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Drug Catalog - Product Detail

Midodrine HCl Tablets 2.5mg 100ct

NDC Mfr Size Str Form
49884-0814-01 PAR PHARMACEUTICAL 100 2.5MG NA
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Generic Name
MIDODRINE HYDROCHLORIDE
Substance Name
MIDODRINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207169
Description
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, microcrystalline cellulose, pregelatinized starch (maize) and stear-o-wet M (magnesium stearate and sodium lauryl sulphate). MIDODRINE HYDROCHLORIDE
How Supplied
HOW SUPPLIED Midodrine Hydrochloride Tablets, USP are available for oral administration, containing 2.5 mg, 5 mg or 10 mg of midodrine hydrochloride, USP. The 2.5 mg tablets are white to off-white, uncoated round shaped, flat-faced beveled edged tablets with “P” on one side and “814” debossed below the score line of other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-814-01 Bottles of 500 tablets NDC 49884-814-05 The 5 mg tablets are white to off-white, uncoated round shaped, flat-faced beveled edged tablets with “P” on one side and “849” debossed below the score line of other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-849-01 Bottles of 500 tablets NDC 49884-849-05 The 10 mg tablets are white to off-white, uncoated round shaped, flat-faced, beveled edged tablets with “P” above the score line on one side and “874” debossed other side of tablet. They are available as follows: Bottles of 100 tablets NDC 49884-874-01 Bottles of 500 tablets NDC 49884-874-05 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. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg.Lic.No.: TN00002121 OS814-01-74-01 Issued: 05/2017
Indications & Usage
INDICATIONS AND USAGE Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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, USP 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, USP 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, USP. After initiation of treatment, midodrine hydrochloride tablets, USP 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.