ProAmatine, Orvaten (midodrine) dosing, indications, interactions, adverse effects, and more

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Sections midodrine
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
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Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

2.5mg
5mg
10mg

Symptomatic Orthostatic Hypotension

2.5-10 mg PO q8hr

Usual dose: 10 mg PO q8hr

Doses greater than 30 mg/day have not been studied; should not exceed 40 mg/day

Stress Incontinence (Off-label)

2.5-5 mg PO q8-12hr

Dosing Modifications

Renal impairment: 2.5 mg PO q8hr; increase as tolerated

Safety & efficacy not established

Interaction Checker

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>10%

Paresthesia (18%)

Piloerection (13%)

Pruritus (13%)

Supine hypertension (7-13%)

Urinary retention or urgency (up to 13%)

1-10%

Chills (5%)

Pain, including abdominal pain (5%)

Rash (2%)

<1%

Anxiety

Canker sore

Confusion

Dizziness

Dry skin

Erythema multiforme

Facial flushing

Flushing

Headache

Hyperesthesia

Insomnia

Intracranial pressure increased

Nausea

Somnolence

Weakness

Xerostomia

Black Box Warnings

May cause marked elevation of supine blood pressure; reserve use for patients whose lives are considerably impaired despite standard clinical care for orthostatic hypotension

Contraindications

Severe organic heart disease, supine HTN, acute renal disease, urinary retention, pheochromocytoma, thyrotoxicosis

Cautions

May slow heart rate primarily due to vagal reflex; use caution when administering concomitantly with negative chronotropes, including digoxin, beta blockers, or other agents that decrease heart rate; discontinue use if signs or symptoms of bradycardia occur

Risk of hypertension increases with concomitant administration of drugs that increase blood pressure (phenylephrine, pseudoephedrine, ephedrine, dihydroergotamine, thyroid hormones, or droxidopa); avoid concomitant use of drugs that increase blood pressure; if concomitant use cannot be avoided, monitor blood pressure closely

Avoid concomitant administration with MAO inhibitors or linezolid

It is essential to monitor supine and sitting blood pressures in patients receiving therapy; uncontrolled hypertension increases risk of cardiovascular events, particularly stroke

Avoid concomitant use with treatment agents that may cause vasoconstriction

Use caution in patients with diabetes mellitus, vision problems, and renal or hepatic impairment

Take drug no later than 6 pm and 3-4 hr before bed to minimize supine HTN

Pregnancy & Lactation

Pregnancy category: C

Lactation: Not known if excreted into breast milk; avoid

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Alpha-1 selective adrenergic agonist; increases peripheral vascular resistance; arteriolar and venous tone increases and results in a rise in sitting, standing, and supine systolic and diastolic blood pressure in patients with orthostatic hypotension

Absorption

Bioavailability: 93%

Onset: 45-90 min (initial effect); 60 min (max effect)

Duration: 2-3 hr

Peak plasma time: 1-2 hr (desglymidodrine); 30 min (midodrine)

Distribution

Protein bound: Minimal

Vd: <1.66 L/kg

Metabolism

Extensively undergoes enzymatic hydrolysis in the systemic circulation; prodrug (midodrine) converted to desglymidodrine (active agent)

Metabolites: Desglymidodrine, 15 times as potent as midodrine; primarily responsible for treatment activity (active)

Elimination

Half-life elimination: 3-4 hr (desglymidodrine); 25 min (midodrine)

Dialyzable: HD: Yes

Renal clearance: 385 mL/min

Excretion: Feces (1-2%); urine (80% [desglymidodrine])

BRAND	FORM.	UNIT PRICE	PILL IMAGE
midodrine oral -	10 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	2.5 mg tablet
midodrine oral -	10 mg tablet
midodrine oral -	2.5 mg tablet

Patient Handout

MIDODRINE - ORAL

(MY-doh-dreen)

COMMON BRAND NAME(S): ProAmatine

WARNING: Midodrine should only be used in carefully selected patients. When you are lying on your back, this medication causes a significant increase in blood pressure. Your blood pressure will be monitored carefully during treatment.

USES: This medication is used for certain patients who have symptoms of low blood pressure when standing. This condition is also known as orthostatic hypotension. Midodrine is used in people whose daily activities are severely affected by this condition, even after other treatments are used (such as support stockings). It is known as a sympathomimetic (alpha receptor agonist) that acts on the blood vessels to raise blood pressure.

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times daily (at least 3 to 4 hours between doses). Follow all your doctor's instructions carefully. This drug is taken during daytime hours, when people stand most often. This medicine should not be taken after the evening meal or less than 4 hours before bedtime. Taking your dose is not recommended if you plan to lie down for a long time afterward (for example, if you plan on taking a nap).Dosage is based on your medical condition and response to treatment. Usually, your doctor will start you at a low dose and gradually increase your dose in order to reduce side effects. Do not increase your dose or take it more frequently than prescribed.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition lasts or gets worse. This drug should be continued only in those people whose symptoms improve during treatment.

SIDE EFFECTS: Skin tingling, chills, "goose bumps," stomach pain, or urinary problems (strong/frequent urge to urinate, frequent urination, trouble urinating) may occur. Less common side effects include dry mouth, dizziness, drowsiness, trouble sleeping, or leg cramps. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause your blood pressure to increase, especially when you are lying down (supine hypertension). Stop taking midodrine and contact your doctor right away if you experience the following signs of supine hypertension: pounding heartbeat, pounding in the ears, headache, blurred vision.Tell your doctor right away if you have any serious side effects, including: slow heartbeat, unusual feeling in the chest, fainting, pressure/fullness in the head, confusion, anxiety, weakness, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking midodrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this drug, tell your doctor your entire medical history, including: high blood pressure, pheochromocytoma, overactive thyroid (hyperthyroidism), difficulty urinating (due to urinary retention or an enlarged prostate), heart disease, liver disease, kidney disease, diabetes.Get up slowly to reduce dizziness when rising from a sitting or lying position.This drug may rarely make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist that you are taking this medication.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using midodrine. Midodrine may harm an unborn baby. If you become pregnant or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include "goose bumps," difficulty urinating, feeling cold.

NOTES: Do not share this medication with others.Blood pressure checks (lying, sitting, and standing) should be routinely taken. Share the results with your doctor. (See also Side Effects section.)You may lessen high blood pressure while lying down by sleeping with the head of the bed lifted up.Lab and/or medical tests (such as kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections midodrine
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

midodrine (Rx)