HYTRIN Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Hytrin 2 mg Tablets. Terazosin 2 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 2 mg of terazosin as monohydrochloride dihydrate. Excipients with known effect: Lactose (127.28 mg) Quinoline yellow aluminium lake E104 (0.100 mg) For a full list of excipients, see ...
Pharmaceutical form
Yellow, round, flat bevelled tablets embossed with logo and triangular facets on one face and plain on the other.
Therapeutic indications
Orally administered Hytrin is indicated in adults for the treatment of mild to moderate hypertension. It may be used in combination with thiazide diuretics and/or other antihypertensive drugs or as sole ...
Posology and method of administration
Posology Paediatric population Hytrin Tablets are not recommended for use in children. Safety and efficacy in children has not been established. Elderly Pharmacokinetic studies in the elderly indicate ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known sensitivity to other alpha-adrenoceptor blockers. Patients with a history of micturition syncope.
Special warnings and precautions for use
Terazosin hydrochloride, like other alpha-adrenoceptor blockers, can cause marked lowering of blood pressure, especially postural hypotension and syncope in association with the first dose or first few ...
Interaction with other medicinal products and other forms of interaction
In patients receiving terazosin plus ACE inhibitors or diuretics the proportion reporting dizziness or related side effects was greater than in the total population of terazosin treated patients from clinical ...
Pregnancy and lactation
Pregnancy Terazosin hydrochloride was not teratogenic in either rats or rabbits when administered at oral doses up to 1330 and 165 times, respectively, the maximum recommended human dose. Fetal resorptions ...
Effects on ability to drive and use machines
Terazosin tablets have a major influence on the ability to drive and use machines. Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent ...
Undesirable effects
Hytrin in common with other alpha-adrenoceptor blockers may cause syncope. Syncopal episodes have occurred within 30 to 90 minutes of the initial dose of the drug. Syncope has occasionally occurred in ...
Overdose
Symptoms Acute hypotension. Management Cardiovascular support is of first importance. Restoration of blood pressure and normalisation of heart rate may be accomplished by keeping the patient in a supine ...
Pharmacodynamic properties
Pharmacotherapeutic group: alpha-adrenoreceptor antagonists ATC Code: G04CA03 Mechanism of action Although the exact mechanism of the hypotensive action is not established, the relaxation of peripheral ...
Pharmacokinetic properties
Absorption Terazosin is well absorbed (80-100%). Terazosin has a minimal first pass effect and almost the complete dose of terazosin is systematically available. The plasma concentration of the parent ...
Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology. No evidence of a genotoxic effect of terazosin has been reported from in vitro and in vivo investigations ...
List of excipients
Lactose Maize starch Pregelatinised starch Purified talc Magnesium stearate Purified water Dye yellow (quinolone yellow, E104)
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Tablets in a blister pack. The 2mg tablets are supplied in a pack of 28 tablets. Blisters are packaged in a carton with a package insert. Starter Pack for Hypertension: The 2mg tablets form part of a starter ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0029
Date of first authorization / renewal of the authorization
23/12/1986
Date of revision of the text
05/10/2018
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