Midodrine Hydrochloride: Package Insert and Label Information (Page 2 of 2)

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, both in young males. One patient ingested midodrine hydrochloride drops, 250 mg, experienced systolic blood pressure 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 mg/kg to 50 mg/kg in rats, 675 mg/kg in mice, and 125 mg/kg 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 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.

HOW SUPPLIED

Midodrine hydrochloride tablets USP, 2.5 mg, 5 mg and 10 mg for oral administration.

The 2.5 mg tablet is white to off-white, round, flat uncoated tablets debossed with “737” on one side and break line on the other side.

Bottles of 100………………………………………….…..……NDC 68382-737-01

The 5 mg tablet is white to off-white, round, flat uncoated tablets debossed with “738” on one side and break line on the other side.

Bottles of 100………………………………………….…..……NDC 68382-738-01

The 10 mg is white to off-white, round, flat uncoated tablets debossed with “739” on one side and break line on the other side.

Bottles of 100………………………………………….…..……NDC 68382-739-01

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured by:

Cadila Healthcare Ltd., India

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 12/18

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-737-01

Midodrine Hydrochloride Tablets, USP

2.5 mg

100 Tablets

Rx only

figure
(click image for full-size original)

NDC 68382-738-01

Midodrine Hydrochloride Tablets, USP

5 mg

100 Tablets

Rx only

figure
(click image for full-size original)

NDC 68382-739-01

Midodrine Hydrochloride Tablets, USP

10 mg

100 Tablets

Rx only

figure
(click image for full-size original)
MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-737
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 737
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-737-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213055 09/17/2020
MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-738
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 738
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-738-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213055 09/17/2020
MIDODRINE HYDROCHLORIDE midodrine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-739
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 739
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-739-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213055 09/17/2020
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Worldwide DMCC (557951127)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (68382-737), ANALYSIS (68382-738), ANALYSIS (68382-739), MANUFACTURE (68382-737), MANUFACTURE (68382-738), MANUFACTURE (68382-739)

Revised: 09/2020 Zydus Pharmaceuticals (USA) Inc.

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