Prilosec otc trial

When will Prilosec OTC be available? FDA originally approved prescription Prilosec in Prilosec OTC is used to treat frequent heartburn. Heartburn occurs when the stomach contents back up and out of the stomach into the esophagus the tube that connects the throat to the stomach. Frequent heartburn is when you have heartburn 2 or more days a week.

Prilosec OTC is not the right medicine for you if you have occasional heartburn, one episode of heartburn a week or less, or if you want immediate relief of heartburn. It is very important that you carefully read and understand the Prilosec OTC label directions, warnings, and side effects. Most importantly, the label will tell you when you should seek medical attention instead of taking Prilosec OTC. Both prescription Prilosec and Prilosec OTC contain the same active ingredient, omeprazole, which effectively stops acid production.

Prescription Prilosec treats diseases that require diagnosis and supervision by a doctor. Prilosec OTC treats only symptoms of frequent heartburn. Prilosec OTC is a delayed-release 20mg tablet, taken once a day every 24 hours for 14 days before eating. You should not take it for more than 14 days or repeat a day course more often than every 4 months unless directed by a doctor. Prilosec OTC is not intended for immediate relief of occasional heartburn. Prilosec OTC may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.

When you are taking Prilosec OTC, it is especially important that your health care provider know if you are taking any of the following:. This section gives an overview about frequent heartburn sufferers and their treatment habits. Heartburn is described as a sensation of mid-chest discomfort moving up to the throat and neck, accompanied by a burning or painful feeling under the sternum.

Figure 1 shows the frequency of all heartburn episodes in a survey of a representative adult heartburn population. Figure 1. Frequency of heartburn in the U. Consumers with frequent heartburn reported having a long history of heartburn symptoms. The majority of consumers with frequent heartburn have discussed their symptoms with healthcare professionals. Most consumers with frequent heartburn self-diagnose and self-treat using available OTC medications.

Prilosec OTC is supplied in tablet, tablet, and tablet sizes. These sizes contain one, two, and three day courses of treatment, respectively. Prilosec OTC is a pink-colored salmon tablet consisting of multiple enteric-coated pellets formulated with The active ingredient is the magnesium salt of omeprazole, which allows tableting.

Prilosec OTC is also available in a Wildberry flavor tablet that provides a burst of flavor while swallowing the tablet. Prilosec OTC Wildberry is not meant to be chewed or sucked. It is a purple colored tablet and is available in 14 and 42 ct.

Currently, this tablet formulation is marketed as an OTC product in Sweden and as a prescription product in more than 30 other countries. The active ingredient in Prilosec OTC delayed-release tablets is omeprazole magnesium; its chemical name is dimethoxy[[ 4-methoxy-3,5-dimethylpyridinyl methyl]sulfinyl]-1H-benzimidazole magnesium. Omeprazole magnesium has a molecular weight of Its structural formula is shown in Figure 2.

Omeprazole magnesium is a crystalline substance that is freely soluble in methanol and slightly soluble in water. Omeprazole magnesium dissociates rapidly in water to form omeprazole and magnesium. Figure 2. Chemical structure of omeprazole magnesium 4. Prilosec OTC Inactive Ingredients: Glyceryl monostearate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, paraffin, polyethylene glycol , polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, starch, sucrose, talc, titanium dioxide, triethyl citrate 5.

Omeprazole belongs to the class of drugs known as substituted benzimidazoles. Figure 3. Mechanism of action of omeprazole 4. Reflux of gastric acid into the esophagus is the major cause of heartburn symptoms.

Omeprazole inhibits both basal and stimulated acid secretion from the parietal cell, irrespective of the stimulus. When omeprazole is discontinued, the ability to secrete gastric acid returns gradually within days, as new proton pumps are generated. Pharmacodynamic data demonstrated that omeprazole 20 mg daily provides a pronounced and consistent inhibition of gastric acid secretion over 24 hours. Figure 4 illustrates the superior and more consistent antisecretory effects of omeprazole administered at 20 mg or higher doses.

Figure 4. Inhibitory effects of one week of treatment with daily doses of omeprazole on hour intragastric acid secretion 9. A study involving 29 healthy U. The study was a randomized, open-label, crossover study with a five-day washout period between treatments.

The tablet formulation is marketed in Sweden as an OTC product and in more than 30 other countries as a prescription product.

Figure 5. Mean plasma concentration of omeprazole vs. Because the pellets that contain omeprazole magnesium in Prilosec OTC tablets are enteric coated, the tablets should not be split, as this would disturb the coating. Because of the enteric coating, absorption begins only after the pellets have entered the duodenum. This is important because exposure to the acidic environment of the stomach before entering the systemic circulation would cause degradation in the omeprazole molecule that might limit its ultimate effectiveness.

Once omeprazole magnesium dissolves in this near-neutral environment of the duodenum, the omeprazole ion converts to its neutral form. The same form of omeprazole is available for absorption regardless of whether it is administered as the free form, omeprazole, or the salt, omeprazole magnesium. The duration of action of omeprazole is more than 24 hours following a single dose, since parietal cells turn over in about three to five days. The inhibition of acid secretion is related to the area under the plasma concentration-time curve but not to the actual plasma concentration at any given time.

Omeprazole is completely metabolized in the liver by cytochrome P isoenzymes. At least six metabolites are formed, which have little or no antisecretory activity. Omeprazole metabolites are removed primarily in the urine and secondarily in feces. Two well-controlled clinical studies involving 3, subjects support the use of a consecutive day therapeutic regimen of omeprazole magnesium to treat frequent heartburn. Both studies were multicenter, double-blind, randomized, parallel, and placebo-controlled.

Each study evaluated 10 mg and 20 mg doses of omeprazole magnesium for 14 consecutive days in subjects with heartburn two or more days a week. The studies had a one-week placebo run-in phase to assess heartburn frequency. Eligible subjects were randomized into a two-week double-blind treatment phase to receive a single daily dose of either omeprazole magnesium 10 mg, omeprazole magnesium 20 mg, or placebo every day.

Subjects took their daily dose of study medication each morning before breakfast. The primary efficacy end point was "no heartburn over the previous 24 hours" i. Efficacy was evaluated following the first dose of medication, on the last dose, and over 14 days of dosing during the double-blind phase.

A number of secondary efficacy end points were also studied following the first dose of medication and subsequent doses. These included "complete prevention of nocturnal heartburn" and "occurrence of no more than mild heartburn. Both clinical studies showed that 20 mg of omeprazole magnesium resulted in a significant treatment effect during the first day. Figure 6. Percentage of subjects with no heartburn for 24 hours—Day 11a.

Figure 7. Percentage of subjects with no heartburn for 24 hours—time course over 14 days 1a. In general, the results for these end points corroborated the findings for the primary end points. Figure 8. Percentage of subjects with no more than mild heartburn—Day 11a. Consumer behavior and understanding of the use of Prilosec OTC were evaluated in label-comprehension studies and an actual-use trial.

This program of studies established the compliance with label directions and use of the product in an unsupervised setting. More specifically, the program was developed to determine whether consumers understood: 1 the population for which Prilosec OTC was best suited self-selection based on frequency of heartburn and understanding of label warning language ; 2 when and how to take Prilosec OTC one tablet per day, 14 consecutive days ; and 3 when to contact a healthcare professional in response to specific warning language or when frequent heartburn returns.

The actual-use study determined adherence to the label directions under conditions of actual use. At a three-month follow-up interview, consumers who experienced a return of heartburn symptoms continued to display behavior consistent with label-use directions.