(and dosage form):
Each tablet and each 5 mL suspension contains:
|Kanamycin sulphate equivalent to||100 mg kanamycin|
|Aminopentamide hydrogen sulphate||0,033 mg|
|Bismuth subcarbonate||250 mg|
|Activated attapulgite||500 mg|
Preservatives: (In suspension)
|Sodium benzoate||0,1% m/v|
Suspension contains TARTRAZINE
A 11.9.1 Antidiarrhoeals in combination with anti-infective agents
Kantrexil has antibiotic, adsorbent, protective and demulcent properties.
Treatment of specific and non-specific gastro-enteritis.
Hypersensitivity to any of the ingredients, or to other amino-glycoside antibiotics. Patients with glaucoma, myasthenia gravis and in patients with prostatic hypertrophy.
A consequence of diarrhoea may be fluid and electrolyte depletion, and rehydration therapy may be necessary, especially in infants and young children.
Kantrexil Suspension contains tartrazine which may cause allergicmtype reactions (including bronchial asthma) in certain susceptible individuals.
Although the overall incidence of Tartrazine sensitivity in the general population is thought to be low it is frequently seen in patients who also have aspirin sensitivity.
DOSAGE AND DIRECTIONS FOR USE
Children 1-6 years: 1 medicine measure (5 mL) every 4-6 hours
Children 6-12 years: 2 medicine measures (10 mL) every 4-6 hours
Adults: 3 medicine measures (15 mL) every 4-6 hours.
The suspension should be thoroughly shaken before the administration of each dose.
Adults: 3 tablets every 6 hours.
In severe cases, this dose may be initially administered every 4 hours. The tablets should be swallowed whole with water.
Therapy should not exceed 3 days.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following side-effects may occur following oral kanamycin administration although less than 1% of a dose is absorbed following oral administration.
Kanamycin may cause irreversible ototoxicity. Kanamycin is more likely to cause auditory than vestibular toxicity. Kantrexil should be withdrawn immediately if symptoms of ototoxicity occur. Reversible nephrotoxicity may occur and acute renal failure has been reported, often in association with the concurrent administration of other nephrotoxic medicines. Patients especially at risk from ototoxicity and nephrotoxicity are those whose condition may lead to raised plasma concentrations such as in patients with renal failure.
Kanamycin may cause hypersensitivity reactions and cross-sensitivity between other aminoglycosides have been reported. Hypomagnesaemia, hypocalcaemia and hypokalaemia have occurred when kanamycin has been given for prolonged periods. Infrequent side-effects which may occur are anaemia, purpura, convulsions, visual disturbances, increased serum aminotransferase values and increased serum bilirubin concentrations. Other side-effects include headache and paraesthesia.
The overgrowth of kanamycin resistant organisms, e.g. bacteroides, some strains of clostridia, enterococci and yeast have been observed. If superinfection appears, Kantrexil should be discontinued and appropriate therapy instituted.
Kanamycin should be given with care to patients receiving other medicines with neuromuscular blocking activity or which are ototoxic or nephrotoxic. Antiemetics may mask ototoxic symptoms.
Kanamycin should be administered separately when concomitant therapy with a betalactam antibiotic is required.
Side-effects of aminopentamide include dry mouth, dimmed vision and cerebral excitation.
Bismuth has been associated with reversible encephalopathy and bone and joint disorders. Bismuth can cause black discolouration of the faeces.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
High doses of kanamycin may cause diarrhoea, nausea or vomiting.
Symptoms of acute bismuth intoxication include gastro-intestinal disturbances, skin reactions, and discolouration of mucous membranes. A characteristic blue line may appear on the gums.
There may be renal failure and liver damage. These effects do not appear to be common with bismuth when used for limited periods.
Refer to “Side-effects and special precautions”.
Treatment is symptomatic and supportive.
Suspension: Yellow uniform suspension with lemon odour.
Tablets: Grey-white round, biconvex tablet and scored on one side.
Suspension: Glass bottles of 100 mL.
Tablets: White securitainers containing 20 and 100 tablets.
Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.