Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
midodrine hydrochloride (UNII: 59JV96YTXV) (midodrine - UNII:6YE7PBM15H)
Upsher-Smith laboratories, LLC
midodrine hydrochloride
midodrine hydrochloride 2.5 mg
ORAL
PRESCRIPTION DRUG
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets 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'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 tablets, 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. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement. Midod
Midodrine hydrochloride tablets, USP are supplied as 2.5 mg, 5 mg and 10 mg tablets for oral administration. The 2.5 mg tablet is a white, round, uncoated tablet, scored on one side with "US" above and "2.5" below the score and "211" on the other side. They are supplied as follows: The 5 mg tablet is a pink, round, uncoated tablet, scored on one side with "US" above and "5" below the score and "212" on the other side. They are supplied as follows: The 10 mg tablet is a purple, round, uncoated tablet, scored on one side with "US" above and "10" below the score and "213" on the other side. They are supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Revised: 06/2020
Abbreviated New Drug Application
MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET UPSHER-SMITH LABORATORIES, LLC ---------- MIDODRINE HYDROCHLORIDE TABLETS, USP WARNING: BECAUSE MIDODRINE 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 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, 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, USP 2.5 mg, 5 mg and 10 mg INACTIVE INGREDIENTS: colloidal silicon dioxide, corn starch, FD&C Blue No. 1 Lake (10 mg tablets), FD&C Red No. 40 Lake (5 mg and 10 mg tablets), magnesium stearate, microcrystalline cellulose and talc. 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_-(β-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 12 18 2 4 SOLUBILITY: Water: Soluble Methanol: Sparingly soluble PKA: 7.8 (0.3% aqueous solution) PH: 3.5 to 5.5 (5% aqueous solution) MELTING RANGE: 200° to 203°C CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Midodrine 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 vasculature, producing an increase i Baca dokumen lengkapnya