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RABETERO L CAPSULE 10'S
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INTRODUCTION
RABETERO L is a combination of Levosulpiride and Rabeprazole which belongs to the group of medicines called Dopamine D2 antagonists and Proton-pump inhibitors respectively. RABETERO L is indicated for the treatment of Gastro-esophageal reflux disease (GERD). GERD is a chronic digestive disease in which the stomach acid frequently flows into the esophagus leading to irritation and inflammation of lining of food pipe. Symptoms include heartburn, chest pain, nausea, sensation of lump in throat and stomach discomfort.
RABETERO L can also be used to treat peptic ulcer (painful sores in the gut), Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to secrete more acid), functional dyspepsia (recurrent signs and symptoms of indigestion without an obvious cause) and diabetic gastroparesis (delayed gastric emptying caused due to diabetes).
Take RABETERO L preferably on an empty stomach. Avoid consumption of alcohol while taking RABETERO L as it could potentiate the CNS depressive side effects.
Patients receiving long-term treatment (>1 year) with RABETERO L should be kept on regular surveillance because it can increase the risk of bone fracture (i.e., in the hip, wrist or spine) which is more predominant in the patients having osteoporosis or taking corticosteroids.
Before taking RABETERO L, inform your doctor if you have any heart, kidney or liver disease as a precaution. RABETERO L is not recommended for use in pregnant or breastfeeding women, including children and adolescents (aged below 18 years).
The most common side effects of taking RABETERO L are nausea, vomiting, stomach pain, diarrhea, constipation and headache. Consult your doctor if any of these symptoms worsen.
USES OF RABETERO L
- Treats Gastro-Esophageal Reflux Disease (GERD)
- Treats function dyspepsia
- Treats peptic ulcer
- Treats Zollinger-Ellison syndrome
- Treats diabetic gastroparesis
HOW RABETERO L WORKS
RABETERO L reduces stomach ulcers, nausea 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 CTZ (area in medulla oblongata that causes vomiting when stimulated) and in the gut, thus facilitating the movement of food from the stomach into the intestines followed by healing of ulcers or inflammatory lesions in the stomach and in the esophagus.
DIRECTIONS FOR USE
Take RABETERO L on an empty stomach or as advised by your physician. Swallow RABETERO L as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF RABETERO L
COMMON
- infections, weakness or flu-like symptoms
- difficulty in sleeping
- headache or dizziness
- cough, runny nose or sore throat
- nausea, vomiting, stomach pain, diarrhea, wind (flatulence) or constipation
- aches or back pain
- benign polyps in stomach
UNCOMMON
- nervousness, drowsiness
- chest infection
- sinusitis (painful and blocked sinuses)
- dryness of mouth
- indigestion or belching
- skin rash or redness
- leg pain, muscle pain or joint pain
- fractures of the spine, hip and wrist
- urinary tract infection
- chest pain
- fever or chills
RARE
- loss of appetite
- depression
- visual disturbance
- sore mouth, taste disturbance
- stomach upset or pain
- sweating
- kidney problems
- weight gain
Stop taking RABETERO L and contact your doctor immediately if you experience any of the following side effects:
- skin rash on sun exposed areas with joint pain
- severe (watery or bloody) diarrhea accompanied with fever, abdominal pain or tenderness
- severe allergic reactions (such as sudden swelling of the face, leading to breathing difficulties or low blood pressure which may cause fainting or collapse)
- frequent infections such as high fever or sore throat or ulcers in the mouth or throat
- bleeding or bruising easily
- severe skin blistering with oral sores
- signs of liver disease (yellowing of the skin and eyes, dark urine and tiredness)
- signs of serious skin reactions (such as erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis causing severe skin redness with blistering or peeling, bleeding in the lips, eyes, mouth, nose and genitals with a high fever and joint pains)
- signs of decreased magnesium levels in the blood (such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia)
HOW TO MANAGE SIDE EFFECTS
Diarrhea:
Drink lot 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 lot of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. 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
RABETERO L is not recommended for use in pregnant women. Consult your doctor before taking RABETERO L.
BREASTFEEDING
RABETERO L is strictly not recommended for use in breastfeeding women. Consult your doctor before taking RABETERO L.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness or sleepiness after taking RABETERO L.
ALCOHOL
Avoid consumption of alcohol while taking RABETERO L, as it could cause CNS depression (characterized by confusion, attention impairment and anxiety), dizziness and/or drowsiness. Consult your doctor before taking RABETERO L.
