Dompy- domperidone tablet & Oral Suspension

COMPOSITION

  • Each Dompy film coated tablet contains… Domperidone 10 mg.
  • Each ml of Dompy oral suspension contains… Domperidone 1 mg.

MODE OF ACTION 

Domperidone is a dopamine antagonist with antiemetic properties. Domperidone does not readily cross the blood-brain barrier. In domperidone extrapyramidal side effects are very rare. The anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lie outside the blood-brain barrier in the area postrema.

Studies in man have shown oral domperidone to increase lower esophageal pressure, improve enteroduodenal motility and accelerate gastric emptying.

دومبى أقراص لعلاج الغثيان و القىء
دومبى أقراص لعلاج الغثيان و القىء

INDICATIONS

A- The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis:

  1. Epigastric sense of fullness, early satiety, feeling of abdominal distention, upper abdominal pain
  2. Bloating, eructation, flatulence.
  3. Nausea and vomiting.
  4. Heartburn with or without regurgitations of gastric contents in the mouth.

B- Nausea and vomiting of functional, organic, infectious or dietetic origin or induced by radiotherapy or drug therapy. A specific indication is nausea and vomiting Induced by dopamine agonists as used in Parkinson’s disease (such as L.-dope and bromocriptine).

CONTRAINDICATIONS

  • Dompy is contraindicated in patients with known intolerance to the drug. Dompy should not be used whenever stimulation of gastric motility is dangerous, e.g. in the presence of gastro-intestinal haemorrhage, mechanical obstruction or  perforation.
  • Dompy is also contraindicated in patients with a prolactin-releasing pituitary tumour (prolactinoma).

SIDE EFFECTS

  • Side effects are rare, exceptionally some transient intestinal cramps have been reported.
  • Extrapyramidal phenomena are rare in young children and exceptional in adults, they reverse spontaneously and completely as soon as the treatment is stopped.
  • As the pituitary gland is located outside the blood-brain barrier, Dompy may Induce an increase in the plasma prolactin level. In rare cases this hyperprolactinemia may give rise to neuro-endocrinological phenomena such as galactorrhoea and gynaecomastia.
  • When the blood-brain barrier is immature as it infants; or impaired, the possible occurrence of neurological side effects cannot be totally excluded.
  • Rare allergic reactions, such as rash and urticaria, have also been reported.
دومبى شراب معلق
دومبى شراب معلق

WARNINGS AND PRECAUTIONS

A- Use in infants: Because the metabolic and blood brain barrier functions are not fully developed during the first months of life, any drug should only be given to infants with great caution and under close medical supervision. Since the typical absence of neurological side effects with Dompy are mainly due to its poor penetration through the blood brain barrier , the  possible occurrence of such effects cannot be totally excluled in infants  under 1 year of age.

B- Use in liver disorders: since domperidone is highly metabolized in the liver. Dompy should be used with caution in patients with hepatic impairments.

C- Use in kidney disorders: In patients with severe renal insufficiency (i.e. when  serum creatinine 6 mg/100 ml, i.e. 0.6 m mol/l) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers. Since very little  unchanged drug is excreted via the kidneys. It is unlikely that the dose of a single acute administration needs to be adjusted in patients with renal Insufficiency. However. On repeated administration,  the dosing frequency should be reduced to once or twice daily, depending on the severity of the impairment, and  the dose may need to be reduced. Generally patients on prolonged therapy should be reviewed regularly.

D- Pregnancy and lactation: Domperidone given to animals at doses up to 160 mg/ kg/ day  did not produce teratogenic effects. However, like most medicines, Dompy should only be used during the first trimester of pregnancy if this is justified by the anticipated therapeutic benefit.  Up to now, there has been no evidence of an increase in the risk of malformations in humans. The drug is excreted in breast milk of lactating rats (mostly as metabolites. Peak concentration of 40 and 60 mg/ml after oral and i.v. administration of 25 mg/ml respectively. In women Domperidone concentration in breast milk is 4 times lower than corresponding plasma. It is not known whether this is harmful to the newborn. Therefore nursing is not recommended for mothers who are taking Dompy, unless the expected benefits outweigh any potential risk. Review medicine safety categories during pregnancy.

E- Use in post-operative: Not recommended for routine prophylaxis of postoperative vomiting or for chronic administration. See Zofran for postoperative vomiting.

DOSAGE AND ADMINISTRATION

A- Chronic dyspepsia (mainly oral administration)

  • Adults: 10 mg(1 tablet or 10 ml) 3 times daily. 15 to 30 minutes before meals and if necessary- once more before retiring.
  • Children: Oral suspension: 2.5 ml  per 10 kg body weight 3 times daily before meals and if necessary, once more in the evening. 

When results are not satisfactory, the above dosage may be doubted in adults and children who are above 1 year.

B- Acute and subacute conditions (particularly nausea and vomiting): Adults Oral 20 mg (2 tablets or 20 ml) 3 to 4  times daily before meals and before bedtime.

DRUG INTERACTIONS

  • Concomitant administration of anticholinergics may antagonise the anti-dyspeptic effect of Dompy.
  • Antacids and antisecretory drugs should  not be given simultaneously with domperidone as they lower its oral bioavailability.
  • Theoretically, since Dompy has gastro-kinetic effects it may influence the absorption of concomitantly orally administered drugs, particularly those with sustained release or enteric-coated formulations.
  • However. In patients already stabilised on digoxin or  paracetamol, concomitant administration of domperidone did not Influence the blood levels of these drugs.
  • Dompy may also be associated with neuroleptics, the action of which it does not potentiate, dopaminergic agonists ( bromocriptine , L-dopa), whose unwanted peripheral effects such as digestive disorders, nausea and vomiting it suppresses without counteracting their central properties.
أهم 15 معلومة عن الــ دومبيريدون domperidone
أهم 15 معلومة عن الــ دومبيريدون domperidone

Patient Information Leaflet

Patient_Information_Leaflet
دومبي- نشرة معلومات المريض
ENG - Patient Information Leaflet
DOMPY – Patient Information Leaflet

Domperidone- Frequently Asked Questions

A- How quickly does domperidone work? Domperidone is usually started at a dose of 10 milligrams (one tablet) three times a day. Domperidone should start to work in about 30 to 60 minutes.

