KANTREXIL SUSPENSION
KANTREXIL TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

KANTREXIL SUSPENSION
KANTREXIL TABLETS

COMPOSITION
Each tablet and each 5 mL suspension contains:

Preservatives: (In suspension)

Suspension contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION
A 11.9.1 Antidiarrhoeals in combination with anti-infective agents

PHARMACOLOGICAL ACTION
Kantrexil has antibiotic, adsorbent, protective and demulcent properties.

INDICATIONS
Treatment of specific and non-specific gastro-enteritis.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, or to other amino-glycoside antibiotics. Patients with glaucoma, myasthenia gravis and in patients with prostatic hypertrophy.

WARNINGS
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
Suspension
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.

Tablets
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 Kantrexil should be withdrawn immediately if symptoms of ototoxicity occur.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.

IDENTIFICATION
Suspension: Yellow uniform suspension with lemon odour.
Tablets: Grey-white round, biconvex tablet and scored on one side.

PRESENTATION
Suspension: Glass bottles of 100 mL.
Tablets: White securitainers containing 20 and 100 tablets.

STORAGE INSTRUCTIONS
Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
Kantrexil Suspension: E793 (Act 101/1965)
Kantrexil Tablets: E802 (Act 101/1965)

ACHROMIDE OINTMENT

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ACHROMIDE OINTMENT

COMPOSITION:
Each 40 g contains:

Preservative:

PHARMACOLOGICAL CLASSIFICATION:
Category A 14.2 Preparations for treatment of wounds. Wound dressings.

PHARMACOLOGICAL ACTION:
An antiseptic with a wide range of activity against Gram-positive and Gram-negative bacteria and other organisms. It has mild astringent, emollient and protective actions.

INDICATIONS:
In cases when an antiseptic and protective wound dressing is required. In the treatment of burns, scalds, wounds, cuts, veldsores and ulcers.

CONTRA-INDICATIONS:
Do not use if a known sensitivity to sulphonamides, mercury and mercurial compounds, and acriflavine exists.

WARNINGS:
FOR EXTERNAL USE ONLY.
It should not be given to patients with a history of hypersensitivity to sulphonamides as cross-sensitivity may occur between agents of this group.

DOSAGE AND DIRECTIONS FOR USE:
Clean the wound first with water which has been boiled and cooled or any other suitable method, then apply the ointment with or without a dressing. Apply as often as directed by the medical practitioner.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity and allergic reactions to mercury and mercurial compounds have been reported.
Dermatitis may occur.
Cross-sensitivity has also been observed between sulphonamides and chemically related drugs such as some diuretics, particularly acetazolamide and thiazides and the sulphonylurea hypoglycaemic agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to “Side-effects and Special precautions” above.
Treatment : Discount use immediately and wash the area using soap and water.
Further treatment is symptomatic and supportive.

IDENTIFICATION:
An orange-pink coloured ointment with an odour of cod liver oil, free from grittiness.

PRESENTATION:
25 g, 40 g and 500 g.

STORAGE INSTRUCTIONS:
Store in a cool place (below 30°C) in airtight containers and protect from light.
KEEP OUT OF REACH OF CHILDREN.

FERRUM PHOS COMP. PILLULES

WELEDA Ref.No. U3645 Act 101/1965

FERRUM PHOS COMP. PILLULES

Childrens Cold and Flu Remedy

COMPOSITION: Per 100 g

Aconitum napellus, Planta tota D1 0,3g

Bryonia, Radix D1 0,6g

Eucalyptus, Folium D1 0,5g

Eupatorium perfoliatum, Herba D1 0,4g

Ferrum phosphoricum D6 1,0g

Sabadilla, Semen D1 0,1g

INDICATIONS:

1) Colds and feverish conditions

2) Influenza and related conditions

3) Catarrhal conditions

MODE OF ACTION:

Aconitum: Is an anti-neuralgic and is good for a sudden onset of symptoms of colds and influenza. It helps reduce excessive fever.

Bryonia: Controls exudation from mucous membranes of head and chest.

Ferrum phos: Helps regulate fever and enables the body’s defence mechanism to act efficiently.

Eucalyptus: Acts as an antiseptic.

Eupatorium: Relieves aching pain of the limbs and frees catarrh.

