HYPOVASE Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Hypovase 1 mg tablets.
Qualitative and quantitative composition
Prazosin hydrochloride equivalent to 1 mg prazosin based on a potency of 93.1 % base activity. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White oblong tablets scored on both sides and engraved M6 on one side. The tablet can be divided into equal doses.
Therapeutic indications
Hypertension Hypovase is indicated in the treatment of all grades of essential (primary) hypertension and all grades of secondary hypertension of varied aetiology. It can be used as the initial and sole ...
Posology and method of administration
Posology Hypertension The dosage range is from 500 micrograms 20 mg daily. It is recommended that therapy be initiated at the lowest dose, 500 micrograms, twice or three times daily for three to seven ...
Contraindications
Hypersensitivity to prazosin, other quinazolines, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In patients with benign prostatic hyperplasia Hypovase is not recommended for patients with a history of micturition syncope. Hypovase decreases peripheral vascular resistance and since many patients with ...
Interaction with other medicinal products and other forms of interaction
Hypovase has been administered without any adverse drug interaction in clinical experience to date with the following: <u>Cardiac glycosides:</u> digitalis and digoxin. <u>Hypoglycaemic agents:</u> insulin, ...
Fertility, pregnancy and lactation
Fertility A decrease in fertility in male and female rats treated with prazosin hydrochloride was observed at high non-clinically relevant doses (225 times the usual maximum recommended human dose). However ...
Effects on ability to drive and use machines
When instituting therapy with any effective antihypertensive agent, the patient should be advised on how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. ...
Undesirable effects
The following side-effects have been associated with Hypovase therapy: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequencies are ...
Overdose
Should over-dosage lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient ...
Pharmacodynamic properties
Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists ATC code: C02CA01 Hypovase causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors ...
Pharmacokinetic properties
Following oral administration in normal volunteers and hypertensive patients plasma concentrations of prazosin reach a peak in one to two hours with a plasma half-life of two to three hours. Pharmacokinetic ...
Preclinical safety data
Prazosin hydrochloride was not mutagenic in genetic toxicology testing, and was not carcinogenic in rats. In chronic studies (>1 year) conducted with prazosin hydrochloride in rats and dogs, testicular ...
List of excipients
Calcium phosphate dibasic anhydrous Maize starch Microcrystalline cellulose Magnesium stearate Sodium lauryl sulfate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
PVC/Aluminium blisters in cartons of 60 tablets (blister strips of 4 15 tablets).
Special precautions for disposal and other handling
No special requirements for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0106R
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 October 1988 Date of last renewal: 22 November 2004
Date of revision of the text
04/2021
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