Medicine Information

Gutset

Name: Gutset
Brand: Gutset
Rating: 4.5 (117 reviews)

Pediatric Drop5 mg/mLProkinetic, AntiemeticATC: A03FA03

Generic Name

Domperidone

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
gutset 5 mg pediatric drop	৳ 25.00	N/A

Description

Overview of the medicine

Domperidone is an antiemetic and prokinetic agent used to treat nausea, vomiting, and gastrointestinal motility disorders, particularly in infants and children. It helps to increase the movement or contractions of the stomach and bowels.

Uses & Indications

For the relief of symptoms of nausea and vomiting.

For the treatment of dyspepsia associated with delayed gastric emptying, gastro-oesophageal reflux disease, and oesophagitis.

To prevent nausea and vomiting induced by dopamine agonist drugs (e.g., in Parkinson's disease).

Dosage

Adults

Not typically recommended as pediatric drop for adults; for adults, the usual dose for other formulations is 10 mg up to three times daily.

Elderly

Not typically recommended as pediatric drop for elderly; dose adjustment may be necessary for elderly patients using other formulations due to reduced renal function.

Renal_impairment

In severe renal impairment (CrCl <30 mL/min), frequency of dosing for other formulations should be reduced to once or twice daily. Consult physician for pediatric use in such cases.

How to Take

Administer orally using the provided calibrated dropper. Give 15-30 minutes before meals. Do not exceed the prescribed dose.

Mechanism of Action

Domperidone acts as a dopamine D2-receptor antagonist, primarily in the chemoreceptor trigger zone (CTZ) and peripherally in the gastrointestinal tract. By blocking dopamine receptors, it prevents nausea and vomiting and enhances gastrointestinal motility. It minimally crosses the blood-brain barrier.

Pharmacokinetics

Onset

30-60 minutes (antiemetic effect)

Excretion

Approximately 66% excreted in feces (unchanged and metabolites) and 33% in urine (mainly metabolites).

Half life

7-9 hours

Absorption

Rapidly absorbed after oral administration; peak plasma levels reached within 30-60 minutes. Bioavailability is low (about 15%) due to extensive first-pass metabolism.

Metabolism

Extensively metabolized in the liver by N-dealkylation and oxidative hydroxylation, primarily by CYP3A4.

Side Effects

Contraindications

Hypersensitivity to Domperidone or any component of the formulation.
Patients with prolactin-releasing pituitary tumor (prolactinoma).
Patients with moderate to severe hepatic impairment.
Patients with known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure.
Co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin).
In children under 1 month of age.

Drug Interactions

Anticholinergics

May antagonize the prokinetic effect of domperidone.

Antacids/H2-receptor blockers

May reduce the oral bioavailability of domperidone; administer domperidone before these medications.

Dopamine agonists (e.g., bromocriptine, levodopa)

Domperidone may increase their plasma levels, potentially reducing their efficacy if used for Parkinson's disease.

Potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)

Increased plasma levels of domperidone, increased risk of QTc prolongation. Contraindicated.

Storage

Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.

Overdose

Symptoms may include somnolence, disorientation, extrapyramidal reactions, and hypotension. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered within an hour of ingestion. ECG monitoring is recommended due to potential cardiac effects.

Pregnancy & Lactation

Pregnancy: Limited data from post-marketing surveillance. Should only be used if the potential benefits outweigh the potential risks to the fetus. Lactation: Domperidone is excreted in small amounts in breast milk. A risk to the breast-fed infant cannot be excluded. The decision should be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

15 mL drop bottle30 mL drop bottle

Shelf Life

24 months from manufacturing date when stored correctly.

Availability

Pharmacies nationwide

Approval Status

Approved by DGDA (Bangladesh)

Patent Status

Off-patent

Clinical Trials

Ongoing studies continue to evaluate the long-term cardiac safety profile of Domperidone in specific populations, especially pediatric patients. Some studies focus on comparing efficacy and safety across different age groups and indications.

Lab Monitoring

Monitor ECG in patients with pre-existing cardiac conditions or those at risk of QTc prolongation.
Monitor for electrolyte imbalances.
Monitor prolactin levels in patients experiencing hyperprolactinemia symptoms.

Doctor Notes

Careful dose calculation based on child's weight and age is crucial to ensure efficacy and avoid adverse effects, especially extrapyramidal symptoms and cardiac events.
Advise parents about potential cardiac risks and symptoms to watch for (e.g., fainting, palpitations, seizures) and to seek immediate medical attention if these occur.
Thoroughly assess for contraindications, especially cardiac conditions and concomitant use of potent CYP3A4 inhibitors, before prescribing.
Re-evaluate the need for continued treatment frequently; limit duration to the shortest necessary.

Patient Guidelines

Always use the provided calibrated dropper for accurate dosing. Do not use household spoons.
Administer the drop 15-30 minutes before meals for best results.
Inform your doctor immediately if the child develops any unusual symptoms like abnormal heartbeats, involuntary movements, or seizures.
Do not share this medicine with others, even if they have similar symptoms.

Missed Dose Advice

If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.

Driving Precautions

Domperidone may cause dizziness or somnolence. Patients (or parents of older children who might drive/operate machinery) should be advised to exercise caution when driving or operating machinery until they are reasonably certain that Gutset does not adversely affect their ability. Pediatric drops are for infants/young children, so direct driving advice is not applicable to the user, but care providers should be aware.

Lifestyle Advice

Encourage frequent, smaller meals instead of large ones to reduce digestive burden.
Avoid trigger foods that worsen reflux or dyspepsia (e.g., fatty foods, spicy foods, caffeine).
Ensure the child is kept upright for some time after feeding if reflux is an issue.