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Best Price*  ₹ 54.00
MRP ₹67.50
(Inclusive of all taxes) *10 Capsule(s) in a Strip * Mkt: Sashwat Pharmaceuticals Pvt Ltd * Country of Origin: India * Delivery charges if applicable will be applied at checkout



INTRODUCTION

BRAZOL DSR is a combination of Domperidone and Rabeprazole which belongs to the group of medicines called Dopamine Antagonists and Proton pump inhibitors respectively. BRAZOL DSR is used to treat Gastro-Esophageal Reflux Disease (GERD) among patients who have not responded adequately to rabeprazole alone. 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. BRAZOL DSR can also be used to treat peptic ulcers caused by H. pylori infection or NSAIDs 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.

Domperidone is a dopamine antagonist which 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 which inhibits gastric acid secretions, thus resulting in rapid symptom relief followed by healing of ulcers and inflammatory lesions in the stomach and in the esophagus. Along treatment with BRAZOL DSR, try to eat less spicy foods, and drink plenty of water or fluids. Avoid smoking or alcohol consumption as it may aggravate your existing condition.

Patients receiving long-term treatment with BRAZOL DSR should be kept on regular surveillance to rule out the risk of hypomagnesaemia (decreased magnesium levels in blood) and bone fracture, predominantly in the elderly patients and in patients with other recognized risk factors. Before taking BRAZOL DSR inform your doctor if you have any liver, kidney, or heart problems. Your doctor may reduce the dose or suggest an alternative therapy.

BRAZOL DSR is not recommended for use in pregnant or breastfeeding women and in children (aged less than 18 years). Consult your doctor for advice before taking. It should be used with caution in elderly patients (above 65 years of age). The most common side effects of taking BRAZOL DSR are nausea, vomiting, stomach pain, diarrhea, or constipation. Consult your doctor if any of these symptoms worsen.  

USES OF BRAZOL DSR

  • Treats peptic ulcer
  • Treats Gastro-Esophageal Reflux Disease (GERD) (not responding to therapy with rabeprazole alone)

HOW BRAZOL DSR WORKS

BRAZOL DSR reduces stomach ulcers and acid reflux, where rabeprazole acts by inhibiting the secretions of stomach acid and domperidone acts by increasing bowel movements and facilitating gastric emptying, thus leading to rapid symptom relief and healing of stomach ulcers and esophageal lesions.

DIRECTIONS FOR USE

Take BRAZOL DSR as advised by your physician. Swallow BRAZOL DSR with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF BRAZOL DSR

COMMON

  • nausea or vomiting
  • diarrhea, constipation, stomach pain, flatulence
  • cough, sore throat, runny nose
  • back pain
  • weakness or loss of strength
  • flu like symptoms
  • sleeplessness
  • headache, dizziness
  • infection
  • dry mouth
  • benign polyps in the stomach

UNCOMMON

  • nervousness
  • sleepiness
  • bronchitis (inflammation of the bronchus)
  • sinusitis (inflammation of the sinus)
  • indigestion, belching in the stomach (excess air accumulation in the stomach)
  • muscle pain, leg pain, joint pain
  • fracture of hip, wrist, or spine
  • urinary tract infection
  • chest pain
  • chills, fever
  • decreased libido
  • anxiety
  • itching
  • breast pain or tenderness
  • galactorrhea (milk discharge from the breast)

RARE

  • changes in white blood cells
  • signs of low platelet count in blood (easy bruising or bleeding)
  • hypersensitivity (swelling of the face, eyelids, mouth, tongue, or throat, decreases in blood pressure, difficulty in breathing)
  • loss of appetite
  • anorexia (an eating disorder)
  • depression
  • visual disturbance
  • gastritis (inflammation of the stomach lining)
  • stomatitis (sore mouth)
  • sweating
  • taste disturbance
  • hepatitis (inflammation of the liver caused by viral infection)
  • jaundice (yellowing of the skin and whites of the eyes)
  • hepatic encephalopathy (brain damage caused by liver infection)
  • bullous reactions (severe skin reactions with fluid filled blisters)
  • interstitial nephritis (inflammation of the kidneys)
  • weight gain

Stop taking BRAZOL DSR and contact your doctor immediately if you experience the following side effects:

  • severe allergic reaction (sudden wheezing, swelling of lips, face or body, rash, fainting, or difficulties swallowing)
  • symptoms of liver problems (yellow skin, dark urine and tiredness)
  • severe skin reactions such as erythema multiforme, stevens-johnson syndrome or toxic epidermal necrolysis (reddening of skin with blisters or peeling and may be associated with a high fever and joint pains, also severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals)
  • seizures
  • involuntary movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm
  • heart rhythm disorders (rapid or irregular heartbeat)

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

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

BRAZOL DSR is not recommended for use during pregnancy. Consult your doctor before taking BRAZOL DSR.

BREASTFEEDING

BRAZOL DSR is not recommended for use in breast-feeding women. Consult your doctor before taking BRAZOL DSR.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience sleepiness, confusion or less control over your movements. Consult your doctor before taking BRAZOL DSR.

ALCOHOL

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

KIDNEY

BRAZOL DSR is not recommended for use in patients with kidney impairment. Consult your doctor before taking BRAZOL DSR.

