Reserpine, hydralazine, and hydrochlorothiazide (Oral)

Reserpine, hydralazine, and hydrochlorothiazide combinations are used to treat high blood pressure (hypertension).

High blood pressure puts extra strain on the heart and arteries. If it lasts 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 chance of these problems.

Reserpine helps control nerve signals along specific nerve pathways. This lowers blood pressure by affecting the heart and blood vessels. Hydralazine relaxes blood vessels and increases blood flow to the heart while making it easier for the heart to work. Hydrochlorothiazide is a thiazide diuretic (water pill) that decreases the amount of water in the body by increasing urine flow. This also helps lower blood pressure.

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

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

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

Before undergoing any kind of surgery (including dental surgery) or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking this medicine.

This medicine may cause some people to experience headaches or feel dizzy or drowsy. Be aware of 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 happen, especially when you get up from lying down or sitting. This is more likely to occur in the morning. Getting up slowly may help. When you get up from lying down, sit at the edge of the bed with your feet hanging for 1 or 2 minutes before standing up slowly. If the problem continues or worsens, consult your doctor.

The 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 taking this medicine, be cautious about how much alcohol you consume. Also, take extra care during exercise or hot weather, or if you must stand for a long time.

In some patients, this medicine may cause mental depression. Notify your doctor immediately if:

• you or someone else notices unusual changes in your mood.
• you start having trouble sleeping in the early morning or experience unusually vivid dreams or nightmares.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that slow down the nervous system and may cause drowsiness). Some examples of CNS depressants include antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medications; prescription pain medicines or narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including dental anesthetics. Consult your doctor before taking any of these while on this medicine.

This medicine may lead to a loss of potassium from your body.

• To help prevent this, your doctor may advise you to eat or drink foods that are high in potassium (for example, orange or other citrus fruit juices), take a potassium supplement, or use another medicine to prevent potassium loss.
• It is very important to follow these instructions. Also, do not change your diet without consulting your doctor. This is especially important 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 in some cases, too much potassium could be harmful.

Check with your doctor if you become ill and have severe or persistent nausea, vomiting, or diarrhea. These issues may lead to additional loss of water and potassium.

For diabetic patients:

• This medicine may increase blood sugar levels. While using this medicine, be particularly careful in testing for sugar in your urine. If you have any questions about this, consult your doctor.

Some people who take this medicine may become more sensitive to sunlight than usual. Exposure to sunlight, even briefly, may cause severe sunburn; skin rash, redness, itching, or discoloration; or vision changes. 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 those with fair skin. If you have questions about this, check with your health care professional.
• Do not use a sunlamp or tanning bed or booth.

If you experience a severe reaction to the sun, consult your doctor.

This medicine often causes nasal stuffiness. However, do not use nasal decongestant medicines without first checking with your health care professional.

This medicine may cause dry mouth. For temporary relief, you can use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth persists for more than 2 weeks, consult your medical doctor or dentist. Ongoing dry mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

In deciding to use a medicine, it's important to consider the risks against the benefits. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

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

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way as in younger adults. While there is no specific information comparing the use of reserpine, hydralazine, and hydrochlorothiazide combination in older people with use in other age groups, this medicine is not expected to cause different side effects or problems in older people compared to younger adults. However, drowsiness, dizziness, faintness, or symptoms of too much potassium loss may occur more often in older patients, who are usually more sensitive to this medicine's effects. This medicine may also reduce tolerance to cold temperatures in elderly patients.

Breast Feeding

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

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen 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
• Deutetrabenazine
• Dofetilide
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Tetrabenazine
• Toloxatone
• Tranylcypromine

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 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
• Colchicine
• 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
• Fosphenytoin
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Iobenguane I 123
• 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
• Phenytoin
• 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 medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. 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 may increase the risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or provide special instructions about food, alcohol, or tobacco use.

• Enteral Nutrition

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor about any other medical issues you have, especially:

• Allergies or other breathing problems such as asthma—Reserpine can cause breathing problems

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

• Epilepsy

• Gallstones or
• Stomach ulcer or
• Ulcerative colitis—Reserpine increases activity of the stomach, which may worsen these conditions

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

• Heart disease—Reserpine can cause heart rhythm issues or slow the heartbeat. Lowering blood pressure may worsen some conditions

• Kidney disease—Some patients may not tolerate blood pressure lowering from this medicine. Effects of hydralazine may be increased due to slower removal from the body. If kidney disease is severe, hydrochlorothiazide may not be effective

• Liver disease—If hydrochlorothiazide causes excessive water loss, liver disease can worsen significantly

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

• Mental depression (or history of)—Reserpine can cause mental depression

• Pancreatitis (inflammation of the pancreas)

• Parkinson's disease—Reserpine can cause symptoms similar to parkinsonism

• Pheochromocytoma

• Stroke (recent)—Lowering blood pressure may worsen issues related to this condition

Suggestions that rauwolfia alkaloids may increase the risk of breast cancer later have not been proven. However, studies in rats and mice given 100 to 300 times the human dose showed an increased number of tumors.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• General feeling of discomfort or illness or weakness

Less common

• Drowsiness or faintness
• impotence or decreased sexual interest
• lack of energy or weakness
• mental depression or inability to concentrate
• nervousness or anxiety
• vivid dreams or nightmares or early-morning sleeplessness

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 heartbeat
• 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

• Black, tarry stools
• blisters on skin
• bloody vomit
• chest pain
• fever and sore throat
• headache
• irregular heartbeat
• joint pain
• numbness, tingling, pain, or weakness in hands or feet
• shortness of breath
• skin rash or itching
• slow heartbeat
• stomach cramps or pain
• swelling of lymph glands

Rare

• Lower back or side pain
• painful or difficult urination
• stiffness
• stomach pain (severe) with nausea and vomiting
• trembling and shaking of hands and fingers
• unusual bleeding or bruising
• yellow eyes or skin

Signs and symptoms of overdose

• Dizziness or drowsiness (severe)
• dryness of mouth
• flushing of skin
• increased thirst
• muscle cramps or pain
• nausea or vomiting (severe)
• pinpoint pupils of eyes
• slow pulse

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. Your health care professional may also have 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
• dizziness, especially when getting up from a lying or sitting position
• loss of appetite
• nausea or vomiting
• stuffy nose

Less common

• Constipation
• flushing or redness of skin
• increased sensitivity of skin to sunlight
• swelling of feet and lower legs
• watering or irritated eyes

After you stop using this medicine, it may still cause some side effects that need attention. During this time, check with your doctor immediately if you notice the following side effects:

• Drowsiness or faintness
• general feeling of discomfort or illness or weakness
• impotence or decreased sexual interest
• irregular heartbeat
• mental depression or inability to concentrate
• nervousness or anxiety
• vivid dreams or nightmares or early-morning sleeplessness

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.

Pharmacologic Class: Monoamine Depletor

Chemical Class: Rauwolfia

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.

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 you have taken 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.

If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea, vomiting, stomach pain or cramps) continues, check with your doctor.

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 form (tablets): For high blood pressure: Adults—1 or 2 tablets three 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.