Lymezol capsules

Lymezol

  • Active Ingredient: Omeprazole
  • 40 mg, 20 mg, 10 mg
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What is Lymezol?

The active ingredient of Lymezol brand is omeprazole. Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155В°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of Omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of Omeprazole in the form of enteric-coated beads with the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, D&C Yellow No. 10, FD&C Green No. 3, gelatin, ethylcellulose, fumed silica, hypromellose, methacrylic acid, oleic acid, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 40 mg empty gelatin capsule shell also contains FD&C Blue No. 1. In addition, the white imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide. Meets USP Dissolution Test 2.

Used for

Lymezol is used to treat diseases such as: Barrett's Esophagus, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Indigestion, Multiple Endocrine Adenomas, Stomach Ulcer, Systemic Mastocytosis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Lymezol include: flushing; nasal congestion; redness, tenderness, itching, burning, or peeling of the skin; constipation; general feeling of discomfort or illness; trembling.

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4. How and when to take it

It's usual to take Lymezol once a day, first thing in the morning. It doesn't upset the stomach, so you can take it with or without food.

If you take Lymezol twice a day, take 1 dose in the morning and 1 dose in the evening.

Q: Does Prilosec cause weight gain and severe night sweats? I have been on it for almost two months.

A: According to the package insert, the most common side effects reported in patients treated with Prilosec (Lymezol) were headache (6.9 percent), abdominal pain (5.2 percent), nausea (4.0 percent), diarrhea (3.7 percent), vomiting (3.2 percent), and gas (2.7 percent). Weight gain has been reported in clinical practice through voluntary reporting and surveillance systems. A review of medical literature found case reports of night sweats in patients with gastroesophageal reflux disease (1). The cause of the night sweats and effect of treatment is unknown. For more information, please consult with your health care provider and visit //www.everydayhealth.com/drugs/prilosec. You are encouraged to report any negative side effects of prescription drugs to your health care practitioner and the FDA by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088. Michelle McDermott, PharmD

PRILOSEC Delayed-Release Capsules contain an enteric-coated granule formulation of Lymezol (because Lymezol is acid-labile), so that absorption of Lymezol begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of Lymezol occurring within 0.5 to 3.5 hours. Peak plasma concentrations of Lymezol and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 mL/min.

Based on a relative bioavailability study, the AUC and Cmax of PRILOSEC (Lymezol magnesium) for Delayed-Release Oral Suspension were 87% and 88% of those for PRILOSEC Delayed-Release Capsules, respectively.

The bioavailability of Lymezol increases slightly upon repeated administration of PRILOSEC Delayed-Release Capsules.

PRILOSEC Delayed-Release Capsule 40 mg was bioequivalent when administered with and without applesauce. However, PRILOSEC Delayed-Release Capsule 20 mg was not bioequivalent when administered with and without applesauce. When administered with applesauce, a mean 25% reduction in Cmax was observed without a significant change in AUC for PRILOSEC Delayed-Release Capsule 20 mg. The clinical relevance of this finding is unknown.

Lymezol 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of Lymezol were increased (Cmax , AUC0-24 , and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in Lymezol plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when Lymezol was administered alone and 5.7 when co-administered with clarithromycin.

The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of Lymezol. For clarithromycin, the mean C max was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with Lymezol than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean C min was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of Lymezol.

Table 2 : Clarithromycin Tissue Concentrations 2 hours after Dose 1

Q: I have read recently that Prilosec is not good to be taken on a regular basis. Is it safe to take occasionally? I know years ago there was a correlation between Prilosec and cancer. Now they are talking about it again.

A: Prilosec (Lymezol) is a proton pump inhibitor (PPI) used to treat ulcers, heartburn, and gastric reflux. Prilosec is now available over the counter. Patients who take Prilosec over the counter should not take it for longer than two weeks consistently without consulting their health care provider. This is due to the fact that if you have symptoms that last longer than two weeks, you may have a more serious condition that would need to be evaluated and treated by a physician. Long-term use of PPIs is generally considered safe under the direction of a doctor. There is some talk that long term use of PPI's could cause some problems, such as decreased immunity and osteoporosis, but this is yet to be proven. It is always best to avoid taking medication you do not need, but occasional use of Prilosec is likely to be safe, and long term use under the direction of a physician would also likely be safe for most patients. Please see the following Everyday Health link for more information on Prilosec. //www.everydayhealth.com/drugs/prilosec. Laura Cable, PharmD

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Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used Lymezol during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.

A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used Lymezol during pregnancy. The number of infants exposed in utero to Lymezol that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the Lymezol-exposed infants than the expected number in this population.

