Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Midodrine Hydrochloride (UNII: 59JV96YTXV) (Midodrine - UNII:6YE7PBM15H)
Apotex Corp
Midodrine Hydrochloride
Midodrine Hydrochloride 2.5 mg
ORAL
PRESCRIPTION DRUG
Midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride 's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride . After initiation of treatment, midodrine hydrochloride should be continued only for patients who report significant symptomatic improvement. M idodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. M idodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.
Midodrine hydrochloride tablets, USP 2.5 mg are available for oral administration as white, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "2.5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1320-3) Bottles of 100 (NDC 60505–1320-1) Bottles of 500 (NDC 60505-1320-5) Bottles of 1,000 (NDC 60505–1320-8). Midodrine hydrochloride tablets, USP 5 mg are available for oral administration as orange, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1321-3) Bottles of 100 (NDC 60505–1321-1) Bottles of 500 (NDC 60505-1321-5) Bottles of 1,000 (NDC 60505–1321-8). Midodrine hydrochloride tablets, USP 10 mg are available for oral administration as light blue, round, scored tablets, imprinted "APO" on one side and "MID" above bisect "10" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-1325-3) Bottles of 100 (NDC 60505-1325-1) Bottles of 500 (NDC 60505-1325-5) Bottles of 1,000 (NDC 60505-1325-8). Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. MIDODRINE HYDROCHLORIDE TABLETS , USP 2.5 mg, 5 mg and 10 mg Revised: February 2017 Rev. 2
Abbreviated New Drug Application
MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET APOTEX CORP ---------- MIDODRINE HYDROCHLORIDE TABLETS, USP 2.5 MG, 5 MG AND 10 MG RX ONLY WARNING: BECAUSE MIDODRINE HYDROCHLORIDE CAN CAUSE MARKED ELEVATION OF SUPINE BLOOD PRESSURE, IT SHOULD BE USED IN PATIENTS WHOSE LIVES ARE CONSIDERABLY IMPAIRED DESPITE STANDARD CLINICAL CARE. THE INDICATION FOR USE OF MIDODRINE HYDROCHLORIDE IN THE TREATMENT OF SYMPTOMATIC ORTHOSTATIC HYPOTENSION IS BASED PRIMARILY ON A CHANGE IN A SURROGATE MARKER OF EFFECTIVENESS, AN INCREASE IN SYSTOLIC BLOOD PRESSURE MEASURED ONE MINUTE AFTER STANDING, A SURROGATE MARKER CONSIDERED LIKELY TO CORRESPOND TO A CLINICAL BENEFIT. AT PRESENT, HOWEVER, CLINICAL BENEFITS OF MIDODRINE HYDROCHLORIDE, PRINCIPALLY IMPROVED ABILITY TO CARRY OUT ACTIVITIES OF DAILY LIVING, HAVE NOT BEEN VERIFIED. DESCRIPTION NAME: Midodrine hydrochloride tablets, USP DOSAGE FORM: 2.5 mg, 5 mg and 10 mg tablets for oral administration ACTIVE INGREDIENT: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg INACTIVE INGREDIENTS: Colloidal silicone dioxide, FD&C Blue #1 (10 mg tablet), FD&C Yellow #6 (5 mg tablet), magnesium stearate, microcrystalline cellulose, starch PHARMACOLOGICAL CLASSIFICATION: Vasopressor/Antihypotensive CHEMICAL NAMES (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5- dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-((beta)- hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine STRUCTURAL FORMULA: MOLECULAR FORMULA: C H N O HCl; MOLECULAR WEIGHT: 290.7 ORGANOLEPTIC PROPERTIES: Odorless, white, crystalline powder SOLUBILITY: Water: Soluble 12 18 2 4 Methanol: Sparingly soluble PKA: 7.8 (0.3% aqueous solution) PH: 3.5 to 5.5 (5% aqueous solution) MELTING RANGE: 200°C to 203°C CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Midodrine hydrochloride forms an active metabolite, desglymidodrine, that is an alpha -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculat Прочетете целия документ