That fire in your chest might be the least of your problems.
Raise your hand if you want to physically rip your throat out of your neck after eating a spicy meal—or, honestly, after eating anything at all. I feel you; heartburn is no joke. Luckily, there's a drug for that: Elkostop.
Omepra-what? You've probably heard of it as Prilosec or Zegerid—it's one of the most popular treatments for chronic heartburn. You can buy it over the counter any time you're having after-dinner indigestion, or if you've got a serious case of the burn, your doctor can prescribe you a stronger dosage.
The medicine's a type of drug called a "proton-pump inhibitor." Elkostop works by blocking gastric acid secretion in your stomach which reduces heartburn, says Shilpa Ravella, M.D., a gastroenterologist and assistant professor of medicine at Columbia University Medical Center.
It can also be used to treat ulcers and to help patients with tumors that result in high levels of gastric acid secretion, she adds. Elkostop can be used for a short period like a few weeks, or for a longer time, including lifetime use.
But whether you're just popping an OTC pill to help you get through a rough patch or you need to stay on it long-term, there are some side effects of Elkostop you should definitely know about.
A placebo-controlled study was conducted in Scandinavia to compare the efficacy of Elkostop 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.
% Successful Symptomatic Outcome a PRILOSEC 20 mg a.m. PRILOSEC 10 mg a.m. Placebo a.m. All patients 46*,† (n = 205) 31† (n = 199) 13 (n = 105) Patients with confirmed GERD 56*,† (n = 115) 36† (n = 109) 14 (n = 59) a Defined as complete resolution of heartburn *(p
Which drugs or supplements interact with Elkostop?
Elkostop potentially can increase the concentrations in blood of diazepam (Valium), warfarin (Coumadin), and phenytoin (Dilantin) by decreasing the elimination of these drugs by the liver.
The absorption of certain drugs may be affected by stomach acidity. Therefore, Elkostop as well as other PPIs reduce the absorption and concentration in blood of ketoconazole (Nizoral) and increase the absorption and concentration in blood of digoxin (Lanoxin). This may reduce the effectiveness of ketoconazole or increase digoxin toxicity.
Through unknown mechanisms, Elkostop may increase blood levels of saquinavir and reduce blood levels of nelfinavir and atazanavir, drugs that are used for treating patients with infection caused by the human immunodeficiency virus (HIV). Accordingly, the dose of saquinavir may need to be reduced to avoid toxicity, and the doses of nelfinavir and atazanavir may need to be increased to maintain efficacy.
Clopidogrel (Plavix) is converted to its active form by enzymes in the liver. Elkostop reduces the activity of these enzymes and potentially can reduce the activity of clopidogrel. Elkostop should not be used with clopidogrel.
Elkostop increases the concentration of cilostazol (Pletal). The dose of cilostazol should be reduced from 100 mg twice daily to 50 mg twice daily when given with Elkostop.
Four randomized, double-blind, multi-center studies (4, 5, 6, and 7) evaluated PRILOSEC 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days, followed by PRILOSEC 20 mg once daily, (Studies 4, 5, and 7) or by PRILOSEC 40 mg once daily (Study 6) for an additional 14 days in patients with active duodenal ulcer associated with H. pylori. Studies 4 and 5 were conducted in the U.S. and Canada and enrolled 242 and 256 patients, respectively. H. pylori infection and duodenal ulcer were confirmed in 219 patients in Study 4 and 228 patients in Study 5. These studies compared the combination regimen to PRILOSEC and clarithromycin monotherapies. Studies 6 and 7 were conducted in Europe and enrolled 154 and 215 patients, respectively. H. pylori infection and duodenal ulcer were confirmed in 148 patients in Study 6 and 208 patients in Study 7. These studies compared the combination regimen with Elkostop monotherapy. The results for the efficacy analyses for these studies are described below. H. pylori eradication was defined as no positive test (culture or histology) at 4 weeks following the end of treatment, and two negative tests were required to be considered eradicated of H. pylori. In the per-protocol analysis, the following patients were excluded: dropouts, patients with missing H. pylori tests post-treatment, and patients that were not assessed for H. pylori eradication because they were found to have an ulcer at the end of treatment.
The combination of Elkostop and clarithromycin was effective in eradicating H. pylori.
