Ulceral capsules

Ulceral

  • Active Ingredient: Omeprazole
  • 40 mg, 20 mg, 10 mg
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What is Ulceral?

The active ingredient of Ulceral brand is omeprazole. Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155В°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of Omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of Omeprazole in the form of enteric-coated beads with the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, D&C Yellow No. 10, FD&C Green No. 3, gelatin, ethylcellulose, fumed silica, hypromellose, methacrylic acid, oleic acid, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 40 mg empty gelatin capsule shell also contains FD&C Blue No. 1. In addition, the white imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide. Meets USP Dissolution Test 2.

Used for

Ulceral is used to treat diseases such as: Barrett's Esophagus, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Indigestion, Multiple Endocrine Adenomas, Stomach Ulcer, Systemic Mastocytosis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Ulceral include: trembling; loss of appetite; confusion; unusual bleeding or bruising; sneezing; continuing ulcers or sores in the mouth; diarrhea or loose stools.

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Q: Can Prilosec cause high blood pressure?

A: Prilosec (Ulceral) belongs to a class of drugs called proton pump inhibitors (PPIs). PPIs decrease or block the production of stomach acid. Prilosec is used to treat the symptoms of gastroesophageal reflux disease (GERD), to promote healing of erosive esophagitis, and to treat or prevent ulcers. Common side effects of Prilosec include gas, stomach pain, nausea, vomiting, diarrhea, and headache. According to the prescribing information for Prilosec, elevated blood pressure has been reported by people taking the drug in post-marketing experience. Post-marketing experience is after the drug has been approved by the U.S. Food and Drug Administration (FDA). In post-marketing experience, patients voluntarily report if they have the side effect. Because it is voluntary, not everyone decides to report if they have the side effect. So, it is hard to know how often the side effect occurs. It is also hard to know if it is caused by the drug or by some other reason. This is different than side effects reported during clinical trials before the drug is approved by the FDA. In clinical trials, researchers have tight control over how side effects are reported and can determine whether they are likely related to the drug or not. So, elevated blood pressure may or may not be caused by Prilosec, but it has been reported in patients taking the drug. See your doctor for proper evaluation of your blood pressure. Your doctor is best able to guide your treatment decisions based on your specific circumstances. Sarah Lewis, PharmD

4. How and when to take it

It's usual to take Ulceral once a day, first thing in the morning. It doesn't upset the stomach, so you can take it with or without food.

If you take Ulceral twice a day, take 1 dose in the morning and 1 dose in the evening.

Q: I have been taking Prilosec for many years and have a fracture. Can Prilosec cause fractures? Are there alternative medications for GERD?

A: Prilosec (Ulceral) belongs to a class of medication that is known as proton pump inhibitors. Recent studies have shown that when used at high doses or for periods of longer than one year, proton pump inhibitors can increase the risk of fractures of the hip, wrist, and spine. There is also an increased risk in people over the age of fifty. There are other classes of medication that can be used for GERD. H2 antagonists are available over-the-counter and through prescription. Some H2 antagonists are Pepcid (famotidine), Zantac (ranitidine), and Tagamet (cimetidine). However, you should speak with your doctor prior to switching your medication to be sure that there are no drug interactions between any of your other medications. Megan Uehara, PharmD

Q: I have read recently that Prilosec is not good to be taken on a regular basis. Is it safe to take occasionally? I know years ago there was a correlation between Prilosec and cancer. Now they are talking about it again.

A: Prilosec (Ulceral) is a proton pump inhibitor (PPI) used to treat ulcers, heartburn, and gastric reflux. Prilosec is now available over the counter. Patients who take Prilosec over the counter should not take it for longer than two weeks consistently without consulting their health care provider. This is due to the fact that if you have symptoms that last longer than two weeks, you may have a more serious condition that would need to be evaluated and treated by a physician. Long-term use of PPIs is generally considered safe under the direction of a doctor. There is some talk that long term use of PPI's could cause some problems, such as decreased immunity and osteoporosis, but this is yet to be proven. It is always best to avoid taking medication you do not need, but occasional use of Prilosec is likely to be safe, and long term use under the direction of a physician would also likely be safe for most patients. Please see the following Everyday Health link for more information on Prilosec. //www.everydayhealth.com/drugs/prilosec. Laura Cable, PharmD

What if I take too much?

It's very unlikely that taking 1 or 2 extra doses by accident will cause any problems.

But you should check with your doctor if you have taken too much and have any of these symptoms:

  • flushed skin
  • feeling sweaty
  • a fast heartbeat
  • feeling sleepy
  • blurred vision
  • feeling confused or agitated

Most people who take Ulceral don't have any side effects. If you do get a side effect, it's usually mild and will go away when you stop taking Ulceral.

