Country: United States
Language: English
Source: NLM (National Library of Medicine)
MIDODRINE HYDROCHLORIDE (UNII: 59JV96YTXV) (MIDODRINE - UNII:6YE7PBM15H)
Mylan Pharmaceuticals Inc.
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 hydrochloride tablets' 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 hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who repo
Midodrine Hydrochloride Tablets, USP are available containing 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. The 2.5 mg tablets are white to off-white, round, scored tablets debossed with MH above the score and 1 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1901-01 bottles of 100 tablets The 5 mg tablets are white to off-white, round, scored tablets debossed with MH above the score and 2 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1902-01 bottles of 100 tablets The 10 mg tablets are white to off-white, round, scored tablets debossed with MH above the score and 3 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1903-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 9/2022 ALP:MIDO:R2 3512/1
Abbreviated New Drug Application
MIDODRINE HYDROCHLORIDE- MIDODRINE HYDROCHLORIDE TABLET MYLAN PHARMACEUTICALS INC. ---------- WARNING BECAUSE MIDODRINE HYDROCHLORIDE TABLETS 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 TABLETS 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 TABLETS, PRINCIPALLY IMPROVED ABILITY TO CARRY OUT ACTIVITIES OF DAILY LIVING, HAVE NOT BEEN VERIFIED. DESCRIPTION Midodrine hydrochloride is a vasopressor/antihypotensive. The chemical name for midodrine hydrochloride is Acetamide, 2-amino-_N_-[2-(2,5-dimethoxyphenyl)-2- hydroxyethyl]-, monohydrochloride, (±)-. The molecular weight of midodrine hydrochloride is 290.7. Its structural formula and molecular formula are: Midodrine hydrochloride, USP is an odorless, white, crystalline powder. It is soluble in water and sparingly soluble in methanol and has a pKa of 7.8 (0.3% aqueous solution) and a pH of 3.5 to 5.5 (5% aqueous solution). It has a melting range of 200° to 203°C. Each midodrine hydrochloride tablet, USP for oral administration contains 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Midodrine hydrochloride tablets form 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 in vascular tone and elevation of Read the complete document