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 Nexmezol delayed-release capsules:
Store Nexmezol 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 Nexmezol delayed-release capsules out of the reach of children and away from pets.
Overdose of Nexmezol in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
A single oral dose of Nexmezol 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 Nexmezol magnesium overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of Nexmezol 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 Nexmezol is known. Since Nexmezol 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 Nexmezol?
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 Nexmezol injection.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Presence of Gastric Malignancy
In adults, symptomatic response to therapy with Nexmezol 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 Nexmezol magnesium. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Nexmezol magnesium if acute interstitial nephritis develops.
Clostridium difficile-Associated Diarrhea
Published observational studies suggest that PPI therapy like Nexmezol 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 Nexmezol magnesium, refer to Warnings and Precautions section of the corresponding prescribing information.
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 Nexmezol. 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 Nexmezol 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 Nexmezol 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 Nexmezol, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg Nexmezol reduces the pharmacological activity of clopidogrel. When using Nexmezol 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, 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 Nexmezol concentrations. Avoid concomitant use of Nexmezol 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 Nexmezol 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 Nexmezol?
Some medical conditions may interact with Nexmezol delayed-release capsules. 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, 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 Nexmezol delayed-release capsules. 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 Nexmezol delayed-release capsules's side effects
Ginkgo biloba, rifampin, or St. John's wort because they may decrease Nexmezol delayed-release capsules's effectiveness
Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, methotrexate, saquinavir, or tacrolimus because the risk of their side effects may be increased by Nexmezol delayed-release capsules
Atazanavir, bosutinib, clopidogrel, dasatinib, erlotinib, indinavir, iron, itraconazole, ketoconazole, mycophenolate, nelfinavir, nilotinib, posaconazole, rilpivirine, or sorafenib because their effectiveness may be decreased by Nexmezol delayed-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexmezol delayed-release capsules 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.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
In the presence of any alarm symptom (eg, significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Nexmezol may alleviate symptoms and delay diagnosis.
Patients on long-term treatment (particularly those treated for >1 year) should be kept under regular surveillance.
Patients on on-demand treatment should be instructed to contact the physician if symptoms change in character. When prescribing Nexmezol for on demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of Nexmezol should be considered.
When prescribing Nexmezol for eradication of Helicobacter pylori possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking other drugs metabolised via CYP3A4 eg, cisapride.
Nexmezol contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Nexmezol. It also contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed).
Treatment with proton-pump inhibitors may lead to slightly increased risk of gastrointestinal infections eg, Salmonella and Campylobacter.
Co-administration of Nexmezol with atazanavir is not recommended. If the combination of atazanavir with a proton-pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; Nexmezol 20 mg should not be exceeded.
Effects on the Ability to Drive or Operate Machinery: No effects have been observed.
Use in pregnancy & lactation: For Nexmezol clinical data on exposed pregnancies are insufficient. With the racemic mixture, omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with Nexmezol do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
It is not known whether Nexmezol is excreted in human breast milk. No studies in lactating women have been performed. Therefore, Nexmezol should not be used during breastfeeding.
What happens if I miss a dose of Nexmezol?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you miss a daily dose of Nexmezol injection.
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).
I am suffering from the severe erosive GERD feel like vomitting I was admitted at the hospital for gastroscop the results were sores that caused by stomach acid and something like stomach bug in the bile which causes acid problem I was given nexmezol tablets 40MG to be taken daily it's been 12days now but my chest is still aching but the oesofugus is now better than before thank you for the word of encouragement that I must continue to take the drug because the problem won't go in a day