Kerlofin capsules


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

The active ingredient of Kerlofin 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

Kerlofin 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 Kerlofin include: redness, tenderness, itching, burning, or peeling of the skin; dryness of the mouth; general feeling of discomfort or illness; Drowsiness; red or irritated eyes; joint pain; pain; sore throat.

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Concomitant Gastric Malignancy

Symptomatic response to therapy with Kerlofin does not preclude the presence of gastric malignancy.

4. How and when to take it

It's usual to take Kerlofin 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 Kerlofin twice a day, take 1 dose in the morning and 1 dose in the evening.

Kerlofin side effects

Get emergency medical help if you have signs of an allergic reaction to Kerlofin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Kerlofin and call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody;

new or unusual pain in your wrist, thigh, hip, or back;

kidney problems - little or no urination, blood in your urine, swelling, rapid weight gain;

low magnesium - dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking this medicine long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use Kerlofin for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common Kerlofin side effects may include:

stomach pain, gas;

nausea, vomiting, diarrhea; or

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Serious allergic reaction

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Kerlofin.

Q: Since I am taking over-the-counter Prilosec or the generic Kerlofin, 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 Kerlofin?

Kerlofin is a medicine that reduces the amount of acid that your stomach produces. It's prescribed for stomach ulcers, but you can also buy it over the counter from pharmacies to relieve heartburn associated with acid reflux.

Kerlofin comes as capsules, tablets and dispersible tablets. These are all available in 10mg, 20mg and 40mg strengths. In hospital Kerlofin is sometimes given by injection or drip into a vein.

Losec, Losec MUPS, Mepradec and Mezzopram are all brand names for Kerlofin. It's also called Prilosec in the USA.

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 Kerlofin 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 Kerlofin 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 Kerlofin therapy compared with Kerlofin therapy alone.

The combination of Kerlofin 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

Mechanism Of Action

Kerlofin belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H + /K + ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, Kerlofin has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after rapid disappearance from plasma, Kerlofin can be found within the gastric mucosa for a day or more.

Q: I have been taking Prilosec OTC for several years. What else is available?

A: Your question concerns alternatives to Prilosec OTC (// It seems from your comments that you are no longer satisfied with the results you are getting from Kerlofin. Other products in the "Proton Pump Inhibitor" class of antiulcer drugs include AcipHex , Kapidex , Nexium , Prevacid , and Protonix . Even though all these drugs work the same way as Prilosec, there are enough differences among them that many people find relief from at least one of them. Gregory Latham, M.S., RPh

Gastric Ulcer

In a U.S. multicenter, double-blind, study of Kerlofin 40 mg once daily, 20 mg once daily, and placebo in 520 patients with endoscopically diagnosed gastric ulcer, the following results were obtained.

Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated) PRILOSEC 20 mg once daily (n = 202) PRILOSEC 40 mg once daily (n = 214) Placebo (n = 104) Week 4 47 5** 55.6** 30.8 Week 8 74.8** 82.7**,+ 48.1 **(p + (p

For the stratified groups of patients with ulcer size less than or equal to 1 cm, no difference in healing rates between 40 mg and 20 mg was detected at either 4 or 8 weeks. For patients with ulcer size greater than 1 cm, 40 mg was significantly more effective than 20 mg at 8 weeks.

In a foreign, multinational, double-blind study of 602 patients with endoscopically diagnosed gastric ulcer, Kerlofin 40 mg once daily, 20 mg once daily, and ranitidine 150 mg twice a day were evaluated.

Treatment of Gastric Ulcer % of Patients Healed (All Patients Treated) PRILOSEC 20 mg once daily (n = 200) PRILOSEC 40 mg once daily (n = 187) Ranitidine 150 mg twice daily (n = 199) Week 4 63.5 78.1**,++ 56.3 Week 8 81.5 91.4**,++ 78.4 ** (p

Drugs you should not use with Kerlofin

Do not take these drugs with Kerlofin. Doing so can cause dangerous effects in the body. Examples of these drugs include:

  • Atazanavir, rilpivirine, and nelfinavir. Kerlofin may greatly decrease the effects of these drugs and could make them less effective over time. You shouldn’t take these drugs with Kerlofin.
  • Clopidogrel. Kerlofin may reduce the effects of clopidogrel, causing your blood to clot. You shouldn’t take this drug with Kerlofin.

Kerlofin dose (20 mg to 360 mg)

The exact dose of Kerlofin 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 Kerlofin administered, the more significantly the medication will suppress stomach acid production via blockade of the H+/K+-ATPase enzyme.

Because larger doses of Kerlofin 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 Kerlofin 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 Kerlofin 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 Kerlofin (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 Kerlofin per day to manage medical symptoms. If you’re taking very high doses of Kerlofin, 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.).

In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m², the disposition of Kerlofin was very similar to that in healthy volunteers, although there was a slight increase in bioavailability. Because urinary excretion is a primary route of excretion of Kerlofin metabolites, their elimination slowed in proportion to the decreased creatinine clearance. No dose reduction is necessary in patients with renal impairment.

Kerlofin belongs to the proton pump inhibitor (PPI) class of medications. Doctors prescribe Kerlofin to reduce stomach acid to help treat a variety of digestive conditions.

People can also use over-the-counter (OTC) Kerlofin to relieve heartburn or acid reflux.

Although most people tolerate Kerlofin well, there are certain risks when people use it for a long period of time.

In this article, we review the uses, side effects, and drug interactions of Kerlofin.

Q: Does Prilosec OTC cause gas, bloating, and constipation?

A: Prilosec OTC (Kerlofin) (// 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. (// 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

Forms and strengths

Generic: Kerlofin

  • Form: delayed-release oral capsule
  • Strengths: 10 mg, 20 mg, 40 mg

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Call a doctor straight away if you have:

  • joint pain along with a red skin rash, especially in parts of your body exposed to the sun, such as your arms, cheeks and nose - these can be signs of a rare condition called subacute cutaneous lupus erythematosus. This can happen even if you have been taking Kerlofin for a long time
  • yellow skin, dark pee and tiredness - these can be signs of liver problems

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