- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- FDA Warning About Heartburn Medications, What Is The Contaminant?
The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which PEPCID Tablets were compared to placebo, the incidence of adverse experiences in the group which received PEPCID Tablets, 40 mg at bedtime, was similar to that in the placebo group.
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with PEPCID has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:
Body as a Whole: fever, asthenia, fatigue
Cardiovascular: arrhythmia, AV block, palpitation. Prolonged QT interval, in patients with impaired renal function, has been reported very rarely.
Gastrointestinal: cholestatic jaundice, hepatitis, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth
Hematologic: rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia
Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection
Musculoskeletal: rhabdomyolysis, musculoskeletal pain including muscle cramps, arthralgia
Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence. Convulsions, in patients with impaired renal function, have been reported very rarely.
Respiratory: bronchospasm, interstitial pneumonia
Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome (very rare), alopecia, acne, pruritus, dry skin, flushing
Special Senses: tinnitus, taste disorder
Other: rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo.
The adverse reactions reported for PEPCID Tablets may also occur with PEPCID for Oral Suspension.
In a clinical study in 35 pediatric patients < 1 year of age with GERD symptoms , agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.
Read the entire FDA prescribing information for Pepcid (Famotidine)
The Federal Drug Administration has recently warned that some common acid-reducing medications may increase the risk of Clostridium difficile (C-diff) infection-related diarrhea.
C-diff is a bacterial infection that causes inflammation and damage to the lining of the colon leading to severe diarrhea. Typically the infection occurs after antibiotic therapy, when too much helpful bacteria has been destroyed allowing the C-diff bacteria to flourish.
Patients with C-diff infections tend to be sicklier with more complicated illnesses than those without the disease. The most common symptom of C-diff infections is frequent, persistent diarrhea. If left untreated, the infection can cause severe dehydration resulting in diseases of the kidney, bowel or colon, or even death.
In recent years, C-diff infections have become more common, and one strain of the infection has developed a greater toxicity and resistance to antibiotics making it harder to treat. Many physicians believe that this trend is a result of overuse of antibiotics, but new data suggests that overuse of heavily advertised acid-reducing drugs may also be a cause.
According to recent FDA reports, proton pump inhibitors which are commonly prescribed for gastrointestinal conditions such as acid reflux disease and stomach ulcers may raise the risk for C-diff infection.
Studies indicate that people taking powerful PPIs, including popular brands such as Nexium, Prilosec, and Prevacid, were nearly three times more likely to be diagnosed with C-diff as those not on the drugs. Gastric acid suppressants such as Zantac and Pepcid may also make it easier for the C-diff infection to survive and multiply in the digestive tract.
Short-term use of acid-fighting drugs for occasional heartburn is not linked to an increased risk of infection in otherwise healthy people. And a prescribed, long-term use of these medications under a doctor’s supervision is generally safe.
But, if you are on long-term proton pump inhibitors or gastric acid suppressants and develop diarrhea that persists for more than three days, see your doctor. A change in medication could make a positive change in your health.
Heartburn sufferers, listen up: Acid-fighting drugs might spell relief, but they could leave a less-welcome gift — diarrhea.
People taking proton pump inhibitors and H2 blockers have greater risk of infection from a potentially dangerous diarrhea bug known as Clostridium difficile, or C-diff, reports researcher Sandra Dial, MD, MSc, a researcher at McGill University in Montreal. Her study appears in this week’s issue of The Journal of the American Medical Association.
Proton pump inhibitors include Prilosec, Prevacid, and Nexium among others. H2 blockers include drugs such as Zantac, Pepcid, and Tagamet. These are the main medications offered to people suffering from stomach acid problems such as gastritis, GERD (acid reflux disease), or heartburn. They work to suppress stomach acid production which helps to alleviate discomfort.
Clostridium difficile is prevalent in the environment and especially in hospitals and nursing homes. Spores from C-diff enter our bodies through the mouth, which is the entryway for the gastrointestinal tract. Diarrhea caused by C-diff is a result of overgrowth of the C-diff bacteria in the colon, or large intestine. It has generally been associated with antibiotic use, which can kill “good” bacteria in the colon which keeps C-diff at bay. Infection has also been associated with stays in hospitals and nursing homes where it is easily passed to others.
The incidence and severity of diarrhea caused by C-diff has increased dramatically, according to recent data, writes Dial. Diarrhea caused by C-diff can be severe, with a cramping form of intestinal inflammation known as colitis.
“Clostridium-difficile-associated disease is becoming an important public health issue,” writes Dial. Gastric (stomach) acid operates as a major defense mechanism against ingested bugs. But when people take gastric acid suppressors the stomach’s normal acidity is lost, and this defense mechanism may become diminished, she explains.