Q: I have taken Prilosec for 14 days. How long will it take to restore my gastric acid?

A: According to the prescribing information for Prilosec (Ulceral), once the drug is discontinued, gastric acid secretion returns gradually over three to five days. Prilosec is categorized as a proton pump inhibitor (PPI) and reduces the amount of stomach acid produced by the body. Prilosec is used to treat the symptoms of gastroesophageal reflux disease (GERD) and other medical conditions that result from too much stomach acid. Prilosec is also used to promote healing of erosive esophagitis and may be used in combination with antibiotics to treat gastric ulcers caused by a Helicobacter pylori (H. pylori) infection. The most commonly reported side effects associated with treatment with Prilosec include headache, abdominal pain, nausea, diarrhea and vomiting. In most cases, Ulceral is taken approximately 30 to 60 minutes before a meal. Take Prilosec exactly as directed by your healthcare provider. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Kristen Dore, PharmD

By Lynn Marks | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2015-01-09 Copyright © 2014 Everyday Health Media, LLC

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 sweaty or light-headed.

You should not use Ulceral if you are allergic to it, or if:

you are also allergic to medicines like Ulceral, such as esUlceral, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others; or

you also take HIV medication that contains rilpivirine (such as Complera, Edurant, Odefsey, Juluca).

Ask a doctor or pharmacist if it is safe for you to use Ulceral if you have other medical conditions, especially:

trouble or pain with swallowing;

bloody or black stools, vomit that looks like blood or coffee grounds;

heartburn that has lasted for over 3 months;

frequent chest pain, heartburn with wheezing;

low levels of magnesium in your blood; or

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using Ulceral if you are pregnant or breast-feeding.

Do not give this medicine to a child without medical advice.

Special considerations

People of Asian descent. Your doctor may give you a lower dose of this medication, especially if you’re taking it for erosive esophagitis.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Ulceral oral capsule is used for short-term treatment of duodenal and gastric ulcers and gastroesophageal reflux disease (GERD). It’s used for long-term treatment of erosive esophagitis and pathological hypersecretory conditions. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your acid reflux, heartburn, or ulcer symptoms may not improve. They may even get worse.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms can include:

  • confusion
  • drowsiness
  • blurred vision
  • fast heart rate
  • nausea
  • vomiting
  • sweating
  • flushing
  • headache
  • dry mouth

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. If you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You should have decreased pain and acid reflux symptoms.

As with all medications, the costs of Ulceral can vary. To find current prices for your area, check out GoodRx.com.

Keep these considerations in mind if your doctor prescribes Ulceral oral capsule for you.

Interactions that increase the risk of side effects

  • Side effects from Ulceral: Taking Ulceral with certain medications raises your risk of side effects from Ulceral. This is because the amount of Ulceral in your body is increased. Examples of these drugs include:
    • Voriconazole. This drug may increase the levels of Ulceral in your body. If you’re taking high doses of Ulceral, your doctor may adjust your Ulceral dose.
  • Saquinavir. Ulceral may greatly increase the levels of saquinavir in your body. Your doctor may lower your dose of saquinavir.
  • Digoxin. Ulceral may increase the levels of digoxin in your body. Your doctor may monitor the levels of digoxin in your blood.
  • Warfarin. Ulceral may increase the levels of warfarin in your body. Your doctor may monitor you for symptoms of bleeding.
  • Phenytoin. Ulceral may increase the levels of phenytoin in your body. Your doctor may watch you for high levels of phenytoin.
  • Cilostazol. Ulceral may increase the levels of cilostazol in your body. Your doctor may lower your dose of cilostazol.
  • Tacrolimus. Ulceral may increase the levels of tacrolimus in your body. Your doctor may monitor the level of tacrolimus in your body.
  • Methotrexate. Ulceral may increase the effects of methotrexate. Your doctor may adjust your dose depending on the levels of methotrexate in your body.
  • Diazepam. Ulceral may increase the levels of diazepam in your body. Your doctor may watch you for more side effects from diazepam.
  • Citalopram. Ulceral may increase the amount of citalopram in your body, leading to an increased risk of heart rhythm problems. Your doctor may limit your dosage of citalopram.

How to use Ulceral

If your doctor has prescribed this medication for you, read the Patient Information Leaflet if available from your pharmacist before you start taking Ulceral and each time you get a refill. If you are taking the over-the-counter product to self-treat, read and follow all directions on the product package before taking this medication.

