Dosage of Omelax in details
Omelax Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omelax.
Patients should be informed that the Omelax 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 Omelax 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 (Omelax/clarithromycin/amoxicillin)
The recommended adult oral regimen is Omelax 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 Omelax 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (Omelax/clarithromycin)
The recommended adult oral regimen is Omelax 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 Omelax 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 Omelax 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 Omelax 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 | Omelax Daily Dose |
| 5 < 10 kg | 5 mg |
| 10 < 20 kg | 10 mg |
| ≥ 20 kg | 20 mg |
On a per kg basis, the doses of Omelax 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
Omelax 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 Omelax 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.
Omelax 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 Omelax 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
Omelax Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Omelax 10 on the body.
Omelax Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Omelax 20 on the body.
Omelax Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Omelax 40 on the body.
Omelax 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 Omelax granules and pale yellow inactive granules.
Storage And Handling
Omelax Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and Omelax 10 on the body. They are supplied as follows:
NDC 0186-0606-31 unit of use bottles of 30
Omelax Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and Omelax 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
Omelax Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and Omelax 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
Omelax 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 Omelax granules and pale yellow inactive granules. Omelax 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 Omelax 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 Omelax 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 Omelax?
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 Omelax + 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 Omelax + SyrSpend SF Alka. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
See also:
Drug Interactions (in more detail)
Omelax interactions
Effects of Omelax on the Pharmacokinetics of Other Drugs: The following combination with Omelax should be avoided: Ketoconazole and itraconazole.
Omelax might influence the absorption of other drugs due to its effect on the gastric pH. The dissolution of ketoconazole tablets in the stomach is adversely affected if the pH of the gastric juice increases as a result of drug treatment (antacids, secretion-inhibiting agents, sucralfate). This leads to ineffective plasma concentrations of ketoconazole. During concomitant administration of Omelax and itraconazole, the plasma concentration and area under the curve (AUC) of itraconazole are reduced by approximately 65%, probably as a result of poorer absorption, which is dependent on pH.
Omelax inhibits the enzyme CYP2C19 and therefore, increased plasma levels of other drugs (diazepam, warfarin, phenytoin) metabolized via this enzyme might be expected. Monitoring is recommended during initiation or withdrawal of Omelax in patients being treated with phenytoin, warfarin or other vitamin K antagonist.
During concomitant administration of clarithromycin or erythromycin and Omelax, the plasma concentrations of Omelax were increased. The plasma concentrations of Omelax are not influenced during concomitant administration with amoxicillin or metronidazole.
Concomitant administration of Omelax (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a marked reduction in total atazanavir exposure (approximately 75% reduction of AUC, Cmax and Cmin). An increase in the atazanavir dose to 400 mg did not compensate for the effect that Omelax had on atazanavir exposure. Proton pump inhibitors including Omelax should therefore not be administered concomitantly with atazanavir.
Concomitant administration of Omelax and tacrolimus may increase the serum levels of tacrolimus. Monitoring of the plasma tacrolimus concentration is recommended when treatment with Omelax is being initiated or discontinued. Omelax (40 mg daily) increased the Cmax and AUC of voriconazole (CYP2C19 substrate) by 15% and 41%, respectively.
Effects of Other Drugs on the Pharmacokinetics of Omelax: Drugs inhibiting the enzymes CYP2C19 or CYP3A (HIV protease inhibitors, ketoconazole, itraconazole) might increase the plasma concentrations of Omelax. Voriconazole increases the AUC of Omelax by 280%. In cases of concomitant treatment, an adjustment of the Omelax dose should be considered for patients with considerable impaired hepatic function and in cases of long-term treatment.
Case reports, published population pharmacokinetic studies and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high doses) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
No interactions between Omelax and antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, metoprolol or ethanol have been detected.
References
- 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).
- MeSH. "Anti-Ulcer Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- 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 Omelax 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 Omelax. 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.User reports
Consumer reported frequency of use
No survey data has been collected yetConsumer reported doses
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
