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Tavegyl |
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Antiallergic and antipruritic agent.
Tablet:
Active substance: 1mg clemastinum (as clemastine fumarate)
Syrup:
Active substance: 0.05g/ml clemastinum (as clemastine fumarate);
Excipients conserv.: E 214, 216, saccharinum, aromatica, propylenglycolum, excip. ad solut.
Ampoule (2ml):
Active substance: 1mg/ml clemastinum (as clemastine fumarate);
Excipients, sorbitolum, ethanolum, propylenglycolum, natrii citras, aqua q.s. ad solut.
What is Tavegyl used for?
When must Tavegyl not be used?
What precautions are required when using Tavegyl?
Can Tavegyl be used during pregnancy or when breast feeding?
What undesirable side effects can Tavegyl have?
Dosage
Drug Interaction
Remarks
What is Tavegyl used for?
Tavegyl is an H1 histamine receptor antagonist of the piperidine derivative group (pyrrolidine type). It selectively inhibits the H1 histamine receptors and reduced capillary permeability. Tavegyl possesses anti-histaminic and anti-pruritic properties. Its effect can last for up to 12 hours.It is favorable in Urticaria and Scabies.
Oral forms (syrup and tablets):
Indicated for hay fever and other forms of allergic rhinitis. Urticaria including dermatographia. Pruritus, itching dermatoses. Adjuvant treatment of acute and chronic eczema, contact eczema and iatrogenic eruptions. Insect stings and bites.
Ampoules:
Adjuvant treatment of anaphylactic and anaphylactoid shock and Quincke¡¯s oedema (angioneurotic oedema).
Prevention or treatment of allergic and pseudo-allergic reactions, e.g. to contrast media, during blood transfusion or during histamine test.
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When must Tavegyl not be used?
Known hypersensitivity to Tavegyl or to other antihistamines of similar structure.
Tavegylt must not be administered to children under 1 year of age.
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What precautions are required when using Tavegyl?
Tavegyl ampoule must not be given by intra-arterial injection. Intravenous injection must be performed slowly (over 2 to 3 minutes). Particularly when given by the parenteral route, Tavegyl may have a sedative effect. This must be taken into account when driving vehicles or using machines. The sedation may also be very marked in young children. Depressing of the central nervous system may occur, particularly in infants.
Antihistamines should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or prostatic hypertrophy with urinary retention and bladder outlet obstruction.
Tavegyl should be kept out of reach of children.
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Can Tavegyl be used during pregnancy or when breast feeding?
No teratogenic effect has been found in animal studies, but embryotoxicity was observed in rats given very large doses. There have been no controlled studies in pregnant women. Consequently, this medicine may be administered only if the potential benefit outweighs the risk to the foetus.
Breast-feeding should be discontinued if it is absolutely necessary to give Tavegyl to a nursing mother.
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What undesirable side effects can Tavegyl have?
Fatigue and sedation, particularly following parenteral administration and in young children. Occasionally CNS stimulation, especially in children. Rarely dry mouth, head aches, dizziness, skin rash, nausea, stomach-ache and constipation.
Hypersensitivity reactions with respiratory distress and/or states of shock have been observed in a few very rare cases after the i.v. injection of Tavegyl.
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What else needs to be taken into account?
Dosage:
Oral forms:
Swallow the Tavegyl tablets with little water before emals.
Adults and children over 12 years of age:
1 tablet or 10ml syrup morning and evening. Up to 6 tablets or 60ml syrup daily may be given in refractory cases.
Children under 12 years of age:
Before breakfast and at bedtime:
1 - 3 years of age: 2.5ml - 5ml syrup
3 - 6 years of age: 5ml syrup
6 - 12 years of age: 7.5ml syrup or 1/2 - 1 tablet
Injectable forms:
Adults: the usual dose is 1 ampoule (2ml = 2mg) by i.v. or i.m. injection morning and evening. To prevent anaphylactic or histamine-induced reactions, 1 ampoule (2ml) should be given by slow i.v. injection immediately before possible occurrence. The solution in the ampoule may be diluted 1:5 with isotonic saline or 5% glucose.
Children: 0.025mg/kg daily by i.m. injection in two divided doses.
Overdosage:
Symptoms: The CNS effects of antihistamine overdosage vary between depression and stimulation. Excitation is particularly common in children. Anticholinergic effects such as dry mouth, fixed dilated pupils, flushing and gastro-intestinal reactions may also occur.
Management: Eliminatiom of the drug by gastric lavage and administration of activated charcoal, plus symptomatic therapy. TOP
Drug Interaction:
Antihistamines enhance the effects of sedaties, hypnotics, MAO inhibitors and alcohol. /
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Remarks:
Tablets, ampoules: Store below 30¢ªC.
Syrup: Store below 25°C
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Packaging:
Tablets: Packs of 20
Syrup: Bottles of 100ml
Ampoules: Packs of 3 ampoules 2ml
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