Nexmezol Side effects

Rating: 2.85 - 14 review(s)
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What are the possible side effects of Nexmezol?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Nexmezol and call your doctor at once if you have:

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Nexmezol in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Trials Experience With

Intravenous NEXIUM

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The safety of intravenous Nexmezol is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).

Symptomatic GERD and Erosive Esophagitis Trials

The data described below reflect exposure to NEXIUM I.V. for Injection in 359 patients. NEXIUM I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in ≥ 1% of patients treated with intravenous Nexmezol (n=359) in clinical trials are listed below:

Table 2 : Adverse reactions occurring at an incidence ≥ 1% in the NEXIUM I.V. group

Adverse Reactions % of patients Nexmezol

Intravenous (n=359)

Headache 10.9
Flatulence 10.3
Nausea 6.4
Abdominal pain 5.8
Diarrhea 3.9
Mouth dry 3.9
Dizziness/vertigo 2.8
Constipation 2.5
Injection site reaction 1.7
Pruritus 1.1

Intravenous treatment with Nexmezol 20 and 40 mg administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of Nexmezol.

Pediatric

A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily Nexmezol in pediatric patients 1 month to 17 years old, inclusive was performed. The safety results are consistent with the known safety profile of Nexmezol and no unexpected safety signals were identified.

Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults

The data described below reflect exposure to NEXIUM I.V. for Injection in 375 patients. NEXIUM I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive NEXIUM I.V. for Injection (n=375) or placebo (n=389). The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, who presented with endoscopically confirmed gastric or duodenal ulcer bleeding. Following endoscopic hemostasis, patients received either 80 mg Nexmezol as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.

Table 3 : Incidence (%) of adverse reactions that occurred in greater than 1% of patients within 72 hours after start of treatment*

Number(%)of patients
Nexmezol

(n=375)

Placebo

(n=389)

Duodenal ulcer haemorrhage 16 (4.3%) 16 (4.1%)
Injection site reaction# 16 (4.3%) 2 (0.5)
Pyrexia 13 (3.5%) 11 (2.8%)
Cough 4 (1.1%) 1 (0.3%)
Dizziness 4 (1.1%) 3 (0.8%)
*Incidence ≥ 1% in the Nexmezol group and greater than placebo group safety population

#Injection site reactions included erythema, swelling, inflammation, pruritus, phlebitis, thrombophlebitis and superficial phlebitis.

With the exception of injection site reactions described above, intravenous treatment with Nexmezol administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of Nexmezol.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NEXIUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing Reports - There have been spontaneous reports of adverse events with postmarketing use of Nexmezol. These reports occurred rarely and are listed below by body system:

Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia;

Eye Disorders: blurred vision;

Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis;

Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice;

Immune System Disorders: anaphylactic reaction/shock;

Infections and Infestations: GI candidiasis;

Metabolism and nutritional disorders: hypomagnesemia;

Musculoskeletal And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture;

Nervous System Disorders: hepatic encephalopathy, taste disturbance;

Psychiatric Disorders: aggression, agitation, depression, hallucination;

Renal and Urinary Disorders: interstitial nephritis;

Reproductive System and Breast Disorders: gynecomastia;

Respiratory, Thoracic and Mediastinal Disorders: bronchospasm;

Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).

Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.

What is the most important information I should know about Nexmezol?

Nexmezol contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Nexmezol is rapidly absorbed after oral doses, with peak plasma levels occurring after about 1-2 hrs. It is acid labile and an enteric-coated formulation has been developed. Bioavailability of Nexmezol increases with both dose and repeated administration to about 68% and 89% for doses of 20 mg and 40 mg, respectively. Food delays and decreases the absorption of Nexmezol, but this does not significantly change its effect of intragastric acidity. Nexmezol is about 97% bound to plasma proteins. It is extensively metabolized in the liver by the cytochrome P450 (CYP450) isoenzyme CYP2C19 to hydroxy and desmethyl metabolites, which have no effect on gastric acid section. The remainder is metabolized by the CYP450 isoenzyme CYP3A4 to Nexmezol sulfone. With repeated dosage, there is a decrease in first-pass metabolism and systemic clearance, probably caused by an inhibition of the CYP2C19 isoenzyme. However, there is no accumulation during once daily use. The plasma elimination half-life (t½) is about 1.3 hrs. Almost 80% of an oral dose is eliminated as metabolites in the urine, the remainder in the feces.


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References

  1. 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).
  2. European Chemicals Agency - ECHA. "6-methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole: 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).
  3. HSDB. "Esomeprazole". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Nexmezol 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 Nexmezol. 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

8 consumers reported side effects

Did you experience side effects while taking Nexmezol drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Nexmezol drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
No side effects6
75.0%
It has side effects2
25.0%


Consumer reviews

Deborah P Mbatha15 Jun 2016 01:35
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


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