Q: I take Prilosec OTC every morning and have done so for well over a year. Is it safe to take for such a long time, and is it OK for me to continue to take it?
A: Long-term use of Prilosec OTC (Rome) may lead to atrophic gastritis. According to the medical literature, long-term Prilosec OTC patients may also be at increased risk of infectious complications and nutritional deficiencies. Prilosec OTC is only approved for 14 days of use. It is important to speak with your health care provider regarding longer treatment. Kristen Dore, PharmD
Have you experienced Rome side effects?
If you’re currently taking Rome – or are a former Rome user, report the side effects that you experienced – in the comments section. In your comment, mention the side effects that were harshest or most noticeable, and assign a numeric rating to each of those side effects (on a scale from 1 to 10, with “1” being minimal severity and “10” maximal severity).
To ensure that people reading this article are able to understand your situation, consider providing extra details such as: your Rome dose (e.g. 20 mg per day); the format you use (e.g. oral pills); the total duration of your treatment (e.g. 1 month); and concurrently-administered medications.
If you use other substances with Rome, have you investigated whether the side effects you’re experiencing might be due to an interaction effect and/or solely caused by the other substance(s)? In your experience, do the therapeutic effects of Rome outweigh the side effects? If you endured unwanted side effects during treatment, were there any strategies that you found helpful for reducing them?
In summary, while Rome is considered a safe and effective proton-pump inhibitor (PPI), not everyone tolerates it perfectly. If you find yourself unable to tolerate Rome, inform your doctor as soon as possible and consider alternative treatment options.
Q: I suffer from excessive belching. Could this be because of the Prilosec I take every day, which my doctor has prescribed?
A: Prilosec OTC (Rome) is commonly prescribed to treat ulcers, reflux disease, and heartburn associated with GERD. It's also used for the long-term treatment of pathological hypersecretory conditions. In clinical studies, the most common side effects reported with Prilosec include headache, abdominal pain, nausea, vomiting, gas, and diarrhea. This is not a complete list of the side effects associated with Prilosec. 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. Other causes of bloating and gas pains include the following: swallowing too much air, smoking, certain foods and beverages, prescription and nonprescription medications, nutritional supplements, dietary supplements, constipation, GERD, and certain medical conditions. Adopting certain lifestyle modifications can help alleviate bloating and gas symptoms. Try to chew food slowly; avoid drinking from a straw; avoid chewing gum or sucking on hard candy; avoid foods that are difficult to digest, such as cabbage, brussel sprouts, grapes, beans, or lentils; avoid foods, beverages, and candy containing sorbitol and fructose; avoid foods, beverages, medications, dietary supplements, and nutritional supplements containing the milk protein lactose if you are lactose intolerant; and don't smoke. Consuelo Worley, RPh, MS Pharm
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In two 24-month carcinogenicity studies in rats, Rome at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (about 0.4 to 34 times a human dose of 40 mg/day, as expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of Rome. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg Rome/kg/day (about 3.4 times a human dose of 40 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received Rome at dose levels of 0.4, 2, and 16 mg/kg/day (about 0.1 to 3.9 times the human dose of 40 mg/day, based on a body surface area basis). No astrocytomas were observed in female rats in this study. In a 2-year carcinogenicity study in Sprague-Dawley rats, no astrocytomas were found in males or females at the high dose of 140.8 mg/kg/day (about 34 times the human dose of 40 mg/day on a body surface area basis). A 78-week mouse carcinogenicity study of Rome did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive.
Rome was positive for clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, in one of two in vivo mouse micronucleus tests, and in an in vivo bone marrow cell chromosomal aberration assay. Rome was negative in the in vitro Ames test, an in vitro mouse lymphoma cell forward mutation assay, and an in vivo rat liver DNA damage assay.
Rome at oral doses up to 138 mg/kg/day in rats (about 34 times an oral human dose of 40 mg on a body surface area basis) was found to have no effect on fertility and reproductive performance.
