Domolin 5

Domolin 5
17 May

Domolin 5

Antiemetic

-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.

Indecation

 DOMOLIN® 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.
 

Dosage & Administration

 It is recommended to take oral DOMOLIN® 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).
 

- Each Film coated Tablet of  DOMOLIN®10 contains:
  Domperidone      10 mg
- Each 5 ml of  DOMOLIN® oral suspension contains:
  Domperidone      5 mg
- Each 1 ml of DOMOLIN® Infant drops Suspension contains:
  Domperidone      1 mg
- Each Suppositories of  DOMOLIN® 30 contains:
  Domperidone    30 mg
- Each Suppositories of  DOMOLIN® 10 contains:
  Domperidone     10 mg     
 

- DOMOLIN® is contra-indicated in patients with known intolerance to 
  the drug(hypersensitivity to Domperidone).
- DOMOLIN® 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 DOMOLIN® with anticholinergic drugs
   may antagonize the anti-dyspeptic effect of DOMOLIN®.
-     Antiacids and antisecretary drugs should not be given simultaneously 
  with DOMOLIN®, because they lower it’s oral bioavailability.
-     The drug that inhibit CYP3A4 increase DOMOLIN® 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 DOMOLIN® .
  DOMOLIN® should not be used during pregnancy unless if necessary.
 

 In general DOMOLIN®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 and 
 supportive therapy is recommended.
 Anti cholinergic or anti-Parkinson drugs may be helpful in controlling 
 the extrapyramidal reaction.        
 

-     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 DOMOLIN®).

-    DOMOLIN® Tablets: Blister of 10 tablets, packs of  2 blisters.
-    DOMOLIN® Suspension: Bottles of  100 ml.
-    DOMOLIN® Infant drops Suspension: Bottles of  30 ml.
-    DOMOLIN® Suppositories 30mg : packs of 5 suppositories.
-    DOMOLIN® Suppositories 10mg : packs of 5 suppositories.

- Store in a dry place at temperature below 30oC.