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INTRODUCTION

ACVOM TABLET is a combination of Domperidone and Omeprazole which belongs to the group of medicines called Prokinetic Drugs and Proton pump inhibitors respectively. It is used to treat peptic ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome (tumours 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.

ACVOM TABLET 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).

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.

ACVOM TABLET 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.

ACVOM TABLET is suitable for use both in adults and in children (aged 12 years or above weighing 35 kg or more). It should be taken at least 15-30 minutes before meals. During treatment with ACVOM TABLET your doctor will closely monitor your kidney functions, liver functions and blood magnesium levels to avoid the risk of unwanted side effects.

Before taking ACVOM TABLET 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.

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

You must also inform your doctor immediately if you experience any abnormal signs such as unusual tiredness, abnormal muscle movements, dizziness, confusion, disorientation, irregular heartbeat, fragile bones, bloody stools or vomits or sudden weight loss.

USES OF ACVOM TABLET

It is used in adults and in children (aged 12 years or older weighing 35 kg or more) to treat:

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

HOW ACVOM TABLET WORKS

ACVOM TABLET contains two medicines namely domperidone and omeprazole. 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 centres and the brain which reduces the onset of nausea and vomiting.

Omeprazole 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, ACVOM TABLET 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 ACVOM TABLET 15-30 minutes 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 ACVOM TABLET unless your doctor advice you to stop.

SIDE EFFECTS OF ACVOM TABLET

COMMON

  • headache
  • diarrhea, stomach pain, constipation, flatulence
  • nausea, vomiting
  • benign polyps in the stomach
  • dry mouth

UNCOMMON

  • low sex drive
  • dizziness, drowsiness
  • anxiety, sleeplessness
  • skin rash or itchiness
  • breast enlargement in both men and in women
  • feeling weak
  • swelling of body parts (oedema)
  • fragile bones (risk of bone fracture)
  • abnormal liver function tests

RARE

  • low WBC or platelet counts in blood
  • signs of low sodium levels in blood (weakness, being sick and cramps)
  • mouth ulcers
  • hair loss
  • fungal infection of the gut (thrush)

Stop taking ACVOM TABLET and inform your doctor immediately if you experience any of the following side effects such as:

  • severe allergic reactions (such as skin rash, itching, swelling of the lips, face or body and difficulty in breathing or swallowing)
  • signs of liver problems (yellowing of the skin and eyes, dark urine and tiredness)
  • severe skin reactions (such as redness, blistering, peeling of skin and bleeding in the lips, eyes, mouth, nose and genitals with fever)
  • chest pain, fast or irregular heartbeat, difficulty in breathing, feeling faint
  • fits
  • uncontrollable body movements (including eye and tongue), twisted neck and abnormal body posture
  • signs of low magnesium levels in blood (such as tiredness, abnormal muscle movements, dizziness, confusion, disorientation, irregular heartbeat)
  • skin rashes on sun exposed areas
  • sudden weight loss, looking pale and weak (anemia)
  • signs of bleeding in the gut (such as bloody vomits/stools)

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try to take ACVOM TABLET with or just after meals. Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea 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.

Dizziness:

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.

Constipation:

Taking ACVOM TABLET 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.

WARNING & PRECAUTIONS

PREGNANCY

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

BREASTFEEDING

ACVOM TABLET may pass through breast milk. Therefore, it should be used in breastfeeding women only if it is considered necessary by the physician. Consult your doctor for advice.

DRIVING AND USING MACHINES

ACVOM TABLET 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 ACVOM TABLET.

ALCOHOL

Avoid consumption of alcohol while taking ACVOM TABLET, as it could aggravate your existing condition.

KIDNEY

ACVOM TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

ACVOM TABLET 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

Do not take ACVOM TABLET if you are allergic to Domperidone, Omeprazole or to any other proton pump inhibitors (such as rabeprazole, pantoprazole).

HEART DISEASE

ACVOM TABLET is not recommended for use in patients with heart problems such as prolongation of QT interval or congestive heart failure. Therefore, consult your doctor before taking it.

OTHERS

ACVOM TABLET is not recommended for use if you:

  • have bloody stools or bleeding in the gut
  • have blockage or tear in the intestines
  • have severe fluid or electrolyte disturbances
  • have prolactinoma (a non-cancerous tumor of pituitary gland)
  • have low blood potassium or magnesium levels
  • have hyperkalemia (high blood potassium levels)

Before taking ACVOM TABLET inform your doctor if you:

  • have osteoporosis
  • have vitamin B12 deficiency (sore tongue, mouth ulcers, pale skin, depression)
  • are going to test Chromogranin A level

Use in pediatrics:

ACVOM TABLET should be used in children and adolescents (aged 12 years or above, weighing 35kg or more). It is not recommended for use in children and adolescents (aged below 12 years). However, consult your doctor before taking it.

