Informasi Obat
Pronetic®
Composition
Each tablet contains :
Cisapride.............................................5 mg and 10 mg.
Pharmacology
Pronetic® tablet, a substituted piperidinyl benzamide, is an
orally administered prokinetic agent which facilitiates or restores
motility of the gastrointestinal tract.
Its mechanism of action is thought to increase the release of
acetylcholine in the myenteric plexus of the gut. Pronetic®
appears to be devoid of dopaminergic blocking activity, and it
does not influence the plasma concentration of prolactin or cause
extrapyramidal symptoms.
Pronetic®:
·
Increases the resting tone of the lower oesophageal sphincter
and increases the amplitude of lower oesphageal contraction.
·
Accelerates gastric emptying and reduces the mouth-to-
coecum transit time.
·
In contrast to other prokinetic agents, Cisapride enhances
the propulsive motor activity of the stomach, small intestine and
colon.
Indications
·
Treatment of symptoms (eg, heart burn, regurgitation) as
well as the mucosal lesions associated with gastroesophageal
reflux.
·
Symptomatic relief (such as nausea, early satiety, anorexia,
bloating and epigastric pain) due to impaired gastric motility
which caused by impaired as well as delayed gastric emptying
associated with diabetes, systemic sclerosis and autonomic
neuropathy.
Contraindications
Pronetic® tablet should not be used when stimulation of
muscular contractions might adversely affect gastrointestinal
conditions as in gastrointestinal haemorrhage, mechanical
obstruction, perforation, or immediately after surgery.
Warnings and precautions
1) Caution should be observed in patients in whom an
increase in gastrointestinal motility could be harmful.
In patients with hepatic or renal impairment, it is advisable to
have the initial daily dose, subsequently, this dose can be adjusted
according tp the clinical response.
2) In the elderly, steady state plasma levels are generally higher
due to a slightly prolongation of the half-life. However, thera-
peutic doses are similar to those used in other patients.
3) Benefit should be weighed against the potential hazards
before giving it during pregnancy, especially during the first
trimester.
4) Although the excretion in breast milk is minimal, it is not
advised to breastfeed while taking this drug.
5) This drug may accelerate the rate of absorption of other
drugs which cause central depression such as barbiturate and
alcohol, therefore be cautious when used concurently.
Adverse reactions
The most commonly reported adverse reactions with
Pronetic® are gastrointestinal disturbances including abdominal
cramps, borborygmi, and diarrhoea. Headache, dizziness, con-
vulsions, and tachycardia have also been reported.
Drug interacfions
Pronetic® tablet could reduce the absorption of drugs from
the stomach, whereas absorption from the small intestine (e.g.:
benzodiazepines, anticoagulants, paracetamol, or H2-antago-
nists) may be increased.
In patients receiving anticoagulants the coagulation times
may somewhat increase. It is advisable to check the coagulation
time one week after the start or discontinuation of cisapride
treatment to adapt the anticoagulant dose if necessary.
Sedative effects of benzodiazepines and alcohol may be
accelerated. Effects of this drug on gastrointestinal motility,
mostly can be partly, antagonized by anticholinergic drugs.
In case of a drug that need individual titration, it is
advisable to check the plasma levels before giving this drug.
Dosage and administration
Adults and children 12 years and over:
·
Gastro-oesophageal reflux:
510mg cisapride 3 to 4 times daily, 15 to 20 minutes
before meals.
Depending upon the symptoms being treated and the clinical
response : a 12 weeks course of treatment is recommended to
obtain maximum benefits.
Cermin Dunia Kedokteran No. 104, 1995 59
Presentation
·
Impaired gastric motility :
5-10 mg cisapride 3 or 4 times daily, l5 to 20minutes before
meal.
An initial course of 6 weeks is recommended, but longer
period of treatment may be required.
Tablets 5mg : Boxes of 3 strips x 10 tablets. Reg. No.
10 mg : Boxes of 3 strips x 10 tablets. Reg. No.
Store in a cool dry place
·
Use for children :
Clinical experience with cisapride in children younger than
12 years is limited. Hence the drug can only be recommended for
use in children aged 12 years and older.
On medical prescription only.
Harus dengan resep dokter.
PT. KALBE FARMA
JAKARTA - INDONESIA
PEMBERITAHUAN
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tersebut.
Redaksi
The desire accomplished is sweet to the soul
Cermin Dunia Kedokteran No. 104, 1995
60