Radinat tablets


  • Active Ingredient: Ranitidine
  • 300 mg, 150 mg
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What is Radinat?

The active ingredient of Radinat brand is ranitidine. Ranitidine is in a group of drugs called histamine-2 blockers. Ranitidine works by reducing the amount of acid your stomach produces. The empirical formula is C13H22N4O3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl USP is a white to pale yellow crystalline powder that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each Ranitidine tablets, USP 150 mg for oral administration contains 168 mg of Ranitidine HCl USP equivalent to 150 mg of Ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red. Each Ranitidine tablets, USP 300 mg for oral administration contains 336 mg of Ranitidine HCl USP equivalent to 300 mg of Ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red.

Used for

Radinat is used to treat diseases such as: Cutaneous Mastocytosis, Duodenal Ulcer, Duodenal Ulcer Prophylaxis, Eczema, Erosive Esophagitis, Gastric Ulcer Maintenance Treatment, Gastrointestinal Hemorrhage, GERD, Indigestion, Pathological Hypersecretory Conditions, Stomach Ulcer, Stress Ulcer Prophylaxis, Surgical Prophylaxis, Urticaria, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Radinat include: ; ; ; ; .

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Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include:

  • Inflammation of your liver, with symptoms such as:
    • yellowing of your skin or the whites of your eyes
    • tiredness
    • dark urine
    • stomach pain
  • confusion
  • agitation
  • depression
  • hallucinations (seeing or hearing something that isn’t there)
  • blurry vision
  • fast heart rate
  • tiredness
  • shortness of breath
  • 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 information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Radinat oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with Radinat are listed below.

    Why it’s used

    Radinat oral tablet is used to treat several conditions, including:

    Radinat may be used as part of a combination therapy. This means you may need to take it with other medications.

    Radinat is typically used for short-term treatment, especially for GERD. If you’re taking this drug for other conditions, you may need long-term treatment. You may need to take it for several weeks or months.

    For the Consumer

    Applies to Radinat: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral injection, parenteral injection for iv infusion only

    Side effects include:

    Oral or parenteral therapy: Headache, sometimes severe.

    IM therapy: Transient pain at injection site.

    IV therapy: Transient local burning or itching.

    Q: Is Zantac okay to take in late pregnancy? I'm 32 weeks pregnant and can't live without them. I'm taking about 2 per day.

    A: For stomach acid during pregnancy, Zantac (Radinat) is a category "B." In pregnancy, there are only 1 or 2 "perfect" drugs that are category "A," so if you need medication, you will probably be prescribed drugs that are in categories "B" or "C." The drugs that should be avoided are in catagories "D" and "X" because they can cause harmful effects. However, you should always consult with your doctor before taking any medication. You can also find helpful information on pregnancy at http://www.whattoexpect.com/pregnancy/week-by-week/landing.aspx. Patti Brown, PharmD

    What Is Radinat and How Does It Work?

    Radinat is a prescription drug used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. Radinat is also used to treat certain stomach and throat problems such as erosive esophagitis, gastroesophageal reflux disease or GERD, and Zollinger-Ellison syndrome. It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Radinat belongs to a class of drugs known as H2 blockers.

    Radinat is available under the following different brand names: Zantac, Zantac 150 Maximum Strength, and Zantac 75.

    Dosages of Radinat

    Adult and pediatric dosages:

    Dosage Considerations -- Should Be Given As Follows:

    Adult Dosage Considerations

    • 150 mg orally every 12 hours or 50 mg intramuscular/intravenously every 6-8 hours

    • Treatment: 150 mg orally every 6 hours or 50 mg intermuscular/intravenously every 6-8 hours intermittent bolus or infusion; alternatively, 6.25 mg/hours intravenously by continuous infusion
    • Maintenance of healing: 150 mg orally every 12 hours

    • 150 mg orally every 12 hours, up to 6 g/day used
    • Parenteral: 50 mg (2 mL) intramuscularly or intermittent intravenous bolus or infusion every 6-8 hours, not to exceed 400 mg/day; alternatively, 6.25 mg/hour continuous infusion

    Dosage for hypersecretory conditions

    Adult dosage (ages 17–64 years)

    • Typical dosage: 150 mg twice per day.
    • Dosage increases: Your doctor may change your dosage as needed.
    • Maximum dosage: 6,000 mg (or 6 g) per day.

    Child dosage (ages 0–17 years)

    It hasn’t been confirmed that this drug is safe and effective in people younger than 18 years for this condition.

    Senior dosage (ages 65 years and older)

    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.

    Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of the drug from building up too much in your body.

    Special dosage considerations

    If you have moderate or severe kidney disease, your doctor may start you on 150 mg taken once per day. They may increase your dosage to twice per day.

    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.

    Radinat is used for long-term or short-term treatment. 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: You may still have stomach pain caused by high amounts of acid in your stomach. This may make your condition 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. For this drug to work well, a certain amount needs to be in your body at all times.

