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Why it's used

Esomac Tablet is used for the short-term treatment and maintenance of inflammation of the food pipe. This medicine works by decreasing the amount of acid in the stomach. This medicine helps by relieving the symptoms of hyperacidity. Esomac is also used for the short-term treatment of backflow of stomach acid into esophagus, to reduce the occurrence of stomach ulcers related to the repeated use of NSAID's in patients, for the long-term treatment of overproduction of acid in the stomach, to reduce the risk of rebleeding in patients with stomach or intestinal ulcers who are undergoing endoscopy procedure, and to treat the patients with H. pylori bacterial infection and intestinal ulcers.
Esomac Tablet may also be used together with other medicines to treat certain conditions as recommended by the doctor. It is used in combination with Amoxicillin, or Clarithromycin to treat the patients with H. pylori bacterial infection and intestinal ulcers.
Proton Pump Inhibitors
Esomac is a prescription medicine that belongs to a class of medicines called Proton Pump Inhibitors. Proton-pump inhibitors (PPIs) are a group of medicines that significantly reduce stomach acid production. Excess acid production causes diseases related to the stomach and intestines. PPIs are used to treat such disorders.

How to use

Read the medicine guide provided by your pharmacist, your doctor, or the medicine company. If you have any questions related to Esomac, ask your doctor or pharmacist. Use Esomac Tablet as per the instructions provided by your doctor.
Esomac is used with food. Patients are advised to mix the granules with food, and the granules should only be mixed with applesauce. This medicine should be taken at least one hour before a meal. Do not crush or chew the capsules.

Typical Dosage

The typical dose of Esomac for adults is 20 mg or 40 mg once daily for 4 to 8 weeks. The maximum dose for adult patients of Esomac is 40 mg per day. This medicine is generally used for a period of 4 to 8 weeks for inflammation of the food pipe, 6 months for the occurrence of stomach ulcers related to the repeated use of NSAID's in patients, 4 weeks for backflow of stomach acid into esophagus, and 10 days for H. pylori bacterial infection and intestinal ulcers. Esomac is commonly used at the same time every day. It takes 1 hour for this medicine to start its action.
This medicine is to be used for longer periods of time. Esomac should be used as directed by the doctor even if you feel well, or even if you think that there is no need for you to use your medicine.
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.
Esomac injection is intended for intravenous use (injected directly into the veins).

Talk to Your Doctor

Discuss with your doctor if you develop new or worsening symptoms. Discuss with your doctor if seizures, dizziness, fast heartbeat, involuntary body movements (jitteriness), shaking (tremors), muscle weakness, contraction of the hands and feet (spasms), muscle aches, and contraction of the voice box. Consult with your doctor before stopping the use of Esomac.
Older patients may see an increase in the incidence of side-effects. As a result, a lower dose may be recommended for older patients.

Use in Children

The safety and effectiveness of using Esomac Tablet in children has not been established. The safety and effectiveness of Esomac have not been confirmed in children.
Medicines may be recommended for uses other than those listed in the medicine guide. You should not use Esomac Tablet for conditions or symptoms for which it was not prescribed. Do not give Esomac Tablet to other people, even if they have the same conditions or symptoms that you have. The use of this medicine without the advice of a doctor may cause harm.

Storage

Follow storage instructions on the product package if available. Store Esomac Tablet 15°-30°C (59°- 86°F) for injection, 68°F to 77°F (20°C to 25°C) for delayed release capsules of Esomac, away from moisture, and away from light. Store this medicine away from children and pets.
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How to take Esomac

Your dose and how often you take Esomac will depend on the following factors:
  • weight
  • patient's health
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements in use

Esomac Dosage

Dosage for inflammation of the food pipe (erosive esophagitis)

Adult
  • Recommended: 20 to 40 mg once daily for 4 to 8 weeks
Children (1 year to 17 years with body weight less than 55 kg or 121.2 lb)
  • Recommended: 10 mg of Esomac directly injected into a vein over 10 minutes to 30 minutes
Children (1 year to 17 years with body weight equal to or more than 55 kg (121.2 lb))
  • Recommended: 20 mg of Esomac directly injected into a vein over 10 minutes to 30 minutes
Children (1 month to less than 1 year of age)
  • Recommended: 0.5 mg/kg (0.23 mg/lb) of Esomac directly injected into a vein over 10 minutes to 30 minutes