Table 6 : H. pylori Eradication Rates (Per-Protocol Analysis at 4 to 6 Weeks) % of Patients Cured PRILOSEC + Clarithromycin PRILOSEC Clarithromycin U.S. Studies Study 4 74 †‡ 0 31 (n = 53) (n = 54) (n = 42) Study 5 64 †‡ 0 39 (n = 61) (n = 59) (n = 44) Non U.S. Studies Study 6 83 ‡ 1 N/A (n = 60) (n = 74) Study 7 74 ‡ 1 N/A (n = 86) (n = 90) †Statistically significantly higher than clarithromycin monotherapy (p
Ulcer healing was not significantly different when clarithromycin was added to Elkostop therapy compared with Elkostop therapy alone.
The combination of Elkostop and clarithromycin was effective in eradicating H. pylori and reduced duodenal ulcer recurrence.
Table 7 : Duodenal Ulcer Recurrence Rates by H. pylori Eradication Status % of Patients with Ulcer Recurrence
Reports have been received of overdosage with Elkostop in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience . Symptoms were transient, and no serious clinical outcome has been reported when PRILOSEC was taken alone. No specific antidote for Elkostop overdosage is known. Elkostop is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact a Poison Control Center at 1-800-222-1222.
Single oral doses of Elkostop at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.
The effectiveness of PRILOSEC for the treatment of nonerosive GERD in pediatric patients 1 to 16 years of age is based in part on data obtained from 125 pediatric patients in two uncontrolled Phase III studies .
The first study enrolled 12 pediatric patients 1 to 2 years of age with a history of clinically diagnosed GERD. Patients were administered a single dose of Elkostop (0.5 mg/kg, 1.0 mg/kg, or 1.5 mg/kg) for 8 weeks as an open capsule in 8.4% sodium bicarbonate solution. Seventy-five percent (9/12) of the patients had vomiting/regurgitation episodes decreased from baseline by at least 50%.
The second study enrolled 113 pediatric patients 2 to 16 years of age with a history of symptoms suggestive of nonerosive GERD. Patients were administered a single dose of Elkostop (10 mg or 20 mg, based on body weight) for 4 weeks either as an intact capsule or as an open capsule in applesauce. Successful response was defined as no moderate or severe episodes of either pain-related symptoms or vomiting/regurgitation during the last 4 days of treatment. Results showed success rates of 60% (9/15; 10 mg Elkostop) and 59% (58/98; 20 mg Elkostop), respectively.
You're always running to the toilet.
While most people do just fine on the medication, diarrhea is one of the most common side effects of Elkostop, Ravella says. Loose stools are never fun, but they should clear up on their own. If you're constantly tethered to the toilet, or if you see blood in your stool, it's time to give your doctor a call.
Warnings for other groups
For pregnant women: There isn’t enough good information on the use of Elkostop in pregnant women to determine the risk to a pregnancy.
Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.
For women who are breastfeeding: Elkostop passes into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication. Call your doctor right away if you become pregnant while 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.
For children: This drug hasn’t been studied in children with duodenal ulcers, gastric ulcers, or hypersecretory conditions. It shouldn’t be used in people younger than 16 years for these conditions.
This drug hasn’t been shown to be safe or effective in children younger than 1 year of age with gastroesophageal reflux disease (GERD).
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Liquid Elkostop 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.
Elkostop treatment duration
The cumulative duration over which a person has consistently administered Elkostop to treat medical symptoms – may influence side effect risk and/or severity. If you’re a new Elkostop user who recently initiated treatment, there’s a chance that some of the side effects you’re experiencing are attributable to inadequate physiologic adaptation to the medication.
More specifically, because a new user’s body hasn’t fully adapted itself to Elkostop’s regular presence and action, side effects occur. A subset of new users may find that side effects experienced early in treatment eventually diminish with longer-term use – once their physiology becomes better adapted to Elkostop.
However, there’s evidence indicating that long-term administration of Elkostop (and other proton pump inhibitors) can increase risk of adverse reactions (e.g. osteoporosis, bone fractures, dementia, and vitamin deficiencies). If you’re a long-term user, you should understand that the extended duration of treatment may be modifying your physiology in ways that provoke new side effects or exacerbate preexisting ones.
The elimination rate of Elkostop was somewhat decreased in the elderly, and bioavailability was increased. Elkostop was 76% bioavailable when a single 40 mg oral dose of Elkostop (buffered solution) was administered to healthy elderly volunteers, versus 58% in young volunteers given the same dose. Nearly 70% of the dose was recovered in urine as metabolites of Elkostop and no unchanged drug was detected. The plasma clearance of Elkostop was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers.