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(Inclusive of all taxes) *10 Capsule(s) in a Strip * Mkt: Unichem Laboratories Ltd * Country of Origin: India * Delivery charges if applicable will be applied at checkout

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INTRODUCTION

IZRA L is a combination of Esomeprazole and Levosulpiride which belongs to the group of medicines called Proton-pump inhibitors and Dopamine D2 antagonists respectively. IZRA L is indicated for the treatment of Gastro-esophageal reflux disease (GERD) among patients who do not adequately respond to proton-pump inhibitors alone (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole).

GERD is a chronic digestive disease in which the stomach acid frequently flows into the esophagus leading to irritation of lining of food pipe. Symptoms include heartburn, chest pain, nausea, sensation of lump in throat and stomach discomfort. IZRA L can also be used to treat peptic ulcer caused by H. pylori infection, or NSAID use. Peptic ulcers are painful sores that develop on the linings of the stomach, esophagus, or intestines. Symptoms include stomach pain, flatulence, indigestion, vomiting and fatigue.

Levosulpiride is a dopamine D2 antagonist which reduces acid reflux by enhancing gastric emptying (propulsion of food from the stomach to the intestines) and rabeprazole is a proton pump inhibitor that reduces gastric acid secretions by inhibiting proton pump present in the stomach, thus resulting in rapid symptom relief followed by healing of ulcers and inflammatory lesions in the esophagus, stomach and in the intestines. Along treatment with IZRA L eat less spicy food and drink plenty of water or fluids as advised by your physician. Avoid consumption of alcohol as it could aggravate your existing disease conditions.

Patients receiving long-term treatment with IZRA L should be kept on regular surveillance to rule out the risk of bone fractures (hip, wrist, or spine), predominantly in patients taking corticosteroids and in patients with other recognized risk factors like osteoporosis. Before taking IZRA L, inform your doctor if you have any heart, kidney, or liver disease as a precaution. IZRA L is not recommended for use in pregnant or breastfeeding women and in children (below 18 years) due to lack of safety and effectiveness. Consult your doctor before taking. The most common side effects of taking IZRA L are headache, nausea, vomiting, stomach pain, diarrhea, or constipation. Consult your doctor if any of these symptoms worsen.

USES OF IZRA L

  • Treats Gastro-esophageal reflux disease (GERD) among patients who do not respond to proton-pump inhibitors (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole) alone
  • Treats peptic ulcer

HOW IZRA L WORKS

IZRA L reduces peptic ulcers and acid reflux, where rabeprazole acts by inhibiting the secretions of stomach acid by blocking the proton pump (H+ K+ ATPase) at the secretory surface of gastric parietal cells and levosulpiride acts by blocking the dopamine D2 receptors in the gut which promotes the secretions of acetylcholine, thus facilitating gastric emptying, and healing of ulcers and/or esophageal lesions.

DIRECTIONS FOR USE

Always take IZRA L as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Do not stop taking IZRA L without informing your doctor.

SIDE EFFECTS OF IZRA L

COMMON

  • headache
  • nausea or vomiting
  • diarrhea, stomach pain, constipation, flatulence
  • benign polyps in stomach

UNCOMMON

  • swollen ankles and feet
  • insomnia (lack of sleep)
  • dizziness
  • pins and needles (tingling sensation in the body)
  • sleepiness
  • vertigo (spinning sensation)
  • dry mouth
  • skin rash, lumpy rash (hives) and itching
  • fracture of wrist, hip, or spine

RARE

  • signs of low blood platelet count (such as increased bleeding or bruising)
  • signs of low blood sodium levels (such as weakness, vomiting and cramps)
  • agitation, confusion, depression, aggression
  • blurred vision
  • changes in taste
  • bronchospasm (difficulty in breathing)
  • mouth sores
  • fungal infection (Ex. thrush)
  • hair loss
  • skin sensitivity (skin rash following sun exposure)
  • joint pain or muscle pains
  • tiredness or lack of energy
  • increased sweating
  • abnormal heart rhythm
  • signs of low white blood cells (repeated infections, fever)

Stop taking IZRA L and contact your doctor immediately if you experience the following side effects:

  • signs of severe allergic reactions (such as skin rash, sudden wheezing, swelling of the lips, tongue and throat or body, fainting or difficulty in swallowing)
  • signs of severe allergic skin reactions (such as skin redness with severe blisters or peeling, bleeding in the eyes, lips, mouth, nose, or genitals associated with a high fever and joint pains)
  • signs of liver problems (such as yellowing of the skin, dark urine, and tiredness)

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take IZRA L with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Diarrhea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. Consult your doctor if the symptom did not improve.

Constipation:

Eat fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

WARNING & PRECAUTIONS

PREGNANCY

IZRA L is not recommended for use in pregnant women. Consult your doctor before taking IZRA L.