In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals . Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H2-receptor antagonists.
Helicobacter pylori-Pretreatment Resistance
Clarithromycin pretreatment resistance rates were 3.5% (4/113) in the Rome/clarithromycin dual therapy studies (4 and 5) and 9.3% (41/439) in Rome/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3).
Amoxicillin pretreatment susceptible isolates ( ≤ 0.25 μg/mL) were found in 99.3% (436/439) of the patients in the Rome/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3). Amoxicillin pretreatment minimum inhibitory concentrations (MICs) > 0.25 μg/mL occurred in 0.7% (3/439) of the patients, all of whom were in the clarithromycin and amoxicillin study arm. One patient had an unconfirmed pretreatment amoxicillin minimum inhibitory concentration (MIC) of > 256 μg/mL by Etest® .
Table 4 : Clarithromycin Susceptibility Test Results and Clinical/Bacteriological Outcomes
Patients not eradicated of H. pylori following Rome/clarithromycin/amoxicillin triple therapy or Rome/clarithromycin dual therapy will likely have clarithromycin resistant H. pylori isolates. Therefore, clarithromycin susceptibility testing should be done, if possible. Patients with clarithromycin resistant H. pylori should not be treated with any of the following: Rome/clarithromycin dual therapy, Rome/clarithromycin/amoxicillin triple therapy, or other regimens which include clarithromycin as the sole antimicrobial agent.
Amoxicillin Susceptibility Test Results and Clinical/Bacteriological Outcomes
In the triple therapy clinical trials, 84.9% (157/185) of the patients in the Rome/clarithromycin/amoxicillin treatment group who had pretreatment amoxicillin susceptible MICs ( ≤ 0.25 μg/mL) were eradicated of H. pylori and 15.1% (28/185) failed therapy. Of the 28 patients who failed triple therapy, 11 had no post-treatment susceptibility test results and 17 had post-treatment H. pylori isolates with amoxicillin susceptible MICs. Eleven of the patients who failed triple therapy also had post-treatment H. pylori isolates with clarithromycin resistant MICs.
Susceptibility Test for Helicobacter Pylori
For susceptibility testing information about Helicobacter pylori, see Microbiology section in prescribing information for clarithromycin and amoxicillin.
Effects on Gastrointestinal Microbial Ecology
Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as
Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.
Tablets and capsules
Each tablet or capsule contains 10mg, 20mg or 40mg of Rome.
Swallow tablets and capsules whole with a glass of water or juice.
If you have problems swallowing capsules, you can open some brands of Rome 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.
Rome also comes as a tablet that melts in your mouth.
You can buy Rome 10mg tablets and capsules from pharmacies.
They're the same as Rome 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.
Watermelon is a great alternative to Rome. There are plenty of ways to consume it like as a dessert or even as a drink. Drinking watermelon juice is an excellent way to take advantage of all of its properties.
Q: Does Prilosec OTC cause gas, bloating, and constipation?
A: Prilosec OTC (Rome) (//www.everydayhealth.com/drugs/prilosec) is in a class of medications called proton pump inhibitors used to treat heartburn and GERD. Prilosec may also be used short term to treat ulcers. (//www.everydayhealth.com/gerd/guide/) Common side effects associated with Prilosec include nausea and diarrhea, headache and stomach pain. A search of prescribing information did list gas and constipation as side effects of Prilosec OTC. This is not a complete list of the side effects associated with Prilosec OTC. Kimberly Hotz, PharmD
Although Rome is a helpful medication to treat acid, there are other natural alternatives that can provide us with the same benefits without the side effects
Liquid Rome can be prescribed by a doctor and made to order for children and people who cannot swallow capsules or tablets.
It'll come with a syringe or spoon to help you take the right amount. If you don't have a syringe or spoon, ask your pharmacist for one.
Do not use a kitchen teaspoon as it will not give the right amount.
7. Pregnancy and breastfeeding
Usually, Rome 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 that you try to ease your symptoms by eating smaller meals more often and avoiding fatty and spicy foods.