Take this medication by mouth as directed, usually once daily before a meal. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.

Do not crush, break, or chew delayed release tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

If you are using the disintegrating delayed release tablets, use dry hands to handle the tablets. Place the tablet on your tongue and let it dissolve. After the tablet has dissolved, it can be swallowed with or without water. The tablets can also be swallowed whole with water.

If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Ulceral 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. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.

Tell your doctor if your condition lasts or gets worse. If you are self-treating, tell your doctor if your heartburn lasts after 14 days or if you need to use this medication more than once every 4 months. The risk of side effects goes up over time. Ask your doctor how long you should take this medication. If you think you may have a serious medical problem, get medical help right away.

Tablets and capsules

Each tablet or capsule contains 10mg, 20mg or 40mg of Ulceral.

Swallow tablets and capsules whole with a glass of water or juice.

If you have problems swallowing capsules, you can open some brands of Ulceral capsules and mix the granules inside with a small amount of water or fruit juice, or sprinkle them on soft food, such as yoghurt or apple puree.

Do not open capsules that have a special coating (like those made by Dexel). Talk to your pharmacist if you're not sure whether you can open your capsules.

Ulceral also comes as a tablet that melts in your mouth.

You can buy Ulceral 10mg tablets and capsules from pharmacies.

They're the same as Ulceral 10mg tablets and capsules that you get on prescription, but they're meant to be taken only by adults, and only for up to 4 weeks.

COMMON BRAND(S): Prilosec OTC

GENERIC NAME(S): Ulceral

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

If you are self-treating with this medication, over-the-counter Ulceral products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away.

For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Pathological Hypersecretory Conditions

In open studies of 136 patients with pathological hypersecretory conditions, such as Zollinger-Ellison (ZE) syndrome with or without multiple endocrine adenomas, PRILOSEC Delayed-Release Capsules significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia, and pain. Doses ranging from 20 mg every other day to 360 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery, and below 5 mEq/hr in patients with prior gastric surgery.

Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients . PRILOSEC was well tolerated at these high dose levels for prolonged periods ( > 5 years in some patients). In most ZE patients, serum gastrin levels were not modified by PRILOSEC. However, in some patients serum gastrin increased to levels greater than those present prior to initiation of Ulceral therapy. At least 11 patients with ZE syndrome on long-term treatment with PRILOSEC developed gastric carcinoids. These findings are believed to be a manifestation of the underlying condition, which is known to be associated with such tumors, rather than the result of the administration of PRILOSEC .

What is Ulceral?

Ulceral is a medicine that reduces the amount of acid that your stomach produces. It's prescribed for stomach ulcers, but you can also buy it over the counter from pharmacies to relieve heartburn associated with acid reflux.

Ulceral comes as capsules, tablets and dispersible tablets. These are all available in 10mg, 20mg and 40mg strengths. In hospital Ulceral is sometimes given by injection or drip into a vein.

Losec, Losec MUPS, Mepradec and Mezzopram are all brand names for Ulceral. It's also called Prilosec in the USA.

A placebo-controlled study was conducted in Scandinavia to compare the efficacy of Ulceral 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.

% Successful Symptomatic Outcome a PRILOSEC 20 mg a.m. PRILOSEC 10 mg a.m. Placebo a.m. All patients 46*,† (n = 205) 31† (n = 199) 13 (n = 105) Patients with confirmed GERD 56*,† (n = 115) 36† (n = 109) 14 (n = 59) a Defined as complete resolution of heartburn *(p

Your stomach is cramping and you feel nauseous.

Stomach pain and nausea are another relatively common side effect of Ulceral, Ravella says. This can be frustrating since the whole point of taking the meds is to help you eat with less pain, and if Ulceral is making your stomach hurt, you're just ruining your meal in a different way.

One possible remedy is to try taking the pill just before your meal instead of first thing in the morning, according to the Mayo Clinic. If the pain is so much that it's interfering with your ability to eat, then call your doctor right away.

Q: Since I am taking over-the-counter Prilosec or the generic Ulceral, is it safe to take while pregnant if I have been prescribed it to treat my acid reflux?

A: If the doctor that prescribed it for you is aware that you are pregnant than it would be okay. The risks and benefits of the medication must be weighed and if your doctor feels that the benefits outweigh the risks, then it is ok. Prilosec is a pregnancy category C. This basically means that studies in animals showed adverse effects but no studies in humans have showed any effects. If you are still concerned, speak with your doctor and they can explain the reason they decided to use Prilosec during your pregnancy. Megan Uehara, PharmD


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