KIDNEY
RABETERO L should be taken with caution in patients with kidney disease. Consult your doctor before taking RABETERO L.
LIVER
RABETERO L should be taken with caution in patients with a previous history of liver problems. Consult your doctor before taking RABETERO L.
ALLERGY
Do not take RABETERO L if you are allergic to Levosulpiride, Rabeprazole or other proton-pump inhibitors (Ex. pantoprazole, omeprazole, lansoprazole).
LUNGS
RABETERO L should be taken with caution in patients with asthma or other respiratory diseases. Consult your doctor before taking RABETERO L.
HEART DISEASE
RABETERO L should be taken with caution in patients with heart disease. Consult your doctor before taking RABETERO L.
OTHERS
RABETERO L is not recommended for use if you have:
- parkinson’s disease
- history of epilepsy
- neuroleptic malignant syndrome (a CNS disorder characterized by high fever, stiffness of the muscles, altered mental status (paranoid behavior) and autonomic dysfunction)
- breast cancer (with high levels of prolactin in the body)
Before taking RABETERO L, inform your physician if you:
- have a tumor in the stomach or breast
- have bleeding or perforation of the gastrointestinal tract
- have or at risk of developing vitamin-B12 deficiency
- had developed any skin reaction following treatment with similar medicines that can reduce stomach acid
- are due to have a specific blood test (Chromogranin A)
- have osteoporosis
- are a smoker
- have porphyria (a rare blood disorder)
- have alcohol intoxication (drinking large amount of alcohol in short period)
- have or had phaeochromocytoma (tumors of adrenal gland) in the past
- have or had prolactinoma (a noncancerous tumor of pituitary gland) in the past
- have hypokalemia (decreased potassium levels in blood)
- have neuroendocrine tumor (tumors in neuroendocrine cells)
- have mania or other mental disorders
- have painful breasts
Use in pediatrics:
RABETERO L is not recommended for use in children and adolescents (aged below 18 years). Consult your doctor before taking RABETERO L.
Use in geriatrics:
RABETERO L should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking RABETERO L. Proper dose adjustments and careful monitoring are required in such patients.
INTERACTIONS
A. Drug-Drug interactions:
Before taking RABETERO L inform to your doctor, if you are taking any of these medicines:
- medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir, rilpivirine)
- antacids (used to neutralize stomach acid secretions) Ex. aluminium hydroxide, magnesium hydroxide
- sucralfate (used to prevent duodenal ulcer)
- cisapride (used to treat heart burn in patients with gastroesophageal reflux disease)
- anticholinergics (medicines that causes smooth muscle relaxation and decreases body secretions) Ex. atropine, scopolamine, homatropine
- levodopa (used for parkinson’s disease)
- medicines causing low levels of potassium in blood such as furosemide (used to treat edema), corticosteroids (used to treat inflammation) Ex. cortisol, laxatives such as bisacodyl (used to treat constipation)
- iron salts (used to treat iron deficiency) Ex. ferrous sulphate, ferric ammonium citrate
- medicines used to treat high blood pressure and other heart problems (Ex. captopril, enalapril, losartan, valsartan, diltiazem, digoxin, quinidine)
- atomoxetine (used to treat attention-deficit hyperactivity disorder)
- terfenadine (used to treat allergic conditions)
- chloroquine (used to prevent or treat malaria)
- clarithromycin or amoxicillin (used to treat bacterial infections)
- medicines used to treat cancer (Ex. erlotinib, dasatinib, nilotinib)
- methotrexate (used to treat cancer and auto-immune disease)
- tacrolimus or mycophenolate mofetil (used to prevent organ rejection after transplant)
- ketoconazole, itraconazole (used to treat fungal infection)
- warfarin (used for blood thinning and prevention of heart problems)
- pregabalin (used to treat neuropathic pain)
- tramadol (used to treat pain)
- ipratropium (used to treat symptoms of COPD/asthma)
Overdosage:
If you or anyone else accidentally take too much of RABETERO L, contact your doctor immediately or go to a hospital straight away.
SYNOPSIS
| Drug | : | Levosulpiride, Rabeprazole |
| Pharmacological Category | : | Dopamine D2 antagonists, Proton-pump inhibitors |
| Therapeutic Indication | : | Peptic ulcer, GERD, Functional dyspepsia, Diabetic gastroparesis, Zollinger-Ellison syndrome |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep RABETERO L out of reach of children
- Store RABETERO L at room temperature
FAQs ABOUT RABETERO L
When and how should I take RABETERO L?
