Terazosin Hydrochloride 2 mg/1
Terazosin Hydrochloride · CAPSULE · Apnar Pharma LP
Terazosin Hydrochloride is a capsule containing terazosin hydrochloride at 2 mg/1, taken oral. Manufactured by Apnar Pharma LP.
Key Facts
- Brand Name
- Terazosin Hydrochloride
- Generic Name
- Terazosin Hydrochloride
- NDC Code (Product)
24689-855- Manufacturer
- Apnar Pharma LP
- Strength
- 2 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA074823
- Marketing Start
- 06/30/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION If terazosin capsules administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen. Benign Prostatic Hyperplasia Initial Dose 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose. Patients should be closely followed during initial administration in order to minimize the risk of severe hypotensive response. Subsequent Doses The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 to 6 weeks may be required to assess whether a beneficial response has been achieved. Some patients may not achieve a clinical response despite appropriate titration. Although some additional patients responded at a 20 mg daily dose, there was an insufficient number of patients studied to draw definitive conclusions about this dose. There are insufficient data to support the use of higher doses for those patients who show inadequate or no response to 20 mg…
Warnings
WARNINGS Syncope and “First-dose” Effect Terazosin capsules, like other alpha-adrenergic blocking agents, can cause marked lowering of blood pressure, especially postural hypotension, and syncope in association with the first dose or first few days of therapy. A similar effect can be anticipated if therapy is interrupted for several days and then restarted. Syncope has also been reported with other alpha-adrenergic blocking agents in association with rapid dosage increases or the introduction of another antihypertensive drug. Syncope is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe supraventricular tachycardia with heart rates of 120 to 160 beats per minute. Additionally, the possibility of the contribution of hemodilution to the symptoms of postural hypotension should be considered. To decrease the likelihood of syncope or excessive hypotension, treatment should always be initiated with a 1 mg dose of terazosin capsules, given at bedtime. The 2 mg, 5 mg and 10 mg capsules are not indicated as initial therapy. Dosage should then be increased slowly, according to recommendations in the…
Contraindications
CONTRAINDICATIONS Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.
Drug Interactions
Drug Interactions In controlled trials, terazosin capsules have been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin capsules have also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin capsules have been used concomitantly in at least 50 patients on the following drugs or drug classes: analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); antigout (e.g., allopurinol); antihistamines (e.g., chlorpheniramine); cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); corticosteroids; gastrointestinal agents (e.g., antacids); hypoglycemics sedatives and tranquilizers (e.g., diazepam).
Adverse Reactions
ADVERSE REACTIONS Benign Prostatic Hyperplasia The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin capsules at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1%, and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin capsules than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin capsules than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS ) adjusted for the length of drug treatment has shown that …
Frequently Asked Questions
What is Terazosin Hydrochloride used for?
Terazosin Hydrochloride contains Terazosin Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Terazosin Hydrochloride a controlled substance?
Terazosin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Terazosin Hydrochloride?
The generic name for Terazosin Hydrochloride is Terazosin Hydrochloride. There are 9 other brand versions of Terazosin Hydrochloride.
What is the NDC code for Terazosin Hydrochloride 2 mg/1?
The NDC (National Drug Code) for Terazosin Hydrochloride 2 mg/1 is 24689-855, listed by Apnar Pharma LP.