Hydralazine and hydrochlorothiazide (Oral)

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

High blood pressure makes the heart and arteries work harder. If it lasts for a long time, the heart and arteries may not work properly. This can damage 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 can help prevent these issues.

Hydralazine helps by relaxing blood vessels and increasing blood and oxygen flow to the heart while lowering its workload. Hydrochlorothiazide is a thiazide diuretic that reduces the amount of water in the body by increasing urine flow through the kidneys.

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

It is important for your doctor to monitor your progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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

This medicine may cause some people to experience headaches or feel dizzy. 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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from lying or sitting down. This is more likely to happen in the morning. Getting up slowly may help. When getting up from lying down, sit on the edge of the bed with your feet hanging down for 1 or 2 minutes. Then stand up slowly. If the issue continues or worsens, consult your doctor.

Dizziness, lightheadedness, or fainting is also more likely if you drink alcohol, stand for a long time, exercise, or if the weather is hot. While you are taking this medicine, be careful with how much alcohol you consume. Also, be cautious during exercise, in hot weather, or if you must stand for a long time.

This medicine may cause a loss of potassium from your body.

• To help prevent this, your doctor may advise you to eat or drink foods high in potassium (such as 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 instructions. Do not change your diet on your own, especially if you are 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 in some cases, too much potassium could be harmful.

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

For diabetic patients:

• Thiazide diuretics may raise blood sugar levels. While using this medicine, be especially careful when testing for sugar in your blood or urine. If you have any questions about this, consult your doctor.

Some people taking this medicine may become more sensitive to sunlight than usual. Sunlight exposure, even for short periods, may cause severe sunburn, skin rash, redness, itching, or discoloration, or changes in vision. When you start taking this medicine:

• Stay out of 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 product with a skin protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF, especially if they have fair skin. If you have questions about this, consult your health care professional.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction to sunlight, contact your doctor.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. 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 about any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies to determine how age affects the use of hydralazine and hydrochlorothiazide combination in children. Safety and effectiveness have not been established.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way as they do in younger adults. While there is no specific information comparing the use of hydralazine and hydrochlorothiazide combination in elderly individuals to other age groups, this medicine is not expected to cause different side effects or issues in older adults than it does in younger adults. However, older adults may be more likely to experience dizziness, lightheadedness, or symptoms of too much potassium loss. Additionally, this medicine may reduce tolerance to cold temperatures in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together despite potential interactions. In these situations, your doctor may need to adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not be all-inclusive.

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

• Dofetilide

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both 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
• 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
• 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
• 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 may increase the risk of certain side effects, but using both medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both medicines.

• Aminolevulinic Acid
• Bepridil
• Carbamazepine
• Cholestyramine
• Ginkgo
• Gossypol
• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following may lead to an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency, or give you special instructions regarding food, alcohol, or tobacco.

• Enteral Nutrition

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to inform your doctor about any other medical problems you have, especially:

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

• Heart or blood vessel disease or
• Stroke (recent)—Lowering blood pressure may worsen problems related to these conditions.

• Hypochloremia (low chloride in the blood) or
• Hypokalemia (low potassium in the blood)
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium in the blood) or
• Parathyroid disease or
• Systemic lupus erythematosus (history of)—Use with caution. This medicine may worsen these conditions.

• Kidney disease—Hydrochlorothiazide may worsen this condition. Additionally, the blood pressure-lowering effects may be enhanced due to slower removal of hydralazine from the body.

• Liver disease—If hydrochlorothiazide causes excessive water loss, liver disease can become much worse.

• Sympathectomy—Use with caution. The effects of this medicine may be intensified.

• Type 2 diabetes mellitus—Hydrochlorothiazide may alter the amount of diabetes medication needed.

Along with its needed effects, Hydralazine and hydrochlorothiazide (Oral) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Signs and symptoms of too much potassium loss

• Dryness of mouth
• increased thirst
• irregular heartbeats
• mood or mental changes
• muscle cramps or pain
• weak pulse

Signs and symptoms of too much sodium loss

• Confusion
• convulsions
• decreased mental activity
• irritability
• muscle cramps
• unusual tiredness or weakness

Less common

• Blisters on skin
• chest pain
• general feeling of discomfort or illness or weakness
• joint pain
• numbness, tingling, pain, or weakness in hands or feet
• skin rash or itching
• sore throat and fever
• swelling of the lymph glands

Rare

• Lower back or side pain
• severe stomach pain with nausea and vomiting
• unusual bleeding or bruising
• 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

• Diarrhea
• fast or irregular heartbeat
• headache
• loss of appetite
• nausea or vomiting

Less common

• Constipation
• decreased sexual ability
• dizziness or lightheadedness, especially when getting up from a lying or sitting position
• increased sensitivity of skin to sunlight
• redness or flushing of face
• shortness of breath with exercise or work
• stuffy nose
• watering or irritated eyes

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.

• Apresazide

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

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. 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.

In addition to the use of the medicine your doctor has prescribed, 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 of these 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.

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 oral dosage forms (capsules): For high blood pressure: Adults—1 capsule two times a day. Children—Use and 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

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.