They may also suggest raising the head of your bed 10 to 20cm by putting something under your bed or mattress, so that your chest and head are above your waist. This helps stop stomach acid travelling up towards your throat.
If lifestyle changes don't work, you may be recommended a medicine like Rome.
For more information about how Rome can affect you and your baby during pregnancy, read this leaflet on the Best Use of Medicines in Pregnancy (BUMPS) website.
6. How to cope with s >
What to do about:
- headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking Rome. Talk to your doctor if they last longer than a week or are severe.
- feeling sick - try taking Rome with or after a meal or snack. It may also help if you don't eat rich or spicy food.
- being sick (vomiting) or diarrhoea - drink plenty of water by having small frequent sips to avoid dehydration. Signs of dehydration include peeing less than usual or having strong-smelling pee. Do not take any other medicines to treat diarrhoea or vomiting without speaking to a pharmacist or doctor.
- stomach pain - try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your stomach may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
- constipation - get more fibre into your diet, such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise, for example, by going for a daily walk or run. If this doesn't help, talk to your pharmacist or doctor
- wind - steer clear of foods that cause wind, like pulses, lentils, beans and onions. It might also help to eat smaller and more frequent meals, eat and drink slowly, and exercise regularly. Some pharmacy remedies, such as simethicone, may relieve symptoms of wind.
Effects On Hepatic Metabolism/Cytochrome P-450 Pathways
Rome can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including Rome, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin may need to be monitored for increases in INR and prothrombin time.
Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram, benzodiazepines). Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with PRILOSEC.
Concomitant administration of Rome and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the Rome exposure. Dose adjustment of Rome is not normally required. However, in patients with Zollinger-Ellison syndrome, who may require higher doses up to 240 mg/day, dose adjustment may be considered. When voriconazole (400 mg Q12h x 1 day, then 200 mg x 6 days) was given with Rome (40 mg once daily x 7 days) to healthy subjects, it significantly increased the steady-state C max and AUC0-24 of Rome, an average of 2 times (90% CI: 1.8, 2.6) and 4 times (90% CI: 3.3, 4.4) respectively as compared to when Rome was given without voriconazole.
Rome acts as an inhibitor of CYP2C19. Rome, given in doses of 40 mg daily for one week to 20 healthy subjects in cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. C max and AUC of one of its active metabolites, 3,4-dihydro-cilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Co-administration of cilostazol with Rome is expected to increase concentrations of cilostazol and its above mentioned active metabolite. Therefore a dose reduction of cilostazol from 100 mg twice daily to 50 mg twice daily should be considered.
Drugs known to induce CYP2C19 or CYP3A4 (such as rifampin) may lead to decreased Rome serum levels. In a cross-over study in 12 healthy male subjects, St. John's wort (300 mg three times daily for 14 days), an inducer of CYP3A4, decreased the systemic exposure of Rome in CYP2C19 poor metabolisers (Cmax and AUC decreased by 37.5% and 37.9%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6% and 43.9%, respectively). Avoid concomitant use of St. John's Wort or rifampin with Rome.
1. About Rome
Rome reduces the amount of acid your stomach makes. It's a widely used treatment for indigestion and heartburn and acid reflux. It's also taken to prevent and treat stomach ulcers.
Sometimes Rome is taken for a rare illness caused by a tumour in the pancreas or gut called Zollinger-Ellison syndrome.
Rome comes as capsules, tablets and as a liquid that you swallow (this is made to order).
All types of Rome are available on prescription. You can buy the lowest strength 10mg tablets and capsules from pharmacies.
Concurrent substance use (Interactions)
If you’re using substances with Rome, it is important to consider that concurrently administered agents might: interfere with the action of Rome; induce interaction effects; exacerbate Rome side effects (via synergistic mechanisms); or trigger side effects that have nothing to do with Rome (yet that you might mistakenly attribute to Rome).