Sabadilla: Helps counteract effects of flu such as the burning watery discharge from the eyes and nose, and a swollen throat.

DOSAGE: Unless otherwise directed,

Children: 4-6 globules

Adults: 6-12 globules

Dissolve under the tongue hourly in acute cases, otherwise three to four hourly.

COMMENT: Ferrum phos comp. is an ideal aid to help overcome colds and flu in children; also in adults who are sensitive to Infludo (Weleda). Use together with Schnupfencreme (Weleda) or Oleum Rhinale (Weleda) where there is a blockage of the sinuses or nasal catarrh and congestion.

INFLUDO DROPS

INFLUDO DROPS

Cold and Flu Remedy

INDICATIONS:

MODE OF ACTION:

OLBETAM^® (Capsules)

COMPOSITION:
Each capsule contains acipimox 250 mg

PHARMACOLOGICAL CLASSIFICATION:
A 7.5 Serum-cholesterol reducers.

PHARMACOLOGICAL ACTION:
Acipimox inhibits the release of fatty acids from adipose tissue and reduces the blood concentration of very low density lipoproteins (VLDL or pre-beta) and low density lipoproteins (LDL or beta) with a subsequent overall reduction in triglyceride and cholesterol levels.
Acipimox is rapidly and completely absorbed orally, reaching peak plasma levels within two hours. The half-life is about two hours. It is not significantly metabolized except in the elderly and is eliminated almost completely intact by the urinary route.

INDICATIONS:
OLBETAM is indicated as adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders.

CONTRA-INDICATIONS:
Hypersensitivity to the drug. Peptic ulcer. Pregnancy and while breastfeeding. Patients with renal failure.

WARNING:
Low-cholesterol and low-fat diets are the preferable therapeutic approach before starting treatment with acipimox.
During prolonged treatment periodical checks should be made of blood lipids and lipoproteins and hepatic and renal function.
Clinical trials have excluded patients with heart failure, hepatic and renal impairment, gastric or duodenal ulceration.

DOSAGE AND DIRECTIONS OF USE:
Daily dosage should be adjusted individually depending on plasma triglyceride and cholesterol levels. The dosage most frequently used is between 500-750 mg/day. In particular the lower dose is advised in type IV and the higher dose in types IIa and IIb hyperlipoproteinaemias. Daily dose should be divided and taken with main meals.
Improvements in plasma lipid picture is usually seen within the first month of therapy.
In the elderly it is advisable to reduce the dosage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Skin vasodilation with a sensation of heat, flushing or itching, especially at the beginning of therapy, rash and erythema. Gastric disturbances including heartburn, epigastric pain, nausea, diarrhoea, headache, asthenia, urticaria, angioedema, bronchospasm and anaphylactic reactions have been reported.
The absorption of OLBETAM is not affected by the concomitant administration of cholestyramine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
As under “SIDE-EFFECTS”.
Treatment: Withdraw the medicine. Treatment is symptomatic and supportive.

IDENTIFICATION:
Opaque hard gelatine capsule with a red cap and red brown body, containing a white to cream powder.

PRESENTATION:
Blister-packed capsules in cartons containing 90 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

SENTINEL ULCER MIXTURE

COMPOSITION:
Each 5 mL contains:

PHARMACOLOGICAL CLASSIFICATION :
11.10 Special Combinations

PHARMACOLOGICAL ACTION:
Sentinel Ulcer Mixture contains an Organic Amphoteric Bismuth Complex which has a marked astringent action on the ulcerated gastro-intestinal mucosa precipitating granulation in situ.
A proteolytic enzyme aids digestion facilitating rapid dissemination of food masses.

INDICATION:
Treatment of Gastric Ulcers

CONTRA-INDICATIONS:
Sensitivity to Bismuth Salts. Bismuth Salts are contraindicated in patients who have Colostomies or Ileostomies.

DOSAGE AND DIRECTIONS FOR USE:
One 5 mL medicine measureful in a small quantity of water three times daily after meals.
Shake the bottle before use.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Sentinel Ulcer Mixture causes discoloration of the tongue.
The effects of acute Bismuth intoxication include Anorexia, Headache, Jaundice, Albuminuria and Stomatitis. Renal Failure leading to death has occured. The syndrome of Bismuth encephalopathy (confusion, tremor and impaired co-ordination) has been reported in patients with Colostomies or Ileostomies who have been given Bismuth preparations in large doses.

