Cetraxal

What is Cetraxal?

• Cetraxal (Ciprofloxacin) is a quinolone antimicrobial used for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Ciprofloxacin

Ciprofloxacin-zwitterion-from-xtal-3D-balls

What are the uses of this medicine?

• Cetraxal (Ciprofloxacin) is used for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

How does this medicine work?

• Ciprofloxacin is a fluoroquinolone antimicrobial.
• The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA.

Ciprofloxacin has been shown to be active against most isolates of the following bacteria:

• Staphylococcus aureus
• Pseudomonas aeruginosa

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of hypersensitivity to ciprofloxacin.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Cetraxal.

Is this medicine FDA approved?

• Ciprofloxacin was patented in 1980 and introduced in 1987.

How should this medicine be used?

Recommended dosage:

• Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.

Administration:

• Wash hands before use.
• The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal.
• The patient should lie with the affected ear upward and then the solution should be instilled.
• This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear.
• Repeat, if necessary, for the opposite ear.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.

This medicine is available in fallowing brand namesː

• Cetraxal

What side effects can this medication cause?

The most common side effects of this medicine include:

• application site pain
• ear pruritus
• fungal ear superinfection
• headache

What special precautions should I follow?

• CETRAXAL is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.
• CETRAXAL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
• As with other anti-infectives, use of CETRAXAL may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy.
• If the infection is not improved after one week of therapy, cultures may help guide further treatment.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• No adequate and well-controlled studies have been performed in pregnant women.
• Caution should be exercised when CETRAXAL is used by a pregnant woman.
• Pregnancy Category C.

Can this medicine be used in children?

• The safety and effectiveness of CETRAXAL in infants below one year of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CIPROFLOXACIN HYDROCHLORIDE

Inactive ingredients:

• POVIDONE, UNSPECIFIED
• GLYCERIN
• WATER
• SODIUM HYDROXIDE
• LACTIC ACID, UNSPECIFIED FORM

Who manufactures and distributes this medicine?

CETRAXAL is:

• Distributed by:
• WraSer™​ PHARMACEUTICALS
• Ridgeland, MS

• Manufactured by:
• The Ritedose Corporation
• Columbia, SC USA

What should I know about storage and disposal of this medication?

• Store at 15ºC to 25ºC (59ºF to 77ºF).
• Discard used containers.
• Store unused containers in pouch to protect from light.

• Dailymed label info on Cetraxal
• FDA Cetraxal

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