PHARMANIAGA DIPHENOXYLATE A TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ATROPINE SULPHATE; DIPHENOXYLATE HYDROCHLORIDE

Available from:

PHARMANIAGA MANUFACTURING BERHAD

INN (International Name):

ATROPINE SULPHATE; DIPHENOXYLATE HYDROCHLORIDE

Units in package:

100 Tablets; 100 Tablets

Manufactured by:

PHARMANIAGA MANUFACTURING BERHAD

Patient Information leaflet

Not Applicable

Summary of Product characteristics

xxx
MANUFACTURER:
/
ROUTE OF ADMINISTRATION
Oral
10th August 2017
Atropine is readily absorbed from the gastro intestinal tract; it is
also
absorbed from mucous membranes, the eye and to some extent
through intact skin.
The side effects of Diphenoxylate A Tablets include malaise,
lethargy, sedation, somnolence, confusion, dizziness, restlessness,
depression, euphoria, hallucinations, headache, and fever.
Anaphylaxis, angioedema, urticaria and pruritus have been reported
side effects.
Gastrointestinal side effects include paralytic ileus, toxic
megacolon,
nausea, vomiting, abdominal discomfort, constipation and anorexia.
The atropine side effects of Diphenoxylate A tablets include
flushing, dryness of the skin and mucous membrane (including dry
mouth), cardiac irregularities such as arrhythmias, bradycardia, and
palpitations, increased intra-ocular pressure, urinary retention and
difficulty in micturition, and respiratory depression in children.
Dilation of pupils with loss of accommodation, photophobia and very
rarely angle closure glaucoma can occur.
_Diphenoxylate A is contraindicated in patients with:-_
_- known hypersensitivity to diphenoxylate hydrochloride or atropine._
_- jaundice_
_- intestinal obstruction_
_- acute ulcerative colitis_
_- in the treatment of diarrhoea associated with pseudomembranous _
_ enterocolitis_
_- raised intracranial pressure_
_- head injury_
_- myasthenia gravis_
_- pyloric stenosis_
_- paralytic ileus_
_- prostatic enlargement_
INTERACTIONS WITH OTHER MEDICAMENTS
The following interaction have to be considered in the use of
Diphenoxylate A Tablets: -
Diphenoxylate A antagonizes the effect of Domperidone,
Metoclopramide, Bethanecol/ Carbachol, Cisapride. Galantamine,
Neostigmine/pyridostigmine, and Pilcarpine.
The antimuscarinic side effects of Diphenoxylate A are increased by
Amantadine, Antihistamines (sedative and non-sedative), Clozapine,
Disopyramide, Fluspiriline, Loxapine, MAOI’s, Nefopam, Olanzapine,
Phenothiazines, Quantiapine, Remoxipride, Terfenadine, Tricyclic
antid