Damelium^® (Tablets) Instructions for Use

Marketing Authorization Holder

Actavis Group hf. (Iceland)

Manufactured By

Fal Duiven, B.V. (Netherlands)

ATC Code

A03FA03 (Domperidone)

Active Substance

Domperidone (Rec.INN registered by WHO)

Dosage Form

Damelium®

Tablets 10 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with an engraving “Dm10” on one side.

Excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, povidone, sodium lauryl sulfate.

10 pcs. – blisters (1) – packs.
10 pcs. – blisters (3) – packs.

Clinical-Pharmacological Group

Centrally acting antiemetic drug blocking dopamine receptors

Pharmacotherapeutic Group

Antiemetic agent – central dopamine receptor antagonist

Pharmacological Action

Antiemetic agent. It has an antiemetic effect, soothes hiccups and in some cases eliminates nausea. The action is due to the blockade of central dopamine receptors. This eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract and increases the evacuation and motor activity of the stomach.

Pharmacokinetics

Absorption after oral administration on an empty stomach is rapid (administration after meals, reduced gastric acidity slow down and reduce absorption). C_max is reached in 1 h. Bioavailability is 15% (effect of “first pass” through the liver). Plasma protein binding is 90%. It penetrates into various tissues, poorly passes through the blood-brain barrier. It is metabolized in the liver and in the intestinal wall (by hydroxylation and N-dealkylation). It is excreted through the intestine 66%, by the kidneys – 33%, including unchanged – 10% and 1%, respectively. T_1/2 is 7-9 h, in severe chronic renal failure it is prolonged.

Indications

Nausea, vomiting, hiccups of various origins (in toxemia, radiation therapy, dietary disorders, intake of certain drugs /morphine/, endoscopic and radiopaque studies, in the postoperative period). Postoperative hypotension and atony of the stomach and intestines, biliary dyskinesia, flatulence, reflux esophagitis, cholecystitis, cholangitis, various types of dyspepsia. Nausea and vomiting caused by the intake of dopamine mimetics.

ICD codes

Dosage Regimen

Administer orally.

Take tablets 15-30 minutes before meals.

For adults and adolescents 12 years and older (with body weight of 35 kg or more), the usual dose is one 10 mg tablet three to four times daily.

Do not exceed the maximum daily dose of 30 mg (3 tablets).

The duration of treatment should not exceed one week for nausea and vomiting.

For chronic conditions like dyspepsia, treatment duration may be extended as determined by a physician.

In patients with severe renal impairment (serum creatinine >6 mg/100 ml), reduce the dosing frequency to once or twice daily.

In patients with hepatic impairment, use with caution and consider a reduced dosage.

The tablet may be placed on the tongue and swallowed with water.

Adverse Reactions

From the central nervous system rarely – increased excitability and/or extrapyramidal disorders, headache.

From the digestive system spasms of the smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions itching, rash, urticaria.

Other increased plasma prolactin levels, galactorrhea, gynecomastia.

Contraindications

Gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestine, prolactinoma, pregnancy, lactation (breastfeeding), hypersensitivity to domperidone; children under 12 years of age and body weight less than 35 kg (for tablets).

Use in Pregnancy and Lactation

Domperidone is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

It should be used with caution in case of liver function disorders.

Use in Renal Impairment

It should be used with caution in case of renal function disorders. In renal failure, the frequency of administration should be reduced.

Pediatric Use

Contraindicated in children under 1 year of age (under 5 years of age and children with body weight less than 20 kg – for tablets).

Special Precautions

It should be used with caution in case of liver and kidney function disorders.

Drugs containing Domperidone should be administered to children in dosage forms intended for the appropriate age.

Drug Interactions

With simultaneous use with antacids, antisecretory drugs (including cimetidine, sodium bicarbonate), the bioavailability of domperidone decreases.

With simultaneous use with anticholinergic drugs, the effect of domperidone is suppressed.

Since Domperidone is metabolized mainly with the participation of the CYP3A4 isoenzyme, it is believed that with simultaneous use of domperidone and inhibitors of this isoenzyme (including azole antifungal drugs, macrolide antibiotics, HIV protease inhibitors, nefazodone), an increase in the plasma level of domperidone is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.