Aldoril

DRUG DESCRIPTION

ALDORIL (Methyldopa-Hydrochlorothiazide) combines two antihypertensives: methyldopa and hydrochlorothiazide.

Methyldopa

Methyldopa is an antihypertensive and is the L-isomer of alphamethyldopa. It 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 Structural Formula Illustration

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

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H- 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

ALDORIL (methyldopa-hydrochlorothiazide) is supplied as tablets in four strengths for oral use:

ALDORIL (methyldopa-hydrochlorothiazide) 15, contains 250 mg of methyldopa and 15 mg of hydrochlorothiazide.

ALDORIL (methyldopa-hydrochlorothiazide) 25, contains 250 mg of methyldopa and 25 mg of hydrochlorothiazide.

ALDORIL (methyldopa-hydrochlorothiazide) D30, contains 500 mg of methyldopa and 30 mg of hydrochlorothiazide.

ALDORIL (methyldopa-hydrochlorothiazide) D50, contains 500 mg of methyldopa and 50 mg of hydrochlorothiazide.

Each tablet contains the following inactive ingredients: calcium disodium edetate, calcium phosphate, cellulose, citric acid, colloidal silicon dioxide, ethylcellulose, guar gum, hydroxypropyl methylcellulose, magnesium stearate, propylene glycol, talc, and titanium dioxide. ALDORIL (methyldopa-hydrochlorothiazide) 15 and ALDORIL (methyldopa-hydrochlorothiazide) D30 also contain iron oxide.

What are the possible side effects of methyldopa and hydrochlorothiazide (Aldoril 15, Aldoril 25, Aldoril D30, Aldoril D50)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • dry mouth, thirst, nausea, vomiting;
  • feeling drowsy, restless, or light-headed;
  • chest pain, fast or uneven heartbeat;
  • muscle pain or weakness;
  • jerky or rolling...

Read All Potential Side Effects and See Pictures of Aldoril

What are the precautions when taking methyldopa-hydrochlorothiazide (Aldoril)?

Before taking methyldopa with hydrochlorothiazide, tell your doctor or pharmacist if you are allergic to either of them; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), 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: severe kidney failure (inability to make urine), active liver disease (e.g., hepatitis or cirrhosis), history of liver disease caused by medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, low red blood count (e.g., hemolytic anemia), diabetes, a...

Read All Potential Precautions of Aldoril


Aldoril Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, nasal congestion, headache, increased need to urinate, and weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

"Water pills" (diuretics) like hydrochlorothiazide can cause large losses of body water and minerals (e.g., potassium, sodium). Tell your doctor immediately if you notice severe muscle cramping, weakness, irregular heartbeat, mental/mood changes (e.g., confusion, depression, difficulty concentrating), a decrease in the amount of urine, extreme thirst/dry mouth, fainting or seizure.

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, missed/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 any of 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/bleeding, involuntary movements, signs of infection (e.g., fever, persistent sore throat), decrease in vision, eye pain.

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

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

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 with hydrochlorothiazide, tell your doctor or pharmacist if you are allergic to either of them; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), 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: severe kidney failure (inability to make urine), active liver disease (e.g., hepatitis or cirrhosis), history of liver disease caused by medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, low red blood count (e.g., hemolytic anemia), diabetes, a certain genetic condition (glucose-6-phosphate dehydrogenase deficiency), gout, heart failure, kidney disease, liver disease, lupus, 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.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst. If you already have diabetes, be sure to check your blood sugar regularly. Report any increases in blood sugar to your doctor.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

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 and difficulty concentrating.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Aldoril Patient Information Including Side Effects

Brand Names: Aldoril 15, Aldoril 25, Aldoril D30, Aldoril D50

Generic Name: hydrochlorothiazide and methyldopa (Pronunciation: HYE droe KLOR oh THYE a zide and METH il DOE pa)

  • What is methyldopa and hydrochlorothiazide (Aldoril)?
  • What are the possible side effects of methyldopa and hydrochlorothiazide (Aldoril)?
  • What is the most important information I should know about methyldopa and hydrochlorothiazide (Aldoril)?
  • What should I discuss with my doctor before taking methyldopa and hydrochlorothiazide (Aldoril)?
  • How should I take methyldopa and hydrochlorothiazide (Aldoril)?
  • What happens if I miss a dose (Aldoril)?
  • What happens if I overdose (Aldoril)?
  • What should I avoid while taking methyldopa and hydrochlorothiazide (Aldoril)?
  • What other drugs will affect methyldopa and hydrochlorothiazide (Aldoril)?
  • Where can I get more information?

What is methyldopa and hydrochlorothiazide (Aldoril)?

Methyldopa and hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Methyldopa and hydrochlorothiazide is used to treat high blood pressure (hypertension).

Methyldopa and hydrochlorothiazide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of methyldopa and hydrochlorothiazide (Aldoril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • dry mouth, thirst, nausea, vomiting;
  • feeling drowsy, restless, or light-headed;
  • chest pain, fast or uneven heartbeat;
  • muscle pain or weakness;
  • jerky or rolling muscle movements that you cannot control;
  • confusion, unusual thoughts or behavior;
  • skin rash, bruising, severe tingling, numbness;
  • painful or difficult urination;
  • urinating less than usual or not at all;
  • swelling in your face, stomach, hands, or feet;
  • a red, blistering, peeling skin rash;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
  • joint pain or swelling with fever, chest pain, or tired feeling.

Less serious side effects may include:

  • mild nausea, vomiting, loss of appetite, diarrhea or constipation;
  • soreness or black discoloration of your tongue;
  • headache;
  • dizziness, spinning sensation;
  • muscle or joint pain; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methyldopa and hydrochlorothiazide (Aldoril)?

You should not use this medication if you are allergic to methyldopa (Apresoline) or hydrochlorothiazide, if you are unable to urinate, or if you have liver disease (including cirrhosis or hepatitis), or a history of liver problems caused by taking methyldopa.

Do not take this medication if you are have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using methyldopa and hydrochlorothiazide, tell your doctor if you have kidney disease (or are on dialysis), angina pectoris (chest pain), asthma or allergies, gout, lupus, diabetes, an allergy to sulfa drugs, or if you have ever had a stroke.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

There are many other medicines that can interact with methyldopa and hydrochlorothiazide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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