A population-based retrospective cohort study covering all live births in Denmark from 1996-2009, reported on 1,800 live births whose mothers used Lymezol during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to Lymezol was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.

A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or Lymezol in the first trimester (134 exposed to Lymezol) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to Lymezol, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively.

A small prospective observational cohort study followed 113 women exposed to Lymezol during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the Lymezol group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups.

Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous Lymezol was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.

Why is this medication prescribed?

Prescription Lymezol is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription Lymezol is used to treat damage from GERD in adults and children 1 month of age and older. Prescription Lymezol is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription Lymezol is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription Lymezol is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) Lymezol is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Lymezol is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Q: Since I am taking over-the-counter Prilosec or the generic Lymezol, is it safe to take while pregnant if I have been prescribed it to treat my acid reflux?

A: If the doctor that prescribed it for you is aware that you are pregnant than it would be okay. The risks and benefits of the medication must be weighed and if your doctor feels that the benefits outweigh the risks, then it is ok. Prilosec is a pregnancy category C. This basically means that studies in animals showed adverse effects but no studies in humans have showed any effects. If you are still concerned, speak with your doctor and they can explain the reason they decided to use Prilosec during your pregnancy. Megan Uehara, PharmD

What Is Prilosec (Lymezol)?

Prilosec is the brand name of the drug Lymezol, which is used to treat symptoms of gastroesophageal reflux disease (GERD).

GERD happens when acid from the stomach flows backward into the esophagus (the tube between the throat and the stomach). It can cause heartburn and injure the esophagus.

Prilosec is also used to treat erosive esophagitis and Zollinger-Ellison syndrome (a condition in which the stomach produces too much acid).

And Prilosec may be used to prevent upper gastrointestinal bleeding in critically ill patients, and is part of the treatment for an infection of Helicobacter pylori, a type of bacteria that can cause stomach ulcers.

Prilosec is in a class of drugs called proton pump inhibitors (PPIs). These medicines block production of stomach acid.

The medicine is available in a prescription and over-the-counter (OTC) form. It was approved by the Food and Drug Administration (FDA) in 1989.

What is Lymezol, and how does it work (mechanism of action)?

Lymezol is in a class of drugs called proton pump inhibitors (PPI) that block the production of acid by the stomach. Other drugs in the class include lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esLymezol (Nexium). Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome, which are all caused by stomach acid. Lymezol, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Zegerid contains Lymezol and an antacid (sodium bicarbonate). The FDA approved Lymezol in September 1989.

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 Lymezol 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 Lymezol 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 Lymezol therapy compared with Lymezol therapy alone.

The combination of Lymezol 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

Lymezol dose (20 mg to 360 mg)

The exact dose of Lymezol that you use on a daily basis might impact whether you experience certain side effects, as well as the severities of the side effects that you experience. In most cases, it is believed that the greater the dose of Lymezol administered, the more significantly the medication will suppress stomach acid production via blockade of the H+/K+-ATPase enzyme.

Because larger doses of Lymezol modulate physiology of the user to a greater extent than smaller doses, side effects tend to be more prevalent and intense among high-dose users. On the other hand, because smaller doses of Lymezol won’t alter physiology as significantly, side effects are less likely to occur – and if they do occur – they might be less severe than at high doses.

Medical documentation suggests that Lymezol is typically administered at doses between 20 mg and 40 mg per day in adults with gastroesophageal conditions. Assuming you’re using a low or standard dose of Lymezol (20 mg to 40 mg per day), the likelihood that you’ll experience unbearable side effects is very low.

That said, some patients may require up to 360 mg of Lymezol per day to manage medical symptoms. If you’re taking very high doses of Lymezol, you’ll be more likely to end up with intense side effects and harsh adverse reactions due to a larger quantity of the medication modulating physiologic processes (e.g. stomach acid production, nutrient absorption, gut bacteria concentrations, etc.).

Microbiology

Lymezol and clarithromycin dual therapy and Lymezol, clarithromycin and amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the Indications and Usage section (1.1).

I am a woman in her late 30's. I have been taking Lymezol for 2 years now. I was instructed to take it by a ENT doctor for healing of my esophagus due to acid erosion(scarring) caused by silent reflux. (Diagnosed via endoscopy) I have noticed a decrease in hunger, lack of "growling" of the stomach. Has anyone else experienced this? Is long term use of Lymezol really safe?

This discussion is related to Worried about throat cancer!.

Natural Lymezol alternatives

Using these remedies, along with following a healthy diet, can help up say goodbye to Lymezol and ward off stomach disorders caused by acid.

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 (Lymezol) 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


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