LIVER

BRAZOL DSR is not recommended for use in patients with moderate or severe liver impairment and it should be used with caution in patients with liver problems. Consult your doctor before taking BRAZOL DSR.

ALLERGY

Do not take BRAZOL DSR if you are allergic to Domperidone or Rabeprazole.

HEART DISEASE

BRAZOL DSR is not recommended for use in patients with heart problems such as prolongation of QT interval or congestive heart failure. Consult your doctor before taking BRAZOL DSR.

OTHERS

BRAZOL DSR 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 phenylketonuria (a metabolic disorder)
  • have problem that causes low levels of potassium or magnesium or high levels of potassium in the blood
  • have hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Before taking BRAZOL DSR, inform your physician 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:

BRAZOL DSR is not recommended for use in children and adolescents (aged less than 18 years) due to lack of safety and effectiveness. Consult your doctor for advice.

Use in geriatrics:

BRAZOL DSR should be taken with caution in elderly patients (aged 65 years or above). Consult your doctor before taking BRAZOL DSR.

INTERACTIONS

A. Drug-Drug interactions:

Before taking BRAZOL DSR inform to your doctor, if you are taking any of these medicines:

  • 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 hepatitis C (Ex. telaprevir)
  • antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
  • antidepressants (used to treat depression) Ex. escitalopram or citalopram
  • 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)
  • bepridil (used to treat hypertension)
  • methadone (used to relieve pain)
  • iron salts (used to treat iron deficiency anemia)
  • tacrolimus or mycophenolate mofetil (used to prevent graft rejection)
  • ketoconazole and itraconazole (used to treat fungal infection)
  • pentamidine (used to treat parasite infections)
  • warfarin (used to treat and prevent clots)

Overdosage:

If you or anyone else take too much of BRAZOL DSR, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of BRAZOL DSR might include altered consciousness, agitation, convulsions, disorientation, sleepiness, and extrapyramidal reactions (such as rigidity, tremor, drooling etc).

SYNOPSIS

Drug :  

Domperidone, Rabeprazole

Pharmacological Category :  

Dopamine antagonist, Proton pump inhibitor

Therapeutic Indication :  

Peptic ulcer, GERD

Dosage Forms :  

Tablet, Capsule

MORE INFORMATION

  • Keep BRAZOL DSR out of reach of children
  • Store BRAZOL DSR at room temperature

FAQs ABOUT BRAZOL DSR

Can BRAZOL DSR cause diarrhoea?

Yes. BRAZOL DSR can cause diarrhea in some individuals. Keep yourself hydrated by drinking plenty of fluids, oral electrolytes, and juices. Do not self-treat diarrhea if it persists for a longer period. Contact your doctor for advice.

Can BRAZOL DSR cause acid reflux?

No. BRAZOL DSR is used to treat Gastro-Esophageal Reflux Disease (GERD) and does not cause acid reflux. If you experience any unusual symptoms after taking BRAZOL DSR, kindly consult your doctor. 

Can BRAZOL DSR cause kidney damage?

BRAZOL DSR may rarely cause damage to your kidneys (Ex. interstitial nephritis). However, inform your doctor immediately if you experience any signs of kidney damage such as dark urine, blood in urine, painful urination, or lower abdominal discomfort during treatment with BRAZOL DSR. Your doctor might reduce the dose or suggest an alternative therapy.

When and how should I take BRAZOL DSR?

Take BRAZOL DSR 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 BRAZOL DSR and duration of therapy for you, depending upon your age, body weight and health condition.

Can BRAZOL DSR be used in children?

No. BRAZOL DSR is not recommended for use in children and adolescents (below 18 years) due to lack of safety and effectiveness. Kindly consult child’s doctor if your child experiences any symptoms of gastro-esophageal reflux disease or peptic ulcer (such as nausea, vomiting, discomfort in upper stomach, stomach pain, heartburn, burping, etc).

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 & 1317-1320.

3. Gerald G. Briggs and Roger K. Freeman. D. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1232 & -3337.

4. Janssen Research & Development, LLC. A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in Newborn Infants with Gastroesophageal Reflux Disease (GERD). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2013] [Accessed on 1st October 2021] https://clinicaltrials.gov/ct2/show/NCT00855361

5. Savita Shahani, Prabha Sawant, Pareen Dabholkar. Rabeprazole plus domperidone: the answer for gastro-esophageal reflux disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 2008. [Accessed on 1st October 2021] https://pubmed.ncbi.nlm.nih.gov/18828350/

6. K Semmanaselvan, Qayum I Mukaddam, Manoj Naik. An Open Label, Prospective, Single Centre Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Rabeprazole (Enteric-Coated, EC) 20 mg + Domperidone (Sustained Release, SR) 30 mg Capsule in Treatment of Patients with Laryngopharyngeal Reflux Disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2015. [Accessed on 1st October 2021] https://pubmed.ncbi.nlm.nih.gov/26731824/

7. Cipla Ltd. RABICIP D Capsules (Rabeprazole sodium + Domperidone). Ciplamed.com. [Revised in January 2020] [Accessed on 1st October 2021] https://www.ciplamed.com/content/rabicip-d-capsules

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    Hsn Code
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