Dial’s study — the largest study thus far of this risk factor — looked at whether these drugs had any association with community-acquired C-diff infection. She and her colleagues examined data from 3 million patients of 400 general practioners in the U.K. from 1994 to 2004. There were 1,672 identified cases of C-diff, with numbers increasing from less than one per 100,000 in 1994 to 22 per 100,000 in 2004.
Those patients taking proton pump inhibitors were nearly three times more likely to acquire a C-diff infection, Dial reports. Patients taking another type of acid-fighting drug — H2 blockers like Pepcid and Zantac — were twice as likely to get a C-diff infection.
Other studies have shown that antibiotic use increases risk for C-diff infection. However, in her study, antibiotic use was seen in only 37 percent of C-diff cases. The study only demonstrated an association between the use of these medications and the risk for getting diarrhea from C-diff. It did not prove how or why this happened.
SOURCE: Dial, S. The Journal of the American Medical Association, Dec. 21, 2005; vol 293: pp 2989-2995. CDC web site.
How does this medication work? What will it do for me?
Famotidine belongs to a class of medications called H2antagonists. It is used to treat stomach and duodenal (intestinal) ulcers, gastroesophageal reflux disease (GERD), and conditions where too much stomach acid is secreted, such as Zollinger-Ellison syndrome. It works by reducing the amount of acid secreted by the stomach.
The over-the-counter form of famotidine is used to treat conditions where a reduction of stomach acid is needed, such as acid indigestion, heartburn, or sour or upset stomach. It can also be used to prevent these symptoms when they are associated with eating food or drinking beverages, including nighttime symptoms.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Pepcid is no longer being manufactured for sale in Canada. For brands that may still be available, search under famotidine. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.
How should I use this medication?
Tablets: The usual adult dose of famotidine tablets ranges from 20 mg or 40 mg at bedtime to 20 mg or 40 mg twice daily, depending on the condition being treated. This medication can be taken with or without food. Seniors and those with decreased kidney function may require lower doses or longer intervals between doses.
- The dose of famotidine for treatment of duodenal ulcer is 40 mg at bedtime for 4 to 8 weeks, or less if healing occurs. Therapy is often continued after healing of the ulcer at a dose of 20 mg once daily for up to 6 to 12 months.
- The usual dose for treatment of benign stomach ulcer is 40 mg once a day at bedtime for 4 to 8 weeks, or less if healing occurs.
- For Zollinger-Ellison syndrome and similar conditions, the dose varies with the individual patient, but often starts with 20 mg every 6 hours.
- When used to relieve the symptoms of GERD or prevent GERD from returning, the usual dose is 20 mg twice daily. When used to treat esophageal damage related to GERD, the usual dose is 40 mg twice daily.
When used over-the-counter to treat acid indigestion, heartburn, or sour or upset stomach, the usual dose for adults and children 12 years of age or older is 10 mg to 40 mg once daily. To prevent symptoms brought on by consuming food or beverages, take the dose 10 to 15 minutes before eating food or drinking beverages that are expected to cause symptoms. The maximum dose is 40 mg every 24 hours. Do not take it in this manner for more than 2 weeks without seeking medical advice.
Injection: The injectable form of famotidine may be used in hospitals under specific circumstances when the patient is not able to swallow tablets. The usual dose of famotidine injection is 20 mg every 12 hours given intravenously (into a vein).
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Store the injection in the refrigerator between 2°C and 8°C, protect it from light, and do not allow it to freeze. Keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to famotidine or any ingredients of the medication
- are allergic to other acid-reducing agents known as H2-receptor antagonists (e.g., ranitidine, cimetidine, nizatidine)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- joint pain
- skin rash
- symptoms of liver problems (e.g., abdominal pain, fatigue, flu-like symptoms, light coloured stools, nausea, yellowing of the skin or eyes, vomiting)
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Kidney disease: Famotidine is eliminated from the body mostly by the kidney. Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Lower doses or longer intervals between doses may be needed.
Severe stomach problems: If you have recurrent vomiting, difficulty swallowing, blood in the stool, significant unintentional weight loss, fatigue (anemia), or are coughing up blood, check with your doctor right away. If you have heartburn that worsens or returns after using this medication continuously for 2 weeks, check with your doctor.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking famotidine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children. For the over-the-counter form, the safety and effectiveness of using this medication have not been established for children less than 12 years of age.
Seniors: Seniors are at an increased likelihood of having decreased kidney function and therefore may be more likely to experience side effects. If you are a senior, your doctor should closely monitor your condition while you are taking famotidine.
What other drugs could interact with this medication?