Dosage for backflow of stomach acid into esophagus

Adult
  • Recommended: 20 mg once daily for 4 weeks

Dosage for stomach ulcers by overuse of NSAID's

Adult
  • Recommended: 20 to 40 mg once daily for up to 6 months

Dosage for overproduction of acid in the stomach

Adult
  • Recommended: 40 mg twice daily
  • Initial: 40 mg twice daily
  • Maximum: 80 mg twice daily

Dosage for risk of rebleeding in endoscopy procedure

Adult
  • Initial: 80 mg of Esomac directly injected into a vein over 30 minutes followed by a constant infusion of 8 mg/h for 72 hours

Dosage for H. pylori infection and intestinal ulcers

Adult
  • Recommended: 40 mg once daily for 10 days
Children
  • Recommended: 20 mg twice daily for one week

Minimum Age

12 years

Maximum Age

84 years

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Capsule delayed release
Strength: 20 mg, 24.65 mg, 40 mg, and 49.3 mg
Granule delayed release
Strength: 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg
Injection
Strength: 20 mg/ 5ml and 40 mg/5 ml
Tablet delayed release
Strength: 20 mg and 40 mg
Capsule delayed release pellets
Strength: 20 mg and 40 mg
Injection, powder, lyophilized, for solution
Strength: 20 mg, 20 mg/5 ml, and 40 mg/ 5ml

Special Instructions

Capsule
Patients are advised to mix the granules with food, and the granules should only be mixed with applesauce. If the applesauce or granules mixture is not used entirely, the remaining mixture should not be used. Do not ingest the granules if they have disintegrated or dissolved.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Esomac?
In case of overdose, supportive care and treatment according to the symptoms should be provided. There is no specific antidote available for the treatment of overdose of Esomac.
Symptoms of an overdose of Esomac
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Esomac Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Esomac

Before you use Esomac, tell your doctor of your medical and health history including the following:
  • a condition in which bones become weak (osteoporosis)
  • auto-immune disorder (systemic lupus erythematosus)
  • heartburn
  • kidney disease
  • liver disease
  • low level of magnesium in the blood
  • low level of vitamin B-12 in the body
  • stomach ulcers
Before you use Esomac Tablet, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic any of the following substances: substituted benzimidazoles, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole.
The use of this medicine may change sodium. The use of Esomac has resulted in reduced levels of sodium in the blood.
The use of Esomac Tablet may change magnesium. The use of Esomac has resulted in decreased levels of magnesium in the blood which is characterized by severe side-effects such as condition marked by muscular spasms, due to malfunctioning of the parathyroid glands and a deficiency of calcium, increased and decreased heartbeat and seizures.
The use of this medicine may change vitamin B-12. The use of Esomac may result in a deficiency of vitamin B-12.

Seizures

Esomac Tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Esomac Tablet can worsen the sleepiness. Esomac Tablet may cause rarely seizures in some people. If you perform any activities where a loss of consciousness may cause harm to you (or others), you should discuss with your doctor.

Use in Pregnancy

The use of Esomac during pregnancy should only be when required. The use of Esomac during pregnancy has indicated no harmful effects on the unborn baby.

Use while Breastfeeding

The use of Esomac Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding a baby, discuss with your doctor if you should either discontinue breastfeeding or stop using this medicine while breastfeeding. There is limited data which suggest that Esomac is present in human milk. So Esomac should not be used during breast-feeding of infants.

Use while Conceiving

It is not known if this medicine is safe for use in women who are conceiving. Consult with your doctor before you use Esomac.

