Drug Catalog - Product Detail
MIDODRINE HCL 5MG TB 100
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
64980-0434-01 | RISING PHARMACEUTICALS | 100 | 5MG | TABLET |
PACKAGE FILES
Generic Name
MIDODRINE HYDROCHLORIDE
Substance Name
MIDODRINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207613
Description
DESCRIPTION Name: Midodrine Hydrochloride Tablets 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 Silicon Dioxide NF, Croscarmellose Sodium NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF and Sodium Lauryl Sulfate NF. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula: Molecular formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: White to off-white powder 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 structrue
How Supplied
HOW SUPPLIED 2.5-mg, 5-mg and 10-mg tablets for oral administration. The 2.5-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “233” on the other side. They are available as follows: Bottles of 100 : NDC 64980-433-01 The 5-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “234” on the other side. They are available as follows: Bottles of 100 : NDC 64980-434-01 The 10-mg tablets are white to off-white, round, flat, scored tablets debossed with “P” above the score on one side of the tablet & “235” on the other side. They are available as follows: Bottles of 100 : NDC 64980-435-01 Store at 25°C (77°F) Excursions permitted to 15-30˚C (59-86˚F) [see USP Controlled Room Temperature] Rx only Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 May 2018
Indications & Usage
INDICATIONS AND USAGE 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'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 hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended dose of midodrine hydrochloride tablets is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before, or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently. Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment. The supine and standing blood pressure should be monitored regularly, and the administration of midodrine hydrochloride tablets should be stopped if supine blood pressure increases excessively. Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5-mg doses. Dosing in children has not been adequately studied. Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.