INTRODUCTION
ESMEGEN 40 INJECTION contains Esomeprazole which belongs to the group of medicines called Proton pump inhibitors. It is used for the treatment of Gastroesophageal reflux disease (GERD) heartburn in adults and in children aged above 1 year. In adults, ESMEGEN 40 INJECTION also helps in treating ulcers in the stomach or upper part of the gut (intestine) caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) medicines and helps in the prevention of rebleeding following therapeutic endoscopic procedures done for acute bleeding stomach (gastric) or intestinal (duodenal) ulcers.
GERD is a disease where acid from the stomach escapes into the tube which connects your throat to your stomach (oesophagus) causing pain, inflammation.
ESMEGEN 40 INJECTION should be given in caution in patients with severe kidney and liver failure. ESMEGEN 40 INJECTION should be given only if considered clearly necessary by your doctor in pregnant women. It is not recommended in breast-feeding women.
It is not recommended for use in children aged less than 1 year. Consult your doctor before receiving the medicine.
Before receiving ESMEGEN 40 INJECTION inform your doctor if you have or ever had a skin reaction after taking medicine to treat acidity or had history of allergic reaction to Esomeprazole or to any other proton pump inhibitor medicines (Ex. pantoprazole, lansoprazole, rabeprazole, omeprazole).
The most common side effects of receiving ESMEGEN 40 INJECTION are headache, diarrhoea, stomach pain, constipation, flatulence, nausea and vomiting. Contact your physician if any of the symptoms worsens with time.
USES OF ESMEGEN 40 INJECTION
Used to:
- Treat Gastroesophageal reflux disease (GERD)
- Treat Stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
- Prevent rebleeding following therapeutic endoscopic procedures done for acute bleeding stomach (gastric) or intestinal (duodenal) ulcers
HOW ESMEGEN 40 INJECTION WORKS
ESMEGEN 40 INJECTION is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of enzymes in the stomach cell. Hence it reduces gastric acidity by blocking the final step in acid production and helps in relief of acid related indigestion and heartburn.
DIRECTIONS FOR USE
ESMEGEN 40 INJECTION is usually injected into a vein by your doctor or nurse Your doctor will administer the correct dose for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ESMEGEN 40 INJECTION
COMMON
- headache
- diarrhoea
- constipation
- flatulence
- injection site reaction such as redness, irritation
- benign polyps in the stomach (masses of cells that form on the lining inside your stomach)
UNCOMMON
- swelling of the feet and ankles
- troubled sleep
- dizziness
- tingling sensations (pins and needles)
- sleepiness
- dry mouth
- skin rash, bumpy rash (hives) and itchy skin
- fracture of joints such as hip, wrist or spine
RARE
- weakness, bruising or make infections due to reduced number of white cells or platelets
- low levels of sodium in the blood causing weakness, being sick (vomiting) and cramps
- agitation, confused or depressed
- taste changes
- blurred vision
- suddenly feeling wheezy, short of breath (bronchospasm)
- oral inflammation
- fungal infection affecting the gut-thrush
- hair loss (alopecia)
- skin rash on exposure to sunshine
- pain in joints (arthralgia) or muscle (myalgia)
- lack of energy and feeling unwell and lacking energy
- increased sweating
Stop receiving ESMEGEN 40 INJECTION and consult your doctor immediately if you experience any of the following side effects:
- significant weight loss (without reason)
- problem in swallowing
- stomach pain or indigestion
- vomiting (food or blood)
- pass black stools (blood-stained)
- severe allergic reaction such as sudden wheezing, swelling of lips, tongue and throat or body, rashes, fainting or difficulty in swallowing
- reddening of the skin with blisters or peeling and ulcers in the lips, eyes mouth, nose, genitals could be indicative of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms
- rashes along with flu-like symptoms such as fever, headache, body ache
- yellow skin, dark-coloured urine and tiredness (liver problems)
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Frequently hydrate yourself by drinking plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if needed. Do not consume too much of alcohol. Consult your doctor if symptom worsens.
Diarrhea:
Drink plenty of liquids such as water, fruit juices or electrolytes to avoid loss of water (dehydration) in your body. Consult your doctor if the symptom persists for long time.
Nausea and Vomiting:
Try to take ESMEGEN 40 INJECTION with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food.
WARNING & PRECAUTIONS
PREGNANCY
ESMEGEN 40 INJECTION should be given in caution during pregnancy only if necessary. Consult your doctor before receiving ESMEGEN 40 INJECTION.
BREASTFEEDING
ESMEGEN 40 INJECTION is generally not recommended for use in breast feeding women as it is unclear whether it passes through the breast milk. Consult your doctor before receiving ESMEGEN 40 INJECTION.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools, machines if you experience dizziness and blurred vision after receiving ESMEGEN 40 INJECTION. Consult your doctor before receiving the medicine.
ALCOHOL
Avoid or limit the consumption of alcohol while receiving ESMEGEN 40 INJECTION because it might increase the amount of acid in your stomach than normal which can irritate your stomach lining and worsen your symptoms.
KIDNEY
ESMEGEN 40 INJECTION should be given in caution in patients with severe kidney problems. Consult your doctor receiving ESMEGEN 40 INJECTION.
LIVER
ESMEGEN 40 INJECTION should be given with caution in patients with severe liver problems. Consult your doctor before receiving ESMEGEN 40 INJECTION.
ALLERGY
Do not receive ESMEGEN 40 INJECTION if you are allergic to Esomeprazole or to any other proton pump inhibitor medicines.
