AEPIO DSR Capsule 10's

INTRODUCTION

AEPIO DSR CAPSULE is a combination of Domperidone and Esomeprazole which belongs to the group of medicines called Prokinetic Drugs and Proton pump inhibitors respectively. It is used in adults to treat peptic ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to secrete more acid).

Peptic ulcers are painful sores that develop on the linings of the stomach, esophagus and/or intestines. It causes severe stomach pain with sensation of flatulence, indigestion, vomiting and fatigue.

AEPIO DSR CAPSULE is effective in treating peptic ulcer caused either due to stomach infection (H. pylori infection) or due to prolong use of non-steroidal anti-inflammatory drugs (such as ibuprofen, Aceclofenac etc.). It can also be used to prevent re-bleeding from the ulcers.

GERD is a chronic digestive disease in which the acid from the stomach 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.

AEPIO DSR CAPSULE acts by reducing the production of gastric acid. It also speeds up the movement of food from the stomach to the intestines, thereby reducing the signs of nausea, vomiting and acid reflux. Due to these actions, it can also reduce the unpleasant signs of GI tract such as nausea, vomiting, indigestion, burping, bloating, acidity or heartburn.

AEPIO DSR CAPSULE should be taken at least 30 minutes before meals. During treatment with AEPIO DSR CAPSULE your doctor will closely monitor your kidney functions, liver functions and blood magnesium levels to avoid the risk of unwanted side effects.

Before taking AEPIO DSR CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones.

AEPIO DSR CAPSULE is not recommended for use in patients having bleeding from the gut. Consult your doctor before taking AEPIO DSR CAPSULE if you are pregnant or breastfeeding. The most common side effects of taking AEPIO DSR CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

USES OF AEPIO DSR CAPSULE

It is used in adults to treat:

• Peptic ulcers
• Gastrointestinal Reflux disease (GERD)
• Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to secrete more acid)
• Nausea and Vomiting
• Acidity, Heartburn, Indigestion, Burping, Bloating

HOW AEPIO DSR CAPSULE WORKS

AEPIO DSR CAPSULE contains two medicines namely domperidone and esomeprazole. Domperidone is a prokinetic medicine with anti-emetic properties. It works by blocking the actions of a chemical messenger called dopamine in the gut and across the brain and spinal cord.

This action stimulates the gut, reduces acid reflux and speeds up the movements of food from the stomach into the intestines. It also blocks the transmission of nerve signals between the vomiting centers and the brain which reduces the onset of nausea and vomiting.

Esomeprazole is a proton pump inhibitor. It reduces gastric acid secretion by the blocking the actions of a protein membrane called H+K+Atpase (proton pump) present in the lining of the stomach.

By reducing stomach acid production, AEPIO DSR CAPSULE prevents the worsening of ulcers, heals the existing ulcers and esophageal lesions and provides relief from the unpleasant symptoms of GI tract (such as acidity, bloating, burping and indigestion).

DIRECTIONS FOR USE

Take AEPIO DSR CAPSULE 30 minutes to 1 hour before meals or as advised by your physician. Swallow the medicine with a glass of water. 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. Do not stop taking AEPIO DSR CAPSULE unless your doctor advice you to stop.

SIDE EFFECTS OF AEPIO DSR CAPSULE

HOW TO MANAGE SIDE EFFECTS

Constipation

Taking AEPIO DSR CAPSULE with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Nausea And Vomiting

Try to take AEPIO DSR CAPSULE with or just after meals. Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

AEPIO DSR CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

BREASTFEEDING

Monitoring required

AEPIO DSR CAPSULE may pass through breast milk. Therefore, it is not recommended for use in breastfeeding women unless considered necessary by the physician.

DRIVING AND USING MACHINES

Use with Caution

AEPIO DSR CAPSULE does not affect your ability in driving or handling heavy tools or machines. However, do not drive or handle heavy tools or machines if your ability is affected by AEPIO DSR CAPSULE.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking AEPIO DSR CAPSULE, as it could aggravate your existing condition.

KIDNEY

Use with Caution

AEPIO DSR CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

Consult your doctor

AEPIO DSR CAPSULE is not recommended for use in patients with moderate or severe liver impairment. It should be used with caution in patients with other mild liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take AEPIO DSR CAPSULE if you are allergic to Domperidone, esomeprazole or to any other proton pump inhibitors (such as rabeprazole, pantoprazole).

HEART DISEASE

Contraindicated

AEPIO DSR CAPSULE is not recommended for use in patients having heart problems (such as prolongation of QT wave, congestive heart failure or arrhythmia). Therefore, consult your doctor before taking it.

USE IN PEDIATRICS

Contraindicated

AEPIO DSR CAPSULE is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. However, consult your doctor before taking it.

USE IN GERIATRICS

Use with Caution

AEPIO DSR CAPSULE should be used with caution in elderly patients (aged 65 years and above). Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking AEPIO DSR CAPSULE inform your doctor if you are taking any of the following medicines such as:

