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DOXAZOSIN TEVA is a brand name for Doxazosin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Essential hypertension. Symptomatic treatment of benign prostatic hyperplasia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The maximum recommended dose is 8 mg doxazosin once daily.
Essential hypertension:
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Symptomatic treatment of prostatic hyperplasia:
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. Doxazosin Teva may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
In hypertensive patients both conditions are treated concomitantly. As with any other medication of this type it is prudent medical practice to monitor the patient during the initial period of therapy. Elderly Same dosage as for adults.
Renal impairment Since there is no significant variation in pharmacokinetics in patients with impaired renal function the usual adult dose of doxazosin tablets is recommended. Doxazosin tablets are not dialyzable. Hepatic impairment As with any drug completely metabolised by the liver, doxazosin tablets should be administered with caution to patients with evidence of impaired hepatic function (see section
The frequencies of adverse events are ranked according to the following: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000), very rare (<1/10 000), not known (cannot be estimated from the available data).
4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycardia, cardiac arrhythmias Vascular disorders Hypotension, postural hypotension Flush Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnoea, rhinitis Epistaxis Bronchospasm Gastrointest inal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, diarrhoea, flatulence, vomiting, gastroenteritis Gastrointesti nal obstruction Hepato- biliary Abnormal liver function Cholestasis, System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,000) Not known disorders tests hepatitis, jaundice Skin and subcutaneou s tissue disorders Pruritus Skin rash Alopecia, purpura, urticaria Musculoskel etal, connective tissue and bone disorders Back pain, myalgia Arthralgia Muscle cramps, muscle weakness Renal and urinary disorders Cystitis, urinary incontinence Dysuria, hematuria, micturition frequency Micturition disorder, nocturia, polyuria, increased diuresis Reproductiv e system and breast disorders Impotence Gynecomastia, priapism Retrograde ejaculation General disorders and administrati on site conditions Asthenia, chest pain, influenza- like symptoms, peripheral oedema Pain, facial oedema Fatigue, malaise Investigatio ns Weight increase Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
). Paediatric population The safety and efficacy of Doxazosin Teva in children and adolescents have not been established. Method of administration Doxazosin Teva can be taken with or without food. The tablets must be swallowed whole with a sufficient amount of liquid.
4). 1 • Patients with a history of orthostatic hypotension • Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. • Patients with a history of gastro- intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract1 • Patients with hypotension2 Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.
4 Special warnings and precautions for use 1 For patients taking the sustained release tablets only 2 For the benign prostatic hyperplasia indication only Information to be given to the patient: Patients should be informed that Doxazosin Teva tablets should be swallowed whole.
Patients should not chew, divide or crush the tablets. For some prolonged-release formulations the active compound is surrounded by an inert, non absorbable coating that is designed to control the release of the drug over a prolonged period.
After transit through the gastrointestinal tract, the empty tablet shell is excreted. Patients should be advised not to be concerned if they occasionally observe remains in their stools that look like a tablet. g. following surgical resection) could result in incomplete absorption.
In view of the long half life of doxazosin the clinical significance of this is unclear.
Initiation of Therapy:
In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy.
1 • Patients with a history of orthostatic hypotension • Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. • Patients with a history of gastro- intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract1 • Patients with hypotension2 Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Doxazosin in United Kingdom.
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Therefore, it is prudent medical practise to monitor blood pressure on initiation of therapy to minimise the potential for postural effects. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of doxazosin therapy.
Priapism:
Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.
Use in patients with acute cardiac conditions:
As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute cardiac conditions: - pulmonary oedema due to aortic or mitral stenosis - heart failure at high output - right-sided heart failure due to pulmonary embolism or pericardial effusion - left ventricular heart failure with low filling pressure In hypertensive patients with one or more additional risk factors for cardiovascular disease, Doxazosin Teva should not be used as a single agent for the treatment of hypertension due to a possible increased risk for development of heart failure.
Hepatic impairment:
As with any drug wholly metabolised by the liver, doxazosin should be administered with particular caution to patients with evidence of impaired hepatic function. Since no clinical experience from patients with severe hepatic impairment exists, use in these patients is not recommended.
g. cimetidine). Doxazosin Teva may influence plasma renin activity and urinary excretion of vanillylmandelic acid. This should be considered when interpreting laboratory data. g. sildenafil, tadalafil, vardenafil) and doxazosin may lead to symptomatic hypotension in some patients.
In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of phospodiesterase-5- inhibitors. Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin.
No studies have been conducted with doxazosin prolonged release formulations.
Use in patients undergoing cataract surgery:
The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded.
As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Screening for prostate cancer:
Carcinoma of the prostate causes many of the symptoms associated with BHP and the two disorders can co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment with BPH symptoms.
Excipient(s) Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per prolonged- release tablet, that is to say essentially ‘sodium-free’.