WITHDRAWAL OF RANITIDINEIn April 2020, the
Food and Drug Administration (FDA)requested that all forms of prescription and over-the-counter (OTC) ranitidine (Zantac) be removed from the U.S. market. This recommendation was made because unacceptable levels of NDMA, a probable carcinogen (cancer-causing chemical), were found in some ranitidine products. If you’re prescribed ranitidine, talk with your doctor about safe alternative options before stopping the drug. If you’re taking OTC ranitidine, stop taking the drug and talk with your healthcare provider about alternative options. Instead of taking unused ranitidine products to a drug take-back site, dispose of them according to the product’s instructions or by following the FDA’s guidance.
Zantac is one drug that treats excess stomach acid and related conditions. You may also know it by its generic name, ranitidine. Ranitidine belongs to a class of drugs called histamine-2 receptor blockers, or H2-blockers. H2-blockers decrease the amount of acid that certain cells in your stomach make.
Zantac can also be a safe and effective way to decrease stomach acid, heartburn, and related pain in your baby, but there are certain precautions. Learn more about heartburn in babies and how certain types of Zantac can work to treat it.
Some babies make too much stomach acid. The muscle between the esophagus (or “food pipe”) and the stomach is called the lower esophageal sphincter. This muscle opens to let food move from the esophagus into the stomach. Typically, it closes to keep acid from moving up into the esophagus from the stomach. In some babies, though, this muscle isn’t fully developed. It may let some acid back into the esophagus.
If this happens, the acid can irritate the esophagus and cause a burning feeling or pain. Too much acid reflux for too long can cause sores or ulcers. These sores can form anywhere from your baby’s esophagus and stomach to the first part of their duodenum (small intestine).
Decreasing your baby’s excess stomach acid can decrease the irritability they have from the pain of acid reflux after feeding. It can also help your baby eat more easily, which improves weight gain and decreases weight loss. As your baby grows, their lower esophageal sphincter will start to work better and they will spit up less. Less spitting up results in less irritation.
For more information about this condition, read about the signs and symptoms of acid reflux in infants.
The type of Zantac that you can give your baby comes in a 15-mg/mL syrup. It’s only available with a prescription. Over-the-counter forms of Zantac are available, but they should only be used by people who are 12 years or older.
You give Zantac 30-60 minutes before you feed your baby. The dose is based on their individual weight. Measure their Zantac syrup dose with a medicine dropper or an oral syringe. If you don’t already have one, you can find either measuring tool at your pharmacy.
Dosage for ulcers of the stomach, esophagus, and duodenum
The typical initial treatment is 2-4 mg/kg of body weight twice per day for four to eight weeks. Do not give your baby more than 300 mg per day.
While the ulcers heal, you can give your baby maintenance treatment with Zantac. The dosage is still 2-4 mg/kg, but you’ll give it only once per day at bedtime. This treatment can last for up to one year. Be sure not to give more than 150 mg per day.
Dosage for GERD or erosive esophagitis
To treat your baby’s gastroesophageal reflux disease (GERD) or erosive esophagitis, the typical dosage is 2.5-5 mg/kg of body weight twice per day. Your baby’s symptoms can improve within 24 hours, but therapy for erosive esophagitis usually lasts for a few months.
Most people tolerate Zantac fairly well, but it is possible for your baby to have side effects. These side effects may include:
Zantac can change how your baby’s body absorbs other medications because of the changes it makes to the amount of stomach acid. It can also affect how the kidneys remove medications from the body. Zantac can block liver enzymes that also break down medications.
These effects may affect other drugs or substances that you may give your baby. Make sure that your baby’s doctor knows about all drugs that you give your baby, including over-the-counter drugs, vitamins, and supplements. This information will help the doctor know if there’s any reason Zantac wouldn’t be safe for your child.
Zantac can be used safely in babies. However, the only form for babies is a syrup that has to be prescribed by your baby’s doctor. The over-the-counter Zantac you may already have in your medicine cabinet is not approved for babies.
Dosages of the approved syrup are based on your baby’s condition and weight. It’s extremely important that you follow the dosage instructions exactly as they are given by the doctor. An overdose in babies can be difficult to detect. If you’re ever in doubt about your baby’s treatment, a good rule of thumb is always to ask your doctor.
While Zantac is considered safe, small changes in feeding and sleeping habits may also help with your infant’s symptoms. To learn about other treatment options, read about treating GERD in infants.