• other medicines used to treat gastrointestinal problems (Ex. cisapride, dolasetron, prucalopride, diphemanil, bepridil, methadone, omeprazole, lansoprazole, rabeprazole, ranitidine, famotidine)
• medicines used to treat arrhythmia or other heart problems (Ex. digoxin, apomorphine, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, diltiazem, or verapamil)
• medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir)
• antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
• antidepressants (used to treat depression) Ex. escitalopram, citalopram, imipramine, St. John’s Wort
• antibiotics (used to treat bacterial infections) Ex. moxifloxacin, erythromycin, levofloxacin, clarithromycin, telithromycin, or amoxicillin
• medicines used to treat malaria (Ex. halofantrine, lumefantrine)
• antihistamines (used to treat allergies) Ex. mizolastine, mequitazine
• medicines used to treat cancer (Ex. toremifene, vandetanib, vincamine, erlotinib, dasatinib, nilotinib)
• methotrexate (used to treat cancer and auto-immune disease)
• tacrolimus (used to prevent graft rejection)
• ketoconazole, itraconazole or voriconazole (used to treat fungal infection)
• rifampicin (used to treat tuberculosis)
• apomorphine (used to treat Parkinson’s disease)
• diazepam (used to treat anxiety)
• phenytoin (used to treat epilepsy)
• cilostazol (used to treat pain in legs)
• warfarin (used for blood thinning)
• clopidogrel (used to treat or prevent blood clots)

B. Drug-Food interaction:

Try to take this medicine before meals to achieve maximum efficacy.

Overdosage:

If you or anyone else accidentally took more AEPIO DSR CAPSULE, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage might include sleepiness, confusion, uncontrollable body movements (including eye and tongue), twisted neck and abnormal posture.

SYNOPSIS

MORE INFORMATION

• Keep AEPIO DSR CAPSULE out of the sight and reach of children
• Store AEPIO DSR CAPSULE at room temperature

FAQs ABOUT AEPIO DSR CAPSULE

Q: What is AEPIO DSR CAPSULE used for?

A: AEPIO DSR CAPSULE is used to treat peptic ulcers, GERD and Zollinger Ellison Syndrome. It can also be used to treat nausea, vomiting, bloating, burping, acidity and heartburn.

Q: How and when to take AEPIO DSR CAPSULE?

A: Take AEPIO DSR CAPSULE at least 30 minutes to 1 hour before meals. Swallow the medicine with a glass of water. Do not cursh 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.

Q: How long should I take AEPIO DSR CAPSULE?

A: You need to take AEPIO DSR CAPSULE for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

Q: What is the best time to take AEPIO DSR CAPSULE?

A: AEPIO DSR CAPSULE must be taken before meals to avoid gastrointestinal side effects.

Q: What to do if I forgot to take a dose of AEPIO DSR CAPSULE?

A: If you forgot to take a dose of AEPIO DSR CAPSULE, take it as soon as you remember. However, if it is time for the next dose of AEPIO DSR CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of AEPIO DSR CAPSULE to compensate the missed ones.

Q: What are the most common side effects of taking AEPIO DSR CAPSULE?

A: The most common side effects of taking AEPIO DSR CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

Q: Can I stop taking AEPIO DSR CAPSULE without consulting your doctor?

A: No. You should not stop taking AEPIO DSR CAPSULE without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using AEPIO DSR CAPSULE, consult your doctor for advice.

Q: Will taking a higher dose of AEPIO DSR CAPSULE be more effective?

A: No, taking a higher dose of AEPIO DSR CAPSULE will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

Q: What precautions do I need to follow while taking AEPIO DSR CAPSULE?

A: Make sure to take AEPIO DSR CAPSULE 30 minutes before meals. Before taking AEPIO DSR CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones. Consult your doctor before taking AEPIO DSR CAPSULE if you are pregnant or breastfeeding. Regularly visit your doctor and take all the blood tests recommended by your doctor without fail.

Q: Can I take medication for high blood pressure along with AEPIO DSR CAPSULE?

A: It is not advisable to take medicines to control blood pressure while taking AEPIO DSR CAPSULE without consulting your doctor as they have known interactions with AEPIO DSR CAPSULE.

Q: Can AEPIO DSR CAPSULE be used in pregnant women?

A: AEPIO DSR CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

Q: How to take AEPIO DSR CAPSULE?

A: You must take AEPIO DSR CAPSULE as advised by your physician. Try to take AEPIO DSR CAPSULE 30 minutes before and swallow it with a glass of water. Do not crush or chew the medicine.

Q: How much AEPIO DSR CAPSULE should I take?

A: AEPIO DSR CAPSULE should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.

Q: Can AEPIO DSR CAPSULE cause constipation?

A: Yes. Constipation is a common side effect of using AEPIO DSR CAPSULE. Eat plenty of fiber rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly when taking this medicine. Contact your doctor if this side effect bothers you.

Q: Can AEPIO DSR CAPSULE cause dry mouth?

A: Yes. Dry mouth is an uncommon side effect of using AEPIO DSR CAPSULE. Contact your doctor if this side effect bothers you.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs & Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 666 & 651-653.

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. D & E. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1232 & 1427-1431.

4. KY Marakhouski, GA Karaseva, DN Ulasivich and Y Kh Marakhouski. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. May 2017. [Accessed on 3rd November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457029/

5. TORRENT PHARMACEUTICALS LTD. IZRA D. Torrentian.com. [Revised in February 2022]. [Accessed on 3rd November 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2977.pdf

6. Cipla Ltd. ESOMAC-D Capsules (Esomeprazole magnesium + Domperidone).  Ciplamed. [Revised in April 2020]. [Accessed on 3rd November 2022] https://www.ciplamed.com/content/esomac-d-capsules

7. Sun Pharmaceutical Industries Europe B.V., and Terapia SA. Electronic Medicines Compendium (EMC). [Revised in July 2022] [Accessed on 3rd November 2022] https://www.medicines.org.uk/emc/files/pil.2326.pdf

8. Vibcare Pharma Pvt Ltd. ESOVIB DSR. [Accessed on 3rd November 2022] https://vibcare.co.in/esomeprazole-domperidone-sr/#!/INDICATION

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 04 Mar 2023 | 12:23 PM(IST)