Increased Risks

This medicine may cause bleeding in the stomach. Regular use of tobacco or alcohol while using this medicine can increase your risk. Discuss with your doctor if you smoke and drink alcohol regularly. This medicine can increase your risk of getting infections or worsen existing infections. Hence you should reduce your chances of getting new infections. Wash your hands regularly. Avoid people who have infectious diseases. Avoid vaccination without discussing with your doctor first. Prevent any cuts, bruises or injuries. The use of Esomac may increase the risk of stomach and intestinal infections. This medicine may increase your sensitivity to sunlight. If this happens, use a sunscreen and cover your skin when you are outdoors. Limit your time in the sun.

Esomac Side-effects

The following side-effects may commonly occur when using Esomac Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Esomac Tablet may cause the following side-effects:
  • a condition in which red blood cells are paler than normal
  • abnormal dermal sensation
  • abnormal exit of an organ or tissue from its normal position (hernia)
  • abnormal vision
  • abnormally painful cramps during monthly cycles
  • appetite increased
  • back pain
  • black tarry stools
  • bowel irregularity
  • chest pain
  • chills accompanied by a rise in temperature (rigors)
  • coughing
  • difficulty to fall asleep
  • dizziness
  • ear ache
  • enlarged abdomen
  • esophageal disorder
  • excessive sweating
  • eye disorders (visual field defect)
  • feeling of discomfort
  • flu-like disorder
  • hives
  • hot flushes
  • increase in muscle tone
  • indigestion
  • inflammation of the kidneys
  • injection site reaction
  • insomnia
  • intense itching
  • loss of interest
  • micturition frequency
  • muscle pain, joint pain, and tiredness
  • muscular weakness
  • neoplastic growth in the stomach and intestinal areas
  • nervousness
  • pain
  • pain below the sternum bone (substernal chest pain)
  • pain in joints
  • pain in muscle or group of muscles
  • pain or discomfort below ribs (epigastric pain)
  • painful swelling and sores inside the mouth
  • physical weakness
  • presence of protein albumin in the urine
  • rash
  • rashes characterized by a flat, red area on the skin, covered with small bumps
  • redness of skin (rash erythematous)
  • repeated sounds produced due to an involuntary opening and closing of the glottis (hiccup)
  • ringing in the ear
  • skin inflammation
  • sweating increased
  • swelling due to fluid accumulation in legs
  • swelling due to fluid accumulation usually in the lower limbs
  • swelling due to the accumulation of fluid in the body
  • swelling due to the accumulation of fluid in the facial tissues
  • swelling of male breast tissue
  • swelling of the tongue due to fluid accumulation
  • swelling or enlargement of cervical lymph nodes
  • the inability of a man to achieve an erection or orgasm
  • the inability of the brain to process smell
  • uncontrollable shaking movement of the body or its individual parts
  • vertigo
  • weakness
  • worsening of inflammatory disease of joints
  • worsening of symptoms of a recurring headache (migraine aggravated)
The following severe side-effects may also occur when using Esomac Tablet:
  • severe allergic reactions
    Symptoms: swelling due to the accumulation of fluid in the larynx, severe allergic reaction, a disorder characterized by lesions on the skin, increased sensitivity to the sun, serious and life-threatening skin disorder (Stevens-Johnson syndrome), difficulty in breathing, throat tightness, rashes swelling of the face
  • heart and blood disorders
    Symptoms: high blood pressure, bleeding from stomach and intestine, deficiency of healthy red blood cells, bleeding from the nose (epistaxis), abnormal rise in white blood cells, low level of thrombocytes in the blood, abnormally low levels of granulocytes, deficiency of red blood cells, white blood cells, and platelets, low levels of magnesium in the blood increased or decreased heartbeat
  • stomach and intestinal disorders
    Symptoms: difficulty in swallowing, a cancerous growth in the stomach and intestinal area, bleeding in the stomach and intestine, loss of appetite diarrhea caused by bacterial infection (Clostridium difficile associated diarrhea)
  • Symptoms: increased liver enzymes (increased alkaline phosphatase), increased level of uric acid (hyperuricemia), bone fractures, a condition marked by muscular spasms due to malfunctioning of the parathyroid glands and a deficiency of calcium
  • liver disorders
    Symptoms: abnormal functioning of the liver, increased levels of liver enzymes (SGOT and SGPT increased), increased level of uric acid, liver failure, inflammatory condition of the liver accompanied with or without yellow discoloration of the skin loss of brain function due to damaged liver
  • central nervous system disorders
    Symptoms: confusion, worsening of symptoms of depression (depression aggravated), excessive sleepiness, aggression, agitation, hallucination disturbance of nerve cell activity in the brain
  • reproductive system disorders
    Symptoms: yeast infection in the male or female reproductive area (genital moniliasis) inflammation of the vagina (vaginitis)
  • sensory organ disorders
    Symptoms: inflammation of the outer membrane of the eyeball, inflammation of tissues inside the sinuses middle ear infection
  • Symptoms: yeast infection (moniliasis), yeast infection in the male or female reproductive area (genital moniliasis), yeast infection in the stomach and intestinal tract (GI candidiasis) diarrhea caused by bacterial infection (Clostridium difficile associated diarrhea)
  • respiratory system disorders
    Symptoms: swelling due to the accumulation of fluid in the larynx, inflammation of the pharynx (pharyngitis), sudden contractions of muscles in lungs worsening of symptoms of asthma
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Interference with diagnostic investigations