There may be an interaction between famotidine and any of the following:
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
- “azole” antifungals (itraconazole, ketoconazole, posaconazole)
- certain protein kinase inhibitors (e.g., bosutinib, dabrafenib, dasatinib, nilotinib, pazotinib)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- iron supplements (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- multiple vitamin supplements with iron
- quinolone antibiotics (e.g., ciprofloxacin, ofloxacin, sparfloxacin)
- risedronate (delayed-release)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetic medications; dolasetron, ondansetron, granisetron)
- tyrosine kinase inhbitors (e.g., lapatinib, pazopanib, sunitinib)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Pepcid
FDA Warning About Heartburn Medications, What Is The Contaminant?
The U.S. Food and Drug Administration (FDA) has learned that some acid-reducing and heartburn … medicines, including Zantac, contain low levels of a cancer-causing impurity. (Photo Illustration by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
SOPA Images/LightRocket via Getty Images
This announcement could give you some heartburn.
The U.S. Food and Drug Administration (FDA) has issued warning about a commonly-used type of heartburn medication. And this warning included some impure thoughts. Testing has found batches of ranitidine to be contaminated with an impurity called NDMA. If you think that this news doesn’t apply to you because you take Zantac, think again. Zantac is actually one brand name for ranitidine. Ranitidine can decrease acid secretion in your stomach acid by blocking histamine H2 receptors and therefore is frequently used to treat stomach ulcers and heartburn, otherwise known as gastroesophageal reflux disease or GERD, which rhymes with turd.
NDMA doesn’t stand for North Dakota-Massachusetts but instead is short for N-nitrosodimethylamine. It’s classified as a probable human carcinogen, meaning that there is a good chance that the compound can cause cancer if present at high enough levels. If you’ve heard of this chemical compound before, it may be because this was the contaminant found in certain blood pressure medications, Angiotensin II Receptor Blockers (ARBs), last year, as I covered previously for Forbes.
If you recall, NDMA contamination did result in recalls of some of these blood pressure medication. So the obvious questions are will ranitidine be recalled, what should you do if you are taking ranitidine, and what rhymes with ranitidine? The answers are “no, not at the present moment”, “talk to your doctor and possibly select an alternative medication”, and “passionate scene or plasma choline.”
The levels of NDMA detected in the ranitidine were apparently quite low, lower than the levels found in the blood pressure medications that were recalled. Ingesting such levels alone probably won’t put you at risk for developing cancer. There is a good chance that you have already been exposed to NDMA since it can be a contaminant in your environment, food, and water. What matters is how much goes into your body over time. As a result, it is a good idea to try to minimize your intake of NDMA.
Therefore, while the FDA “is not calling for individuals to stop taking ranitidine at this time,” you may want to find alternatives if you can. Ranitidine is certainly not the only medication available for heartburn, stomach ulcers, and other stomach acid-related problems. There are other H2-receptor blockers that work by the same mechanism as ranitidine. These include nizatidine (sold via the brand name Axid), famotidine (Pepcid, Pepcid AC), and cimetidine (Tagamet, Tagamet HB). All of these also sort of rhyme with “passionate scene” and “plasma choline,” so you won’t miss much switching to them.
Heartburn is the most common reason for people to take ranitidine. Pictured here is Rick Hoffman as … Louis Litt in the “Heartburn” episode of Suits. (Photo by: Ian Watson/USA Network/NBCU Photo Bank via Getty Images)
NBCU Photo Bank via Getty Images
If you are on ranitidine, check with your doctor. You may not even need to be on such medications. For example, for heartburn, there are a number of options including lifestyle modifications such as eating less oily or acidic foods, cutting down on your caffeine and alcohol intake, adjusting when and how you sleep, and wearing more loose-fitting clothes that don’t compress your tummy and force acid up into your esophagus. So ease off on wearing Spider Man costumes and munching on deep-fried tomatoes and drinking Iced Irish Coffee while hanging upside down.
Meanwhile, stay tuned as the FDA continues its investigation.
With all the blood pressure medication recalls over this past year, this latest FDA announcement does seem like déjà vu all over again. The question is whether drug manufacturers are maintaining appropriate safety and quality control measures and how these are being monitored. As more and more manufacturing is being done overseas, it can be harder and harder to keep track of what’s happening. It can be tempting to cut manufacturing costs to save money but producing drugs is not the same as making handbags. Even a small mistake with a medication can have serious consequences. The thought of that alone could give you heartburn.
September 19, 2019 UPDATE: Due to these aforementioned concerns, Novartis has stopped shipping their generic form of Zantac. Before you say, “oh my GERD,” Novartis is describing this as a “precautionary distribution stop.” Investigations are still underway.
Also, note that this is not a recall. So if you try to return or mail back any ranitidine that you have already purchased, you ain’t going to get anything in return.
For now, Sanofi, the makers of the original Zantac, has not announced any plans to stop distribution of the medication. As they say about evolving situations and guitars, stay tuned.