What happens if I overdose Esomeprazole GH?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; fast heartbeat; flushing; increased sweating; severe headache, drowsiness, or nausea.
Proper storage of Esomeprazole GH delayed-release capsules:
Store Esomeprazole GH delayed-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Esomeprazole GH delayed-release capsules out of the reach of children and away from pets.
Overdose of Esomeprazole GH in details
A single oral dose of Esomeprazole GH at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
The symptoms described in connection with deliberate Esomeprazole GH magnesium overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of Esomeprazole GH were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. No specific antidote for Esomeprazole GH is known. Since Esomeprazole GH is extensively protein bound, it is not expected to be removed by dialysis. 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.
What should I avoid while taking Esomeprazole GH?
This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Avoid taking an herbal supplement containing St. John's wort at the same time you are using Esomeprazole GH injection.
Esomeprazole GH warnings
Presence of Gastric Malignancy
In adults, symptomatic response to therapy with Esomeprazole GH magnesium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including Esomeprazole GH magnesium. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Esomeprazole GH magnesium if acute interstitial nephritis develops.
Clostridium difficile-Associated Diarrhea
Published observational studies suggest that PPI therapy like Esomeprazole GH magnesium 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 Esomeprazole GH magnesium, refer to Warnings and Precautions section of the corresponding prescribing information.
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.
5.5 Cutaneous and Systemic Lupus Erythematosus
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including Esomeprazole GH. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.
The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.
Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.
Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Esomeprazole GH magnesium, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.
Interaction with Clopidogrel
Avoid concomitant use of Esomeprazole GH magnesium 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 Esomeprazole GH, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg Esomeprazole GH reduces the pharmacological activity of clopidogrel. When using Esomeprazole GH magnesium consider alternative anti-platelet therapy.
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 acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
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), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Interaction with St. John’s Wort or Rifampin
Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease Esomeprazole GH concentrations. Avoid concomitant use of Esomeprazole GH magnesium 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 Esomeprazole GH 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.
Interaction 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 Esomeprazole GH?
Some medical conditions may interact with Esomeprazole GH 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 Esomeprazole GH 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 Esomeprazole GH suspension's side effects
- Ginkgo biloba, rifampin, or St. John's wort because they may decrease Esomeprazole GH suspension's effectiveness
- Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, methotrexate, saquinavir, or tacrolimus because the risk of their side effects may be increased by Esomeprazole GH suspension
- Atazanavir, bosutinib, clopidogrel, dasatinib, erlotinib, indinavir, iron, itraconazole, ketoconazole, mycophenolate, nelfinavir, nilotinib, posaconazole, rilpivirine, or sorafenib because their effectiveness may be decreased by Esomeprazole GH suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Esomeprazole GH 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.
Esomeprazole GH precautions
Inform the physician if experiencing signs eg, excessive, unintentional weight loss, persistent vomiting, difficulty swallowing, vomiting blood or blood in the feces.
If stomach ulcer is possible, the physician will examine the possibility of tumors, as Esomeprazole GH Sandoz reduces symptoms and may delay the diagnosis.
Caution in taking other medicines, eg, clarithromycin, to eliminate the H. pylori bacteria.
Severe hepatic and renal impairment.
Esomeprazole GH is a CYP2C19 inhibitor. When starting or discontinuing treatment with Esomeprazole GH, the potential for interactions with drugs metabolized through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of Esomeprazole GH and clopidogrel should be discouraged.
Esomeprazole GH contains glucose and sucrose. Contact the physician before taking Esomeprazole GH Sandoz if there is an intolerance to some sugars.
Effects on the Ability to Drive or Operate Machinery: Driving and used of machines is allowed since the effects have not been observed.
Use in pregnancy: Take only if the physician indicates that it is absolutely necessary, as insufficient knowledge exists.
Use in lactation: Taking Esomeprazole GH during breastfeeding is not recommended as insufficient knowledge exists.
What happens if I miss a dose of Esomeprazole GH?
Call your doctor for instructions if you miss a daily dose of Esomeprazole GH injection.
References
- DailyMed. "ESOMEPRAZOLE STRONTIUM: 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. "Esomeprazole". http://www.drugbank.ca/drugs/DB00736 (accessed September 17, 2018).
- MeSH. "Proton Pump Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