Precautions:
Bismuth preparations should not be given in large doses for a prolonged period of time. Concomitant use with alcohol should be avoided. Bismuth preparations should be used with caution in constipated patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic. Consult nearest hospital or doctor immediately. Refer to symptoms as under “Side Effects and Special Precautions”. (Severe Bismuth intoxication may be treated with Dimercaprol. The excretion of Bismuth may be assisted by acidification of the urine with Ammonium Chloride.)

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A deep magenta-coloured clear solution with a slight ammoniacal odour.

PRESENTATION:
100 mL glass bottle with white concap.
350 mL glass bottle with black bakelite screw cap.

STORAGE INSTRUCTIONS:
Store below 30°C out of direct sunlight.
Keep out of reach of children.

ADRENALINE HYDROCHLORIDE TOPICAL SOLUTION

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ADRENALINE HYDROCHLORIDE TOPICAL SOLUTION

COMPOSITION:
Each mL contains 1 mg Adrenaline base as the hydrochloride.
Preservative: Chlorbutol 0,5% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 5.1 (Adrenomimetic).

PHARMACOLOGICAL ACTION:
The topical effect of Adrenaline is peripheral vasoconstriction.

INDICATIONS:
Topical application to check capillary bleeding, epistaxis, and bleeding from superficial wounds and abrasions, and after tooth extraction.

CONTRA-INDICATIONS:
Adrenaline should not be used in patients with burns because it has been reported to increase capillary oozing from the burned area.

DOSAGE AND DIRECTIONS FOR USE:
To be applied on sterile swabs in strengths of 1 –۱ ۰۰۰ to 1 –۵۰ ۰۰۰٫

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
None.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Adrenaline may cause oedema, hyperaemia, and inflammation of mucous membranes if applied frequently.

IDENTIFICATION:
Clear solution in amber vials.

PRESENTATION:
Sterile solution in 30 mL amber vials.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

AMINOPHYLLIN® ۵۰۰ SUPPOSICONES

AMINOPHYLLlN® ۲۵۰ mg/l0 mL INJECTION

AMINOPHYLLIN® ۵۰۰ mg/2 mL INJECTION

SCHEDULING STATUS:

Ampoules S4

Supposicones S1

PROPRIETARY NAME

(and dosage form):

AMINOPHYLLIN® ۵۰۰ SUPPOSICONES

AMINOPHYLLlN® ۲۵۰ mg/l0 mL INJECTION

AMINOPHYLLIN® ۵۰۰ mg/2 mL INJECTION

COMPOSITION:

AMINOPHYLLIN 500 SUPPOSICONES contain 500 mg aminophylline with 60 mg benzocaine

AMINOPHYLLIN 250 mg/10 mL INJECTION contains 250 mg aminophylline dihydrate in 10 mL

AMINOPHYLLIN 500 mg/2 mL INJECTION contains 500 mg aminophylline dihydrate in 2 mL. Contains 2% benzyl alcohol.

PHARMACOLOGICAL CLASSIFICATION:

A 10.2 Bronchodilators

PHARMACOLOGICAL ACTION :

Aminophylline is a soluble complex containing approximately 85% theophylline and 15% ethylenediamine. Aminophylline directly relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels, thus acting mainly as a bronchodilator, pulmonary vasodilator and smooth muscle relaxant.

INDICATIONS:

AMINOPHYLLIN is indicated for relief of acute bronchial asthma and reversible bronchospasm associated with chronic bronchitis and emphysema, and in status asthmaticus; congestive heart failure; Cheyne-Stokes respiration; reduction of coughing, expectoration and exertional dyspnoea in emphysema patients, and for cardiac paroxysmal dyspnoea.

AMINOPHYLLIN SUPPOSICONES are intended for use in conditions requiring less urgent and more prolonged administration. AMINOPHYLLIN INJECTIONS are primarily for use in emergency situations.

CONTRA-INDICATIONS:

AMINOPHYLLIN should not be given to patients with active peptic ulcers, since it may increase the volume and acidity of gastric secretions. Patients with a history of hypersensitivity to aminophylline or theophylline should not be treated with AMINOPHYLLIN. Do not administer AMINOPHYLLIN with other xanthine preparations. Safe use of AMINOPHYLLIN in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:

Supposicones:

Adults: One 500 mg supposicone once or twice daily.

