Vazculep (Intravenous)

Phenylephrine injection is used to treat hypotension (low blood pressure) that may happen during surgery.

This medicine is to be given only by your doctor or under their direct supervision.

Your doctor will monitor your progress closely while you receive this medicine. This will help your doctor determine if the medicine is working properly and if you should continue using it. Blood tests may be needed to check for unwanted effects.

This medicine may cause a permanent depression (necrosis) under the skin at the injection site. Tell your doctor immediately if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you and your doctor will make together. 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 if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the results of phenylephrine injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies so far have not shown any specific problems in older adults that would limit the usefulness of phenylephrine injection. However, older patients are more likely to have kidney, liver, or heart issues, which may require caution and a dose adjustment when receiving phenylephrine injection.

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.

Interactions with Medicines

Some medicines should never be used together, while in other situations, two different medicines may be used together even if an interaction might happen. In these cases, your doctor might change the dose, or other precautions may be necessary. When you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. 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.

• Dihydroergotamine
• Linezolid
• Rasagiline
• Selegiline

Using this medicine with any of the following medicines is usually not recommended but may be needed 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.

• Ergonovine
• Iobenguane I 123
• Iobenguane I 131
• Methylergonovine
• Midodrine
• Zavegepant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Allergy to sulfites or
• Asthma—This medicine contains sodium metabisulfite, which can worsen these conditions.

• Angina, or a history of
• Bradycardia (slow heartbeat) or
• Severe blood vessel problems (e.g., arteriosclerosis), or
• Heart failure or
• Peripheral vascular disease or
• Pulmonary arterial hypertension or
• Spinal cord injury—Use with caution. May worsen these conditions.

• Severe kidney disease, or
• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

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

Check with your doctor or nurse right away if you have any of these side effects:

Incidence not known

• Blurred vision
• chest pain or discomfort
• difficult or labored breathing
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• headache
• nausea or vomiting
• nervousness
• pain in the shoulders, arms, jaw, or neck
• pounding in the ears
• sweating
• tightness in the chest
• unusual tiredness

Get emergency help immediately if you have any of these symptoms of overdose:

Symptoms of overdose

• Feeling of fullness in the head
• pounding or rapid pulse
• tingling in the arms or legs
• vomiting

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

Incidence not known

• Heartburn
• itching skin
• nausea
• pain in the neck
• pain or discomfort in chest, upper stomach, or throat

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.

• Biorphen
• Vazculep

Available Dosage Forms:

• Solution

Therapeutic Class: Vasopressor

Pharmacologic Class: Adrenergic System

Chemical Class: Alkylarylamine

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.

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