Cetraxal

Generic name: ciprofloxacin otic
Brand names: Cetraxal, Otiprio
Drug class: Otic anti-infectives

Medically reviewed by A Ras MD.

What is Cetraxal?

Cetraxal is a prescription medicine that is used to treat ear infections.

Description

CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.

Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3•HCl•H2O, and molecular weight is 385.82.

The chemical structure of ciprofloxacin hydrochloride is:

Mechanism of Action

Ciprofloxacin is a fluoroquinolone antimicrobial (see 12.4 Clinical Pharmacology, Microbiology).

Before taking Cetraxal, tell your doctor:

If you are allergic to Cetraxal; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are breast-feeding or plan to breast-feed.

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 Cetraxal 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 Cetraxal?

Tell all of your health care providers that you take Cetraxal. This includes your doctors, nurses, pharmacists, and dentists.
Do not use longer than you have been told. A second infection may happen.
Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Cetraxal while you are pregnant.

How is Cetraxal best taken?

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

For the ear only.
Use as you have been told, even if your signs get better.
Wash your hands before and after use.
Warm solution in hands 1 to 2 minutes before putting drops in ear.
Lie on your side with problem ear up.
For children younger than 3 years of age, pull the outer ear outward and downward.
For children 3 years of age and older and adults, pull the outer ear outward and upward.
Put drops in ear without touching dropper to ear. Stay on side for 1 minute.
Do not touch the container tip to the skin.

What do I do if I miss a dose?

Use a missed dose as soon as you think about it.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not use 2 doses at the same time or extra doses.

What are the side effects of Cetraxal 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 ear pain.
Very bad ear irritation.

What are some other side effects of Cetraxal?

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.
Itching.
Short-term pain after use.

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 Cetraxal?

Store at room temperature.
Store unused containers in foil pouch until use.
Protect from light.
Throw away any part left over after the dose is given.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

SRC: NLM .

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