Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Hypovase is indicated in the treatment of all grades of essential (primary) hypertension and 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.
Hypovase may be used alone or 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.
Hypovase is indicated for the symptomatic treatment of patients with Raynaud’s phenomenon and Raynaud’s disease.
Hypovase 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 500 micrograms – 20 mg daily. It is recommended that therapy be initiated at the lowest dose, 500 micrograms, twice or three times daily for three to seven days, with the starting dose administered in the evening. This dose should be increased to 1mg 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 Hypovase alone of up to 15 mg daily in divided doses. Maximum recommended daily dosage: 20 mg in divided doses.
The dosage of the other drug should be reduced to a maintenance level and Hypovase initiated at 500 micrograms in the evening, then continuing with 500 micrograms twice or three times daily. Subsequent dosage increases should be made gradually depending upon the patient’s response.
There is evidence that adding Hypovase 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 500 micrograms 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 Hypovase 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 500 micrograms 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 1mg or 2mg twice daily.
The recommended dosage is 500 micrograms 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 Hypovase as antihypertensive therapy. Patients with benign prostatic hyperplasia receiving hypertensive therapy, should be administered Hypovase only under the supervision of the practitioner responsible for treating the patient’s hypertension.
Evidence to date shows that Hypovase 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 Hypovase, it is recommended that therapy be initiated at 500 micrograms daily and that dosage increases be instituted cautiously.
No information is available on the use of Hypovase in this patient group, however, since Hypovase normally undergoes substantial first pass metabolism and subsequent metabolism and excretion by the liver, it is recommended that therapy be initiated at 500 micrograms daily and that dosage increases be instituted cautiously.
Hypovase 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.
Hypovase tablets are for oral administration only.
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 Hypovase is not dialysable because it is protein bound.
3 years.
Store below 30°C.
PVC/Aluminium blisters in cartons of 60 tablets (blister strips of 4 × 15 tablets).
No special requirements for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
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