SOMGRAM D Capsule

SOMGRAM-D

Esomeprazole Magnesium 40 mg + Domperidone 30 mg Sustained Release Capsules

SOMGRAM-D is a prescription medicine containing Esomeprazole Magnesium equivalent to Esomeprazole 40 mg in enteric-coated pellets and Domperidone 30 mg in sustained-release . The formulation combines an acid-suppressing medicine with a gastrointestinal prokinetic/antiemetic agent and should be used only under the direction of a qualified healthcare professional.

Composition

Each hard gelatin capsule contains:

• Esomeprazole Magnesium IP equivalent to Esomeprazole 40 mg
  As enteric-coated pellets
• Domperidone IP 30 mg
  As sustained-release pellets
• Excipients: q.s.
• Approved colours used in the capsule shell and pellets.

Dosage: As directed by the physician.

What is SOMGRAM-D?

SOMGRAM-D is a combination capsule for potential suppression of gastric acid secretion along with control of GI symptoms linked  with nausea & vomiting.

Esomeprazole is a  proton pump inhibitors (PPIs). It reduces the production of gastric acid by inhibiting  proton pump which secrete acid .

Domperidone is a dopamine receptor antagonist that has antiemetic and gastrointestinal prokinetic properties. It can help reduce nausea and vomiting and promote coordinated gastrointestinal motility. Because domperidone has important cardiovascular safety considerations, it should be prescribed at an appropriate dose and for an appropriate duration after assessment of the individual patient.

How Does SOMGRAM-D Work?

Esomeprazole

Esomeprazole is the S-isomer of omeprazole and belongs to the proton pump inhibitor class. Following activation in the acidic environment of the gastric parietal cell, it inhibits the H+/K+-ATPase proton pump, thereby reducing both basal and stimulated gastric acid secretion.

By reducing gastric acidity, esomeprazole can help provide relief in acid-related gastrointestinal conditions and allows healing of acid-related mucosal injury when prescribed appropriately.

The enteric-coated pellet formulation is designed to protect the active ingredient from degradation by gastric acid and facilitate delivery to the appropriate site for absorption.

Domperidone

Domperidone primarily acts as a peripheral dopamine D2-receptor antagonist. It has antiemetic activity and can influence upper gastrointestinal motility. Its use requires appropriate clinical judgment because domperidone has been associated with QT-interval prolongation and potentially serious cardiac arrhythmias, particularly in patients with certain cardiac risk factors, higher doses, or interacting medicines. European Medicines Agency (EMA)

Uses and Therapeutic Role

SOMGRAM-D may be prescribed by a physician when acid suppression with esomeprazole is clinically indicated and treatment with domperidone is considered appropriate.

Depending on the patient’s diagnosis, symptoms and clinical assessment, esomeprazole may be used in the management of conditions such as:

• Gastroesophageal reflux disease (GERD)
• Acid-related heartburn and reflux symptoms
• Erosive esophagitis
• Acid-related dyspeptic symptoms
• Gastric and duodenal acid-related disorders
• Other conditions requiring proton pump inhibitor therapy, as determined by the physician

Domperidone may be prescribed for the relief of nausea and vomiting in appropriate patients. Regulatory safety reviews have emphasized that domperidone should be used at the lowest effective dose for the shortest appropriate duration. European Medicines Agency (EMA)

SOMGRAM-D should not be considered a self-medication product. The indication, suitability and duration of treatment should be determined by the treating physician.

Key Features of SOMGRAM-D

1. Potent acid suppression

Esomeprazole 40 mg provides proton pump inhibition and reduces gastric acid secretion.

2. Enteric-coated pellet technology

Esomeprazole is provided as enteric-coated pellets to protect the active ingredient from gastric acid and support appropriate drug delivery.

3. Sustained-release domperidone

Domperidone is incorporated as sustained-release pellets, providing the prescribed formulation characteristics.

4. Prescription-based therapy

The combination is intended for use under medical supervision, particularly because domperidone requires careful consideration of cardiovascular risks and drug interactions.

Dosage and Administration

SOMGRAM-D should be taken strictly according to the dosage and duration prescribed by the physician.

The capsule should be swallowed whole with water. Do not chew, crush or open the capsule, as doing so may interfere with the intended release characteristics of the pellets.

The timing of administration should follow the prescribing physician’s instructions.

Do not increase the dose, reduce the dose or extend the duration of treatment without medical advice.

Important Safety Information

SOMGRAM-D is a prescription medicine and is not suitable for everyone.

