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INTRODUCTION
ATYPRIDE LR CAPSULE is a combination of Levosulpiride and Rabeprazole which belongs to the group of medicines called Dopamine D2 antagonists and Proton-pump inhibitors respectively. ATYPRIDE LR CAPSULE 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.
ATYPRIDE LR CAPSULE 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).
Levosulpiride is a dopamine D2 antagonist that reduces acid reflux by enhancing gastric emptying (propulsion of food from the stomach to the intestines) and bowel movements and rabeprazole is a proton pump inhibitor that inhibits the secretions of stomach acid, thus leading to healing of ulcers and inflammatory lesions in the stomach and in the intestines.
Take ATYPRIDE LR CAPSULE preferably on an empty stomach. Avoid consumption of alcohol while taking ATYPRIDE LR CAPSULE as it could potentiate the CNS depressive side effects. Patients receiving long-term treatment (>1 year) with ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE, inform your doctor if you have any heart, kidney, or liver disease as a precaution. ATYPRIDE LR CAPSULE is not recommended for use in pregnant or breastfeeding women and in children (below 18 years. The most common side effects of taking ATYPRIDE LR CAPSULE are nausea, vomiting, stomach pain, diarrhea, constipation, infections, cough, sore throat, or fatigue. Consult your doctor if any of these symptoms worsen.
USES OF ATYPRIDE LR CAPSULE
- Treats Gastro-Esophageal Reflux Disease (GERD)
- Treats function dyspepsia
- Treats peptic ulcer
- Treats Zollinger-Ellison syndrome
- Treats diabetic gastroparesis
HOW ATYPRIDE LR CAPSULE WORKS
ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE on an empty stomach or as advised by your physician. Swallow ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE
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
- low blood platelet count (easy bleeding or bruising)
- changes in white blood cells (repeated infection)
Stop taking ATYPRIDE LR CAPSULE and contact your doctor immediately if you experience any of the following symptoms:
- 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 blood (such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia)
HOW TO MANAGE SIDE EFFECTS
Loss Of Appetite
Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Try to have a nutritious snack that is rich in calories and protein, such as dried fruit and nuts.
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.
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.
Dizziness Or Drowsiness
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.
Skin Rash Or Itching
Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.
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.
Headache
Rest and relax. Drink lot 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.
Indigestion
Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedATYPRIDE LR CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking ATYPRIDE LR CAPSULE.
BREASTFEEDING
ContraindicatedATYPRIDE LR CAPSULE is strictly not recommended for use in breastfeeding women. Consult your doctor before taking ATYPRIDE LR CAPSULE.
DRIVING AND USING MACHINES
Use with CautionDo not drive or operate any heavy tools or machines if you experience dizziness, drowsiness, or sleepiness after taking ATYPRIDE LR CAPSULE.
ALCOHOL
Consult your doctorAvoid consumption of alcohol while taking ATYPRIDE LR CAPSULE, as it could cause CNS depression (characterized by confusion, attention impairment, and anxiety), dizziness and/or drowsiness. Consult your doctor before taking ATYPRIDE LR CAPSULE.
KIDNEY
Use with CautionATYPRIDE LR CAPSULE should be taken with caution in patients with kidney disease. Consult your doctor before taking ATYPRIDE LR CAPSULE.
LIVER
Use with CautionATYPRIDE LR CAPSULE should be taken with caution in patients with a previous history of liver problems. Consult your doctor before taking ATYPRIDE LR CAPSULE.
ALLERGY
ContraindicatedDo not take ATYPRIDE LR CAPSULE if you are allergic to Levosulpiride, Rabeprazole, or other proton-pump inhibitors (Ex. pantoprazole, omeprazole, lansoprazole).
LUNGS
Use with CautionATYPRIDE LR CAPSULE should be taken with caution in patients with asthma or other respiratory diseases. Consult your doctor before taking ATYPRIDE LR CAPSULE.
HEART DISEASE
Use with CautionATYPRIDE LR CAPSULE should be taken with caution in patients with heart disease. Consult your doctor before taking ATYPRIDE LR CAPSULE.
USE IN PEDIATRICS
ContraindicatedATYPRIDE LR CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking ATYPRIDE LR CAPSULE.
USE IN GERIATRICS
Use with CautionATYPRIDE LR CAPSULE should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking ATYPRIDE LR CAPSULE. Proper dose adjustments and careful monitoring are required in such patients.
OTHERS
ATYPRIDE LR CAPSULE is strictly 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 ATYPRIDE LR CAPSULE, inform your physician if you:
- have a tumor in the stomach or breast
- have bleeding or perforation the gastrointestinal tract
- have or at risk of developing vitamin-B12 deficiency
- have 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
INTERACTIONS
A. Drug-Drug interactions:
Before taking ATYPRIDE LR CAPSULE 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 graft rejection)
- 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 ATYPRIDE LR CAPSULE, 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 ATYPRIDE LR CAPSULE out of reach of children
- Store ATYPRIDE LR CAPSULE at room temperature
FAQs ABOUT ATYPRIDE LR CAPSULE
Q: When and how should I take ATYPRIDE LR CAPSULE?
A: Take ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE and duration of therapy for you, depending upon your age, body weight and health condition.
Q: Can ATYPRIDE LR CAPSULE be used in children?
A: ATYPRIDE LR CAPSULE 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.)
Q: Can I consume alcohol while taking ATYPRIDE LR CAPSULE?
A: No. Avoid consumption of alcohol while taking ATYPRIDE LR CAPSULE, 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 ATYPRIDE LR CAPSULE.
Q: Can I drive while taking ATYPRIDE LR CAPSULE?
A: ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE
Q: Can prolong use of ATYPRIDE LR CAPSULE cause bone fractures?
A: Yes. Prolonged use of ATYPRIDE LR CAPSULE 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 ATYPRIDE LR CAPSULE. During treatment with ATYPRIDE LR CAPSULE your doctor may monitor to rule out the risk of fractures. Do not take ATYPRIDE LR CAPSULE for a prolonged period without consulting your doctor.
Q: What to do If I forget to take ATYPRIDE LR CAPSULE?
A: You should take ATYPRIDE LR CAPSULE immediately when you remember. If it is time for your next dose of ATYPRIDE LR CAPSULE skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
Q: What are the common side effects of ATYPRIDE LR CAPSULE?
A: The most common side effects of taking ATYPRIDE LR CAPSULE are nausea, vomiting, stomach pain, diarrhea, constipation, infections, cough, sore throat, or headache. Consult your doctor if any of these symptoms 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
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