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Tarazosin
Overview
What is Tarazosin?
Terazosin hydrochloride USP, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following structural formula, molecular formula and chemical name:
Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-, monohydrochloride, anhydrous.
Terazosin hydrochloride, USP is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.9. Each terazosin capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride, USP anhydrous. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, silicon dioxide and titanium dioxide. In addition, the 1 mg capsule contains yellow iron oxide; the 2 mg and 5 mg capsules contain black iron oxide. The black imprinting ink for the 1 mg, 5 mg and 10 mg capsules contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The white imprinting ink for the 2 mg capsules contains the following ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.
What does Tarazosin look like?
What are the available doses of Tarazosin?
Sorry No records found.
What should I talk to my health care provider before I take Tarazosin?
Sorry No records found
How should I use Tarazosin?
Terazosin capsules 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. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.
Terazosin capsules are also indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
If terazosin capsule administration is discontinued for several days, therapy should be reinstituted using the initial dosing regimen.
What interacts with Tarazosin?
Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.
What are the warnings of Tarazosin?
Syncope and "First-Dose" Effect
Priapism
Rarely, (probably less than once in every several thousand patients) terazosin and other α-antagonists have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). Two or three dozen cases have been reported. Because this condition can lead to permanent impotence if not promptly treated, patients must be advised about the seriousness of the condition (see ).
What are the precautions of Tarazosin?
General
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Carcinoma of the prostate and BPH cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined prior to starting terazosin hydrochloride therapy to rule out the presence of carcinoma of the prostate.
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Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on/or previously treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.
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While syncope is the most severe orthostatic effect of terazosin (see ), other symptoms of lowered blood pressure, such as dizziness, light-headedness and palpitations, were more common and occurred in some 28% of patients in clinical trials of hypertension. In BPH clinical trials, 21% of the patients experienced one or more of the following: dizziness, hypotension, postural hypotension, syncope, and vertigo. Patients with occupations in which such events represent potential problems should be treated with particular caution.
Information for Patients
Laboratory Tests
Small but statistically significant decreases in hematocrit, hemoglobin, white blood cells, total protein and albumin were observed in controlled clinical trials. These laboratory findings suggested the possibility of hemodilution. Treatment with terazosin for up to 24 months had no significant effect on prostate specific antigen (PSA) levels.
Drug Interactions
In controlled trials, terazosin has been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).
Use with Other Drugs
In a study (n=24) where terazosin and verapamil were administered concomitantly, terazosin's mean AUC increased 11% after the first verapamil dose and after 3 weeks of verapamil treatment it increased by 24% with associated increases in C (25%) and C (32%) means. Terazosin mean T decreased from 1.3 hours to 0.8 hours after 3 weeks of verapamil treatment. Statistically significant differences were not found in the verapamil level with and without terazosin. In a study (n=6) where terazosin and captopril were administered concomitantly, plasma disposition of captopril was not influenced by concomitant administration of terazosin and terazosin maximum plasma concentrations increased linearly with dose at steady-state after administration of terazosin plus captopril (see ).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Terazosin was devoid of mutagenic potential when evaluated and (the Ames test, cytogenetics, the dominant lethal test in mice, Chinese hamster chromosome aberration test and V79 forward mutation assay).
Terazosin, administered in the feed to rats at doses of 8, 40, and 250 mg/kg/day (70, 350, and 2100 mg/M/day), for 2 years, was associated with a statistically significant increase in benign adrenal medullary tumors of male rats exposed to the 250 mg/kg dose. This dose is 175 times the maximum recommended human dose of 20 mg (12 mg/M). Female rats were unaffected. Terazosin was not oncogenic in mice when administered in feed for 2 years at a maximum tolerated dose of 32 mg/kg/day (110 mg/M; 9 times the maximum recommended human dose). The absence of mutagenicity in a battery of tests, of tumorigenicity of any cell type in the mouse carcinogenicity assay, of increased total tumor incidence in either species, and of proliferative adrenal lesions in female rats, suggests a male rat species specific event. Numerous other diverse pharmaceutical and chemical compounds have also been associated with benign adrenal medullary tumors in male rats without supporting evidence for carcinogenicity in man.
The effect of terazosin on fertility was assessed in a standard fertility/reproductive performance study in which male and female rats were administered oral doses of 8, 30 and 120 mg/kg/day. Four of 20 male rats given 30 mg/kg (240 mg/M; 20 times the maximum recommended human dose) and five of 19 male rats given 120 mg/kg (960 mg/M; 80 times the maximum recommended human dose) failed to sire a litter. Testicular weights and morphology were unaffected by treatment. Vaginal smears at 30 and 120 mg/kg/day, however, appeared to contain less sperm than smears from control matings and good correlation was reported between sperm count and subsequent pregnancy.
Oral administration of terazosin for one or two years elicited a statistically significant increase in the incidence of testicular atrophy in rats exposed to 40 and 250 mg/kg/day (29 and 175 times the maximum recommended human dose), but not in rats exposed to 8 mg/kg/day (> 6 times the maximum recommended human dose). Testicular atrophy was also observed in dogs dosed with 300 mg/kg/day (> 500 times the maximum recommended human dose) for 3 months but not after one year when dosed with 20 mg/kg/day (38 times the maximum recommended human dose). This lesion has also been seen with prazosin, another selective alpha-1 blocking agent.
Pregnancy
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In a peri- and post-natal development study in rats, significantly more pups died in the group dosed with 120 mg/kg/day (> 75 times the maximum recommended human dose) than in the control group during the 3 week postpartum period.
Nursing Mothers
It is not known whether terazosin is excreted in breast milk. Because many drugs are excreted in breast milk, caution should be exercised when terazosin is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been determined.
What are the side effects of Tarazosin?
Sorry No records found
What should I look out for while using Tarazosin?
Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.
What might happen if I take too much Tarazosin?
Should overdosage of terazosin capsules 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 and renal function should be monitored and supported as needed. Laboratory data indicate that terazosin is 90% to 94% protein bound; therefore, dialysis may not be of benefit.
How should I store and handle Tarazosin?
Store the generator at 20-25°C (68-77°F) [See USP].Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:Terazosin Capsules USP, 1 mg, 2 mg and 5 mg contain 1 mg, 2 mg or 5 mg of terazosin as terazosin hydrochloride, USP anhydrous, respectively.The 1 mg capsule has a rich yellow opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-936-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 2 mg capsule has a black opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in white ink on both the cap and body. They are available as follows:NDC 51079-937-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).The 5 mg capsule has a iron gray opaque cap and a light lavender opaque body. The capsule is axially imprinted with over in black ink on both the cap and body. They are available as follows:NDC 51079-938-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each).Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light and moisture.PHARMACIST:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.In controlled trials, terazosin has been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. Terazosin has also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. Terazosin has been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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