Medication info
Sama Domperidone Maleate Tablets

Sama Domperidone Maleate Tablets

Prescription medicationTabletOral
Ingredient · strength
Domperidone Maleate›12.72mg / 1 tablet
Manufacturer / importer
Sama Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
1000 tablets (bottle)
Approval status
Active

MFDS item code 201400453 · Approved 2014.01.29

Summary

Main use
Relief of nausea and vomiting
Who takes it
Adults · Children
Adult dose
Adults: Administer domperidone 10mg (5mg when levodopa is administered) orally 3 times daily before meals. The maximum daily dose is 30mg. In general, use should not exceed 1 week.
Child dose
Adolescents (12 years or older, 35kg or more): Administer domperidone 10mg (5mg when levodopa is administered) orally 3 times daily before meals. The maximum daily dose is 30mg.

Ingredients

Manufacturer
Sama Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of nausea and vomiting

  • Nausea
  • vomiting symptoms
View approved original text

This medication is used to relieve nausea and vomiting symptoms.

How to take

Adult dose

Adults: Administer domperidone 10mg (5mg when levodopa is administered) orally 3 times daily before meals. The maximum daily dose is 30mg. In general, use should not exceed 1 week.

Child dose

Adolescents (12 years or older, 35kg or more): Administer domperidone 10mg (5mg when levodopa is administered) orally 3 times daily before meals. The maximum daily dose is 30mg.

Precautions

This drug is contraindicated in certain patients. For example, it should not be administered to patients with allergies to this drug's components or those with gastrointestinal bleeding, mechanical obstruction, or perforation. It should also not be given to patients with prolactin-secreting tumors, certain heart conditions, liver dysfunction, or pregnant women. Patients with lactose intolerance or galactose absorption disorders should avoid taking this medication. The use of this drug should be cautious in children, patients with impaired kidney or liver function, the elderly, and patients with a history of heart disease. Especially, the elderly may require dose adjustments due to diminished bodily functions. While taking this medication, side effects such as indigestion, dry mouth, drowsiness, headache, and diarrhea may occur, and in rare cases, cardiac arrhythmias or allergic reactions may also happen. This drug can prolong cardiac conduction intervals, thus caution is needed for patients with heart diseases or electrolyte imbalances. Since this medication is primarily metabolized in the liver, patients with impaired liver function should adjust the dosage or be monitored carefully. Patients with severely impaired kidney function should reduce the frequency and amount of medication, and regular monitoring is necessary. This drug may cause drowsiness and dizziness, so it is advisable to avoid driving or operating machinery after taking it. There are many drug interactions, so it's essential to consult a doctor or pharmacist before concomitant use with other medications. Particularly, caution is needed when taken with drugs metabolized in the liver or those affecting the heart. Women who are pregnant or may become pregnant should not take this medication, and breastfeeding mothers should consult a doctor as it may affect the baby. In case of overdose, symptoms such as neurological abnormalities, seizures, and confusion may appear, requiring ECG monitoring and urgent medical treatment. Particular care should be taken when administering this medication to children, and it is not suitable for children under 35 kg. Finally, this medication should be stored out of reach of children and kept in the original container. Also, caution is needed as it may discolor when stored with certain drugs.

Side effects

  • Dyspepsia
  • gastroesophageal reflux disease
  • irritable bowel syndrome
  • nausea
  • vomiting
  • dry mouth
  • loss of libido
  • anxiety
  • drowsiness
  • headache
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  • diarrhea
  • rash
  • itching
  • galactorrhea
  • breast pain
  • breast tenderness
  • asthenia
  • restlessness
  • breast discharge
  • gynecomastia
  • breast swelling
  • breast engorgement
  • depression
  • hypersensitivity
  • lactation disorder
  • irregular menstruation
  • anaphylactic reaction
  • agitation
  • irritability
  • dizziness
  • extrapyramidal disorder
  • seizures
  • oculomotor seizures
  • ventricular arrhythmias
  • acute cardiac death
  • Torsades de Pointes
  • prolonged QTc
  • vascular edema
  • urticaria
  • urinary retention
  • male gynecomastia
  • amenorrhea
  • abnormal liver function tests
  • increased serum prolactin
  • edema
  • confusion
  • altered consciousness
  • spatial disorientation
  • Parkinsonism

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air exposure and is best kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain drug effectiveness and prevent degradation.

Appearance and packaging

Appearance

White round tablet

Package unit

1000 tablets (bottle)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.