Methyldopa and hydrochlorothiazide (Oral)

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

High blood pressure increases the workload of the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. High blood pressure may also raise the risk of heart attacks. Controlling blood pressure may help reduce the chances of these problems.

Methyldopa controls nerve impulses along certain nerve pathways, which helps relax blood vessels so blood can flow through them more easily. Hydrochlorothiazide decreases the amount of water in the body by increasing urine flow. Together, these actions help lower blood pressure.

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

It is important for your doctor to check your progress at regular visits to ensure that this medicine is working properly.

Do not take other medicines unless your doctor has discussed them with you. This includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, as these may increase your blood pressure.

This medicine may cause your body to lose potassium:

• To help prevent this, your doctor may recommend that you eat or drink foods high in potassium (like orange or other citrus fruit juices), take a potassium supplement, or take another medicine to help prevent potassium loss.
• It is very important to follow these recommendations. Do not change your diet on your own, especially if you are already on a special diet (like for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be needed, and too much potassium could be harmful.

Check with your doctor if you become sick and have severe or ongoing vomiting or diarrhea. These issues may cause you to lose more water and potassium.

Before any type of surgery (including dental surgery) or emergency treatment, inform the medical doctor or dentist that you are taking this medicine.

If you have a fever with no clear reason, consult your doctor. This is especially important during the first few weeks of taking this medicine, as fever may indicate a serious reaction to methyldopa.

This medicine may make some people feel drowsy or less alert than usual. This is more likely when you first start taking it or if you increase your dose. Know how this medicine affects you before driving, using machines, or doing anything that could be dangerous if you are not alert.

Dizziness, light-headedness, or fainting may occur, especially when getting up from lying down or sitting. Getting up slowly may help, but if the problem persists or worsens, contact your doctor.

Dizziness, light-headedness, or fainting is also more likely if you drink alcohol, stand for long periods, exercise, or if it's hot outside. Alcohol may also worsen drowsiness. Be cautious about alcohol consumption while taking this medicine, and take extra care when exercising, in hot weather, or if you must stand for long periods.

For diabetic patients:

• This medicine may raise blood sugar levels. Be particularly careful when testing for sugar in your urine while using this medicine. If you have any questions, consult your doctor.

This medicine may cause dryness in your mouth. For temporary relief, you can use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. If your mouth remains dry for more than 2 weeks, check with your doctor or dentist. Ongoing dryness may increase the risk of dental problems, including tooth decay, gum disease, and fungal infections.

Hydrochlorothiazide may make your skin more sensitive to sunlight than usual. Even brief exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn. When you start taking this medicine:

• Avoid direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat, and sunglasses.
• Use a sunblock with a skin protection factor (SPF) of at least 15. Some patients may need a higher SPF, especially if they have fair skin. If you have questions, consult your healthcare professional.
• Use a sunblock lipstick with an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction to the sun, check with your doctor.

Before any medical tests, inform the doctor in charge that you are taking this medicine. Some test results may be affected by this medicine.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

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 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

While there is no specific information comparing the use of this medicine in children to other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Dizziness or light-headedness, drowsiness, or signs of too much potassium loss may be more likely to occur in older adults, who are more sensitive to the effects of methyldopa and hydrochlorothiazide.

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.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

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

• Brofaromine
• Clorgyline
• Dofetilide
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• 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 of the medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Entacapone
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Iobenguane I 131
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Pseudoephedrine
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Valdecoxib
• Vildagliptin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Alprenolol
• Aminolevulinic Acid
• Bepridil
• Bisoprolol
• Carbamazepine
• Cholestyramine
• Ferric Ammonium Citrate
• Ginkgo
• Gossypol
• Haloperidol
• Iron
• Licorice
• Phenylpropanolamine
• Sotalol
• Timolol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Angina (chest pain)—Methyldopa may worsen this condition.

• Type 2 diabetes mellitus—Hydrochlorothiazide may change the amount of diabetes medicine needed.

• Gout (history of)—Hydrochlorothiazide may raise uric acid levels in the blood, which can lead to gout.

• High cholesterol—Hydrochlorothiazide may increase cholesterol levels.

• Kidney disease—The effects of methyldopa and hydrochlorothiazide may be stronger due to slower removal from the body. If severe, hydrochlorothiazide may not work.

• Liver disease—The effects of methyldopa may be stronger due to slower removal from the body. If hydrochlorothiazide causes a loss of too much water, liver disease can worsen significantly.

• Lupus erythematosus (history of)—Hydrochlorothiazide may worsen this condition.

• Mental depression (history of)—Methyldopa can lead to mental depression.

• Pancreatitis (inflammation of the pancreas)

• Parkinson's disease—Methyldopa may worsen this condition.

• Pheochromocytoma—Methyldopa may interfere with tests for this condition. Additionally, there have been reports of increased blood pressure.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

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

Rare

• Unexplained fever shortly after starting to take this medicine

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

Signs and symptoms of too much potassium loss

• Dry mouth
• increased thirst
• irregular heartbeats
• muscle cramps or pain
• nausea or vomiting
• unusual tiredness or weakness
• weak pulse

Less common

• Mental depression or anxiety
• nightmares or unusually vivid dreams

Rare

• Cough or hoarseness
• dark or amber urine
• diarrhea or stomach cramps (severe or continuing)
• fever, chills, troubled breathing, and fast heartbeat
• general feeling of discomfort or illness or weakness
• joint pain
• lower back or side pain
• painful or difficult urination
• pale stools
• skin rash, hives, or itching
• stomach pain (severe) with nausea and vomiting
• tiredness or weakness after having taken this medicine for several weeks (continuing)
• yellow eyes or skin

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness or light-headedness when getting up from a lying or sitting position
• drowsiness
• dryness of mouth
• headache

Less common

• Decreased sexual ability or interest in sex
• diarrhea
• increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin or severe sunburn after exposure to sunlight)
• loss of appetite
• numbness, tingling, pain, or weakness in hands or feet
• slow heartbeat
• stuffy nose
• swelling of breasts or unusual milk production

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.

• Aldoril

Available Dosage Forms:

• Tablet

Therapeutic Class: Alpha-Adrenergic Agonist/Thiazide Combination

Pharmacologic Class: Alpha-Adrenergic Agonist

Chemical Class: Thiazide

In addition to the use of the medicine your doctor has prescribed, appropriate treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which factors are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After taking the medicine for a while, these effects should lessen. In general, to keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.
• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

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 treating high blood pressure: For oral dosage form (tablets): Adults: Two to four tablets a day, taken as a single dose or in divided doses. Children: 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

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.