BREASTFEEDING

IZRA L is not recommended for use in breastfeeding women. Consult your doctor before taking IZRA L.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness or blurred vision after taking IZRA L.

ALCOHOL

Avoid consumption of alcohol while taking IZRA L, as it could aggravate your existing disease condition.

KIDNEY

IZRA L is not recommended for use in patients with severe kidney disease. Kindly consult your doctor before taking IZRA L.

LIVER

IZRA L is not recommended for use in patients with severe liver disease. Kindly consult your doctor before taking IZRA L.

ALLERGY

Do not take IZRA L if you are allergic to Levosulpiride, Esomeprazole or other proton pump inhibitors (Ex. pantoprazole, rabeprazole, omeprazole).

HEART DISEASE

IZRA L should be used with caution in patients with prolongation of QTc interval (irregular electrical activity of the heart), stroke and cardiac insufficiency. Kindly consult your doctor before taking IZRA L.

OTHERS

IZRA L is not recommended for use if you have:

  • Parkinson’s disease
  • history of epilepsy
  • porphyria (a rare blood disorder)
  • breast cancer or non-cancerous tumor in breast
  • alcohol intoxication (drinking too much alcohol in short period)
  • certain tumors like phaeochromocytoma (tumor in adrenal glands) or pituitary prolactinoma (tumors of pituitary gland)
  • hypokalemia (low blood potassium levels)
  • bleeding or perforation in the stomach or intestines
  • manic states (abnormally elevated mood)

Before taking IZRA L, inform your physician if you:

  • are due to have a specific blood test (Chromogranin A)
  • reduced vitamin B12 levels in body
  • osteoporosis

Use in pediatrics:

IZRA L is generally not recommended for use in children and adolescents (below 18 years) due to lack of safety and effectiveness. Kindly consult your doctor before taking IZRA L.

Use in geriatrics:

IZRA L should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking IZRA L.

INTERACTIONS

A. Drug-Drug interactions:

Before taking IZRA L inform to your doctor, if you are taking any of these medicines:

  • medicines used to treat HIV infection (Ex. nelfinavir, atazanavir)
  • medicines used to treat fungal infections (Ex. ketoconazole, itraconazole or voriconazole)
  • medicines used to treat depression (Ex. citalopram, imipramine, clomipramine, rasagiline, selegiline, phenelzine or St. John’s wort)
  • anticholinergics (used to reduce gastrointestinal movements) such as atropine, biperiden or hyoscine butyl bromide
  • narcotic analgesics (used to provide pain relief) Ex. morphine, pethidine, fentanyl
  • medicines that can make you feel sleepy or drowsy such as sedatives or hypnotics (Ex. phenobarbital) or tranquilizers (Ex. diazepam, clonazepam, lorazepam)
  • clopidogrel (an antiplatelet medicine used to prevent blood clots)
  • erlotinib (used to treat cancer)
  • phenytoin (used to treat epilepsy)
  • medicines used for blood thinning (Ex. warfarin)
  • cilostazol (a medicine used to treat intermittent claudication (pain in legs))
  • cisapride (used to treat heartburn or indigestion)
  • digoxin (used to treat abnormal heart rhythm)
  • methotrexate (a medicine used treat cancer or other auto-immune disease)
  • tacrolimus (used to suppress immune function and prevent graft rejection)
  • rifampicin (used to treat tuberculosis)
  • diuretics (used to reduce blood pressure by increasing urine output) Ex. furosemide, hydrochlorothiazide

B. Drug-Food interaction:

IZRA L can be taken with food or on an empty stomach. Try to take this medicine at least one hour before meals to maximize the efficacy. However, consult your doctor before taking IZRA L.

Overdosage:

If you or anyone else accidentally take too much of IZRA L, contact your doctor immediately or go to a hospital straight away.

SYNOPSIS

Drug :   Esomeprazole, Levosulpiride
Pharmacological Category :   Proton pump inhibitors, Dopamine D2 antagonists
Therapeutic Indication :   Gastro-esophageal reflux disease (GERD), Peptic ulcer
Dosage Forms :   Tablet, Capsule

MORE INFORMATION

  • Keep IZRA L out of reach of children
  • Store at room temperature

FAQs ABOUT IZRA L

Can IZRA L be used in children?

IZRA L is generally not recommended for use in children and adolescents (below 18 years) due to lack of safety and effectiveness. Kindly consult your doctor before taking IZRA L.

Can IZRA L be used during pregnancy?

No. IZRA L is generally not recommended for use in pregnant women. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking IZRA L.

Can IZRA L cause depression?

Yes. IZRA L can rarely cause depression in some individuals. If you experience any signs of depression such as feeling extremely sad, solitary attitude, lack of social connectivity, please contact your doctor immediately.

Can IZRA L be taken for long term?

IZRA L can be taken as a long-term therapy for gastrointestinal disorders. However, consult your doctor before taking IZRA L. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Do not stop taking IZRA L abruptly or take for a longer period than prescribed without consulting your doctor.

