Esomeprazole Normon

Esomeprazole.

Esomeprazole NORMON is a white or almost white porous appearance lyophilized powder, made into a solution before administered.
The active substance is esomeprazole sodium. Each vial of powder for injectable solution and for infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
Excipients/Inactive Ingredients: The other ingredients (excipients) are disodium edetate and sodium hydroxide. Each vial contains less than 1 mmol sodium (23 mg) i.e. essentially 'sodium-free'.

Esomeprazole NORMON contains a medicine called esomeprazole: This belongs to a group of medicines called 'proton pump inhibitors' (PPIs). They work by reducing the amount of acid that the stomach produces.

Esomeprazole NORMON is used for the short-term treatment in certain conditions, when it's unable to have treatment by mouth: Gastro-oesophageal reflux disease (GERD) in adults, adolescents and children. This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain, inflammation and heartburn.
Stomach ulcers in adults caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole NORMON can also be used to stop stomach ulcers from forming if patient is taking NSAIDs.
Prevention of rebleeding in adults following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Prevention of gastric and duodenal ulcers associated with NSAID therapy in adult, in patients at risk.

Esomeprazole NORMON can be given to children and adolescents aged 1-18 years and adults, including elderly.
Adults: The usual dose is 20 mg or 40 mg once a day.
If patient has severe liver problems, the maximum dose for GERD is 20 mg a day.
The medicine will be given as an injection or infusion into one of the veins. This will last for up to 30 minutes.
For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily.
The usual dose for prevention of rebleeding of gastric or duodenal ulcer is 80 mg administered as intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/hr given over 3 days. If patient has severe liver problems, a continuous infusion of 4 mg/hr given over 3 days may be sufficient.
Children aged 1-18 years: For children 1-11 years, the usual dose is 10 or 20 mg given once a day.
For children 12-18 years, the usual dose is 20 or 40 mg given once a day.
The medicine will be given as an injection or infusion into a vein. This will last up to 30 minutes.

In case of overdose, advise patient to contact the doctor or pharmacist at once, or go to the nearest hospital, indicating the amount received.

Esomeprazole NORMON must not be given: If patient is allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (see Description).
If patient is allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
If patients is taking a medicine containing nelfinavir (used to treat HIV).

Before giving Esomeprazole NORMON, check if patient has severe liver problems; severe kidney problems; if patient has ever had a skin reaction after treatment with a medicine similar to Esomeprazole NORMON that reduces stomach acid.
Esomeprazole NORMON may hide symptoms of other diseases. Therefore, be advised if any of the following happen to the patient before giving Esomeprazole NORMON or after it was given: Patient loses a lot of weight for no reason and has problems swallowing; patient gets stomach pain or indigestion; patient begins to vomit food or blood; patient passes black stools (blood-stained faeces).
Risk of bone fracture: Taking a proton pump inhibitor like Esomeprazole NORMON, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Be advised if patient has osteoporosis or if he/she is taking corticosteroids (which can increase the risk of osteoporosis). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Potential risk of low serum magnesium levels: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors (PPIs) for at least three months, in most cases after a year of therapy. Serious adverse effects 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), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Clostridium difficile associated diarrhoea: Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Esomeprazole NORMON. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Driving and using machines: Esomeprazole NORMON is not likely to affect ability to drive or use any tools or machines.

Before giving Esomeprazole NORMON, be advised if the patient is pregnant or trying to get pregnant.
It is not known if Esomeprazole NORMON passes into breast milk. Therefore, Esomeprazole NORMON should not be given during breast-feeding.