OTHERS
Before receiving ESMEGEN 40 INJECTION, inform your doctor if you:
- have ever had a skin reaction (after taking medicine to treat acidity)
- are going to have a specific blood test (Chromogranin A)
- had a weight loss
- have problems with swallowing
- have stomach pain or indigestion
- pass black stools (blood-stained faeces)
- have osteoporosis
Use in pediatrics:
ESMEGEN 40 INJECTION is not recommended for use in children aged less than 1 year of age. Your doctor will administer the right dose depends on your child’s age, body weight and disease condition. Consult your doctor before receiving ESMEGEN 40 INJECTION.
Use in geriatrics:
ESMEGEN 40 INJECTION should be used with caution in elderly patients (65 years and above). Consult your doctor before receiving ESMEGEN 40 INJECTION.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving ESMEGEN 40 INJECTION, inform your doctor if you are receiving any of these following medicines:
- medicines used to treat HIV infection (Ex. nelfinavir, atazanavir)
- corticosteroids (Ex. hydrocortisone, cortisone, prednisone and prednisolone)
- medicines used to prevent blood clots (Ex. clopidogrel, warfarin)
- anti-fungal medicines (Ex. ketoconazole, itraconazole or voriconazole)
- medicine used to treat cancer (Ex. Erlotinib)
- anti-depressants used to treat depression (Ex. citalopram, imipramine, clomipramine or St. John’s wort (Hypericum perforatum)
- medicines used to treat anxiety, relax muscles (Ex. diazepam)
- medicine used to treat fits (Ex. Phenytoin)
- medicines used to treat intermittent pain in your legs while walking caused by an insufficient blood supply (Ex. cilostazol)
- medicines used for indigestion and heartburn (Ex. cisapride)
- digoxin (medicine used for heart problems)
- methotrexate (a chemotherapy medicine used in high doses to treat cancer)
- immunosuppressants for organ transplantation (Ex. tacrolimus)
- medicines used for treatment of tuberculosis (Ex. rifampicin)
Overdosage:
ESMEGEN 40 INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.
SYNOPSIS
| Drug | : | Esomeprazole |
| Pharmacological Category | : | Proton Pump Inhibitors |
| Therapeutic Indication | : | Gastroesophageal reflux disease (GERD), Stomach ulcers, Intestinal ulcers caused by NSAID’s, Prevents rebleeding following therapeutic endoscopic procedures done for acute bleeding stomach (gastric) or intestinal (duodenal) ulcers |
| Dosage Forms | : | Tablet, Capsule, Injection, Infusion, Sachet, Granules |
MORE INFORMATION
- Keep ESMEGEN 40 INJECTION out of reach of children
- Store at room temperature
FAQs ABOUT ESMEGEN 40 INJECTION
Can ESMEGEN 40 INJECTION used to treat heartburn?
Yes. ESMEGEN 40 INJECTION contains Esomeprazole used to treat symptoms of stomach acid reflux such as heartburn, indigestion in adults and children above 1 year of age. Consult your doctor regarding the symptoms before receiving it.
Can I take an antacid along while receiving ESMEGEN 40 INJECTION?
Yes. It is safe to receive ESMEGEN 40 INJECTION with antacids as there is no known interaction. However, consult your doctor before taking antacid after receiving ESMEGEN 40 INJECTION.
Can I drive after receiving ESMEGEN 40 INJECTION?
It is advisable not drive as you may experience dizziness and blurred vision after receiving ESMEGEN 40 INJECTION. Consult your doctor before receiving the medicine.
Can ESMEGEN 40 INJECTION be given in children?
ESMEGEN 40 INJECTION is not recommended for use in children aged less than 1 year for the treatment of GERD. The dose may be adjusted based on age and body weight. Consult your doctor before receiving ESMEGEN 40 INJECTION.
Can ESMEGEN 40 INJECTION be given to pregnant women?
ESMEGEN 40 INJECTION should be given in pregnant women only if considered clearly necessary by your doctor. If you think you may be pregnant or planning to become pregnant, consult your doctor for advice before receiving ESMEGEN 40 INJECTION.
Can ESMEGEN 40 INJECTION cause headaches?
Yes, headache is one of the most common side effects of receiving ESMEGEN 40 INJECTION. In case if you are experiencing a headache after receiving ESMEGEN 40 INJECTION, try to rest and relax. Keep drinking plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if needed. Do not consume too much of alcohol. Consult your doctor if headache persists for a long time.
REFERENCES
1. KD Tripathi. Drugs for Peptic Ulcer and G.E.R.D. Essentials of Medical Pharmacology. seventh edition. 2013. Page – 649, 653, 657.
2. Franke, Andreas, Caroline Hepp, Hermann Harder, Christoph Beglinger, and Manfred V. Singer. Esomeprazole reduces gastroesophageal reflux after beer consumption in healthy volunteers. Scandinavian journal of gastroenterology. NIH National Library of Medicines, National Library of Medicine. 2008. [Accessed on 4th October 2022] https://pubmed.ncbi.nlm.nih.gov/18924018/
3. AstraZeneca Pharmaceuticals LP. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 4th October 2022] https://www.medicines.org.uk/emc/files/pil.43.pdf
4. Laboratorios NORMON, S.A. R. Esomeprazole. [Revised in September 2018] [Accessed on 4th October 2022] https://cdn.accord healthcare.com/ie/public/pil/bbba3599_esomeprazole_40_mg_powder_for_solution_for_infusion_pil_ie_02.pdf
5. Safarimex. Health Products Regulatory Authority [Revised in March 2017] [Accessed on 4th October 2022] https://www.hpra.ie/img/uploaded/swedocuments/2191053.PA1852_002_001.b829a905-b910-49b9-b19b-ebc6c1c72f32.000001PIL.170608.pdf
6. AstraZeneca Pharmaceuticals LP. U.S. Food & Drug Administration. [Revised in September 2012] [Accessed on 4th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s026lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Complete Blood Count
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