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DOXAZOSIN 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 (BPH).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The duration of therapy will be decided by the physician.
Hypertension:
The usual dosage limits of doxazosin lie between 1 and 8 mg per day. The maximum recommended dosage is 16 mg per day. The initial dosage is 1 mg, to be taken before retiring to bed. This dose is maintained for 1 or 2 weeks. The dose can then be increased to 2 mg once a day for another 1 or 2 weeks.
If necessary the daily dose can then be gradually increased, observing equal intervals, to 4, 8 and 16 mg once a day, depending on the patient's response.
The maximum daily dose should not exceed 16mg Benign prostate hyperplasia:
The initial dose of doxazosin is 1 mg (1 mg tablet) on the 1st to 8th day once daily and 2 mg (2 mg tablet) on the 9th to 14th day. Subsequently, dose should be titrated individually to 4 mg and to the maximum recommended dosage of 8 mg, depending on the urodynamic parameters and the BPH symptomatology of the patient.
The recommended titration interval is 1 to 2 weeks. The usual recommended dose is 2-4 mg daily. Doxazosin is administered once a day. If the doxazosin treatment has been stopped for a number of days, the regimen should be determined again.
Renal impairment Because the pharmacokinetics of doxazosin remain unchanged in patients with renal insufficiency, and no evidence exists that doxazosin will exacerbate an existing renal insufficiency, the application of the usual dosages is generally advised.
As in rare cases an increased sensitivity cannot be ruled out, a more cautious approach with respect to initiating the treatment in such patients may be called for. As doxazosin is highly protein bound, it is not removed by dialysis.
Elderly Normal adult dosage. In common with other drugs of this class, dosage should be kept as low as possible and increments made under close supervision. Hepatic impairment The doxazosin dose should be titrated particularly carefully in patients with impaired liver function.
4). Paediatric population The safety and efficacy of Doxazosin mesilate in children and adolescents have not been established. Method of administration The tablets should be taken with a sufficient amount of water once daily.
Hypotension In clinical trials involving patients with hypertension, the most common reactions associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific. Benign prostatic hyperplasia Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
) Ear and labyrinth disorders Common Vertigo Uncommon Tinnitus Cardiac disorders Common Palpitation Tachycardia Uncommon Angina pectoris Myocardial infarction Very rare Bradycardia Cardiac arrhythmias Vascular disorders Common Hypotension Postural hypotension Very rare Hot flushes Respiratory, thoracic and mediastinal disorders Common Bronchitis Cough Dyspnoea Rhinitis Uncommon Epistaxis Very rare Bronchospasm Gastrointestinal disorders Common Abdominal pain Dyspepsia Dry mouth Nausea Uncommon Constipation Diarrhoea Flatulence Vomiting Gastroenteritis Hepatobiliary disorders Uncommon Abnormal liver function tests Very rare Cholestasis Hepatitis Jaundice Skin and subcutaneous tissue disorders Common Pruritus Uncommon Skin rash Very rare Alopecia Purpura Urticaria Musculoskeletal and connective Common Back pain tissue disorders Myalgia Uncommon Arthralgia Rare Muscle cramps Muscle weakness Renal and urinary disorders Common Cystitis Urinary incontinence Uncommon Dysuria Micturition frequency increased Hematuria Rare Polyuria Very rare Increased diuresis Micturition disorder Nocturia Reproductive system and breast disorders Uncommon Impotence Very rare Gynaecomastia Priapism Not known Retrograde ejaculation General disorders and administration site conditions Common Asthenia Chest pain Influenza-like symptoms Peripheral oedema Uncommon Pain Facial oedema Very rare Fatigue Malaise Investigations Uncommon 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.
Postural Hypotension/Syncope:
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.
Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects. When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop.
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 antihypertensive 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 Use in hepatically impaired patients: 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 there is no clinical experience in patients with severe hepatic impairment, using doxazosin in these patients is not recommended.
g. prazosin, terazosin). - patients with history of orthostatic hypotension - patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones - BPH patients with hypotension.
Doxazosin is contraindicated as monotherapy in patients with overflow bladder, anuria or 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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Use in patients with renal impairment:
There is no evidence that doxazosin aggravates renal dysfunction. However, doxazosin dosage introduction and adjustment should be carried out with great care.
Use with PDE-5 inhibitors:
Concomitant administration of doxazosin with phosphodiesterase-5-inhibitors (eg sildenafil, tadalafil, and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients.
To reduce the risk of orthostatic hypotension it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. 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.
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 cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery. Chronic heart failure The mean terminal half-life of doxazosin is 22 hours.
This may be prolonged in patients with congestive heart failure. The rate of dose adjustment may need to be slowed. In some patients with left ventricular failure, the decrease in left ventricular filling associated with vigorous therapy may result in a significant fall in cardiac output and systemic blood pressure after administration of doxazosin.
These effects should be kept in mind when introducing therapy and continuous adjustment of dose used.
Screening for Prostate Cancer:
Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders can co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment of BPH symptoms.
Excipient(s) Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.