Orvaten

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

Midodrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• numbness and tingling
• scalp itching
• goose bumps
• chills
• frequent urination
• urgent need to urinate
• difficulty urinating
• rash
• stomach pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking midodrine and call your doctor immediately or get emergency medical treatment:

• slow heartbeat
• dizziness
• fainting

Midodrine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Orvaten is a prescription medication used to treat orthostatic hypotension. This medication belongs to a group of drugs called alpha receptor agonists, which help to maintain adequate blood pressure and to prevent symptoms of OH including dizziness or lightheadedness.

This medication comes in tablet form and is taken 3 times a day, with or without food.

Common side effects include tingling sensations, itching, problems with urinating, and stomach pain.

Contraindications

Severe organic heart disease.1

Acute renal disease.1

Urinary retention.1

Pheochromocytoma.1

Thyrotoxicosis.1

Persistent and excessive supine hypertension.1

Warnings/Precautions

Warnings

Supine hypertension (SBP of about 200 mm Hg) has been reported in up to 13.4% of patients receiving the usual dosage (10 mg 3 times daily); symptoms may include cardiac awareness, pounding in the ears, headache, and blurred vision.22 Increased risk of severe and persistent systolic supine hypertension in patients receiving higher than recommended dosages.1 21 (See Prescribing Limits under Dosage and Administration.)

Supine hypertension occurs most frequently in patients with increased pretreatment SBP (average 170 mm Hg).22 Use not recommended in patients with initial supine SBP >180 mm Hg.22 Elevated sitting BP also reported.22 Monitor supine and sitting BP during therapy.22

If supine hypertension occurs, reduce dosage;2 20 if supine hypertension persists, withdrawal of the drug may be necessary.1 Sleeping with the head of the bed elevated may relieve supine hypertension in some patients.1 5 17 18 20

General Precautions

Possible decreased heart rate, due to vagal reflex.22 If symptoms of bradycardia occur (e.g., decreased pulse, increased dizziness, syncope, cardiac awareness), discontinue therapy and reevaluate patient.22 Use caution if used concomitantly with other agents that reduce heart rate.22 (See Specific Drugs under Interactions.)

Use with caution in patients with a history of urinary retention due to midodrine’s α-adrenergic activity at the bladder neck.1 16

Use with caution in orthostatic hypotensive patients with diabetes mellitus.1 16 22

Specific Populations

Category C.1

Not known if midodrine is distributed into milk.1 Use with caution.1

Safety and efficacy not established in children <18 years of age.1 16

Plasma midodrine and desglymidodrine concentrations in patients ≥65 years of age do not appear to differ from those in younger adults; dosage adjustment not required.22

Not studied systematically in patients with hepatic impairment.1 Use with caution since midodrine is metabolized in part by the liver.1 (See Elimination under Pharmacokinetics.)

Possible increased plasma desglymidodrine concentrations.22 Use with caution and adjust initial dosage.22 Assess renal function prior to initiating therapy.1

Common Adverse Effects

Supine and sitting hypertension, paresthesias and pruritus (mainly of the scalp), goosebumps, chills, urinary urge, urinary retention, urinary frequency.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In August 2010, FDA proposed to withdraw approval of midodrine hydrochloride; however, the drug remains on the US market while additional clinical studies are conducted.23 24 25 26 28

(See Orthostatic Hypotension under Uses.)

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name