TEVA-PRAZOSIN

5 mg starting dose. 5 mg. d. d. for at least three days. d. d. for at least a further three days. • Thereafter, as determined by the patient’s response to the blood pressure lowering effect, the dose should be increased gradually. Response to TEVA-PRAZOSIN is usually seen within one to fourteen days if it is to occur at any particular dose.

When a response is seen, therapy should be continued at that dose until the degree of response has reached the optimum before the next dose increment is added. • Incremental increases should be continued until a desired effect is achieved or a maximum daily dose of 20 mg is reached.

• The maintenance dose of TEVA-PRAZOSIN may be given as a twice or three times daily dosage regimen. 5 mg daily and that dose increases be instituted gradually. See 7 WARNINGS AND PRECAUTIONS, Renal. s. d. d. After the initial period of observation, the dose of TEVA-PRAZOSIN should be gradually increased as determined by the patient’s response.

s. d. d. Subsequent dosage increase should be made depending upon the patient’s response. d. d. and retitration then carried out. * Appropriate precautions should be observed when the dosage of these other antihypertensive agents is reduced.

4 Administration It is recommended that the TEVA-PRAZOSIN tablets should be given with food preferably with the evening meal, at least two or three hours before retiring. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.

If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.

5%). In most instances side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following reactions of unknown frequency have also been observed during prazosin hydrochloride administration.

Cardiac disorders: syncope (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular), tachycardia, faintness. Ear and labyrinth disorders: vertigo, tinnitus. TEVA-PRAZOSIN (prazosin hydrochloride tablets) Page 11 of 28 Eye disorders: blurred vision, reddened sclera.

Gastrointestinal disorders: vomiting, diarrhea, constipation, abdominal discomfort and/or pain, pancreatitis. General disorders and administration site conditions: edema, fever. Hepatobiliary disorders: liver function abnormalities (increase in AST or ALT).

Hematologic: decreased hematocrit/hemoglobin, positive ANA titer. Musculoskeletal and connective tissue disorders: arthralgia. Nervous system disorders: paresthesia. Psychiatric disorders: nervousness, depression, hallucinations. Renal and urinary disorders: urinary frequency, incontinence.

Reproductive system and breast disorders: impotence, priapism. Respiratory, thoracic and mediastinal disorders: dyspnea, epistaxis, nasal congestion. Skin and subcutaneous disorders: rash, pruritus, alopecia, lichen planus, diaphoresis.

Vascular disorders: orthostatic hypotension. Single reports of pigmentary mottling and serous retinopathy have been reported. In these instances, the exact causal relationship has not been established because the baseline observations were frequently inadequate.

, Reproductive Health: Female and Male Potential 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .................................................................................................

3 TABLE OF CONTENTS .................................................................................................................... 3 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................

5 1 INDICATIONS .............................................................................................................................. 1 Pediatrics .............................................................................................................................

2 Geriatrics ............................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................................

5 4 DOSAGE AND ADMINISTRATION ............................................................................................... 1 Dosing Considerations .........................................................................................................

2 Recommended Dose and Dosage Adjustment..................................................................... 4 Administration .....................................................................................................................

5 Missed Dose ........................................................................................................................ 7 5 OVERDOSAGE.............................................................................................................................

TEVA-PRAZOSIN is contraindicated in patients with known sensitivity to this drug or other quinazolines or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.