Doxazosin Mesylate (Cardura)

Trade Name

Cardura

Active Ingredient

Power

1 mg/1

Type / form

Tablets

Status

Manufacturer

Roerig

Storage and handling for Cardura

DOXAZOSIN MESYLATE Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Doxazosin Mesylate (Cardura) which is also known as Cardura and Manufactured by Roerig. It is available in strength of 1 mg/1 per ml. Read more

Doxazosin Mesylate (Cardura) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • CARDURA is an alpha adrenergic antagonist indicated for:
  • Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
  • Treatment of Hypertension
  • No data
  • For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose maybe titrated at 1 to 2 week intervals, up to 8 mg once daily.()
  • For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ()
  • Tablets (scored): 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green).
  • Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
  • The use of CARDURA is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components.
  • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in CARDURA. ()
  • No data
  • Postural hypotension with or without syncope may occur. ()
  • Risk of Intraoperative Floppy Iris Syndrome during cataract surgery. ()
  • Screen for the presence of prostate cancer prior to treatment for BPH and at regular intervals afterwards. ()
  • The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • No data
  • Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ()
  • Concomitant administration of CARDURA with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ()
  • No data
  • Hepatic Impairment: Monitor for hypotension. (, )
  • Experience with CARDURA overdosage is limited. Two adolescents, who each intentionally ingested 40 mg CARDURA with diclofenac or acetaminophen, were treated with gastric lavage with activated charcoal and made full recoveries. A two-year-old child who accidently ingested 4 mg CARDURA was treated with gastric lavage and remained normotensive during the five-hour emergency room observation period. A six-month-old child accidentally received a crushed 1 mg tablet of CARDURA and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg CARDURA (blood level = 0.9 mcg/mL; normal values in hypertensives = 0.02 mcg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39-year-old female who ingested 70 mg CARDURA, alcohol, and Dalmane (flurazepam) developed hypotension which responded to fluid therapy.
  • The oral LD of doxazosin is greater than 1000 mg/kg in mice and rats. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid. As doxazosin is highly protein bound, dialysis would not be indicated.
  • CARDURA (doxazosin mesylate) is a quinazoline compound that is a selective inhibitor of the alpha subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is CHNO u2219 CHOS and the molecular weight is 547.6. It has the following structure:
  • CARDURA (doxazosin mesylate) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25u00b0C), and very slightly soluble in acetone and methylene chloride. CARDURA is available as colored tablets for oral use and contains 1 mg (white), 2 mg (yellow), 4 mg (orange) and 8 mg (green) of doxazosin as the free base.
  • The inactive ingredients for all tablets are: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg tablet contains FD & C yellow 6; the 8 mg tablet contains FD & C blue 2 and D & C yellow 10.
  • No data
  • No data
  • No data
  • CARDURA (doxazosin mesylate) is available as scored tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green) of the active constituent, doxazosin.
  • Recommended Storage: Store at 25u00b0C (77u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • LAB-0071-8.0
  • No data
  • Pfizer
  • Cardura
  • 1 mg*
  • 100 Tabletsn n
  • Pfizer
  • Cardura
  • 2 mg*
  • 100 Tabletsn n
  • Pfizer
  • Cardura
  • 4 mg*
  • 100 Tabletsn n
  • Pfizer
  • Cardura
  • 8 mg*
  • 100 Tabletsn n

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