MOTIL10® Tablets
MOTIL10® Tablets
Anti-nausea and vomiting

Indication

MOTIL® is indicated for the treatment of:

  • Nausea and vomiting.
  • The dyspeptic symptom complex that is often associated with delayed gastric emptying.
  • Gastroesophageal reflux and Oesophagitis.
  • Epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain.
  • Bloating eructation and flatulence.
  • Heartburn with or without regurgitation of gastric contents to the  mouth.
  • Nausea and vomiting of functional organic, infections or dietetic origin or induced by radiotherapy.

Composition

Each Film coated Tablet of  MOTIL®10 contains:

  • Domperidone      10 mg

Each 5 ml of  MOTIL® oral suspension contains:

  • Domperidone      5 mg

Each 1 ml of MOTIL® Infant drops Suspension contains:

  • Domperidone      1 mg

Each Suppositories of  MOTIL® 30 contains:

  • Domperidone    30 mg

Each Suppositories of  MOTIL® 10 contains:

  • Domperidone     10 mg     

Dosage

 It is recommended to take oral MOTIL® before meals. If taken 
 after meals, absorption of the drug is somewhat delayed.
*Adults and adolescents (over 12 years and weighing 35 kg or more)

  • 1 to 2 tablets three to four  times per day, with a maximum daily dose of 80mg. 
  • Suppositories the maximum daily dose  60 mg two times per day.

*Infants and children: 
•Tablets, Oral suspension

  • 0.25 -0.5 mg/kg three to four times per day with a maximum daily dose of 2.4 mg/kg (but doesn't exceed 80 mg per day).
  • Tablets are unsuitable for use in children weighing less than 35kg. 

• Suppositories:

The total daily dose is dependent on the child’s weight:

  • For a child weighing 5- 15 kg: one 10 mg suppository two times per day).
  • For a child weighing more than 15 kg: one 30 mg suppository two times per day).  
  • Suppositories are unsuitable for use in children weighing less than 5 kg.mg/kg (but doesn't exceed 80 mg per day).
  • Domperidone is dopamine antagonist, which selectively blocks peripheral dopamine receptors both in  the gastrointestinal wall and in the chemoreceptor trigger zone  which lies outside the blood brain barrier in the area postrema.
  • Domperidone has antiemetic properties similarl to those at  metoclopramide and certain neuroleptic drugs.
  • Unlike metoclopramide and certain neuroleptic drugs, Domperidone does not cross the blood brain barrier and hence significantly lacks the extrapyramidal side effects associated with these drugs.
  • Domperidone is rapidly absorbed after oral administration, with peak plasma concentration at approximately 30 minutes.
  • The low absolute bioavailability of oral dose approximately 15% is due to an extensive first pass metabolism in the gut wall and liver.
  • More than 90% of Domperidone is bound to plasma proteins, and has a terminal half-life of about 7.5 hours,but it is prolonged in patients with severe renal impairment.

Each Film coated Tablet of  MOTIL®10 contains:

  • Domperidone      10 mg

Each 5 ml of  MOTIL® oral suspension contains:

  • Domperidone      5 mg

Each 1 ml of MOTIL® Infant drops Suspension contains:

  • Domperidone      1 mg

Each Suppositories of  MOTIL® 30 contains:

  • Domperidone    30 mg

Each Suppositories of  MOTIL® 10 contains:

  • Domperidone     10 mg     

MOTIL® is indicated for the treatment of:

  • Nausea and vomiting.
  • The dyspeptic symptom complex that is often associated with delayed gastric emptying.
  • Gastroesophageal reflux and Oesophagitis.
  • Epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain.
  • Bloating eructation and flatulence.
  • Heartburn with or without regurgitation of gastric contents to the  mouth.
  • Nausea and vomiting of functional organic, infections or dietetic origin or induced by radiotherapy.
  • MOTIL® is contra-indicated in patients with known intolerance to the drug(hypersensitivity to Domperidone).
  • MOTIL® should not be used whenever stimulation of gastric motility might be dangerous (e.g. in the presence of gastro-intestinal hemorrhage, mechanical obstruction or perforation.)
  • Coadministration with oral Ketoconazole, Voriconazole,Telithromycin ,Erythromycin or CYP3A4 inhibitors which prolong the (QTc) interval such as Fluconazole, Amiodarone, Clarithromycin.
  • Prolactin releasing pituitary tumor (prolactinoma).

