Omeprazole Amel Dosage

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Dosage of Omeprazole Amel in details

infoThe dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Omeprazole Amel Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole Amel.

Patients should be informed that the Omeprazole Amel Delayed-Release Capsule should be swallowed whole.

For patients unable to swallow an intact capsule, alternative administration options are available.

Short-Term Treatment Of Active Duodenal Ulcer

The recommended adult oral dose of Omeprazole Amel is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

H. pylori Eradication For The Reduction Of The Risk Of Duodenal Ulcer Recurrence

Triple Therapy (Omeprazole Amel/clarithromycin/amoxicillin)

The recommended adult oral regimen is Omeprazole Amel 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole Amel 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual Therapy (Omeprazole Amel/clarithromycin)

The recommended adult oral regimen is Omeprazole Amel 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole Amel 20 mg once daily is recommended for ulcer healing and symptom relief.

Gastric Ulcer

The recommended adult oral dose is 40 mg once daily for 4-8 weeks.

Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.

Maintenance Of Healing Of Erosive Esophagitis

The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months.

Pathological Hypersecretory Conditions

The dosage of Omeprazole Amel in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole Amel for more than 5 years.

Pediatric Patients

For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:

Patient Weight Omeprazole Amel Daily Dose
5 < 10 kg 5 mg
10 < 20 kg 10 mg
≥ 20 kg 20 mg

On a per kg basis, the doses of Omeprazole Amel required to heal erosive esophagitis in pediatric patients are greater than those for adults.

Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule.

Alternative Administration Options

Omeprazole Amel is available as a delayed-release capsule or as a delayed-release oral suspension.

For patients who have difficulty swallowing capsules, the contents of a Omeprazole Amel Delayed-Release Capsule can be added to applesauce.

One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

Omeprazole Amel For Delayed-Release

Oral Suspension should be administered as follows:

  • Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
  • Empty the contents of a 10 mg packet into a container containing 15 mL of water.
  • Stir
  • Leave 2 to 3 minutes to thicken.
  • Stir and drink within 30 minutes.
  • If any material remains after drinking, add more water, stir and drink immediately.

For patients with a nasogastric or gastric tube in place:

  • Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering Omeprazole Amel through a nasogastric tube or gastric tube.
  • Immediately shake the syringe and leave 2 to 3 minutes to thicken.
  • Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.
  • Refill the syringe with an equal amount of water.
  • Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

How supplied

Dosage Forms And Strengths

Omeprazole Amel Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Omeprazole Amel 10 on the body.

Omeprazole Amel Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Omeprazole Amel 20 on the body.

Omeprazole Amel Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Omeprazole Amel 40 on the body.

Omeprazole Amel For Delayed-Release

Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish Omeprazole Amel granules and pale yellow inactive granules.

Storage And Handling

Omeprazole Amel Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Omeprazole Amel 10 on the body. They are supplied as follows:

NDC 0186-0606-31 unit of use bottles of 30

Omeprazole Amel Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Omeprazole Amel 20 on body. They are supplied as follows:

NDC 0186-0742-31 unit of use bottles of 30

NDC 0186-0742-82 bottles of 1000

Omeprazole Amel Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Omeprazole Amel 40 on the body. They are supplied as follows:

NDC 0186-0743-31 unit of use bottles of 30

NDC 0186-0743-68 bottles of 100

Omeprazole Amel For Delayed-Release

Oral Suspension, 2.5 mg or 10 mg

, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish Omeprazole Amel granules and pale yellow inactive granules. Omeprazole Amel unit dose packets are supplied as follows:

NDC 0186-0625-01 unit dose packages of 30: 2.5 mg packets

NDC 0186-0610-01 unit dose packages of 30: 10 mg packets

Storage

Store Omeprazole Amel Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Store Omeprazole Amel For Delayed-Release

Oral Suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F).

AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Revised December 2014

What other drugs will affect Omeprazole Amel?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect Omeprazole Amel + SyrSpend SF Alka, especially:

  • clopidogrel;

  • methotrexate;

  • St. John's wort; or

  • an antibiotic--amoxicillin, clarithromycin, rifampin.

This list is not complete and many other drugs may affect Omeprazole Amel + SyrSpend SF Alka. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Drug Interactions (in more detail)

Omeprazole Amel interactions

infoInteractions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Omeprazole Amel, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Effects of Omeprazole Amel on The Pharmacokinetics of Other Active Substances: Active Substances with pH Dependent Absorption: The decreased intragastric acidity during treatment with Omeprazole Amel might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, Atazanavir: The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with Omeprazole Amel. Concomitant administration of Omeprazole Amel with nelfinavir is contraindicated. Co administration of Omeprazole Amel (40 mg once daily) reduced mean nelfinavir exposure by approximately 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by approximately 75 90%. The interaction may also involve CYP2C19 inhibition. Concomitant administration of Omeprazole Amel with atazanavir is not recommended. Concomitant administration of Omeprazole Amel (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact of Omeprazole Amel on atazanavir exposure. The co administration of Omeprazole Amel (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300 mg/ritonavir 100 mg once daily.

Digoxin: Concomitant treatment with Omeprazole Amel (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be exercised when Omeprazole Amel is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should then be reinforced.

Clopidogrel: In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with Omeprazole Amel (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and Omeprazole Amel were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hrs) and 30% (Day 5) when clopidogrel and Omeprazole Amel were administered together. In another study it was shown that administering clopidogrel and Omeprazole Amel at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of Omeprazole Amel on CYP2C19. Inconsistent data on the clinical implications of this pharmacokinetic/pharmacodynamic interaction in terms of major cardiovascular events have been reported from observational and clinical studies. Avoid concomitant use of clopidogrel and Omeprazole Amel. Co-administration of clopidgrel with 80 mg Omeprazole Amel, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hrs apart.

Other Active Substances: The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and thus clinical efficacy may be impaired. For posaconazole and erlotinib concomitant use should be avoided.

Active Substances Metabolised by CYP2C19: Omeprazole Amel is a moderate inhibitor of CYP2C19, the major Omeprazole Amel metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol: Omeprazole Amel, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.

Phenytoin: Monitoring phenytoin plasma concentration is recommended during the first 2 weeks after initiating Omeprazole Amel treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending Omeprazole Amel treatment.

Unknown Mechanism: Saquinavir: Concomitant administration of Omeprazole Amel with saquinavir/ritonavir resulted in increased plasma levels up to approximately 70% for saquinavir associated with good tolerability in HIV infected patients.

Tacrolimus: Concomitant administration of Omeprazole Amel has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.

Effects of Other Active Substances on the Pharmacokinetics of Omeprazole Amel: Inhibitors of CYP2C19 and/or CYP3A4: Since Omeprazole Amel is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased Omeprazole Amel serum levels by decreasing Omeprazole Amel’s rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the Omeprazole Amel exposure. As high doses of Omeprazole Amel have been well-tolerated adjustment of the Omeprazole Amel dose is not generally required. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4: Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John’s wort) may lead to decreased Omeprazole Amel serum levels by increasing Omeprazole Amel’s rate of metabolism.


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References

  1. DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. MeSH. "Anti-Ulcer Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(S)- sodium 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Omeprazole Amel are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Omeprazole Amel. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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