Blood chromogranin A levels may lead to an increased drug-induced decrease in stomach acidity. The elevated blood chromogranin A levels may cause false positive results in diagnosis for neuroendocrine tumors. Esomac therapy should be stopped temporarily before assessing blood chromogranin A levels and consider repeating the test if initial blood chromogranin A levels are high. The same practical lab should be used for testing (monitoring) of chromogranin A levels in the blood.

Use of Esomac strontium with rifampin

Drugs which induce CYP3A4 or CYP2C19 (such as St. John’s Wort or rifampin) can essentially decrease Esomac levels. Avoid combined use of Esomac strontium with rifampin or St. John’s Wort.

Low levels of magnesium

Patients using proton pump inhibitors including Esomac for at least three months and after a year of therapy are at an increased risk of low levels of magnesium characterized by adverse events such as involuntary contraction of muscles (tetany), irregular heartbeat, and seizures. Proper monitoring of magnesium levels is required before starting therapy with proton pump inhibitors.

Increased risk of bone fractures

Patients who are using high-dose, defined as multiple daily doses, and long-term treatment with proton pump inhibitors are at an increased risk. Studies suggest that proton pump inhibitor (PPI) including Esomac therapy may be associated with an enhanced risk for osteoporosis-related fractures of the hip, spine, or wrist. Such patients should use the lowest dose and shortest duration of proton pump inhibitors therapy appropriate to the suitable condition.

Interaction with clopidogrel

The metabolism of clopidogrel can be worsened by combined use with medicines, such as Esomac, that block CYP2C19 activity. The combined use of clopidogrel with Esomac 40 mg reduces the pharmacological action of clopidogrel. Avoid the combined use of Esomac strontium with clopidogrel, which is a prodrug. Blockage of platelet aggregation by clopidogrel is entirely due to an active metabolite. When using Esomac strontium, consider other alternative anti-platelet therapy.

Inflammation of the colon

Hospitalized patients who are on proton pump inhibitors therapy are at an increased risk when using this medicine. Studies suggest that PPI therapy like Esomac strontium is related to an increased risk of diarrhea associated with Clostridium difficile bacteria infection. Proper diagnosis should be considered in patients with the worsening condition of diarrhea associated with inflammation of the colon (Clostridium difficile bacteria infection).

Vitamin B-12 deficiency

Regular therapy with any acid-suppressing medicines over a prolonged period (longer than three years) may lead to a deficiency of vitamin B-12 caused by the absence of hydrochloric acid from the gastric juice (achlorhydria). A diagnostic approach should be followed if any clinical symptoms consistent with vitamin-B12 deficiency are observed.

Swelling in between the kidney tubules

Patients using proton pump inhibitors including Esomac are at an increased risk. Swelling in between the kidney tubules may happen during proton pump inhibitors treatment and is generally associated with a severe allergic reaction without any known cause. Discontinue the use of Esomac if acute interstitial nephritis develops.

