Novaplus HydrALAZINE Hydrochloride (Injection)

Hydralazine injection is used to treat high blood pressure (hypertension). High blood pressure increases the workload on 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. Reducing blood pressure can lower the risk of heart attacks and strokes.

Hydralazine helps by relaxing the blood vessels, which increases the flow of blood and oxygen to the heart and decreases its workload.

This medicine should only be given by or under the direct supervision of your doctor.

It is important for your doctor to monitor you closely while you are using this medicine. This will help your doctor determine if the medicine is working correctly. Blood tests may be required to check for negative effects.

Hydralazine may cause some people to experience headaches or feel dizzy. Be sure you understand how this medicine affects you before driving, operating machines, or doing anything else that could be risky if you are dizzy or not alert.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits of the medicine. Here are some important things to consider:

Allergies

Let your doctor know 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 allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how hydralazine injection affects children. However, no specific problems for children have been documented so far.

Geriatric

There is no information available on how hydralazine injection affects older adults.

Breast Feeding

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, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain 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 it may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine or provide special instructions regarding food, alcohol, or tobacco use.

• Enteral Nutrition

Other Medical Problems

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

• Angina (severe chest pain) or
• Blood disease or
• History of heart attack or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Peripheral neuritis (nerve problem) or
• History of stroke or
• Systemic lupus erythematosus—Use with caution. May worsen these conditions.

• Coronary artery disease or
• Mitral valvular rheumatic heart disease—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Arm, back, or jaw pain
• Chest pain or discomfort
• Chest tightness or heaviness
• Fast, pounding, or irregular heartbeat or pulse
• Nausea
• Shortness of breath
• Sweating

Less common

• Black, tarry stools
• Blindness or vision changes
• Blurred vision
• Burning of the face or mouth
• Burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• Chills
• Clumsiness or unsteadiness
• Confusion
• Cough
• Difficulty or labored breathing
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fever and sore throat
• Lower back or side pain
• Painful or difficult urination
• Pale skin
• Shakiness in the legs, arms, hands, feet
• Swelling
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Trembling or shaking of the hands or feet
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weakness in the hands or feet

Rare

• Dark urine
• General tiredness and weakness
• Light-colored stools
• Nausea and vomiting
• Upper right abdominal or stomach pain
• Yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose happen:

Symptoms of overdose

• Feeling of warmth
• Headache
• Redness of the face, neck, arms, and sometimes, upper chest

Some side effects may happen 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, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• Headache
• Loss of appetite
• Weight loss

Less common

• Difficulty having a bowel movement (stool)
• Difficulty with moving
• Dizziness
• Feeling anxious or depressed
• Muscle cramps, pain, or stiffness
• Pain in the joints
• Rash, hives or welts, itching

Other side effects not listed may also happen 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.

• Apresoline
• Novaplus HydrALAZINE Hydrochloride

Available Dosage Forms:

• Solution

Therapeutic Class: Peripheral Vasodilator

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.