Metopirone (Oral)

Metyrapone is used to diagnose certain issues with the adrenal glands, which are located near the kidneys. These glands produce a steroid called cortisol (hydrocortisone) that helps the body handle stress or illness. By using the results from a metyrapone test, your doctor can determine if your adrenal glands produce the right amount of cortisol when you are under stress or ill.

How the test is done: You take metyrapone by mouth in one or more doses the day before the test. The following day, blood and/or urine samples are collected. A tube called a catheter may be placed in your bladder to assist in taking the urine sample. The levels of hormones in your blood or urine are measured, and then the test results are analyzed.

Metyrapone may also be used for other conditions as determined by your doctor.

Metyrapone is available only with your doctor's prescription.

This medicine may make some people feel dizzy, lightheaded, drowsy, or less alert than usual. Even if taken at bedtime, it may cause some people to feel drowsy or less alert when they wake up. Be sure to understand how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you feel dizzy or are not alert.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, 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 children and has not shown different side effects or problems in children compared to adults.

Geriatric

There is no specific information about the use of metyrapone in elderly patients, but it is not expected to cause 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. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. When using this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

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

• Tegafur

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

• Breast cancer or
• Type 2 diabetes mellitus or
• Heart disease or
• Liver disease or
• Low blood sugar or
• Thyroid disease—These conditions may cause false results in metyrapone testing and lead to an incorrect diagnosis.

• Excessive body hair in females—Long-term use may increase body hair growth.

• Porphyria—Metyrapone may worsen active cases of porphyria.

• Underactive adrenal or pituitary gland—Metyrapone may severely reduce the production of certain hormones by the adrenal glands, which are needed to respond to stress or illness.

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:

Rare (with long-term use)

• Irregular heartbeat

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Skin rash

Rare (usually with long-term use)

• Enlargement of clitoris
• Muscle cramps or pain
• Sore throat or fever
• Swelling of feet or lower legs
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weight gain (rapid)

Symptoms of overdose

• Abdominal or stomach pain (severe)
• Confusion
• Decrease in consciousness
• Diarrhea (severe)
• Nausea (severe)
• Nervousness
• Unusual thirst
• Vomiting (severe)
• Weakness (sudden)

Some side effects may occur 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 be able to tell you 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

• Dizziness
• Drowsiness
• Headache
• Lightheadedness
• Nausea

Rare

• Confusion or mental slowing
• Excessive hair growth
• Greater-than-normal loss of scalp hair
• Increased sweating
• Loss of appetite
• Upper abdominal or stomach pain
• Vomiting
• Worsening of acne

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.

• Metopirone

Available Dosage Forms:

• Capsule

Therapeutic Class: Diagnostic Agent, Pituitary Function

Metyrapone may cause nausea and vomiting, especially if taken in larger doses. Taking each dose with food or milk or immediately after eating may lessen this effect.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 tablet dosage form: For testing the adrenal glands: Adults—750 milligrams (mg) (3 tablets) every four hours for six doses. Or, your doctor may want you to take 2000 to 3000 mg (8 to 12 tablets) as a single dose at eleven p.m. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kilogram (kg) (6.8 mg per pound) of body weight every four hours for six doses.

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.

If you are taking metyrapone for a test procedure and you miss a dose, contact your physician. Missing doses or taking them on the wrong schedule may cause false test results.

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.