and an intravenous (IV) form that’s injected into your vein by a healthcare provider.

    Will my dose go up or down?

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

    Depending on the reason you take Ulcotenal, 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.

    How long will I take it for?

    If you buy Ulcotenal from a pharmacy, you can usually take it for up to 2 weeks. After 2 weeks:

    • if your symptoms have improved - you can take it for another 2 weeks
    • if your symptoms haven't improved - or they are worse, speak to a doctor before taking any more Ulcotenal

    Do not take Ulcotenal for more than 4 weeks without speaking to your doctor first. If your symptoms haven't improved, you may need some tests to find out what's causing them.

    If you take it on prescription, you may only need to take it for a few weeks or months, depending on your illness. Sometimes your doctor may advise you to take it for longer, even for many years.

    Your doctor may suggest taking Ulcotenal only when you have symptoms. This means you won't have to take it every day. Once you feel better, you can stop taking it - often after a few days or weeks. Taking Ulcotenal this way isn't suitable for everyone. Speak to your doctor about what's best for you.

    Ulcotenal is the generic name for Protonix, a drug that helps treat problems related to acid reflux and peptic ulcers. It works by decreasing acid in the stomach.

    Ulcotenal is a proton pump inhibitor (PPI). People use it to treat and manage the symptoms of erosive esophagitis and Zollinger–Ellison syndrome.

    Doctors also prescribe Ulcotenal to stop ulcers from forming.

    In this article, we take a look at the uses of Ulcotenal, possible side effects, and warnings when taking this drug.


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