Take RABETERO L on an empty stomach or as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose of RABETERO L and duration of therapy for you depending upon your age, body weight and health condition.
Can RABETERO L be used in children?
RABETERO L is not recommended for use in children and adolescents (aged below 18 years). Kindly consult child’s doctor if your child experiences any symptoms of gastro-esophageal reflux disease (such as nausea, discomfort in upper stomach, heartburn, burping, etc.)
Can I consume alcohol while taking RABETERO L?
No, avoid consumption of alcohol while taking RABETERO L, as it could cause CNS depression (characterized by confusion, attention impairment and anxiety), dizziness and/or drowsiness. Also, if you are a chronic alcoholic or suffering from acute alcohol intoxication, please inform your doctor as a precaution before taking RABETERO L.
Can I drive or operate machinery after taking RABETERO L?
RABETERO L may cause dizziness in some individuals and so avoid driving or operating any tools or machines while you are feeling dizzy. Try to rest and relax. Get enough sleep. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor before taking RABETERO L.
Does prolong use of RABETERO L cause bone fractures?
Yes, prolonged use of RABETERO L can increase the risk of bone fracture (particularly in the hips, wrist or spine), particularly in the elderly patients and in patients with other risk factors such as having osteoporosis or taking corticosteroids. Consult your doctor before taking RABETERO L. During treatment with RABETERO L your doctor may monitor to rule out the risk of fractures. Do not take RABETERO L for a prolonged period without consulting your doctor.
What to do If I forget to take RABETERO L?
You should take RABETERO L immediately when you remember. If it is time for your next dose of RABETERO L skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
What are the common side effects of RABETERO L?
The most common side effects of taking RABETERO L are nausea, vomiting, headache, stomach pain, diarrhea, constipation, infections, cough or sore throat. Consult your doctor if any of the side effects worsen.
REFERENCES
1. KD. Tripathi. Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 651-654.
2. Gerald G. Briggs and Roger K. Freeman. P. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3337 & -2775.
3. E. Distrutti, S. Fiorucci, S. K. Hauer, M. O. Pensi, M. Vanasia, A. Morelli. Effect of acute and chronic levosulpiride administration on gastric tone and perception in functional dyspepsia. Alimentary Pharmacology and Therapeutics. September 2002. [Accessed on 28th October 2022] https://onlinelibrary.wiley.com/doi/epdf/10.1046/j.1365-2036.2002.01180.x
4. Ratnani IJ, Panchal BN, Gandhi RR, Vala AU and Mandal K. Role of Levosulpiride in the Management of Functional Dyspepsia. Journal of Family medicine. 2015. [Accessed on 28th October 2022] https://austinpublishinggroup.com/family-medicine/fulltext/jfm-v2-id1034.php
5. 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 28th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936295/
6. C Mansi, V Savarino, S Vigneri, D Perilli, P Melga, L Sciabà, D De Martini, G S Mela. Gastrokinetic effects of levosulpiride in dyspeptic patients with diabetic gastroparesis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 1995. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/7485007/
7. P W Y Lim, K L Goh. Review article: efficacy and safety of rabeprazole in treating gastroesophageal reflux disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. September 2004. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/15324384/
8. Torrent pharmaceuticals Ltd. Veloz L. Torrentian.com. [Revised in Match 2020]. [Accessed on 28th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2425.pdf
9. Cipla Ltd. Rabicip L Capsules (Rabeprazole sodium + Levosulpiride). Ciplamed.com [Revised in January 2020]. [Accessed on 28th October 2022] https://www.ciplamed.com/content/rabicip-l-capsules
10. Accord Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 28th October 2022] https://www.medicines.org.uk/emc/files/pil.2843.pdf
11. Eisai R&D Management Co., Ltd. Aciphex. U. S. Food and administration. [Revised in December 2014]. [Accessed on 28th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf
12. Akesiss Pharma Pvt Ltd. Rabipot LS. [Accessed on 28th October 2022] https://akesiss.com/divisions/glyvo-life/rabipot-ls/
USEFUL DIAGNOSTIC TESTS
- Anti-Saccharomyces Cerevisiae (ASCA), IgA
- Anti-Saccharomyces Cerevisiae (ASCA), IgG
- Complete Blood Count
- Helicobacter Pylori IgA
- Helicobacter Pylori IgG
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 07 Nov 2022 | 01:41 PM(IST)
The contents of this website are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Do not disregard professional medical advice or delay in seeking it because of something you have read on this website.