Can IZRA L cause black stools?

Yes. IZRA L can rarely cause black stools or blood-stained stools in some individuals. If your experience black stools or blood-stained stools with or without stomach pain or indigestion, stop taking IZRA L and consult your doctor immediately.

Can IZRA L be taken after food?

Yes. IZRA L can be taken before or after food. But try to take IZRA L at least one hour before meals to maximize its efficacy. If you have more queries, consult your doctor before taking IZRA L.

REFERENCES

1. KD. Tripathi. Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 653.

2. Keith A. Sharkey and John L. Wallace. Treatment of disorders of bowel motility and water flux; Antiemetics; Agents used in biliary and pancreatic disease and Pharmacotherapy of gastric acidity, peptic ulcer, and gastroesophageal reflux disease. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1326 & 1311-1313.

3. Gerald G. Briggs and Roger K. Freeman. E. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1427 & -2775.

4. Evangelos Kalaitzakis and Einar Björnsson. A review of esomeprazole in the treatment of gastroesophageal reflux disease (GERD). NCBI; PMC US National Library of Medicine, National Institute of Health. August 2007. [Accessed on 25th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2374928/

5. Caroline M den Hoed, Ernst J Kuipers. Esomeprazole for the treatment of peptic ulcer bleeding. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. December 2010. [Accessed on 25th October 2021] https://pubmed.ncbi.nlm.nih.gov/21108587/

6. Syed Ibrahim Hassan, Syed Mohd Akbar Hassan. COMPARISON OF SAFETY AND EFFICACY OF LEVOSULPIRIDE AND ITOPRIDE IN TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE. Journal of Evidence based medicine and healthcare. January 2017. [Accessed on 25th October 2021] https://jebmh.com/latest_articles/95552

7. R Lozano, MG Peralta Concha, A Montealegre, L de Leon, J Ortiz Villalba, HO Lee Esteban, M Cromeyer, JA Rivas García, A Brossa, G Lluberes, E Izquierdo Sandí and H Burgos Quirós. Effectiveness and safety of levosulpiride in the treatment of dysmotility-like functional dyspepsia. NCBI; PMC US National Library of Medicine, National Institute of Health. March 2007. [Accessed on 25th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936295/

8. Chi-Wook Song, Hoon-Jae Chun, Chang-Duck Kim, Ho-Sang Ryu, Jae-Gol Choe and Jin-Hai Hyun. Effects of Levosulpiride in Patients with Functional Dyspepsia Accompanied by Delayed Gastric Emptying. . NCBI; PMC US National Library of Medicine, National Institute of Health. February 1998. [Accessed on 25th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531935/

9. TORRENT PHARMACEUTICALS LTD. NEXPRO L Esomeprazole DR and Levosulpiride ER Capsules. Torrentian.com. [Revised in June 2020]. [Accessed on 25th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2500.pdf

10. Cipla Ltd. ESOMAC-L Capsules (Esomeprazole magnesium + Levosulpiride). Ciplamed.com. [Revised in July 2020]. [Accessed on 25th October 2021] https://www.ciplamed.com/content/esomac-l-capsules

11. Soigner Pharma. Esomeprazole & Levosulpiride Capsules. [Accessed on 25th October 2021] https://www.soignerpharma.com/product/esperam-ls/

12. Alniche Life science Pvt Ltd. Gastroenterology. [Accessed on 25th October 2021] https://www.alniche.com/product/esobiz-dsr-l/

13. Steris Healthcare PVT Ltd. ESOMEPRAZOLE+ LEVOSULPRIDE. [Accessed on 25th October 2021] https://www.sterisindia.com/latest-update/esomeprazole-levosu/1111

14. AELIDA HEALTHCARE. Esomeprazole 40 Mg +levosulpiride 75 Mg Sustain Release Caps. [Accessed on 25th October 2021] http://www.aelidahealthcare.in/esomeprazole-40-mg-levosulpiride-75-mg-sustain-release-caps-6423328.html

15. Mits Healthcare Private Limited. Esomeprazole sodium and levosulpiride capsule. [Accessed on 25th October 2021] https://www.mitshealthcare.in/product/esomeprazole-sodium-and-levosulpiride-capsule-manufacturers-and-suppliers

16. Vibcare Pharma Pvt. Ltd. ESOVIB L. [Accessed on 25th October 2021] https://vibcare.co.in/esomeprazole-levosulpiride/#!/INDICATION

PRODUCT DETAILS

    Net Qty
    1 N
    Item Weight
    17.5 g
    Ingredient
    ESOMEPRAZOLE 40MG+LEVOSULPIRIDE 75MG
    Hsn Code
    30049099
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Izra L Capsule 10'S

Izra L Capsule 10'S Mkt: Unichem Laboratories Ltd

M.R.P.: Rs.265.30
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