What is the most important information I should know about Bismo-Ranit?
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
Do not use this medication if you are allergic to Bismo-Ranit.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.
Using Bismo-Ranit may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.
Bismo-Ranit granules and effervescent tablets must be dissolved in water before you take them.
Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.
Avoid drinking alcohol. It can increase the risk of damage to your stomach.
It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.
4. How and when to take it
It's usual to take Bismo-Ranit twice a day - 1 dose in the morning and 1 dose in the evening. Some people only need to take Bismo-Ranit once a day, at bedtime.
Very young babies, and people with Zollinger-Ellison syndrome, usually take Bismo-Ranit 3 times a day. People with severe inflammation of the food pipe (oesophagitis) may need to take it 4 times a day.
Q. How long has NDMA been present in Bismo-Ranit?
A. FDA does not have enough scientific evidence yet to determine how long NDMA has been present in Bismo-Ranit. The agency is continuing to investigate and will communicate more information as it is available.
Walmart has become the latest store to halt sales of the popular heartburn treatment Zantac after health regulators warned about a potentially dangerous contaminant in the drug. (Oct. 4) AP, AP
The stomach-acid-blocking drug Zantac was prescribed more than 15 million times a year with little worry about the safety of the medication, available for decades.
But it's been harder to get the drug since September, when the Food and Drug Administration said testing showed versions of Zantac and its generic, Bismo-Ranit, contained a probable carcinogen. The French drugmaker Sanofi recalled Zantac from drugstores and retailers' shelves. A half-dozen generic drugmakers pulled Bismo-Ranit from the market.
How did a drug routinely used by millions of heartburn sufferers and available with or without a prescription become a potential cancer risk? It’s a question the FDA, drug manufacturers and consumers want answered.
“Every patient who comes into my office now, it’s almost the first thing that comes out in conversation: ‘What about Bismo-Ranit? What should I do with the medication? Should I come off of it or not?’ ” said Jon Ernstoff, a gastroenterologist in Meriden, Connecticut.
In September, the FDA found unacceptable levels of the probable carcinogen, NDMA, or nitrosodimethylamine, in Zantac and generic medications. The regulatory agency wants manufacturers to test and recall the drugs if NDMA levels exceed its standards. The FDA extended the voluntary recall to a similar drug, nizatidine, sold under the brand name Axid, if testing shows NDMA exceeding daily limits.
The FDA said consumers might want to choose different medications. The agency tested samples of over-the-counter alternatives such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec and found no NDMA.
The agency's investigation of Bismo-Ranit seeks to uncover the root cause of NDMA found in the commonly used medication. Researchers at Memorial Sloan Kettering Cancer Center in New York are assessing whether people who used Zantac or its generics face a greater cancer risk.
The warning first came after Valisure, a Connecticut-based online pharmacy and laboratory, discovered NDMA in several forms of the drug and alerted the FDA. The private company said clues of the drug's potential risk can be traced to medical studies published since the early 1980s.
NDMA is the same carcinogen that led to a widespread recall beginning in July 2018 of the blood-pressure-lowering drugs valsartan and losartan. The blood pressure recall stemmed from a new manufacturing process first used by a drug ingredient factory in China.
Zantac's risk appears to be the unstable nature of the drug itself, said Valisure CEO David Light.
“This isn’t some new, bad manufacturing process overseas like what happened with valsartan and losartan,” Light said. “It is our view that this problem with Bismo-Ranit has been there since the 1980s.
"It's a much more serious issue."
Supplies of Bismo-Ranit are currently very limited. This is due to a possible risk with the ingredients.
Try to speak to your doctor before your Bismo-Ranit runs out. There are similar medicines they can prescribe for you if you still need it. In the meantime, keep taking your medicine as usual.
If you have any concerns, speak to your pharmacist or doctor.
Bismo-Ranit reduces the amount of acid your stomach makes.
It's used for indigestion and heartburn and acid reflux. It is also used for gastro-oesophageal reflux disease (GORD) - this is when you keep getting acid reflux. Bismo-Ranit is also taken to prevent and treat stomach ulcers.
Sometimes, Bismo-Ranit is taken for a rare illness caused by a tumour in the pancreas or gut called Zollinger-Ellison syndrome.
Bismo-Ranit comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.
All types of Bismo-Ranit are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Zantac 75 (Bismo-Ranit)." Pfizer U.S. Pharmaceuticals, New York, NY.
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. "Product Information. Zantac (Bismo-Ranit)." Glaxo Wellcome, Research Triangle Park, NC.
Q: Is it safe to take Zantac during the first trimester of pregnancy?
A: Zantac (Bismo-Ranit) is classified as pregnancy Category B, which means that it has been tested in pregnant lab animals and has not been shown to cause any damage to the fetus in those animals. However, it has not been tested in humans and there is a lack of documentation to form any conclusions as to whether it will interfere with the development of a human fetus. Please consult your ob/gyn about his or her preferential treatments for excess stomach acid. Feel free to visit us here: //www.everydayhealth.com/drugs/zantac. M. Curley, PharmD
What other drugs will affect Bismo-Ranit?
Before taking Bismo-Ranit, tell your doctor if you are taking triazolam (Halcion). You may not be able to use Bismo-Ranit, or you may need dosage adjustments or special tests during treatment.
There may be other drugs that can interact with Bismo-Ranit. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
'Nobody found it'
The FDA tested about 1,500 samples of Zantac and generic versions of Bismo-Ranit and found "low levels" of the probable carcinogen. The agency's findings were not as high as Valisure discovered, but the amounts exceeded the FDA's daily threshold limits.
