Saturday, September 7, 2013

Domperidone

Domperidone 
Domperidone SEDICO Tablets, Oral suspension & Suppositories 
Composition: 
Each 
tablet contains: 
Dompendone 10 mg 
Each teaspoonful (5 ml)of suspension contains: 
Domperidone 
5 mg Each suppository contains: 
Domperidone 10mg, 30mg or6O mg 
Properties: 
Domperidone is derivative of benzimidazole that possesses both prokineticand aniemetic properties. 
Domperidone is a dopaminergic antagonist. It increases the basal lower oesophageal sphincter pressure, inhibits relaxation of the gastricfundus, enhances antral contractility & relaxes the pyloricsphincter. 
It is well absorbed after oral administration & peak plasma levels are achieved within 1 hour after rectal administration. It’s half life is about 7.5 hours. 
About 90% is bound to plasma proteins. 
It is metabolized in the liver & eliminated in the unne & faeces. 
Indications: - Short-term Ireatment of nausea & vomiting of various origins(functional, Infectious, organicordietetic & those 
induced by radiotherapy or drug therapy). 
- Gastrointestinal disorders due to delayed gastnc emptying, gastro-oesphageal reflex and oesphagilis. 
Side effects: 
- Plasma prolactin concentrations may be increased which may lead to galactorrhoea or gynaecomastia. 
- Reduced libido. 
- Central effects such as extrapyramidal dystonic reactions ordrowsitiess. 
- Occasional rashes and other allergic reactions. 
Contra-indications: - Domperidone is contra-indicated in patients with known hypersensitivity to this drug, or when stimulation of 
gastric motility may be dangerous e.g: 
G.I.T hemorrhage, obstruction or perforation. 
- Domperidone is also contra-indicated in patients with prolactin-releasing pituitary tumer(prolactinoma) 
Drug interactions: Opioid analgesics & antimuscarinics mayantagonise the prokinetic effects of Domperidone. 
Domperidone may antagonise the hypoprolactinaemic effect ofdrugs such as Bromocriptine. 
Precautions: -The dose frequency should be reduced in patents with renal insufficiency. 
- In the treatment of nausea and vomiting in parlcinsonian patients, therapy may be continued for a maximum 12 weeks. 
-When antacids or antisecretory agents are used concomitantly they should be taken after meals(i.e. they should not be taken simultaneously with domperidone). 
Use during pregnancy and lactation: Domperidone given to animals at doses up to 160mg/kg/day did not produce teratogenic effects. However, as most medicines, Domperidone 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 any increase in the risk of malformations in humans. It is not known whether there is harm to the new born. There for nursing is not recommended for motherswho are taking Domperidone, unless the expected benefits outweight any potential risk.The safty of drug during pregnancy and lactation has not been established. Dosage: Tablets: 
— - In nausea & vomiting: 2 tablets 3-4 times daily. 
- In gastrointestinal disorders: 1 tablet 3 times daily 
( preferably 15-30 minutes before meals ) & if necessary 1 tablet given before bed time & dosage can be doubled when required. 
Oral suspension: 
Adults 
- 10-20 ml, 3-4 times daily before meals & before bed time 
( according to seventy). 
Children 
- 2.5 - 5 ml! 10 kg body weight, 3 -4 times daily before meals & before bed time 
( according to severity) Suppositories: Adults 
-30-6omgevery4-8hours. 
Children 
- Upto2 years :1 suppository(10 mg)2-4timesdaily. 
- From 2104 years :1 suppository (30 mg) twice daily. ___________ 
- From 4106 years 
: I suppository (30 mg) 3 times daily. 
- Over 6 years 
: 1 suppository (30 mg) 4 times daily. Storage: .a Ln Keep at temperature not exceeding 30 C & suppositories at temp. not exceeding 15 C. I Keepoutofreachofchildren. 
Presentation: 
Boxcontains2o,1000 tablets. 
Bottleofl2omlsuspension. 
Hi Boxcontains6suppositories( 1O,3Oor6Omg). C; 
Produced by in 
SEDICO Pharmaceutical Co. 6OctoberClty-Egypt 
P.OBox43,PostalcodeNo.: 12566