Before starting treatment, inform your doctor if you have:

• A history of heart rhythm abnormalities or prolonged QT interval
• Heart disease or congestive heart failure
• Significant electrolyte disturbances
• Liver impairment
• Severe kidney impairment
• Previous allergy or hypersensitivity to esomeprazole, other PPIs, domperidone or any component of the formulation
• A history of gastrointestinal bleeding or other significant gastrointestinal disease

Domperidone has been associated with QT-interval prolongation, ventricular arrhythmias and, rarely, sudden cardiac death. The risk may be higher in susceptible patients, older individuals, patients receiving higher doses, and those taking medicines that prolong the QT interval or strongly inhibit CYP3A4. European Medicines Agency (EMA)

Patients taking other prescription or non-prescription medicines should inform their doctor before starting SOMGRAM-D because clinically significant drug interactions may occur.

Kidney-Related Precaution

Acute kidney injury has been reported as an adverse drug reaction with proton pump inhibitor therapy. Patients should seek medical attention if they develop unexplained changes in urination, swelling, unusual fatigue or other symptoms suggestive of kidney problems.

Patients with existing kidney impairment should use SOMGRAM-D only under appropriate medical supervision.

Possible Side Effects

Like all medicines, SOMGRAM-D may cause side effects, although not everybody experiences them.

Possible adverse effects associated with esomeprazole may include:

• Headache
• Abdominal discomfort
• Diarrhoea or constipation
• Nausea
• Flatulence

Domperidone may cause:

• Dry mouth
• Headache
• Abdominal discomfort
• Diarrhoea
• Other gastrointestinal symptoms

Rare but potentially serious cardiac effects associated with domperidone require immediate medical attention. Seek urgent medical care if symptoms such as palpitations, fainting, severe dizziness or an unusually rapid or irregular heartbeat occur. European Medicines Agency (EMA)

Drug Interactions

Tell your doctor about all medicines you are currently taking.

Particular attention is required with medicines that:

• Prolong the QT interval
• Increase domperidone exposure through CYP3A4 inhibition
• Affect electrolyte balance
• Interact with esomeprazole metabolism or gastric acid suppression

The concomitant use of domperidone with certain QT-prolonging medicines and potent CYP3A4 inhibitors is contraindicated in relevant regulatory guidance. European Medicines Agency (EMA)

Do not start or stop any medication without consulting your healthcare professional.

Pregnancy and Breastfeeding

If you are pregnant, planning pregnancy or breastfeeding, inform your doctor before using SOMGRAM-D.

The medicine should be used during pregnancy or lactation only when specifically prescribed by a qualified healthcare professional after assessment of the potential benefits and risks.

Use in Children

SOMGRAM-D 40 mg/30 mg is a prescription formulation intended for use according to the physician’s clinical judgment. The safety and appropriateness of this particular strength and combination should be determined individually, particularly in paediatric patients.

Do not administer this medicine to children unless specifically prescribed by a doctor.

Storage

• Store in a cool and dry place.
• Protect from light.
• Keep the capsules in their original packaging until use.
• Keep out of reach of children.
• Do not use the medicine after the expiry date printed on the pack.

Frequently Asked Questions

What is SOMGRAM-D used for?

SOMGRAM-D contains esomeprazole and domperidone. It may be prescribed when acid suppression is required and when the physician considers domperidone appropriate for associated nausea/vomiting symptoms.

Can SOMGRAM-D be taken without a prescription?

No. SOMGRAM-D is a prescription medicine and should be taken only on the advice of a registered medical practitioner.

Can the capsule be opened or chewed?

No. The capsule should be swallowed whole unless your physician or pharmacist specifically advises otherwise.

Can SOMGRAM-D be used for long-term treatment?

The duration of treatment should be determined by the physician. Long-term acid-suppressive therapy should be periodically reviewed, while domperidone requires particular attention to dose, duration and cardiovascular risk. European Medicines Agency (EMA)

What should I do if I miss a dose?

Take the missed dose when remembered unless it is close to the next scheduled dose. Do not double the dose. Follow your physician’s specific instructions.

Important Disclaimer

SOMGRAM-D is a prescription medicine. The information provided on this website is intended for general educational and informational purposes and should not replace professional medical advice, diagnosis or treatment. The medicine should be used only under the supervision of a qualified healthcare professional.

Do not self-medicate or alter the prescribed dose or duration of treatment. Patients should inform their doctor about existing medical conditions and all medicines being taken before starting therapy.

For Healthcare Professionals: Please refer to the approved prescribing information and applicable local regulatory requirements before prescribing SOMGRAM-D.

Schedule H Prescription Drug — Caution: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

Disclaimer: The information provided on this website by Ingram Biosciences Private Limited is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. All medicines should be used strictly as per the advice of a qualified healthcare professional and applicable prescribing information. Product information is subject to change in accordance with applicable regulatory requirements. The Company endeavours to ensure accuracy but does not warrant that all information is complete or error-free. To the extent permitted by applicable law, the Company shall not be liable for any loss arising from misuse or unauthorised reliance on website information. Nothing in this disclaimer excludes any liability or rights that cannot legally be excluded or limited under applicable Indian law. For medical advice or product-related concerns, please consult a qualified healthcare professional or contact the Company through its official channels.