Precedex

What is Precedex?

Precedex is a prescription medicine that is used to cause sleep during a procedure.

Description

Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Precedex has a molecular weight of 236.7 and the empirical formula is C13H16N2 ∙ HCl and the structural formula is:

Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89.

Precedex in 0.9% Sodium Chloride Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.

Mechanism of Action

Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties. Alpha2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10–300 mcg/kg). Both alpha1 and alpha2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid intravenous administration.

Before taking Precedex, tell your doctor:

• If you are allergic to Precedex; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Precedex with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Precedex?

• Tell all of your health care providers that you take Precedex. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until the effects of Precedex wear off and you feel fully awake.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Low blood pressure and slow heartbeat have happened with Precedex. Sometimes, these have been deadly. Talk with the doctor.
• The doctor will watch blood pressure, heart rate, and oxygen levels closely. Talk with the doctor.
• If you are 65 or older, use Precedex with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Precedex best taken?

Use Precedex as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Precedex that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble breathing, slow breathing, or shallow breathing.
• Fast, slow, or abnormal heartbeat.
• Feeling agitated.
• Feeling nervous and excitable.
• Headache.
• Call your doctor right away if you have any of these signs within 48 hours after getting Precedex: Change in thinking clearly and with logic, constipation, diarrhea, dizziness, salt cravings, stomach pain, sweating, weakness, or weight loss.

What are some other side effects of Precedex?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Precedex?

• If you need to store Precedex at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 50 ML BOTTLE TRAY

• 20 Units X 50 mL
  Rx only
  NDC 0409-1454-20
• Single-dose bottle. Discard unused portion.
  Contains 20 of NDC 0409-1454-01
• Precedex™
  Dexmedetomidine HCl
  in 0.9% Sodium Chloride Injection
• 200 mcg/50 mL
  (4 mcg/mL)
• For Intravenous Use
• novaplus™

 

PRINCIPAL DISPLAY PANEL – 20 ML VIAL LABEL

• 20 mL
  NDC 0409-3301-01
• Single-dose vial.
  Discard unused portion.
• Precedex™
  Dexmedetomidine HCl in
  0.9% Sodium Chloride Injection
• 80 mcg/20 mL
  (4 mcg/mL)

SRC: NLM .