The Inflammatory mucous membrane of the stomach

Patients who are on long-term treatment with omeprazole are at an increased risk. Such patients may suffer from an increased risk of inflammation of the mucous membrane of the stomach (atrophic gastritis).

Stomach cancer (concurrent gastric malignancy)

Response according to the symptoms of treatment with Esomac strontium does not prevent the presence of stomach cancer.

The combined use of Esomac strontium with methotrexate

The combined use of PPIs with methotrexate (primarily at high dose) may raise and progress blood levels of methotrexate or its metabolite, probably leading to the condition of harmful effects of the methotrexate. In high-dose methotrexate ingestion, a short-term withdrawal of the proton pump inhibitors including Esomac should be considered in such patients.

Non scaring skin lesions

Use of proton pump inhibitors including Esomac may lead to an increased risk of development of skin lesions in sun-exposed areas. The patient should seek medical help promptly, and discontinue the use of Esomac after consultation with the health care professional.

Stomach and intestinal infections

Therapy with proton pump inhibitors including Esomac may lead to increased risk of stomach and intestinal infections such as infections caused by bacteria Campylobacter and Salmonella.

Interactions with Esomac

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Esomac Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.
Esomac Tablet interacts with Medicinal products metabolized by CYP2C19 enzyme. When Esomac is used in combination with active drugs metabolized by CYP2C19 enzymes, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, may lead to increased levels of active substances in the blood. Treatment with a lower dose of these active drugs is recommended in the patients who are on Esomac therapy.
There may be an interaction of Esomac with Drugs for which gastric pH can affect bioavailability. Due to effects of Esomac on stomach acid secretion, Esomac can decrease the absorption of drugs where stomach pH is an essential factor in their bioavailability. The absorption of drugs such as erlotinib, ketoconazole, iron salts, atazanavir, mycophenolate mofetil can decrease, while the absorption of drugs, e.g. digoxin may increase during therapy with omeprazole. Ingestion of digoxin with Esomac strontium is expected to increase the absorption of digoxin. Patients should be carefully monitored when digoxin is used with Esomac. Take necessary precautions while using this medicine in transplant patients receiving the treatment with mycophenolate mofetil.

Antiretroviral therapy

Esomac Tablet may interact with Antiretroviral drugs (atazanavir or nelfinavir), which are used to treat HIV infections. The combined use of atazanavir with proton pump inhibitors is expected to decrease atazanavir blood levels mainly and may result in a deterioration of therapeutic effect and the rise of drug resistance. Similarly, the combined use of saquinavir with proton pump inhibitors is expected to increase saquinavir levels, which may increase harmful effects and require dose reduction. Omeprazole, of which Esomac is an enantiomer, has been reported to interact with some antiretroviral drugs. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. The combined use of nelfinavir and atazanavir with proton pump inhibitors is not recommended. Clinical and laboratory monitoring for saquinavir harmful effects is recommended during combined use with Esomac.

Immunosuppressive drugs

Your doctor's guidelines may need to be followed while taking this medicine along with Immunosuppressive drugs, such as tacrolimus which are used mainly to lower the risk of organ rejection. The combined use of Esomac and tacrolimus may increase the levels of tacrolimus in the blood.
Special instructions need to be followed while taking this medicine along with Interactions with investigations of tumors arise from the cells of the endocrine (hormonal) and nervous systems (neuroendocrine tumors). Drug-induced reduction in the acidic condition of the stomach results in an enlargement of cell found in the gastric glands and increased Chromogranin A levels, which may interfere with investigations for neuroendocrine tumors.

Antimetabolites, which are used to treat cancer

There may be an interaction of Esomac with Methotrexate. While undergoing treatment with high-dose of methotrexate, a temporary withdrawal of Esomac may need to be taken into account.

Combination therapy with clarithromycin

Esomac Tablet may interact with Antibiotics, which are used to treat various bacterial infections. The combined use of Esomac, amoxicillin, and clarithromycin resulted in increases in the blood levels of Esomac and 14-hydroxyclarithromycin. The combined use of clarithromycin with other drugs also leads to serious side effects due to drug interactions. Clarithromycin is not recommended for use with certain drugs due to severe drug interactions.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Esomac is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

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