B- How long should you take domperidone? It is recommended that you take domperidone for the shortest possible time and at the lowest dose that works for you. Your doctor will advise you to take domperidone for up to a week.

C- Is it safe to take domperidone? For most people, taking domperidone is safe. However, if you have heart problems or are taking other medicines, you should first check with your healthcare professional that this medicine is appropriate. Use the lowest dose that works for you and stop as soon as you can.

D- Does domperidone cause sleepiness? Sleepiness is a Possible side effect of domperidone. Sleepiness can affect between 1 in 10 and 1 in 100 people taking domperidone. Dry mouth is a common side effect of domperidone.

F- Can I take domperidone and omeprazole together? Domperidone in combination with omeprazole can achieve ideal effect in the treatment of Gastritis, which is of great significance to the treatment and prognosis of patients. Omeprazole in combination with domperidone can give full play to the acid and helicobacter pylori inhibition effects of omeprazole as well as the emesis resistance and gastric emptying effect of domperidone.

G- Can domperidone cause weight gain? Some people may experience headache, dry mouth, abdominal cramps, weight gain/increased appetite, and alteration of menstrual periods . Most of those who experience side effects find they disappear after a few days of drug discontinuation.

H- Does domperidone help milk supply? Domperidone is the most effective medicine used to improve breast milk supply. This is a medication that was developed to treat nausea, vomiting, indigestion and gastric reflux, but has been found to be effective when used to increase milk supply for nursing mothers.Some mothers may notice an increase in their supply within a few days of taking Domperidone , while it may take a few weeks or more for others. A trial of Domperidone for 4 to 6 weeks is often needed before deciding if it doesn’t help.

I- Can you take domperidone before bed? Your doctor may ask you to take Domperidone for a maximum of 1 week for the treatment of acute nausea and vomiting. Domperidone is best taken 15 to 30 minutes before meals and if necessary at bedtime.

J- Does domperidone cause anxiety? Rarely domperidone may cause muscle/nervous system problems (EPS). Tell your doctor right away if any of these rare but serious side effects occur: feelings of anxiety/agitation/jitteriness. trouble swallowing.

K- Can I take domperidone long term? Because a review has shown that the risks of domperidone are greatest at high doses or when it is used for a longer period, the medicine should only be approved for use in low doses to treat symptoms of nausea and vomiting (feeling or being sick). Treatment should generally only be given for up to one week.

L- Does domperidone cause gas? No, it does not. Domperidone is used for the relief of symptoms of excessive fullness, nausea, stomach bloating and belching occasionally accompanied by stomach discomfort and heartburn after meals.

Domperidone Brands and Generics

  1. Dompy Film Coated Tablets and Oral Suspension. Manufactured by Jamjoom pharma.
  2. DOMI-GEST 10MG domperidone Sachets. Manufactured by PHAROPHARMA , EGYPT.
  3. DOMPERIDONE Sedico 10 mg tablet & 30 mg suppository. Manufactured by SEDICO- EGYPT.
  4. DOMPIDONE Tablet, Oral Suspension and Suppository. Manufactured by ARAB DRUG COMPANY (ADCO)- EGYPT.
  5. FARCOTILIUM- domperidone Capsule, Sachet, Suppository and Suspension. Manufactured by PHARCO , EGYPT.
  6. GASTROMOTIL – domperidone tablet, Suppository and Suspension. Manufactured by EIPICO , EGYPT.
  7. GASTRONORM 10MG SACHET by SIGMA , EGYPT.
  8. MORLIMIN 10mg domperidone Orally Disintegrating Tablet. Manufactured by GLOBAL NAPI PHARMACEUTICALS , EGYPT. 
  9. MOTIL FAST 10MG domperidone Sachets. Manufactured by AMOUN , EGYPT.
  10. MOTILIUM- domperidone tablet & Oral Suspension. Manufactured by JANSSEN CILAG , BELGIUM.
  11. MOTINORM – domperidone Tablet, Suppository and Suspension. Manufactured by GLAXO SMITHKLINE , EGYPT.
  12. SYNCHROGIT 10 mg domperidone Tablet. Manufactured by RAMEDA , EGYPT.
  13. Prokinin- domperidone tablet & Oral Suspension. Manufactured by Tabuk Pharma.
  14. Nauselium- domperidone tablet & Oral Suspension. Morocco domperidone generic.
  15. Motalon – domperidone tablet, Suppository and Suspension. Syrian domperidone generic.
  16. Motinil- domperidone Capsule, Suppository and Suspension. By Kuwait Saudi Pharmaceutical Industries Co.
  17. Vitaperidone – domperidone Suppository. Syrian domperidone brand.
  18. Doprin- domperidone tablet & Oral Suspension. By GROUPE SANTE.
  19. Peridium- domperidone tablet & Oral Suspension.
  20. MODODOM- domperidone tablet & Oral Suspension. By julphar.

References: , , , , , , , , .Category: ALIMENTARY TRACT AND METABOLISM.Tags: DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS, PROPULSIVES, domperidone, ATC code: A03FA03, #tablet, #oral suspension,#dompy_based, #D_letter, #حرف_د، #jamgom pharam.

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