Children: Use of the 500 mg supposicone is not recommended.

Supposicones must be removed from Rotoplast shells before use.

Ampoules:

250 mg/10 mL (Intravenous):

For intravenous administration, AMINOPHYLLIN is supplied in ampoules of 10 mL (250 mg) in aqueous solution.

Adults: 250 mg or 500 mg as required.

Children: The dose is proportionally smaller and is based upon the child’s age and body weight.

Note: AMINOPHYLLIN should be injected slowly, at a rate of 1 mL per minute. Too-rapid intravenous administration may have transient hypotensive effects.

500 mg/2 mL (intramuscular):

For intramuscular administration, AMINOPHYLLIN is supplied in ampoules of 2 mL (500 mg) in aqueous solution with 2% of benzyl alcohol.

Adults: 500 mg as required.

Children: The dose is proportionally smaller and is based upon the child’s age and body weight.

Note: The intramuscular administration of AMINOPHYLLIN is painful. The pain may last for several hours.

Therapeutic serum levels are considered to be between 10 mcg/mL and 20 mcg/mL. Levels above 20 mcg/mL may produce toxic effects.

Do not exceed the recommended dosage.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Precautions:

Some children may be unusually sensitive to AMINOPHYLLIN.

Administration of ephedrine or other sympathomimetic drugs to patients already on treatment with AMINOPHYLLIN may result in toxic synergism.

Use with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury, cor pulmonale, severe hypoxemia, hepatic impairment, or alcoholism, and in the elderly (especially males) and in neonates. Particular caution in dose administration must be exercised in patients with a history of peptic ulcer since the condition may be exacerbated. Caution should be used in giving aminophylline to patients in congestive heart failure. Serum levels in such patients may persist for long periods following discontinuation of the medicine. Theophylline half-life is shorter in smokers than non-smokers; therefore, smokers may require larger or more frequent doses.

Aminophylline may lower the seizure threshold.

Elevated serum levels of theophylline may occur in patients treated concomitantly with aminophylline and cimetidine, troleandomycin, erythromycin, allopurinol, or oral contraceptive steroids. Co-medication with phenobarbitone, phenytoin, or rifampicin may increase theophylline clearance and an increase of the aminophylline dose may be required. The excretion of lithium carbonate is increased in patients receiving aminophylline.

Consumption of coffee, tea, cola beverages, chocolate, or paracetamol contributes to falsely high serum theophylline levels when theophylline is measured spectrophotometrically without previous isolation by chromatography.

SIDE-EFFECTS:

The most consistent adverse reactions observed with therapeutic amounts of aminophylline are:

1. Gastrointestinal: nausea, vomiting, anorexia, bitter aftertaste, dyspepsia, heavy feeling in the stomach, and gastrointestinal distress.

2. Central nervous system: dizziness, vertigo, light-headedness, headache, nervousness, insomnia, and agitation.

3. Cardiovascular: palpitation, tachycardia, flushing, extrasystoles and cardiac rhythm disturbances.

4. Respiratory: increase in respiratory rate.

5. Dermatologic: urticaria.

Proctitis may follow the repeated administration of aminophylline suppositories. The benzocaine in the suppositories may cause local irritation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

The most consistent reactions observed with toxic overdoses of aminophylline are:

1. Gastrointestinal: nausea, vomiting, epigastric pain, haematemesis and diarrhoea.

2. Central nervous system: in addition to those cited above, the patient may exhibit hyperreflexia, fasciculations, and clonic and tonic convulsions. These are especially prone to occur in cases of overdosage in infants and small children.

3. Cardiovascular: in addition to those outlined above, marked hypotension and circulatory failure may be manifest.

4. Respiratory: tachypnoea and respiratory arrest may occur.

5. Renal: Increased excretion of renal tubular cells has been observed.

Management of Toxic Symptoms:

1. Discontinue drug immediately.

2. There is no known specific antidote.

3. Gastric lavage.

4. Emetic medication may be of value.

5. Avoid administration of sympathomimetic drugs.

6. Intravenous fluids, oxygen, and other supportive measures to prevent hypotension and overcome dehydration.

7. Central nervous system stimulation and seizures may respond to short-acting barbiturates.

8. Monitor serum levels until below 20 mcg/mL.

IDENTIFICATION:

AMINOPHYLLIN 500 SUPPOSICONES: white opaque wax suppositories.

