MIDODRINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Midodrine Hydrochloride (UNII: 59JV96YTXV) (Midodrine - UNII:6YE7PBM15H)

Available from:

Apotex Corp

INN (International Name):

Midodrine Hydrochloride

Composition:

Midodrine Hydrochloride 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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