What happens if I overdose Omenex?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Omenex delayed-release capsules:
Store Omenex delayed-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Omenex delayed-release capsules out of the reach of children and away from pets.
Overdose of Omenex in details
Reports have been received of overdosage with Omenex in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. Symptoms were transient, and no serious clinical outcome has been reported when Omenex Delayed-Release Capsules was taken alone. No specific antidote for Omenex overdosage is known. Omenex is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact a Poison Control Center at 1-800-222-1222.
Single oral doses of Omenex at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.
What should I avoid while taking Omenex?
Omenex + SyrSpend SF Alka + SyrSpend SF Alka can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.
Omenex warnings
Concomitant Gastric Malignancy
Symptomatic response to therapy with Omenex does not preclude the presence of gastric malignancy.
Atrophic Gastritis
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Omenex.
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including Omenex Delayed-Release Capsules. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Omenex Delayed-Release Capsule if acute interstitial nephritis develops.
Cyanocobalamin (vitamin B-12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo-or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acidsuppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Clostridium difficile associated diarrhea
Published observational studies suggest that PPI therapy like Omenex Delayed-Release Capsules may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Omenex Delayed-Release Capsules, refer to WARNINGS and PRECAUTIONS sections of those package inserts.
Interaction with Clopidogrel
Avoid concomitant use of Omenex Delayed-Release Capsules with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as Omenex, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg Omenex reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using Omenex Delayed-Release Capsules, consider alternative anti-platelet therapy.
Bone Fracture
Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Concomitant Use of Omenex Delayed-Release Capsules with St. John's Wort or rifampin
Drugs which induce CYP2C19 or CYP3A4 (such as St. John's Wort or rifampin) can substantially decrease Omenex concentrations. Avoid concomitant use of Omenex Delayed-Release Capsules with St. John's Wort or rifampin.
Interactions with Diagnostic Investigations for Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop Omenex treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Concomitant use of Omenex Delayed-Release Capsules with Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.
What should I discuss with my healthcare provider before taking Omenex?
Some medical conditions may interact with Omenex suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have low blood potassium or magnesium levels, low blood vitamin B12 levels or vitamin B12 deficiency, liver problems, or stomach or bowel cancer
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)
Some MEDICINES MAY INTERACT with Omenex suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased
- Voriconazole because it may increase the risk of Omenex suspension's side effects
- Ginkgo biloba, rifampin, or St. John's wort because they may decrease Omenex suspension's effectiveness
- Anticoagulants (eg, warfarin), benzodiazepines (eg, diazepam), cilostazol, citalopram, cyclosporine, digoxin, disulfiram, escitalopram, hydantoins (eg, phenytoin), methotrexate, saquinavir, or tacrolimus because the risk of their side effects may be increased by Omenex suspension
- Ampicillins, azole antifungals (eg, ketoconazole), clopidogrel, certain HIV protease inhibitors (eg, atazanavir, nelfinavir), iron, mycophenolate, rilpivirine, or tyrosine kinase inhibitors (eg, dasatinib, erlotinib) because their effectiveness may be decreased by Omenex suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Omenex suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Omenex precautions
In long-term studies in rats, Omenex produced a dose-related increase in gastric carcinoid tumours. Biopsy specimen from human stomach has not detected risk from short-term exposure to Omenex. Further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy with Omenex (Omenex).
Use in pregnancy & lactation: The safety of Omenex in human pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Omenex is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Omenex and because of the potential for tumorigenicity shown for Omenex in rat carcinogenic studies, a decision should be made whether to discontinue nursing or to discontinue Omenex, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children have not been established.
What happens if I miss a dose of Omenex?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
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).
- DrugBank. "omeprazole". http://www.drugbank.ca/drugs/DB00338 (accessed September 17, 2018).
- MeSH. "Anti-Ulcer Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
