Metopirone

Name: Metopirone

Before Using Metopirone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and has not been shown to cause different side effects or problems in children than it does in adults.

Geriatric

Although there is no specific information about the use of metyrapone in the elderly, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

  • Tegafur

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 result in a wrong diagnosis
  • Excessive body hair in females—Long-term use may increase growth of body hair
  • Porphyria—Metyrapone may worsen active cases of porphyria
  • Underactive adrenal or pituitary gland—Metyrapone may severely reduce the amount of certain hormones produced by the adrenal glands; these hormones are needed to respond to stress or illness

Proper Use of Metopirone

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.

Metopirone

Metopirone®

metyrapone USP

Capsules

Diagnostic Test of Pituitary

Adrenocorticotropic Function

Rx only

Prescribing Information

Metopirone Description

Metopirone, metyrapone USP, is an inhibitor of endogenous adrenal corticosteroid synthesis, available as 250-mg capsules for oral administration. Its chemical name is 2-methyl-1, 2-di-3-pyridyl-1-propanone, and its structural formula is

Metyrapone USP is a white to light amber, fine, crystalline powder, having a characteristic odor. It is sparingly soluble in water, and soluble in methanol and in chloroform. It forms water-soluble salts with acids. Its molecular weight is 226.28.

Inactive Ingredients.       Polyethylene glycol, glycerine, gelatin, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, ethyl vanillin, 4-methoxyacetophenone, titanium dioxide, brown ink.

Warnings

Metopirone may induce acute adrenal insufficiency in patients with reduced adrenal secretory capacity.

Adverse Reactions

Cardiovascular System: Hypotension

Gastrointestinal System: Nausea, vomiting, abdominal discomfort or pain.

Central Nervous System: Headache, dizziness, sedation.

Dermatologic System: Allergic rash.

Hematologic System: Rarely, decreased white blood cell count or bone marrow depression.

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