Midodrine Hydrochloride (Page 3 of 3)

OVERDOSAGE

Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with midodrine hydrochloride tablets, both in young males. One patient ingested midodrine hydrochloride drops, 250 mg, experienced systolic blood pressure of greater than 200 mmHg, was treated with an IV injection of 20 mg of phentolamine, and was discharged the same night without any complaints. The other patient ingested 205 mg of midodrine hydrochloride (41 5 mg tablets), and was found lethargic and unable to talk, unresponsive to voice but responsive to painful stimuli, hypertensive and bradycardic. Gastric lavage was performed, and the patient recovered fully by the next day without sequelae.

The single doses that would be associated with symptoms of overdosage or would be potentially life threatening are unknown. The oral LD50 is approximately 30 to 50 mg/kg in rats, 675 mg/kg in mice, and 125 to 160 mg/kg in dogs.

Desglymidodrine is dialyzable.

Recommended general treatment, based on the pharmacology of the drug, includes induced emesis and administration of alpha-sympatholytic drugs (e.g., phentolamine).

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 life. 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.

HOW SUPPLIED

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 round, white scored tablet with C/149 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-157-01
Bottle of 100 Tablets

The 5 mg are tablets round, white scored tablet with C/150 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-158-01
Bottle of 100 Tablets

The 10 mg tablets are round, white scored tablet with C/151 on the upper side; and plain on the lower side. They are available as follows:

NDC 70700-159-01
Bottle 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:
Xiromed, LLC.

Florham Park, NJ 07932

PI-159-00
Rev.: 07/2019

PRINCIPAL DISPLAY PANEL

NDC 70700-157-01

Midodrine Hydrochloride Tablets, USP 2.5 mg

Rx only 100 Tablets

midodrine2-5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70700-158-01

Midodrine Hydrochloride Tablets, USP 5 mg

Rx only 100 Tablets

midodrine-5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 70700-159-01

Midodrine Hydrochloride Tablets, USP 10 mg

Rx only 100 Tablets

midodrine-10mg
(click image for full-size original)
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code C;149
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-157-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code C;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-158-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
MIDODRINE HYDROCHLORIDE
midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIDODRINE HYDROCHLORIDE (MIDODRINE) MIDODRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code C;151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-159-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207849 10/15/2020
Labeler — Xiromed, LLC (080228637)
Registrant — Cerovene, Inc. (790387927)
Establishment
Name Address ID/FEI Operations
Cerovene, Inc. 790387927 analysis (70700-157), manufacture (70700-157), analysis (70700-158), manufacture (70700-158), analysis (70700-159), manufacture (70700-159)
Establishment
Name Address ID/FEI Operations
Nutra-Med Packaging Inc. 080274725 pack (70700-157), pack (70700-158), pack (70700-159)

Revised: 10/2020 Xiromed, LLC

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