Prazopress 1mg

Tablet
Prazosin Hydrochloride
Unimed Unihealth MFG. Ltd

Other Strength:
- Prazopress 2mg
- Prazopress ER 2.5mg
- Prazopress ER 5mg

Alternative:
- Prazolok 1mg



Prazopress
Presentation
Prazopress-1 tablet: Pink, shield-shaped, scored, having ª engraved on other side, each tablet contains Prazosin hydrochloride BP equivalent to Prazosin 1 mg.
Prazopress-2 tablet: Pink, diamond-shaped, scored, having engraved on other side, each tablet contains Prazosin hydrochloride BP equivalent to Prazosin 2 mg.

Indication
Hypertension: Prazosin 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.
Congestive heart failure: Prazosin 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. Raynaud’s phenomenon and Raynaud’s disease: Prazosin is indicated for the symptomatic treatment of patients with Raynaud’s phenomenon and Raynaud’s disease. Benign prostatic
hyperplasia: Prazosin is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia. It may therefore be of value in patients awaiting prostatic surgery.

Dosage & administration
Hypertension: 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 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 Prazosin alone of up to 15 mg daily in divided doses. Maximum recommended daily dosage: 20 mg in divided doses. Patients receiving other antihypertensive therapy but with inadequate control: The dosage of the other drugs should be reduced to a maintenance level and Prazosin 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 Prazosin to angiotensin converting enzyme inhibitor, betaadrenergic antagonist or calcium antagonist therapy may bring about a substantial reduction in blood pressure. Therefore, the low initial dosage regimen is recommended. Congestive heart failure: 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 Prazosin therapy in some patients to maintain optimal clinical improvement. Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.

Raynaud’s phenomenon and Raynaud’s disease: 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 1 mg or 2 mg twice daily.

Benign prostatic hyperplasia: 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 Prazosin as antihypertensive therapy. Patients with benign prostatic hyperplasia receiving hypertensive therapy, should be administered Prazosin only under the supervision of the practitioner responsible for treating the patient’s hypertension. Patients with moderate to severe grades of renal impairment: It is recommended that therapy be initiated at 500 micrograms daily and that dosage increases be instituted cautiously. Patients with hepatic dysfunction: 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 500 micrograms daily and that dosage increases be instituted
cautiously.

Use in children: Prazosin is not recommended for the treatment of children under the age of 12 years since safe conditions for its use have not been established.

Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.

Contraindications, warnings, etc.
Contraindications: Patients with known sensitivity to quinazolines, prazosin or any of the inert ingredients of prazosin.
Warnings: As with all alpha-blockers, prazosin may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by about of severe tachycardia with heart rates of 120-160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of prazosin. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient’s regimen with caution. Hypotension may develop in patients given prazosin who are also receiving a betablocker such as propranolol.

Drug interaction: Prazosin has been administered without any adverse drug interaction in clinical experience to date with the following: Digitalis and digoxin, insulin, chlorpropamide, phenformin, tolazamide and tolbutamide, chlordiazepoxide, diazepam and Phenobarbital, allopurinol, colchicine and probenecid, procainamide, propranolol and quinidine, propoxyphene, aspirin, indomethacin and phenylbutazone type. Addition of a diuretic or other antihypertensive agent to prazosin has been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the dose of prazosin to 1-2 mg 3 times a day, by introducing additional antihypertensive drugs cautiously and then by retitrating prazosin based on clinical response.

Use in pregnancy & lactation : Studies to date are inadequate to establish the safety of prazosin in pregnancy; accordingly, it should be used only when in the opinion of the physician, potential benefit outweights potential risk. Prazosin has been shown to be excreted in small amounts in human milk. Caution should be exercised when prazosin is administered to nursing mothers.

Side-effects: Less frequent adverse reactions which are reported to occur in 1–4% of patients are: vomiting, diarrhea, constipation, edema, orthostatic hypotension, dyspnea, syncope, vertigo, depression, nervousness, rash, urinary frequency, blurred vision, dry
mouth, nasal congestion.

Overdose: Accidental ingestion of at least 50 mg of prazosin in a 2-year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was uneventful. 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 should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate prazosin is not dialyzable because it is protein-bound.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Prazopress-1 tablet: Each box contains 30 tablets in blister pack.
Prazopress-2 tablet: Each box contains 30 tablets in blister pack.

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