Sefety Advices
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CAUTION
Caution is advised when consuming alcohol with Esotac. Please consult your doctor.
CONSULT YOUR DOCTOR
Esotac may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Esotac is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
CONSULT YOUR DOCTOR
It is not known whether Esotac alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED
Esotac is safe to use in patients with kidney disease. No dose adjustment of Esotac is recommended.
However, inform your doctor if you have any kidney disease.
CAUTION
Esotac should be used with caution in patients with severe liver disease. Dose adjustment of Esotac may be needed. Please consult your doctor.
Medical Overview
Introduction
Esotac is a medicine which reduces the amount of acid produced in your stomach. It is used to treat heartburn, acid reflux and problems in your food pipe. It is also used to prevent and treat stomach ulcers.
You should take Esotac as your doctor advises. The dose will depend on what you are being treated for, but it should be the lowest dose for the shortest amount of time needed to treat your condition. Normally it should be swallowed whole about an hour before a meal and at the same time each day. It may take up to a few weeks to work properly but your doctor will tell you how long you need to be taking it for. You should keep on taking it as prescribed even if your symptoms disappear quickly. If you are taking this medicine for a long time, your doctor may carry out regular tests to check your levels of magnesium which can fall with this medicine.
Common side effects include headache, constipation or diarrhoea, stomach pain and feeling or being sick. These tend to be mild but talk to your doctor if they bother you or do not go away. The risk of side effects may increase the longer you take this medicine. Serious side effects are rare, but some need immediate medical attention. Ask your doctor what these are. You may be more likely to have a broken bone if you take it for a long time. It is best to avoid foods that seem to make your symptoms worse, such as rich, spicy and fatty foods. It also helps to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.
Esotac is not suitable for some people. Before taking this medicine, you need to tell your doctor if you have severe liver problems, are taking medicines for HIV, have had an allergic reaction to similar medicines in the past or have osteoporosis. Alcohol does not interfere with the way Esotac works. However, drinking alcohol makes your stomach produce more acid than normal. This medicine can make you feel dizzy, sleepy, or affect your vision. If this happens, do not drive, cycle or use machinery or tools until you feel better. It is not usually recommended during pregnancy and breastfeeding.
Uses of Esotac
- Gastroesophageal reflux disease (Acid reflux)
- Peptic ulcer disease
Side effects of Esotac
Common
- Headache
- Dizziness
- Dryness in mouth
- Nausea
- Abdominal pain
- Constipation
- Flatulence
- Diarrhea
How to use Esotac
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Esotac is to be taken empty stomach.
How Esotac works
Esotac is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn.
What if you forget to take Esotac?
If you miss a dose of Esotac, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- It is a well-tolerated medicine and provides relief for a long time.
- Avoid eating late at night or before bedtime.
- Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
- Long-term use of Esotac can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by your doctor.
- Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.
Brief Description
Indication
Heartburn, Acid Related Dyspepsia, Peptic ulcer disease, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD), Helicobacter pylori infection, Erosive Esophagitis, Gouty arthritis, Duodenal and Gastric Ulcer.
Administration
Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals.
Tab: May be taken with or without food.
Adult Dose
GERD Without Erosive Esophagitis
20 mg PO qDay for 4 weeks; consider an additional 4 weeks of treatment if symptoms do not resolve completely in the first 4 weeks
GERD With Erosive Esophagitis
20-40 mg PO qDay for 4-8 weeks
If oral therapy inappropriate or not possible: 20-40 mg qDay IV up to 10 days; switch to PO once patient able to swallow
Maintenance: 20 mg PO qDay for up to 6 months
Risk Reduction of NSAID-Associated Gastric Ulcer
20-40 mg PO qDay for up to 6 months
NSAID-Induced Gastric Ulcer
20 mg PO qDay for 4-8 weeks
Zollinger-Ellison Syndrome
80 mg PO divided q12hr (initial); adjust regimen to efficacy; up to 240 mg PO qDay, OR
120 mg PO q12hr administered to patients
Elderly: No dosage adjustment needed.
Hepatic Impairment
Oral administration
Mild to moderate (Child-Pugh A/B): No dosage adjustment required
Severe (Child-Pugh C): Not to exceed 20 mg/day
Child Dose
GERD Without Erosive Esophagitis
Oral
<1 year: Safety and efficacy not established
1-12 years: 10-20 mg PO qDay for up to 8 weeks
>12 years: 20-40 mg PO qDay for up to 8 weeks
GERD With Erosive Esophagitis (Healing)
<1 month: Safety and efficacy not established
1 month to 1 year
3.5 kg: 2.5 mg PO qDay for up to 6 weeks
>3.5-7.5 kg: 5 mg PO qDay for up to 6 weeks
>7.5 kg: 10 mg PO qDay for up to 6 weeks
1-12 years
<20 kg: 10 mg PO qDay for 8 weeks
>20 kg: 10-20 mg qDay for 8 weeks
>12 years
20-40 mg PO qDay for 4-8 weeks
Maintenance: 20 mg PO qDay up to 6 months
Renal Dose
Renal impairment: No dosage adjustment needed.
Contraindication
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.
Mode of Action
Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.
Precaution
Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded.
Lactation
Risk Summary
Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Esomeprazole and any potential adverse effects on the breastfed infant from Esomeprazole or from the underlying maternal condition.
Side Effect
>10%
Headache (2-11%)
1-10%
Flatulence (10%),Indigestion (6%),Nausea (6%),Abdominal pain (1-6%),Diarrhea (2-4%),Xerostomia (3-4%),Dizziness (2-3%),Constipation (2-3%),Somnolence (1-2%),Pruritus (1%)
<1%
Blood and lymphatic system disorders: Agranulocytosis, pancytopenia
Blurred vision,
GI disorders: Pancreatitis, stomatitis, microscopic colitis
Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice
Anaphylactic reaction/shock
GI candidiasis
Hypomagnesemia
Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture
Nervous system disorders: Hepatic encephalopathy, taste disturbance
Psychiatric disorders: Aggression, agitation, depression, hallucination
Interstitial nephritis
Gynecomastia
Bronchospasm
Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal)
Pregnancy Category Note
Pregnancy
There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use; reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person)
Lactation
Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no clinical data on effects of esomeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
Interaction
Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts.
Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.
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Disclaimer
The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.