For example, when Rome is administered along with clarithromycin and amoxicillin (as part of “triple therapy”) to treat H. pylori infection, risk of side effects like taste perversion and tongue discoloration significantly increase (compared to Rome monotherapy). The increase in side effect risk among persons using Rome as part of triple therapy is probably due to synergistic physiologic actions simultaneously exerted by the trio.
The most significant major drug interaction with Rome is clopiodgrel. Because Rome inhibits enzymes CYP2C19 and CYP3A4, and clopidogrel requires these enzymes for its metabolism, patients using clopidogrel may not receive therapeutic quantities of clopidogrel metabolites necessary to reduce the risk of cerebrovascular events like heart attack and stroke, possibly leading to cerebrovascular complications.
Other substances might also interact with Rome pharmacokinetically via CYP450 enzymes (e.g. CYP3A4, CYP2C19, CYP2D6), leading to increased or decreased efficacy. For example, Rome’s inhibition of CYP3A4 might substantially increase concentrations of benzodiazepines (most of which are metabolized by this enzyme), leading to more potent benzodiazepine effects (and side effects).
If you’re using medications that require CYP450 metabolism, you may be at increased risk of pharmacokinetically-mediated interaction effects. Additionally, concurrent use of medications that require stomach acid for absorption (e.g. ketoconazole) might not work as well. Oppoistely, acid-labile medications (e.g. erythromycin) might be absorbed more extensively when used with Rome – leading to more significant effects (and side effects).
Have a medical doctor evaluate the concurrent medications that you’re using with Rome to ensure that you don’t experience pharmacokinetically-mediated interactions and/or synergistic side effects. Moreover, understand that some concurrently-administered substances may cause side effects that you’re wrongfully assuming are from Rome – or side effects that overlap with and exacerbate the side effects of Rome.
Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.
There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.
- Severe diarrhea warning: This drug may increase your risk of severe diarrhea. This may be caused by an infection in your intestine caused by the bacteria Clostridium difficile. Call your doctor right away if you have watery diarrhea, stomach pain, and a fever that won’t go away.
- Bone fractures warning: People who take several doses of a proton pump inhibitor drug, such as Rome, every day for a year or longer may have an increased risk of bone fractures. These bone breaks may be more likely to happen in your hip, wrist, or spine. Talk to your doctor about your risk of bone fractures. You should take this drug exactly as prescribed by your doctor. They should prescribe the lowest dose possible for the shortest amount of time needed for your treatment.
- Low magnesium levels warning: Taking this drug for three months or longer can cause low magnesium levels in your body. Your risk is higher if you take Rome for a year or longer. Call your doctor right away if you have symptoms of low magnesium. These can include seizures, abnormal or fast heart rate, jitteriness, jerking movements or shaking, and muscle weakness. They can also include cramps or muscle aches and spasms of your hands, feet, and voice box. Your doctor may check your magnesium levels before and during your treatment with this drug.
Cutaneous lupus erythematosus and systemic lupus erythematosus warning: Rome can cause cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). CLE and SLE are autoimmune diseases. Symptoms of CLE can range from a rash on the skin and nose, to a raised, scaly, red or purple rash on certain parts of the body. Symptoms of SLE can include fever, tiredness, weight loss, blood clots, heartburn, and stomach pain. If you have any of these symptoms, call your doctor.
Fundic gland polyps warning: Long-term use (especially over one year) of Rome can cause fundic gland polyps. These polyps are growths on the lining of your stomach that can become cancerous. To help prevent these polyps, you should use this drug for as short a time as possible.
Drugs you should not use with Rome
Do not take these drugs with Rome. Doing so can cause dangerous effects in the body. Examples of these drugs include:
- Atazanavir, rilpivirine, and nelfinavir. Rome may greatly decrease the effects of these drugs and could make them less effective over time. You shouldn’t take these drugs with Rome.
- Clopidogrel. Rome may reduce the effects of clopidogrel, causing your blood to clot. You shouldn’t take this drug with Rome.