Farcotilium Gastroprokinetic and Antiemetic
Capsules, Oral Suspension & Adult Suppositories
Composition:
Each formulation contains : Capsule oral susp supp
domperidone 10 mg 5 mg/5ml 60 mg
Properties:
Farcotilium (domperidone) is an eUactive antiemehc ~nd Gas1roprokt\etic agent for treatment of necsee, vomItIng and other dyspeptIC symptoms ecceted WIth delayed gastnc emptyng and gaslroesophageal reflux FARCOTIUUM IS a selectIVe per1>heral dopanllne antagonist at the raceplors It stimulates copee GI motility, increases the Iowor esophageal sphincter pressure, promotes esophageal and antral ccntrectens. relaxes. pyloric sphincter and ncreases duodenal and j8J16\41 peretetsre. The over allefleclof FARCOTlUUMIS prevenllOnol gastroesophageal rel1ux, acceleration 01 gastric emptYing and reduction 01 the transit tene 01 Intestmal contants from the duodenum 10 ueccecet valve Clinically, F~RCOTllIUM therapy corrects dISturbances of GI molitity with prompt reliel of associated eructation, flatulence, heartburn and abdominal deccmtcrt fAACOTIUUM has no eflecl on
Gl secretions or colonic motiLly and does not cause diarrhea Also, FARCOTIUUM does not cross the blood-brain barrier, so its use 11 the treatment of nausea and ,vomrting does not cause .the psychotropic or
suit pahoots of all age groups underdifferoot condltlOOS
Pharmacokinetics :
Following FARCOTIUUM administratio.n, domperidone is rapidly absorbed from the GIT, Presystemic metabolism occurs in the gut wall and liver, Peak plasma ccnceotretcns are achieved within 30 minutes of oral administration and after about one hour following rectal administration Domperidone is distributed into most body tissues end Iluds but does not cross the blood-brain barrier, More than 90 % of the drug is is about 7,5 hours
Indications :
Prevention and IrealmSflt of nausea and vomiting associated with:
– Cytotoxic chemolherapy and radiotherapy
– Levodopa and bromocriptine administration as in parkinsonism
– Gastritis, hepatitis and pancraatilis
– Severe migraine
– Dysmenorrhea
– Prior to GI radiography and endoscopy
Correction of gastrointeslinaJ. motility disorders as in :
– Non-uleerdyspep associated with eroctetcn flalulonce, heartburn discomfort
– Gastroesophageal reflux
– Gastroiniestinal paresis associated with diabetes mellitus and neurologic diseases
– Postoperative nausea and vomiting
Dosage :
The capsutes and oral suspension should be given 15 – 30 minutes belore meals and at beotene I1 required
Adutts:
Capsulea : 1-2 capsules (10 – 20 mg), 3·4 timesdaity
Suspension: 2·4 teaspoonfuls (10 – 20 rnl ), 3 – 4 tsnes daily
Suppoaltorles : one SloflPOSitory every 8 hours
Children :
02· 0.4 m~g body wei~t every 4 – 8 hours
Contraindications:
Hypersensitivity to domperidone
Precautions:
Oomperidone should be used with caution in renal impainnent
Side effecta:
FARCOnUUM is safe and weU tolerated However, dry mouth, headache, iae0I flushing and increased senm prolacln levefs may oocur
Pregnancy and lactation :
A1thoug, aninal studies did not demonstrate any t8f’Zltogonie effect on the letus, domperiOOne should be used dumg pregnancy under medical supervision, Dompendone may Improve postnalallactation and its secretion In breast mdk IS very smaH and insufficient to cause hann to the baby
Drug Interactions:
Domperidone antagonizes the hypoprolactnemie effect of bromocrcune The effect 01 domperidone on GI motility may be anta~ized by antimuscarinies an~ opiOid analg~ies Domperidone may enhance the ebsorpton of concomitantly
aaninistered drugs particuiarty in patients with delayed gastric emptying
Interterence with laboratory tests:
None reported
Packing:
A box eontainin~ 24 capsules or 5 adult suppoeltcrtee
A bottle conlaimng120 ml or 200 ml suspension
Storage :
Keep altemperature (15 _ 3QoC).
The capsulos and suppositories should be
kept amy from moisture
Keep out 01 the reach of children
produced by :
Pharco Pharmacuticals
Union of Arab Pharmaclsts
Made In Egypt
Alexandria
