Nexium/Esomeprazole Tablets

Nexium contains a medicine called esomeprazole which belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid the stomach produces.

Nexium 20mg and 40mg tablets contain esomeprazole, a proton pump inhibitor that is used to treat conditions caused by excess gastric acid by reducing the amount of gastric acid released in the stomach. Stomach acid is necessary for the digestion of proteins in your diet and is produced by the parietal cells of the stomach wall. Gastric acid production depends on the action of the enzyme H + / K + -ATPase, which is the proton pump responsible for pumping positive hydrogen ions out of the cells into the stomach, increasing the acidity of the stomach contents. Nexium esomeprazole tablets inhibit the function of H + / K + -ATPase, which prevents acid secretion by blocking the source of acid production.

This action of esomeprazole reduces the acidity of the stomach contents, reducing acid damage that can be caused by gastroesophageal reflux disease (GERD) and esophagitis and relieves symptoms caused by excess gastric acids such as heartburn and dyspepsia. By inhibiting gastric acid secretion, Nexium tablets also help prevent the formation of gastric (stomach) and duodenal (upper intestine) peptic ulcers and also help heal ulcers and damage caused by gastric reflux.

Nexium (esomeprazole)  is used for the treatment of the following disorders:

Adults

• Gastroesophageal reflux disease (GERD). It occurs when stomach acid rises up the esophagus (the tube from the throat to the stomach) causing pain, inflammation and burning.
• Ulcers in the stomach or upper intestine (duodenum) that are infected by a bacteria called Helicobacter pylori. If you have this disorder, your doctor will likely prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by medications called NSAIDs (Nonsteroidal Anti-inflammatory Drugs). Nexium can also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuing treatment for prevention of rebleeding from intravenous Nexium-induced peptic ulcer.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). It occurs when stomach acid rises up the esophagus (the tube from the throat to the stomach) causing pain, inflammation and burning.
• Ulcers in the stomach or upper intestine (duodenum) that are infected by a bacteria called Helicobacter pylori. If you have this disorder, your doctor will likely prescribe antibiotics to treat the infection and allow the ulcer to heal.

Always use the Nexium tablets exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist again.

If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than a year).

If your doctor has told you to take this medicine only when you notice any symptoms, tell your doctor if the symptoms change.

How much to take

Your doctor will have told you how many tablets to take and when to take them. This will depend on your condition, age, and how your liver is working.

The recommended doses are listed below:

Use in adults 18 years of age and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has determined that your esophagus is slightly affected, the recommended dose is one Nexium 40 mg gastro-resistant tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not yet healed.

Once the esophagus has healed, the recommended dose is one Nexium 20 mg gastro-resistant tablet once daily.

If your esophagus is not affected, the recommended dose is one Nexium 20 mg gastro-resistant tablet once a day. Once your condition has been controlled, your doctor may direct you to take your medicine only when you notice any symptoms, up to a maximum of one Nexium 20 mg gastro-resistant tablet each day. If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their reappearance:

The recommended dose is one Nexium 20 mg gastro-resistant tablet twice a day for one week.

Your doctor will also prescribe known antibiotics such as amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (Nonsteroidal anti-inflammatory drugs):

The recommended dose is one Nexium 20 mg gastro-resistant tablet once daily for 4 to 8 weeks.

To prevent gastric ulcers if you are taking NSAIDs (Nonsteroidal Anti-inflammatory Drugs):

The recommended dose is one gastro-resistant tablet of Nexium 20 mg once a day.

To treat excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

The recommended dose is 40 mg of Nexium twice a day.

Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice a day

Continuing treatment for prevention of rebleeding from intravenous Nexium-induced peptic ulcer:

The recommended dose is one Nexium 40 mg tablet once a day for 4 weeks.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Nexium and contact a doctor immediately:

• Sudden shortness of breath, swelling of the lips, tongue, and throat or body in general, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. Major blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also appear. It could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and tiredness that can be symptoms of liver problems.

These effects are rare and can affect up to 1 in 1,000 people.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling dizzy.
• Dry mouth.
• Impaired blood tests that determine how the liver is working.
• Skin rash, hives, itchy skin.
• Hip, wrist, or spinal fracture (if Nexium is used at high doses and over a long period).

Rare (may affect up to 1 in 1,000 people)

• Blood disorders such as decreased white blood cell or platelet count. This can lead to weakness, bruising, or increase the chance of infection.
• Low blood sodium levels. This can lead to weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• A sudden feeling of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection is known as "yeast infection" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice which can lead to yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis from exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• A general feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in the number of cells in the blood, including agranulocytosis (decreased number of white blood cells).
• Aggressiveness
• Seeing, feeling, or hearing things that don't exist (hallucinations).
• Liver disorders that can lead to liver failure or inflammation of the brain.
• Sudden onset of severe skin rash, blisters, or peeling skin. These symptoms can be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscular weakness.
• Severe kidney disorders
• Increased breast size in men.

Frequency not known (frequency cannot be estimated from the available data)

• If you are on Nexium for more than three months, your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to carry out regular tests to monitor your magnesium levels.
• Inflammation in the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

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