Use in geriatrics:

ACVOM TABLET 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 ACVOM TABLET 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)
  • medicines used to treat heart problems or hypertension (Ex. digoxin, apomorphine, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, diltiazem or verapamil)
  • medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir)
  • medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole)
  • medicines used for blood thinning (Ex. warfarin and phenprocoumon)
  • medicines used to treat hepatitis C infection (Ex. telaprevir)
  • antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
  • antidepressants (used to treat depression) Ex. escitalopram or citalopram, fluvoxamine, 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 (a medicine used to treat cancer and auto-immune disease)
  • bepridil (a medicine used to treat hypertension)
  • methadone (a medicine used to relieve pain)
  • diazepam (a medicine used to treat epilepsy, anxiety and to induce sleep)
  • phenytoin (a medicine used to treat epilepsy)
  • cilostazol (a medicine used to treat pain and spasms of calf muscles)
  • clopidogrel (a medicine used to prevent blood clots)
  • tacrolimus or mycophenolate mofetil (used to prevent graft rejection)
  • pentamidine (a medicine used to treat parasite infections)
  • rifampicin (a medicine used to treat tuberculosis)

Overdosage:

If you or anyone else accidentally took more ACVOM TABLET, 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 body posture.

SYNOPSIS

Drug :   Domperidone, Omeprazole
Pharmacological Category :   Dopamine (D2) Receptor antagonists, Proton pump inhibitors
Therapeutic Indication :   Peptic ulcer, GERD, Zollinger Ellison Syndrome, Acidity, Heartburn, Indigestion
Dosage Forms :   Tablet, Capsule

MORE INFORMATION

  • Keep ACVOM TABLET out of the sight and reach of children
  • Store ACVOM TABLET at room temperature

FAQs ABOUT ACVOM TABLET

What is ACVOM TABLET used for?

ACVOM TABLET 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.

How and when to take ACVOM TABLET?

Take ACVOM TABLET at least 15-30 minutes 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.

How long should I take ACVOM TABLET?

You need to take ACVOM TABLET 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

What is the best time to take ACVOM TABLET?

ACVOM TABLET must be taken before meals to avoid gastrointestinal side effects.

What to do if I forgot to take a dose of ACVOM TABLET?

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

What are the most common side effects of taking ACVOM TABLET?

The most common side effects of taking ACVOM TABLET are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

Can I stop taking ACVOM TABLET without consulting your doctor?

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

Will taking a higher dose of ACVOM TABLET be more effective?

No, taking a higher dose of ACVOM TABLET 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.

What precautions do I need to follow while taking ACVOM TABLET?

Make sure to take ACVOM TABLET 30 minutes before meals. Before taking ACVOM TABLET 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 ACVOM TABLET if you are pregnant or breastfeeding. Regularly visit your doctor and take all the blood tests recommended by your doctor without fail.

Can I take medication for high blood pressure along with ACVOM TABLET?

It is not advisable to take medicines to control blood pressure while taking ACVOM TABLET without consulting your doctor as they have known interactions with ACVOM TABLET.

Can ACVOM TABLET be used in pregnant women?

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

How to take ACVOM TABLET?

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

How much ACVOM TABLET should I take?

ACVOM TABLET 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.

Can ACVOM TABLET cause constipation?

Yes. Constipation is a common side effect of using ACVOM TABLET. 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.

Can ACVOM TABLET cause dry mouth?

Yes. Dry mouth is a common side effect of using ACVOM TABLET. 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.

2. Wang, Fengxiu, Xiaoqi Zhang and Jinqiang Wang. Effects of domperidone in combination with omeprazole in the treatment of chronic superficial gastritis. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. March-April 2017. [Accessed on 27th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5432694/

3. Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in March 2021]. [Accessed on 27th October 2022] https://www.medicines.org.uk/emc/files/pil.556.pdf

4. Teva pharma. Omeprazole. [Revised in June 2021] [Accessed on 27th October 2022] https://products.tevauk.com/mediafile/id/51245.pdf

5. Central Drugs Standard Control Organization. Domperidone SR Tablet. [Revised in January 2003]. Omeprazole (20mg) enteric coated + domperidone (30mg) S.R. capsule. [Revised in March 2005]. [Accessed on 27th October 2022] https://cdscoonline.gov.in/CDSCO/Drugs

6. Torrent Pharmaceutical Ltd. DOMSTAL O 10mg, 10mg. [Revised in June 2020]. [Accessed on 27th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1387.pdf

7. Torrent Pharmaceutical Ltd. DOMSTAL PLUS. [Revised in November 2016]. [Accessed on 27th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2521.pdf

8. Torrent Pharmaceutical Ltd. DOMSTAL RD 10, 20mg. [Revised in March 2022]. [Accessed on 27th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/1388.pdf

9. Invision Medi science Pvt Ltd. OMICOOL - DXR Caps. [Accessed on 27th October 2022] http://www.invisionmedi.com/category/omicool-dxr.htm

10. Leeford Healthcare Ltd. Omefol-D. [Accessed on 27th October 2022] https://www.leeford.in/product/23/omefol-d

11. Ikon Remedies. Omepep-RD Tablets. [Accessed on 27th October 2022] https://www.ikonremedies.com/product/omipep-rd-tablets/

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    Country Of Origin
    India
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