AMINOPHYLLIN 250 mg/10 mL INJECTION: clear glass ampoules containing a clear, colourless to slightly yellow liquid.

AMINOPHYLLIN 500 mg/2 mL INJECTION: clear glass ampoules containing a clear colourless to slightly yellow liquid.

PRESENTATION:

AMINOPHYLLIN 500 SUPPOSICONES: boxes containing 10 suppositories

AMINOPHYLLIN 250 mg/10 mL INJECTION: boxes containing 5 ampoules

AMINOPHYLLIN 500 mg/2 mL INJECTION: boxes containing 6 ampoules

STORAGE INSTRUCTIONS:

Store in a cool dry place (below 25°C) away from light.

Keep out of reach of children.

DIPHENAMILL

REGISTRATION NUMBER:

PHARMACOLOGICAL CLASSIFICATION:
10.1 (Antitussives and Expectorants)

SCHEDULING STATUS:
S2

TRADE NAME
(and dosage form):

DIPHENAMILL

COMPOSITION:
Each 10 mL contains:

IDENTIFICATION:
Dark brown, syrupy liquid with a menthol/cherry flavour.

PHARMACOLOGICAL ACTION:
Diphenamill is an expectorant cough syrup containing the bronchodilator, Aminophylline, and Diphenhydromine HCl as an antihistamine. Ammonium Chloride and Sodium Citrate exert and expectorant action which aids the expulsion of thick bronchial mucous.

INDICATIONS:
For the relief of coughs associated with respiratory infection.

CONTRA-INDICATIONS:
Diphenamill is contra-indicated in diabetes, alcoholism (rehabilitated alcoholics), severe hypotension, peptic ulcer, gout, renal or hepatic disease and hypersensitivity to antihistamines.

DOSAGE AND DIRECTIONS FOR USE:
Adults:        Two 5 mL measuresful every 4 hours after meals.
Children:        One 5 mL measureful every 4 hours after meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
It may cause gastro-intestinal disturbances.

WARNING:
The use of this medicine leads drowsiness which is aggravated by the simultaneous intake of alcohol.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Large doses may cause gastric irritation, nausea, vomiting, thirst, headache, hyperventillation, progressive drowsiness, mental confusion and hyperchloraemic acidosis. Acidosis and electrolyte loss may be corrected by intravenous administration of Sodium Bicarbonate and Potassium Gluconate. Antihistamine overdosage causes sedation varying from slight drowsiness to deep sleep as well as dizziness, muscular weakness and inco-ordination. Since there is no specific antidote for acute antihistamine poisoning (histamine must not be used) the patient should be taken to a doctor immediately.

PRESENTATION:
Bottles of 100 mL and 2,5 L.

STORAGE INSTRUCTIONS:
Store in a cool dry place and protect from light.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

KANTREXIL SUSPENSION
KANTREXIL TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

KANTREXIL SUSPENSION
KANTREXIL TABLETS

COMPOSITION
Each tablet and each 5 mL suspension contains:

Preservatives: (In suspension)

Suspension contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION
A 11.9.1 Antidiarrhoeals in combination with anti-infective agents

PHARMACOLOGICAL ACTION
Kantrexil has antibiotic, adsorbent, protective and demulcent properties.

INDICATIONS
Treatment of specific and non-specific gastro-enteritis.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, or to other amino-glycoside antibiotics. Patients with glaucoma, myasthenia gravis and in patients with prostatic hypertrophy.

WARNINGS
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
Suspension
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.

Tablets
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.

IDENTIFICATION
Suspension: Yellow uniform suspension with lemon odour.
Tablets: Grey-white round, biconvex tablet and scored on one side.

PRESENTATION
Suspension: Glass bottles of 100 mL.
Tablets: White securitainers containing 20 and 100 tablets.

STORAGE INSTRUCTIONS
Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.

