COMPOSITION
Prokind tablet: Each tablet contains Propantheline Bromide USP 15 mg
PHARMACOLOGICAL INFORMATION
Pharmacological Action
Propantheline is an anticholinergic drug, a medication that reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle (a type of muscle). It also has a direct relaxing effect on smooth muscle. Propantheline is used to treat or prevent spasm in the muscles of the gastrointestinal tract in the irritable bowel syndrome. In addition, Propantheline inhibits gastrointestinal propulsive motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions. Slow gastric emptying and long intestinal transit time have been shown to improve lactose absorption
Mechanism of Action
Action is achieved via a dual mechanism: (1) a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites and (2) a direct effect upon smooth muscle (musculotropic).
Pharmacokinetic properties
After oral administration to man, propantheline bromide is extensively metabolized primarily by hydrolysis to the inactive materials xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide, approximately half of which occurs in the gastrointestinal tract prior to its absorption. Food appears to substantially decrease the extent of absorption following oral administration.
It appears that it does not readily penetrate the CNS and eye, due to complete ionisation and poor lipid solubility.
CLINICAL INFORMATIONS
Therapeutic Indications
- Prokind is indicated as an adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal) and for the relief of the symptoms of gastritis.
- Prokind is also indicated for Spastic and inflammatory disease of GI and urinary tracts such as the symptomatic treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis, acute enterocolitis, nervous diarrhoea and functional gastrointestinal disorders). Other indications include renal colic, hyperhidrosis, as adjunctive therapy in ulcerative colitis, diverticulitis, cholecystitis and pancreatitis and for certain gastrointestinal diagnostic procedures( Duodenography).
- Control of salivation and enuresis.
- Second-line therapy for urinary incontinence.
- Improves lactose intolerance
Dosage And Administration
Dosage should be individualized.
The usual initial adult dosage is 15 mg (One tablet) 30 minutes before each meal and 30 mg at bedtime (i.e., 75 mg daily). Dosage should be carefully titrated until therapeutic effect is achieved or adverse effects become intolerable using the lowest possible effective dosage. The maximum daily dosage should not exceed 120mg.
Subsequent dosage adjustments should be made according to the patient's individual response and tolerance. The administration of one 7.5 mg tablet 3 times a day may be sufficient for patients with mild manifestations, for geriatric patients, and for those of small stature.
When used in contrast radiology, 30 mg should be given 45 minutes before the procedure.
For other indications, the dose is 15 to 30 mg 4 times daily.
Use In Children
Safety and efficacy of propantheline bromide in children have not been established.
Use In The Elderly
Caution should also be exercised in elderly patients because of the possibility of inducing urinary retention. Urinary retention may be avoided if these patients are advised to micturate at the time of taking medication. Caution should also be exercised in elderly patients due to the danger of precipitating undiagnosed glaucoma.
Use In Pregnancy
Safe use of Prokind in pregnancy has not been established. Therefore, the use of this medicine in women of child-bearing potential requires that the benefits be weighed against its possible hazards to mother and foetus.
Use In Lactation
As many agents are excreted in human milk, caution should be exercised when propantheline bromide is administered to a breast-feeding woman. Suppression of lactation may occur with anticholinergic agents.
Side Effects
With the exception of fewer effects on the eye and the CNS, propantheline can be expected to have a similar adverse reaction profile as atropine (dry mouth, dry eyes, urinary hesitancy, tachycardia, constipation, etc.)
Contraindications
The medicine is contraindicated in patients with:
- Hypersensitivity to propantheline bromide or other anticholinergic agents, or any of the ingredients in Prokind tablets.
- Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.
- Glaucoma, since mydriasis is to be avoided
- Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc)
- Obstructive uropathy (prostatism)
- Intestinal atony of elderly or debilitated patients
Precaution
- Take propantheline tablets at least an hour before food or on an empty stomach.
- If you miss a dose of propantheline, take it as soon as possible. If it is almost time for your next dose, then skip the missed dose and continue taking at the usual times.
- This medicine may cause drowsiness and blurred vision. If affected do not drive or operate machinary.
- Propantheline can cause a dry mouth. For relief try sucking sugar-free sweets, pieces of ice or chewing sugar-free gum.
Drug Interaction
- Antacids or Absorbent Antidiarrhoeals: May reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide.
- Anticholinergics: May delay absorption of other medication given concomitantly.
- Antimyasthenics: Concurrently used with propantheline bromide may further reduce intestinal motility.
Over Dosage & Treatment
The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behaviour), hyperthermia, circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis and coma.
PHARMACEUTICAL INFORMATION
Storage Conditions
Keep this medication out of the reach of children. Store at room temperature in a tightly sealed container and away from light.
Presentation
Prokind tablet : Each commercial box contains 50 tablets in Alu-Alu blister pack. |