Orvaten (Oral)

Midodrine is used to treat low blood pressure (hypotension). It works by stimulating nerve endings in blood vessels, which causes the blood vessels to tighten. This results in an increase in blood pressure.

This medicine is available only with your doctor's prescription.

Do not take other medicines unless you have talked about them with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hayfever, or sinus problems, as they may raise your blood pressure.

In deciding to use a medicine, you and your doctor will consider the risks and benefits. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

This medicine has been tested in a limited number of children aged 6 months to 12 years. At effective doses, it has not been shown to cause different side effects or problems compared to adults.

Geriatric

This medicine has been tested and has not shown different side effects or problems in older adults compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together despite possible interactions. In such situations, your doctor may adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust some of the other medicines you take.

• Dihydroergotamine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Deslanoside
• Digitoxin
• Droxidopa
• Ephedrine
• Furazolidone
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Isocarboxazid
• Levothyroxine
• Linezolid
• Liothyronine
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Pseudoephedrine
• Rasagiline
• Safinamide
• Selegiline
• Thyroid
• Toloxatone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Perphenazine
• Promethazine
• Risperidone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Severe heart disease
• Hypertension (high blood pressure)
• Overactive thyroid
• Visual problems—Effects of midodrine on blood pressure may worsen these issues.

• Kidney disease
• Liver disease—The effects of midodrine may be stronger due to slower elimination from the body.

• Urinary retention—Effects of midodrine on the bladder may worsen this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision
• cardiac awareness
• headache
• pounding in the ears

Rare

• Fainting
• increased dizziness
• slow pulse

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Burning, itching, or prickling of the scalp
• chills
• goosebumps
• urinary frequency, retention, or urgency

Less common

• Anxiety or nervousness
• confusion
• dry mouth
• flushing
• headache or feeling of pressure in the head
• skin rash

Rare

• Backache
• canker sores
• dizziness
• drowsiness
• dry skin
• leg cramps
• pain or sensitivity of the skin to touch
• stomach problems such as gas, heartburn, or nausea
• trouble seeing
• trouble with sleeping
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Orvaten
• Proamatine

Available Dosage Forms:

• Tablet

Therapeutic Class: Vasopressor

Pharmacologic Class: Alpha-Adrenergic Agonist

The last dose of midodrine should not be taken after the evening meal or less than 3 to 4 hours before bedtime because high blood pressure upon lying down (supine hypertension) can occur, which can cause blurred vision, headaches, and pounding in the ears while lying down after taking this medicine.

Also, midodrine should not be taken if you will be lying down for any length of time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For low blood pressure: Adults—10 milligrams (mg) three times a day in approximately 4-hour intervals during daytime hours: shortly before or upon rising in the morning, at midday, and in the late afternoon (not later than 6 p.m.). Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.