Naropin

What is Naropin used for?

Naropin is a prescription medicine that is used to numb an area before a procedure. It is used to ease the pain.

Description

Naropin ® Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics.  Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment.  It is administered parenterally.

Ropivacaine HCl is chemically described as S-(-)-1-propyl-2′,6′-pipecoloxylidide hydrochloride monohydrate.  The drug substance is a white crystalline powder, with the following structural formula:

At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution.  The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7).  However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine.

Naropin Injection is preservative-free and is available in single dose containers in 2 (0.2%), 5 (0.5%), 7.5 (0.75%) and 10 mg/mL (1%) concentrations.  The specific gravity of Naropin Injection solutions range from 1.002 to 1.005 at 25°C.

Before taking Naropin, tell your doctor:

• If you are allergic to Naropin; 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 Naropin 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 Naropin?

For all uses of Naropin:

• Tell all of your health care providers that you take Naropin. 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 Naropin wear off and you feel fully awake.
• A severe blood problem called methemoglobinemia has happened with drugs like this one. The risk may be raised in people who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be raised while taking certain other drugs and in infants younger than 6 months of age. Tell your doctor if you have ever had methemoglobinemia.
• If you are 65 or older, use Naropin 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.

Epidural:

• This medicine may cause short-term loss of feeling and motor activity in the lower half of your body. Do not try to get out of bed or do other tasks or actions until feeling and motor activity have returned to normal.

How is Naropin best taken?

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

• It is given as a shot.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are the side effects of Naropin 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.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
• Feeling very tired or weak.
• Chest pain.
• Fast, slow, or abnormal heartbeat.
• A burning, numbness, or tingling feeling that is not normal.
• Change in balance.
• Restlessness.
• Anxiety.
• Change in speech.
• Metallic taste.
• Ringing in ears.
• Dizziness or passing out.
• Feeling lightheaded, sleepy, confused, or having blurred eyesight.
• Shakiness.
• Twitching.
• Very nervous and excitable.
• Low mood (depression).
• Seizures.
• Trouble breathing, slow breathing, or shallow breathing.

What are some other side effects of Naropin?

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 any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Back pain.

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 Naropin?

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

Label

PACKAGE LABEL – PRINCIPAL DISPLAY – Naropin 20 mL Ampule Label

• NDC 63323-288-25        NP278827
• Naropin ® (ropivacaine HCl Injection, USP)1%  200 mg per 20 mL  (10 mg per mL)
• NOT FOR INHALATION.
• 20 mL ampule
• Rx only 
  

PACKAGE LABEL – PRINCIPAL DISPLAY – Naropin 20 mL Ampule Lidding Label

• NDC 63323-288-25        NP278827
• Naropin ® (ropivacaine HCl Injection, USP)
• Sterile-Pak
• 1%  200 mg per 20 mL  (10 mg per mL)
• For Epidural Administration Only.
• Not for Intravenous Administration.

PACKAGE LABEL – PRINCIPAL DISPLAY – Naropin 20 mL Ampule Carton Panel

• NDC 63323-288-27        NP278827
• Naropin ® (ropivacaine HCl Injection, USP)1%  200 mg per 20 mL  (10 mg per mL)
• For Epidural Administration Only.
• Not for Intravenous Administration.
• Contains Five Presterilized 20 mL Plastic Ampule Units
• NOT FOR INHALATION.

Rx only

SRC: NLM .