ESOZEL-D Capsule

Esomeprazole sodium-ESOZEL-D Capsule

Each hard gelatin capsule contains

  • Esomeprazole sodium equivalent to esomeprazole 40mg.
  • Domperidone HCl SR (as sustained release capsule) 30 mg.

DESCRIPTION

ESOZEL-D is a combination of Esomeprazole (proton-pump inhibitor) and Domperidone (prokinetic agent). Domperidone resembles metoclopramide in its pharmacological actions (ie. Antidopaminergic) in the Gastrointestinal tract. Esomeprazole is classified as a proton-pump inhibitor and is used for treatment of peptic ulcer disease, erosive esophagitis, duodenal ulcers and gastroesophageal reflux. It effectively reduces secretion of acid from the parietal cells of the stomach. Domperidone is a relatively older prokinetic agent used for treatment of gastroesophageal disease, dyspepsia and chronic indigestion. The drug inhibits neurotransmitters that inhibit gastrointestinal motility and consequently improves gastric emptying. As a result, food passes faster into the intestine and thus, there is less acid secreted for the digestive process. Domperidone is also an effective agent for treatment of emesis, nausea, abdominal cramps and bloating. The combination of esomeprazole and Domperidone results in reduction of acid secretion and enhanced gastric motility.

INDICATIONS

ESOZEL-D is indicated for the treatment of gastroesophageal reflux disease, erosive esophagitis, dyspepsia, duodenal and peptic ulcers.

DOSAGE & ADMINISTRATION

The adult oral dose of ESOZEL-D contains 40 mg Esomeprazole and 30 mg Domperidone, taken once a day. The formula is available as a capsule that is taken orally, as directed by the physician. ESOZEL-D can be prescribed for 4-6 weeks and re-evaluation is necessary before extending use. The formula is best taken first thing in the morning with a glass of water. Patients should be advised not to chew or crush ESOZEL-D in the mouth but swallow it whole.

CONTRAINDICATIONS

ESOZEL-D is not recommended in children less than 12 year of age.

Esomeprazole is also contraindicated in patients with known hypersensitivity to proton pump inhibitors.

Domperidone is contraindicated in patients with:

  • Moderate or severe liver impairment.
  • Known prolongation of cardiac conduction intervals, particularly Qtc
  • Significant electrolyte disturbances
  • Underlying cardiac disorders like congestive heart failure
  • Prolactin-releasing pituitary tumor (prolactinoma)
  • Known hypersensitivity to Domperidone or any of the excipients.
  • Kidney impairment

In addition, Domperidone should not be co-administered with other QT prolonging medications (eg., antipsychotics, Type 1C and class 3 antiarrhythmics, and other potent CY3A4 inhibitors).

Domperidone should not be administered to patients in situations where enhance intestinal motility could be harmful: eg in patients with gastrointestinal bleeding, bowel perforation of bowel obstruction.

Domperidone should not be prescribed to patients with Parkinson disease as it may worsen the symptoms because of its antidopaminergic effects.

ESOZEL-D is not indicated in any patient with allergy to Esomeprazole or Domperidone or any other constituents used to make the formula.

PRECAUTIONS

Caution should be exercised when ESOZEL-D is prescribed to patients with a history of liver and kidney disease, and other gastrointestinal disorders like food poisoning, diarrhea, and inflammatory bowel disease.

Long term use of ESOZEL-D may be associated with electrolyte changes and hence, if the treatment is prolonged, blood work should be obtained.

Prolonged used of ESOZEL-D is not recommended without evaluating renal and liver function every 4-6 weeks.

ESOZEL-D should be stored at room temperature and away from the reach of children.

ESOZEL-D may interact with other medications. Hence, it is important to obtain a complete drug and herbal usage history from patients before prescribing the formula.

ADVERSE EFFECTS

Most frequent side effects of ESOZEL-D include a mild headache, nausea, diarrhea, insomnia, hot flashes, dry mouth and flatulence. Other rare side effects include tremor, abdominal cramps and itching. These adverse effects are transient and usually disappear with in the first 5-7 days. Patients should be advised that if the side effects include chest pain, irregular or fast heart beat, swelling of the ankles, then they should discontinue the medication and seek immediate medical assistance. In most cases, a change in dose or the medication will be beneficial.

PREGNANCY & LACTATON

The effects of these agents on the newborn have not yet been determined and to be on the safe side, it should be avoided in this population.

PRESENTATION

ESOZEL-D Capsules are available in a 10X10ís Alu Alu pack

The medical information on this site is provided as an information resource only, and is not to be used or relied on for any diagnostic or treatment purposes. This information is not intended to be patient education, does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment. Please note it is dangerous to take any medication without doctorís prescription or professional advice from a registered health practitioner. Always follow the instructions of physician / doctor / registered medical practitioner before using any medicine. Do not exceed the recommended dosage. Keep all medicines away from your children. Store as recommended. Please consult your health care provider, before making any healthcare decisions or for guidance about a specific medical condition. The allopathic medicine as per the law in India must be sold by retail pharmacies holding valid trading drug license only.

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