Like all medicines, Esomeprazole NORMON can cause side effects, although not everybody gets them.
If any of the following serious side effects is noticed, advise patient to stop taking Esomeprazole NORMON and to contact a doctor immediately: Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis'.
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
These effects are rare, affecting 1 to 10 patients in 10,000.
Other side effects include: Common (may affect up to 1 in 10 people): Headache.
Effects on the stomach or gut: stomach pain, constipation, diarrhoea, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).
Injection site reaction.
Uncommon (may affect up to 1 in 100 people): Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling feelings such as "pins and needles", feeling sleepy.
Spinning feeling (vertigo).
Eyesight problems such as blurred vision.
Dry mouth.
Changes in blood tests that check how the liver is working.
Skin rash, lumpy rash (hives) and itchy skin.
Fracture of the hip, wrist or spine (if Esomeprazole NORMON is used in high doses and over long duration).
Rare (may affect up to 1 in 1,000 people): Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Taste changes.
Suddenly feeling wheezy or short of breath (bronchospasm).
An inflammation of the inside of the mouth.
An infection called "thrush" which can affect the gut and is caused by a fungus.
Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash on exposure to sunshine.
Joint pains (arthralgia) or muscle pains (myalgia).
Generally feeling unwell and lacking energy.
Increased sweating.
Very rare (may affect up to 1 in 10,000 people): Changes in blood count including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Severe kidney problems.
Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data): If patient is on Esomeprazole NORMON for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If patient gets any of these symptoms, advise patient to tell the doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Regular blood tests can be performed to monitor the levels of magnesium.
Inflammation in the gut (leading to diarrhoea).
Rash, possible with pain in the joints.
Esomeprazole NORMON may in very rare cases affect the white blood cells leading to immune deficiency. If patient has an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, advise patient to consult a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for the patient to give information about his/her medication at this time.
Do not be concerned by this list of possible side effects. Patient may not get any of them. If any of the side effects get serious, or in case of any side effects not listed in this monograph, advise patient to tell a doctor or pharmacist.

Be advised if the patient is taking or has recently used any other medicines. This includes medicines that the patient buys without a prescription. This is because Esomeprazole NORMON can affect the way some medicines work and some medicines have an effect on Esomeprazole NORMON.
Esomeprazole NORMON must not be given if patient is taking a medicine containing nelfinavir (used to treat HIV).
Be advised if patient is using any of the following medicines: Atazanavir (used to treat HIV).
Clopidogrel (used to prevent blood clots).
Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
Erlotinib (used to treat cancer).
Citalopram, imipramine, clomipramine (used to treat depression).
Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Phenytoin (used in epilepsy). If patient is taking phenytoin, when to start or stop Esomeprazole NORMON may need to be monitored.
Medicines that are used to thin the blood such as warfarin. When to start or stop Esomeprazole NORMON may need to be monitored.
Cilostazol (used to treat intermittent claudication - a pain in the legs when walking which is caused by an insufficient blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if patient is taking a high dose of methotrexate, Esomeprazole NORMON treatment may be temporarily stopped.
Tacrolimus (organ transplantation).
Rifampicin (used for treatment of tuberculosis).
St. John's wort (Hypericum perforatum) (used to treat depression).
Concomitant use with clopidogrel: Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolized through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.
Concomitant use of Proton Pump Inhibitor (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.

Esomeprazole NORMON contains 40 mg of esomeprazole, as a sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium).
Vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, any unused solution should be discarded.
For further information on dose recommendations and storage conditions, see Dosage & Administration and Storage sections.
Preparation and Administration of Reconstituted Solution: For the reconstitution of solution, withdraw the plastic cap of colour at the top of the vial of Esomeprazole NORMON and pierce the stopper in the centre of the designed circle, by maintaining the needle vertically, in order to be able to cross the stopper correctly.
The reconstituted solution for injection or infusion should be clear and colourless to very slightly yellow. It should be inspected visually for particulate matter and discolouration before administration and only clear solution should be used.
The shelf life after reconstitution in terms of chemical and physical stability has been demonstrated for 12 hours at 30°C. However, from a microbiological point of view, the product should be used immediately.
Esomeprazole NORMON injection: To prepare a solution for injection: Injection 40 mg: For 8 mg/ml esomeprazole reconstituted solution: Prepare the solution by adding 5 ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial.
The reconstituted solution for injection should be administered intravenously over a period of at least 3 minutes.
Esomeprazole NORMON infusion: To prepare a solution for infusion: Infusion 40 mg: Dissolve the content of one esomeprazole 40 mg vial in up to 100 ml of 0.9% sodium chloride for intravenous use.
Infusion 80 mg: Dissolve the contents of two esomeprazole 40 mg vials in up to 100 ml of 0.9% sodium chloride for intravenous use.
Disposal: Any unused product or waste material should be disposed of in accordance with local requirements.

The doctor and hospital pharmacist are responsible for storing, using and disposing of Esomeprazole NORMON correctly.
Store below 30°C.
Keep the vial in the outer carton in order to protect from light. Vials can, however, be stored exposed to normal indoor light outside the box for up to 24 hours.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.

Antacids, Antireflux Agents & Antiulcerants

A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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