ALDOMET^* (Methyldopa) is an antihypertensive drug.

Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C₁₀H₁₃NO₄, with a molecular weight of 211.22, and its structural formula is:

Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water.

ALDOMET (methyldopa) is supplied as tablets, for oral use, in three strengths: 125 mg, 250 mg, or 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: calcium disodium edetate, cellulose, citric acid, colloidal silicon dioxide, D&C Yellow 10, ethylcellulose, guar gum, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, propylene glycol, talc, and titanium dioxide.

*Registered trademark of MERCK & CO., Inc., COPYRIGHT © MERCK & CO., Inc., 1985 All rights reserved

Remember that your doctor has prescribed this medication because he or she 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.

In rare cases, this medication may increase your level of a certain natural substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of ankles/feet, unexpected or rapid weight gain, unusual bruising or bleeding, involuntary movements, joint/muscle aches, mental/mood changes (e.g., confusion, depression), signs of infection (e.g., fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, slow/fast/irregular heartbeat.

This drug may infrequently cause serious (rarely fatal) liver disease. If you notice any of the following unlikely but very serious side effects, tell your doctor immediately: persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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 methyldopa, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., hepatitis or cirrhosis), a history of liver disease caused by medications.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low red blood cell count (e.g., hemolytic anemia), certain genetic conditions (glucose-6-phosphate dehydrogenase deficiency), heart failure, kidney disease, liver disease, stroke/transient ischemic attack, pheochromocytoma, Parkinson's disease.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to its effects, especially dizziness, difficulty concentrating, and memory problems.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.