    If you take too much: Radinat overdose is very rare. You would usually have to take much more than recommended before having overdose symptoms. However, if you take too much Radinat, you could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

    • trouble walking
    • low blood pressure (may make you feel dizzy or faint)

    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. But 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 less stomach pain.

    Certain prescription and over-the-counter (OTC) medications that contain the ingredient ranit >FDA site .

    Radinat is a drug that’s available in a prescription version and an over-the-counter version. This article only addresses the prescription version. Prescription Radinat comes as an oral tablet, oral capsule, or oral syrup. It also comes as an injectable solution.

    Radinat oral tablet is available as the brand-name drug Zantac. 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.

    Radinat and breastfeeding

    Radinat is safe to take while you're breastfeeding. It passes into breast milk, but only in small amounts which aren't harmful to the baby.

    However, if your baby is premature or has health problems check with your doctor first.


    Allergy alert: Do not use if you are allergic to Radinat or other acid reducers

    Before using Radinat

    Do not use this medication if you are allergic to Radinat.

    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.

    Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

    liver disease; or

    porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

    Radinat is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Radinat passes into breast milk. Do not take this medicine without telling your doctor if you are breast-feeding a baby.

    Using this medicine 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.

    The effervescent tablet may contain phenylalanine. Talk to your doctor before using the effervescent tablets if you have phenylketonuria (PKU).

    Q. Are other H2 blockers and other drugs for stomach acid conditions impacted by the impurity? Are there safe alternatives to Radinat?

    A. FDA’s testing has not found NDMA in Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) at this time. In addition, assessment of their manufacturing processes indicates these medicines should not contain NDMA. FDA continues to test and assess other H2 blockers and proton pump inhibitors (PPIs) that could be used as alternatives to Radinat.

    What other drugs will affect Radinat?

    Before taking Radinat, tell your doctor if you are taking triazolam (Halcion). You may not be able to use this medicine, or you may need dosage adjustments or special tests during treatment.

    There may be other drugs that can interact with Radinat. 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.

    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 Radinat. For a full list see the leaflet inside your medicines packet.

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

    7. Pregnancy and breastfeeding

    Usually, Radinat is safe to take during pregnancy and while breastfeeding.

    If you're pregnant, it's always better to try to treat indigestion without taking a medicine.

    Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.

    If these lifestyle changes don't work, you may be recommended a medicine like Radinat.

    Studies pointing to risk date to 1980s

    In 2016, Stanford University researchers tested urine samples of 10 people who took a 150-milligram tablet of Zantac and found NDMA levels far greater than the FDA's daily limits.

    William Mitch is a Stanford University professor of civil and environmental engineering who studies wastewater converted to drinking water. He said his Zantac-urine study was a "chance finding from a peripheral field" after a study on potential NDMA contamination in drinking water.

    He said it should be followed by a more robust study using the FDA's testing methods.

    "The challenge is there's so much concern about cancer risk. Could you get approval from someone to eat a Zantac and collect the urine sample?" Mitch said, noting such a request would be odd and ethically challenging, given the drug has a known carcinogen and remains on the market.

    Lior Braunstein, a Memorial Sloan Kettering oncologist and researcher, is studying Radinat and cancer risk. He does not want to discuss the study until the findings are published in a peer-reviewed journal, according to Caitlin Hool, a hospital spokeswoman.

    Light said studies conducted in the 1980s raised concern about potential safety risks. In a citizen petition to the FDA, Valisure said Zantac's originator, Glaxo Research Group, conducted its own study in 1987 "after numerous studies raised concerns" about Radinat.

    The Glaxo study examined stomach contents of people who took the drug. It found people had no significant increase in nitrosamines such as NDMA within 24 hours of taking Radinat.

    Light said the study's testing methods were less accurate and researchers discarded stomach samples that contained Radinat. Without those samples, researchers would not find NDMA or nitrosamines that form as a result of taking the drug, Light said.

    Light said the Stanford study and his lab's own analysis shows the potential health risk for people who took the drug.

    "The negative effect of exposure to this drug and its formation of NDMA is something that has created a huge public health problem," he said, "and we’re going to be dealing with it going forward."

    Q. Is NDMA in drugs a new problem? Over the past year, why have there been so many reports of drugs containing NDMA?

    A. FDA has ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public.

    Certain drug manufacturing processes pose a risk for forming genotoxic impurities. For decades, FDA has provided guidance and recommendations for controlling impurities in drug substances and manufacturers have had an ongoing responsibility to test for impurities based on an understanding of their manufacturing process. In 2018, FDA issued a guidance to provide information to manufacturers regarding their responsibilities to assess the risk of impurities and implement appropriate controls for the manufacturing process. The agency identified some of the root causes of the nitrosamine impurity problem in angiotensin II receptor blockers (ARBs).

    We are working to determine the reason for the NDMA impurity in Radinat.

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