¤ Concomitant administration of MOTIL® with anticholinergic drugs may antagonize the anti-dyspeptic effect of MOTIL®.

¤ Antiacids and antisecretary drugs should not be given simultaneously with MOTIL®, because they lower it’s oral bioavailability.

¤ The drug that inhibit CYP3A4 increase MOTIL® plasma level such as: 

  • Azole antifungal such as Fluconazole, Itraconazole, Ketoconazole and Voriconazole.
  • Macrolide antibiotics such as Clarithromycin.
  • HIV protease inhibitors such as amprenavir.
  • Calcium antagonists such as Diltiazem.
  • Amiodarone, Aprepitant, Nefazodone and Telithromycin.
  • The total amount of Domperidone excreted in breast milk is expected to be less than 7µg per day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore breast-feeding is not recommended for mothers who are taking MOTIL® .
  • MOTIL® should not be used during pregnancy unless if necessary.

 In general MOTIL® is well tolerated but there are some rare side effects:

  • Immune system disorders: very rare allergic reactions.
  • Endocrine disorders: rare increase prolactin levels.
  • Nervous system disorders: very rare extra pyramidal side effects.
  • Gastrointestinal disorders: including very rare transient intestinal cramps.
  • Skin and subcutaneous disorders: very rare urticaria.
  • Reproductive system and breast disorders are rare: galactorrhea , gynoecomastia, amenorrhea.

Over dose:
Symptoms of overdose may include drowsiness, disorientation and
extrapyramidal reactions, especially in children.

Treatment:

there is no specific antidote to Domperidone, but in the event of overdose

  • gastric lavage as well as the administration of activated charcoal may be useful Close medical supervision.
  • supportive therapy is recommended. 
  • Anti cholinergic or anti-Parkinson drugs may be helpful in controlling the extrapyramidal reaction. 

 It is recommended to take oral MOTIL® before meals. If taken 
 after meals, absorption of the drug is somewhat delayed.
*Adults and adolescents (over 12 years and weighing 35 kg or more)

  • 1 to 2 tablets three to four  times per day, with a maximum daily dose of 80mg. 
  • Suppositories the maximum daily dose  60 mg two times per day.

*Infants and children: 
•Tablets, Oral suspension

  • 0.25 -0.5 mg/kg three to four times per day with a maximum daily dose of 2.4 mg/kg (but doesn't exceed 80 mg per day).
  • Tablets are unsuitable for use in children weighing less than 35kg. 

• Suppositories:

The total daily dose is dependent on the child’s weight:

  • For a child weighing 5- 15 kg: one 10 mg suppository two times per day).
  • For a child weighing more than 15 kg: one 30 mg suppository two times per day).  
  • Suppositories are unsuitable for use in children weighing less than 5 kg.mg/kg (but doesn't exceed 80 mg per day).
  • Not recommended in patients with pheochromocytoma.
  • Should be avoided in patients with epilepsy.
  • Care should be taken when administered to patient with renal or hepatic impairment.
  • When antiacids or antisecretory agents are used concomitantly, they should be taken after meals and not before meals, (i.e. they should not be taken simultaneously with MOTIL®).
  • MOTIL® Tablets: Blister of 10 tablets, packs of  2 blisters.
  • MOTIL® Suspension: Bottles of  100 ml.
  • MOTIL® Infant drops Suspension: Bottles of  30 ml.
  • MOTIL® Suppositories 30mg : packs of 5 suppositories.
  • MOTIL® Suppositories 10mg : packs of 5 suppositories.
  • Store in a dry place at temperature below 30°C