Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Atodel is indicated in the treatment of all grades of essential (primary) hypertension and of all grades of secondary hypertension of varied aetiology. It can be used as the initial and sole agent or it may be employed in a treatment regimen in conjunction with a diuretic and/or other antihypertensive drug as needed for proper patient response.
Atodel may be added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides.
Atodel is indicated for the symptomatic treatment of patients with Raynaud’s phenomenon and Raynaud’s disease.
Atodel is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). It may therefore be of value in patients awaiting prostatic surgery.
The dosage range is from 0.5 mg – 20 mg daily. It is recommended that therapy be initiated at the lowest dose, 0.5 mg, twice or three times daily for three to seven days, with the starting dose administered in the evening.
This dose should be increased to 1 mg twice or three times daily for a further three to seven days. Thereafter, the daily dose should be increased gradually as determined by the patient’s response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Atodel alone of up to 15 mg daily in divided doses. Maximum recommended daily dosage: 20 mg in divided doses.
If additional diuretic therapy is to be introduced, the dose of Atodel should be at least halved.
The dosage of the other drug should be halved and Atodel initiated at 0.5 mg in the evening, then continuing with 0.5 mg twice or three times daily. Subsequent dosage increase should be made gradually depending upon the patient’s response.
There is evidence that adding prazosin to angiotensin converting enzyme inhibitor, beta-adrenergic antagonist or calcium antagonist therapy may bring about a substantial reduction in blood pressure. Therefore, the low initial dosage regimen is recommended.
The recommended starting dose is 0.5 mg two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient’s clinical response, based on careful monitoring of cardiopulmonary signs and symptoms, and when indicated, haemodynamic studies. Dosage may be adjusted as often as every two to three days in patients under close medical supervision. In severely ill, decompensated patients, rapid dosage adjustment over one to two days may be indicated and is best done when haemodynamic monitoring is available. In clinical studies the therapeutic dosages ranged from 4 mg to 20 mg daily in divided doses. Adjustment of dosage may be required in the course of Atodel therapy in some patients to maintain optimal clinical improvement.
Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.
The recommended starting dosage is 0.5 mg twice daily given for a period of three to seven days and should be adjusted according to the patient’s clinical response. Usual maintenance dosage is 1 mg or 2 mg twice daily.
The recommended dosage is 0.5 mg twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response. The usual maintenance dosage is 2 mg twice daily. This dose should not be exceeded unless the patient requires Atodel as antihypertensive therapy. Patients with benign prostatic hyperplasia receiving hypertensive therapy, should be administered Atodel only under the supervision of the practitioner responsible for treating the patient’s hypertension.
Evidence to date shows that prazosin does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of prazosin, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
No information is available on the use of prazosin in this patient group, however, since prazosin normally undergoes substantial first pass metabolism and subsequent metabolism and excretion by the liver, it is recommended that therapy be initiated at 0.5 mg daily and that dosage increases be instituted cautiously.
Atodel is not recommended for the treatment of children under the age of 12 years since safe conditions for its use have not been established.
Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.
Oral administration.
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 in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary vasopressors including angiotensin should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate prazosin is not dialysable because it is protein bound.
5 years.
Store below 25°C. Protect from light and moisture.
Atodel 1 mg tablets:
PVC/PVDC-Aluminium blisters. Pack sizes of 30 and 1000 tablets.
Atodel 2 mg tablets and Atodel 5 mg tablets:
PVC/PVDC-Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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