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Losec 10 mg Dosage |
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Losec 10 mg Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Losec 10 mg.
Patients should be informed that the Losec 10 mg Delayed-Release Capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available.
The recommended adult oral dose of Losec 10 mg is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
The recommended adult oral regimen is Losec 10 mg 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 Losec 10 mg 20 mg once daily is recommended for ulcer healing and symptom relief.
The recommended adult oral regimen is Losec 10 mg 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 Losec 10 mg 20 mg once daily is recommended for ulcer healing and symptom relief.
The recommended adult oral dose is 40 mg once daily for 4-8 weeks.
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.
The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months.
The dosage of Losec 10 mg 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 Losec 10 mg for more than 5 years.
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 | Losec 10 mg Daily Dose |
5 < 10 kg | 5 mg |
10 < 20 kg | 10 mg |
≥ 20 kg | 20 mg |
On a per kg basis, the doses of Losec 10 mg 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.
Losec 10 mg 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 Losec 10 mg 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.
Losec 10 mg For Delayed-Release
For patients with a nasogastric or gastric tube in place:
Losec 10 mg Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Losec 10 mg 10 on the body.
Losec 10 mg Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Losec 10 mg 20 on the body.
Losec 10 mg Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Losec 10 mg 40 on the body.
Losec 10 mg 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 Losec 10 mg granules and pale yellow inactive granules.
Losec 10 mg Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Losec 10 mg 10 on the body. They are supplied as follows:
NDC 0186-0606-31 unit of use bottles of 30
Losec 10 mg Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Losec 10 mg 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
Losec 10 mg Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Losec 10 mg 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
Losec 10 mg For Delayed-Release
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
Store Losec 10 mg 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 Losec 10 mg 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
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 Losec 10 mg + 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 Losec 10 mg + 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)
Effects of Losec 10 mg on The Pharmacokinetics of Other Active Substances: Active Substances with pH Dependent Absorption: The decreased intragastric acidity during treatment with Losec 10 mg 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 Losec 10 mg. Concomitant administration of Losec 10 mg with nelfinavir is contraindicated. Co administration of Losec 10 mg (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 Losec 10 mg with atazanavir is not recommended. Concomitant administration of Losec 10 mg (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 Losec 10 mg on atazanavir exposure. The co administration of Losec 10 mg (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 Losec 10 mg (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 Losec 10 mg 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 Losec 10 mg (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 Losec 10 mg were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hrs) and 30% (Day 5) when clopidogrel and Losec 10 mg were administered together. In another study it was shown that administering clopidogrel and Losec 10 mg at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of Losec 10 mg 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 Losec 10 mg. Co-administration of clopidgrel with 80 mg Losec 10 mg, 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: Losec 10 mg is a moderate inhibitor of CYP2C19, the major Losec 10 mg 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: Losec 10 mg, 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 Losec 10 mg treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending Losec 10 mg treatment.
Unknown Mechanism: Saquinavir: Concomitant administration of Losec 10 mg 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 Losec 10 mg 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 Losec 10 mg: Inhibitors of CYP2C19 and/or CYP3A4: Since Losec 10 mg is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased Losec 10 mg serum levels by decreasing Losec 10 mg’s rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the Losec 10 mg exposure. As high doses of Losec 10 mg have been well-tolerated adjustment of the Losec 10 mg 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 Losec 10 mg serum levels by increasing Losec 10 mg’s rate of metabolism.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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