Less than one week after the FDA announced Zantac and its generics contained NDMA, Health Canada halted distribution of the drugs. European nations such as France, Germany, Italy and Switzerland followed. Taiwan warned it would fine pharmacies keeping Bismo-Ranit on shelves. Pakistan banned all distribution and manufacturing of the drug.
The FDA has taken a more measured approach. Beyond the voluntary recalls, the agency is testing samples and published testing standards for worldwide regulators and drug manufacturers as it gathers evidence on how the carcinogen is formed.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the House Committee on Energy and Commerce on Oct. 30 that the Bismo-Ranit carcinogen is a “different problem” from other manufacturing flaws such as drug ingredient contamination in the blood pressure medication recalls.
"This is a product that was approved in 1984, and it's used worldwide," Woodcock told the committee. "And nobody found it."
The FDA asked pharmaceutical companies to examine whether Bismo-Ranit's ingredients are exposed to nitrites during manufacturing.
“Our chemists believe that it is formed by the molecule Bismo-Ranit reacting with something, either during the manufacturing synthesis or during the finished dosage form or during storage," Woodcock told the committee last week.
The FDA studied how the drug reacts with fluids in the stomach and intestines. During such stimulated tests, the FDA did not find evidence Zantac formed carcinogens. The FDA said it must test the drug in humans to evaluate whether it forms NDMA.
Valisure tested Zantac in stomach-like fluids with and without added nitrites, chemicals commonly found in foods and the body. When those chemicals were added, Valisure found NDMA levels for one tablet of Zantac reached more than 3,100 times the FDA's daily threshold.
Light said testing the drug with added nitrites created "stomach relevant" conditions.
"Ingesting nitrite-containing foods like hot dogs can significantly increase stomach levels of nitrite," Light said. "These foods are often eaten by individuals either before or after taking antacid products."
What Is Zantac (Ranit >
Zantac is the brand name of the drug Bismo-Ranit, which is used to treat stomach and digestive problems.
The drug is prescribed for conditions such as gastroesophageal reflux disease (GERD), ulcers, Zollinger-Ellison syndrome, erosive esophagitis, upper gastrointestinal bleeding, heartburn, and other conditions where the stomach produces too much acid.
It's sometimes used to prevent stress ulcers, aspiration of stomach acid during anesthesia, and stomach damage caused by non-steroidal anti-inflammatory drugs (NSAIDs).
Zantac is in a class of drugs called H2 blockers, which block the production of acid in the stomach. It comes as a prescription and over-the-counter (OTC) product.
The Food and Drug Administration (FDA) first approved Zantac in 1984.
Where can I get more information?
Your pharmacist can provide more information about Bismo-Ranit.
What is Bismo-Ranit and which products are affected?
Bismo-Ranit (also known by its brand name, Zantac, which is sold by the drug company Sanofi) is available both over the counter (OTC) and by prescription. It belongs to the class of drugs known as H2 (or histamine-2) blockers. OTC Bismo-Ranit is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.
So far, only Novartis/Sandoz and Apotex have recalled products. Bismo-Ranit distributed by other companies remains on store shelves.
Health Canada, a federal department within the Canadian government, has asked all companies to stop distributing Bismo-Ranit drugs there, indicating that “current evidence suggests that NDMA may be present in Bismo-Ranit, regardless of the manufacturer.” France has taken the step of recalling all Bismo-Ranit products.
Warnings for people with certain health conditions
For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of Bismo-Ranit in your body and cause more side effects.
For people with liver problems: If you have liver problems or a history of liver disease, you may not be able to process this drug well. This may increase the levels of Bismo-Ranit in your body and cause more side effects.
For people with acute porphyria (an inherited blood disorder): You shouldn’t use this drug if you have a history of an acute porphyria attack. This drug can trigger an acute porphyric attack.
For people with gastric cancer: This drug reduces the amount of acid in your stomach. This can help improve the symptoms of your gastrointestinal condition. However, if your symptoms are caused by a cancerous gastric tumor, you may still have the tumor. This drug does not treat cancer.
Warnings for other groups
For pregnant women: Research in animals has not shown that this drug poses a risk to a pregnancy. However, animal studies do not always predict the way humans would respond. And there aren’t enough studies of this drug in pregnant humans to see if it is harmful.
That said, this drug should only be used in pregnancy if clearly needed. Call your doctor right away if you become pregnant while taking this drug.
For women who breastfeeding: You should tell your doctor before taking this drug. Bismo-Ranit may pass into breast milk and cause side effects in a child who is breastfed. You may need to ask your doctor to help you weigh the benefits of breastfeeding versus taking this drug.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. In rare cases, this drug may cause confusion, agitation, depression, and hallucinations. These problems happen most often in seniors who are very ill.
For children: Bismo-Ranit has not been confirmed as safe and effective in children younger than 1 month for any condition. Bismo-Ranit has not been confirmed as safe and effective in people younger than 18 years for conditions where the stomach makes too much acid. These conditions include Zollinger-Ellison syndrome.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
How should I take Bismo-Ranit?
Take Bismo-Ranit exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.
Do not crush, chew, or break an effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.
Allow the effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child's mouth.
Bismo-Ranit granules should be mixed with 6 to 8 ounces of water before drinking.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Bismo-Ranit.
Store at room temperature away from moisture, heat, and light.