Class: Genitourinary System
Dosage Form: Tablets
Doxazosin mesylate………………1, 2, and 4 mg
Microcrystalline cellulose, lactose, magnesium stearate, sodium laurylsulphate, sodium starch glyconate.
In patients with symptomatic BPH, urodynamics and symptoms are improved by the use of Cardura. This effect is due to selective blockade of alhpa1-receptors in muscles of prostate and neck of the bladder. Doxazosin has been shown to be an effective blocker of the I.A. subtypes of the alpha1-adrenoreceptor which account for over 70% of the subtypes in the Prostats. This accounts for BPH patients.
In hypertensives, blockage of alpha1-receptors in vascular smooth muscles results in peripheral vasodilation. This leads to blood pressure reduction by means of a decrease in peripheral vascular resistance.
Tolerance has not been observed. Elevations of plasma renin activity and tachycardia were seen infrequently.
Clincal studies in hypertensives have shown that doxazosic produces slight plasma concentration reduction in triglycerides and total cholesterol as well as LDL fraction.
Treatment with Cardura has been shown to result in regression of left ventricular hypertrophy as well as an improved insulin sensitivity in patients with such impairment.
Cardura is indicated in:
- Benign Prostatic Hyperplasia (BPH)
Cardura potentiates the blood pressure lowering action of other antihypertensive drugs.
At the start of treatment adverse reactions occur, which disappear in most cases with continued treatment or subside so that the patients can tolerate.
The following may occur:
- Circulatory disorders with tendency for blood pressure fall when changing positions for instance from lying to standing, rarely associated with syncope.
- Dizziness, headache, nausea, fatigue, malaise, vertigo, asthenia, edema, dry mouth, palpitation, somnolence, rhnitis and non-specific gastrointestinal side effects, rarely non-specific skin reactions.
- Extremely rare cases of urinary incontinence were reported.
The following additional adverse events have been reported that are typical among patients treated for hypertension, but it’s not clear whether these can be attributed to the intake of Cardura like: tachycardia, palpitation, cehst pain, angina pectoris, myocardial infarction, cardiac arryhtmias and cerebrovascular accident. Isolated cases of priapism have been reported to be associated with alpha-1-antagonists, including doxazosin. In patients with BPH, a similar adverse event profile had been inidicated in the controlled clincial trials.
Special Note: After the start of treatment, circulatory disorders with a tendency for blood pressure fall when changing position may occur. Since such adverse reactions are more likely at higher doses than the recommended intial dose, dosage instructions should be carefully adhered to.
Dosage and Administration:
Unless otherwise prescribed the following dosage guidelines are recommended.
1. In Benign Prostatic Hyperplasia:
Therapy should be initiated by Cardura 1 mg tablet once daily. The daily dosage should then be increaesd after one to two weeks to 2 mg doxazosin once daily and if necessary to 4 mg of doxazocin once daily as determined by patient response.
The maximum recommended dose is 8 mg of doxazocin once daily.
The following dosage schedule with Cardura 1 mg is recommended for the start of treatment:
- 1st to 8th day: 1 Cardura 1 mg tablet (1 mg of doxazocin), once daily.
- 9th to 14th day: 2 Cardura 1 mg tablet (2 mg doxazocin) , once daily.
Thereafter individual titration to the required maintenance dose.
For this purpose, tablets with 2 mg and 4 mg are available.
The usual dose is 2-4 mg once daily.
Doxazocin may be administered either in the morning or in the evening.
2. In Hypertension:
The same as the above. However, the maximum recommended dose of Doxazocin in hypertension is 16 mg once daily.
Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures should be perfromed if thought appropriate in individual cases. Since doxazocin is highly protein bound, dialysis is not indicated.
Pregnancy and Lactation:
Cardura should not be used during pregnancy or lactation because clinical experience is not available.
Animal experience did not reveal any teratogenic potential.
Effects on driving and operating machinery: Treatment with Cardura requires periodic medical check-up because of individually different reactions the ability to engage in activities such as operating machinery or driving motor vehicles may be impaired, especially when initiating therapy, upon drug switching and upon simultaneous alcohol consumption.
Pack of 3 or 2 strips of 5 capsules each.
Store at room temperature, below 25°C.