MINAMINO SYRUP

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

MINAMINO SYRUP

COMPOSITION:
Each 5 mL contains:
Amino acids 100 mg
Alanine, * Arginine, * Aspartic acid, Glutamic acid, Glycine, * Histidine, * Isoleucine, * Leucine, * Lysine, * Methionine, * Phenylalanine, Proline, * Threonine, Tryptophan, Tyrosine, * Valine.
(* ۱۰ Essential Amino acids)

Vitamins:

Minerals:

Biologicals:

Preservatives:

PHARMACOLOGICAL CLASSIFICATION:
A 22. 1.4 Vitamins – other.

PHARMACOLOGICAL ACTION:
Amino acids are the basic building blocks of proteins and enzymes and are essential for normal healthy bodily function especially during growth and convalescence. The essential amino acids cannot be made in the body and must be included in the diet or as a supplement.
Vitamins B₁, B₂, B₆ and nicotinamide form parts of co-enzyme systems concerned with release of energy from foodstuffs. Like the essential amino acids and minerals, they cannot be made in the body and must be included in the diet in small quantities. The B-complex vitamins are water-soluble and are not stored in the body in appreciable amounts. Consequently, regular replenishment of these vitamins is required. Their presence prevents the development of certain deficiency diseases such as beri-beri, riboflavinosis and pellagra.
Iron is essential for haemoglobin formation and is needed to prevent iron-deficiency anaemia. Vitamin B₁₂ is the extrinsic factor, which together with the intrinsic factor found in gastric mucosa will prevent pernicious anaemia. Liver extract contains variable amounts of Vitamin B₁₂, folic acid and other blood-building factors.
Manganese, copper and iron are components of important enzyme systems essential for normal body functioning.

INDICATIONS:
Minamino is used as a supplement in the treatment of conditions associated with deficiency of certain B-complex vitamins, minerals and amino acids, such as severe infections, degenerative diseases, endocrine dysfunction, surgical procedures, injuries, burns, old age, beri-beri, riboflavinosis or pellagra.

WARNINGS:
In the U.S.A. the Eosinophilia Myalgia Syndrome has been associated with the intake of L-Tryptophan.

DOSAGE AND DIRECTIONS FOR USE:
Shake before use
Adults: Two medicine measures (10 mL) one to three times daily.
Children: One medicine measure (5 mL) in a little water, four times a day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
As Minamino contains sugar, it is not suitable for diabetics.

IDENTIFICATION:
Minamino is a dark, syrupy liquid having a characteristic taste and odour.

PRESENTATION:
Minamino is packed in amber glass bottles of 200 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

AMILORETIC® TABLETS
AMILORETIC® H.S. TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

AMILORETIC^® TABLETS
AMILORETIC^® H.S. TABLETS

COMPOSITION:
Each Amiloretic tablet contains:

Each Amiloretic H.S. tablet contains

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics.

PHARMACOLOGICAL ACTION:
Hydrochlorothiazide and amiloride are both oral diuretics which act by reducing reabsorption of electrolytes from the renal tubules thereby increasing the excretion of sodium and chloride ions and consequently of water. Hydrochlorothiazide also increases the excretion of potassium ions while amiloride has the opposite effect and has been found to diminish the kaluretic effects of other diuretics i.e. hydrochlorothiazide in this combination.
Hydrochlorothiazide slightly increases the bicarbonate excretion without appreciable alteration to the acid-base balance or the pH of the urine. It has an anti-hypertensive effect and enhances the action of other hypotensive agents.

INDICATIONS:
Oedema of cardiac decompensation or associated with hepatic cirrhosis and corticosteroid therapy.
Essential hypertension.

