MARADON Tablet

Indications:

Functional disorder in gastrointestinal system, such as nausea, vomit, poor appetite, abdominal inflation, epigastric discomfort, stomachache, heartburn, belching, etc., by the illnesses and drugs as below.

• Adult: chronic inflammation of the stomach, gastroptosis, reflux esophagitis, postgastrectomy syndrome, anti­malignant tumor drug or levodopa.

• Infant: periotic vomiting, infection of the upper respiratory tract, anti-malignant tumor drug.

Dosage and administration:

Adults: Oral dosage is 10-20mg (L-Dopa administration: 5-10mg) three times a day before meals.

Children: Divided dosage is 1-2 mg/kg, three times a day before meals. Total daily dose should not exceed 30mg.

The dosage can be adjusted by age and severity of symptoms.

MALADON tablet is contraindicated in these patients.

1. Patients with intolerance to this drug.

2. Patients with gastrointestinal blooding, mechanical ileus or perforation.

3. Patients with prolactinoma.

4. Patients using oral ketoconazole.

1. Shock: shock, anaphylactoid symptoms (exanthema, flare, dyspnea, facial edema, pachycheilia etc.)

2. Endocrine system: rise of prolactin, gynecomastia, mamma distention, delacrimation etc.

3. Extrapyramidal system: oculogyric crisis, extension of upper limb

4. Digestive system: diarrhea, coprostasis, gastralgia, abdominal compression, hydrodipsomania, heartburn, sector, emesis, pot belly, transient visceral convulsion.

5. Circulatory system: Palpitation

6. Psychiatric and nervous systems: conscious disorders, convulsion

7. Skin: urticaria, exanthem

8. Others: diaphoresis, drowsiness, perturbation, hydrodipsomania.

1. The concomitant administration of following medicines may reveal pathocrine or extrapyramidal symptoms. Therefore, it is required that enough watch and careful administration: Phenothiazines (prochlorperazine, chlorpromazine, thiethylperazine etc.), Butyrophenone (haloperidol etc.), rauvolfia alkaloids (reserpine etc.)

2. The concomitant administration of digitalis agent may hiding the symptomatic vomiting, emesis, inappetence. Therefore, it Is required that enough watch and careful administration to the patients in dosage of digitalis agent.

3. The concomitant administration of anticholinergic drugs may compromise the beneficial effects of domperidone.

4. Domperidone has gastro-kinetic effects It could influence the absorption of concomitantly orally administered medicine, particularly those of sustained release or enteric-coated formulation. However, in patients already stabilized on digoxin, paracetamol or haloperidol, concomitant administration of domperidone did not influence the blood levels of these medicines.

5. Domperidone did not influence the effect of neuroleptic.

6. Domperidone suppresses the peripheral effects (digestive disorders, nausea and vomiting) of dopaminergic agonists.

7. Antacid and antisecretory agents should not be given simultaneously with domperidone because they lower its bioavailability.

8. Opiates and antimuscarinics may antagonise the action of domperidone in the intestinal tract and vice versa.

9. The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of this drug and CYP3A4 inhibitor may result in increased plasma levels of domperidone. Examples of CYP3A4 inhibitor include: azole antifungals, macrolide antibiotics, HIV protease inhibitor and nefazodone.

Pregnancy:

Domperidone given to animals at doses up to 60 mg/kg/day did not produce teratogenic effects. There are no adequate and well-controlled studies or Domperidone in pregnant women. The potential risk for humans is unknown. Therefore, maradon should only be used during pregnancy when justified by the anticipated therapeutic benefit.

Nursing Mothers :

The drug is excreted in breast mild of lactating rats (mostly as metabolites: peak concentration of 40 and 80 mg/mL after oral and i.v. administration of 2.5mg/kg respectively). Domperidone concentrations in breast milk of lactating women are 10 to 50% of the corresponding plasma concentrations and expected not to exceed 10mg/ml. The total amount of domperidone excreted in human breast milk in expected to less than 7 µg per day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore, maradon should only be used during pregnancy when justified by the anticipated therapeutic benefit.

Carefully administer this drug to these patients

1. Infant

2. Patients with hepatic impairment.