- Each tablet contains Doxazosin Mesylate (Ph Eur) equivalent to Doxazosin 1 mg.
- Each tablet contains Doxazosin Mesylate (Ph Eur) equivalent to Doxazosin 4 mg.
Doxazosin Mesylate is a quinazoline derivative postsynaptic alpha1 adrenergic blocking agent. In patients with symptomatic benign prostatic hyperplasia (BPH), urodynamics and symptoms are improved by the use of ELAXICOPA, this is due to selective blockade of alpha1-receptors in muscles of prostate and neck of the bladder.
In hypertension, Doxazosin competitively inhibits postsynaptic alpha-adrenergic receptors, which results in vasodilation of veins and arterioles and a decrease in total peripheral resistance and blood pressure.
Clinical studies in hypertensives have shown that doxazosin produces slight plasma concentration reductions in triglycerides and total cholesterol as well as LDL fraction.
Treatment with ELAXICOPA has been shown to result in regression of left ventricular hypertrophy as well as an improved insulin sensitivity in patients with such impairment.
ELAXICOPA is indicated in the treatment of:
- Benign Prostatic hyperplasia (BPH): Treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH.
Hypersensitivity to the doxazosin or other gurnazolnes such as: prazosin, terazosin or any component of the formulation.
- Use with caution in patients with hepatic impairment, renal impairment and heart failure.
- Care should be taken with the initial dose as marked hypotension (postural hypotension) may occur with the first dose. Similar effect may also occur if dosage is increased rapidly, or if therapy is interrupted for a few days.If ELAXICOPA administration is discontinued for several days, therapy should be restarted using the initial ELAXICOPA regimen.
- To decrease the likelihood of excessive hypotension and syncope. it’s essential that treatment of BPH and hypertension be initiated with 1 mg dose.
- Prostate cancer should be ruled out before commencing therapy with ELAXICOPA for BPH.
- Safety and efficacy of doxazosin in children younger than 18 years of age have not been established.
Postural hypotension, dizziness. Headache, somnolence, nausea, diarrhoea, dry mouth, dyspepsia, vomiting, oedema, rash. pruritus. vertigo. fatigue. asthenia, rhinitis, less frequently abdominal discomfort, agitation, tremor rarely blurred vision, thrombocytopenia. purpura, leucopenia, hepatitis, jaundice, cholestasis. urinary Incontinence, isolated cases of priapism and impotence reported.
Enhanced hypotensive effect may occur when ELAXICOPA is co-administered with beta-blockers, diuretics, angiotensin converting enzyme inhibitors. calcium channel blockers and other antihypertensive drugs.
Nonsteroidal anti-inflammatory drugs and phosphodiesterase type 5 inhibitors such as: Sildenafil may antagonize the hypotensive effect of ELAXICOPA.
USE DURING PREGNANCY AND LACTATION
There are no adequate and controlled studies for the use of doxazosin in pregnant and nursing women, so ELAXICOPA should be used only if clearly necessary during pregnancy and lactation.
Dosage must be individualized depending on the individual patient’s response.
Benign Prostate Hyperplasia dosage:
- The initial dosage of ELAXICOPA is 1 mg given once daily in the morning or in the evening. Depending on the individual patient’s urodynamics and BPH symptomatology. dose may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily.
- The recommended titration interval is 1 to 2 weeks.
- The maximum recommended dose for BPH is 8 mg once daily.
The following dosage schedule with ELAXICOPA 1 mg is recommended for the start of treatment:
- 1st to 8th days: 1 mg of doxazosin once daily.
- 9th to 14th day: 2 mg of doxazosin once daily.
- Thereafter individual titration to the required maintenance dose.
The initial dosage of ELAXICOPA is 1 mg once daily. Depending on the individual patient’s standing blood pressure response, dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg and 16 mg to achieve the desired reduction in blood pressure. The recommended titration interval is 1 to 2 weeks. The maximum recommended dose for treatment of hypertension is 16 mg once daily.
Overdosage should lead to hypotension. the patient should be immediately placed in supine, head down position. Other supportive measures such as IV infusion of fluids should be performed if thought appropriate in individual cases. Since doxazosin is highly protein bound, dialysis is not indicated.
INFORMATION FOR PATIENT
Patients should be made aware of the possibility of syncope and orthostatic symptoms, especially at the initiation of therapy and urged to avoid driving or operate heavy machinery for 24 hours after the first dose, after a dosage increase and after interruption of therapy when treatment is resumed.
Store at room temperature (15 to 25) degrees celsius. Do not use the drug after the expiry date printed on the package.
Categories and tags: C02CA04, Doxazosin, Alpha-adrenoreceptor antagonists, ANTIADRENERGIC AGENTS, PERIPHERALLY ACTING, ANTIHYPERTENSIVES, CARDIOVASCULAR SYSTEM Medicines.