CONTRA-INDICATIONS:
Patients with a hypersensitivity towards either hydrochlorothiazide or amiloride. Severe renal and/or hepatic insufficiency.
Patients with hyperkalaemia.
Safety in pregnancy, lactation and childhood has not been established.
Chlorothiazide crosses the placenta which may cause neonatal jaundice, thrombocytopenia, and electrolyte imbalances. Chlorothiazide is excreted in the breast milk. Treatment with thiazide diuretics can inhibit lactation.
The safe use of hydrochlorothiazide is contentious in patients with porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Amiloretic: One tablet daily.
Amiloretic H.S.: One to two tablets daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Amiloride hydrochloride:
The following side-effects may occur: nausea, vomiting, abdominal pain, diarrhoea or constipation, paraesthesia, thirst, dizziness, skin rash, pruritus, weakness, muscle cramps, and minor psychiatric or visual changes. Orthostatic hypotension and rises in blood-urea-nitrogen concentrations have been reported. Its potassium-sparing effect may lead to hyperkalaemia. Occasional abnormalities in liver-function tests have been reported.
Hydrochlorothiazide:
The following side-effects have been reported: anorexia, gastric irritation, nausea, vomiting, constipation, diarrhoea, headache, dizziness, postural hypotension, paraesthesia, impotence, and yellow vision. Hypersensitivity reactions include skin rashes, photosensitivity, pulmonary oedema, and pneumonitis. Cholestatic jaundice, pancreatitis, and blood dyscrasias including thrombocytopenia and, less frequently, granulocytopenia, leucopenia, and aplastic- and haemolytic anaemia have been reported.

SPECIAL PRECAUTIONS:
Amiloride:
Amiloride should not be given to patients with hyperkalaemia or progressive renal failure and should not be given with other potassium-sparing drugs or potassium supplements. Elderly patients, and patients with impaired renal function or diabetes mellitus, are at particular risk of developing hyperkalaemia. It should be given with care to patients likely to develop acidosis, to patients with diabetes mellitus, and to those with impaired hepatic or renal function. Amiloride should be discontinued at least 3 days before glucose-tolerance tests are given to patients with diabetes mellitus because of the risks if patients are hyperkalaemic. Serum electrolytes and blood-urea-nitrogen should be estimated periodically.
Hydrochlorothiazide:
Hydrochlorothiazide should be used with caution in patients with impaired hepatic function since they may increase the risk of hepatic encephalopathy. They should also be given with caution in renal impairment since they can further reduce renal function. They may precipitate attacks of gout in susceptible patients. All patients should be carefully observed for signs of fluid and electrolyte imbalance, especially in the presence of vomiting or during parenteral fluid therapy. Thiazide diuretics may exacerbate or activate systemic lupus erythematosus in susceptible patients.
Hydrochlorothiazide and other thiazide diuretics may enhance the neuromuscular blocking action of competitive muscle relaxants, such as tubocurarine. They may enhance the effect of antihypertensive agents, while postural hypotension associated with thiazide diuretic therapy may be enhanced by concomitant ingestion of alcohol, barbiturates or opioids. The potassium depleting effect of thiazide diuretics may be enhanced by corticosteroids, corticotrophin, or carbenoxolone.
Hydrochlorothiazide and other thiazide diuretics may cause a number of metabolic disturbances. They may provoke hyperglycaemia and glycosuria in diabetic and other susceptible patients. They may cause hyperuricaemia and precipitate attacks of gout in some patients. Administration of thiazide diuretics may be associated with electrolyte imbalances including hypochloraemic alkalosis, hyponatraemia, and hypokalaemia. Hypokalaemia intensifies the effect of digitalis on cardiac muscle and administration of digitalis or its glycosides may have to be temporarily suspended. Patients with severe coronary artery disease and cirrhosis of the liver are particularly at risk from hypokalaemia.
Hyponatraemia may occur in patients with severe congestive heart failure who are very oedematous, particularly with large doses in conjunction with restricted salt in the diet. The urinary excretion of calcium is reduced. Hypomagnesaemia has also occurred. There is some evidence to suggest that electrolyte imbalances during long-term treatment with thiazides may be associated with an increased incidence of cardiac arrhythmias. Adverse changes in plasma lipids have also been noted, but their clinical significance is unclear.
Signs of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain and cramps and gastro-intestinal disturbances.
Concomitant administration of thiazide diuretics and lithium is not generally recommended since the association may lead to toxic blood concentrations of lithium. Blood-glucose concentrations should be monitored in patients taking antidiabetic agents, since requirements may change. Thiazide diuretics may interfere with a number of diagnostic tests, including tests for parathyroid function; serum concentrations of protein-bound iodine may increase without signs of thyroid disturbance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Dehydration, hypochloraemic alkalosis and hypokalaemia or hyperkalaemia.
See “Side-effects and Special Precautions”.
Treatment is symptomatic and supportive.

IDENTIFICATION:

PRESENTATION:
Packs containing 30, 100, 500 and 1000 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.