Power to Soothe & Power to Cure
for acute otitis externa also known as “swimmers ears”
For the treatment of Otitis Externa, CETRAXAL is the first Food and Drug Administration (FDA) Ciprofloxacin single agent prescription ototopical antibiotic approved for the treatment of acute otitis externa in adults and children 1 year and older in the United States. CETRAXAL individual dosing vials make it easy for accurate dosing. CETRAXAL is preservative free, which minimizes the risk of ototoxicity.
What is Otitis Externa?
What is “swimmer’s ear” or acute external otitis?
External otitis or “swimmer’s ear” is an infection of the skin covering the outer ear and ear canal. Acute external otitis is commonly a bacterial infection caused by streptococcus, staphylococcus, or pseudomonas types of bacteria. The swimmer’s ear infection is usually caused by excessive water exposure. When water collects in the ear canal (frequently trapped by wax), the skin will become soggy and serve as an inviting culture media for bacteria. Cuts or abrasions in the lining of the ear canal (for example, from cotton swab injury) can also predispose to bacterial infection of the ear canal.
What are the symptoms of swimmer’s ear?
The first symptom of infection is that the ear will feel full, and it may itch. Next, the ear canal will swell and ear drainage will follow. At this stage the ear will be very painful, especially with movement of the outside portion of the ear. The ear canal can swell shut, and the side of the face can become swollen. Finally, the glands of the neck may enlarge, making it difficult or painful to open the jaw. People with swimmer’s ear may experience a decreased capacity for hearing in the affected ear.
Q. What is Cetraxal?
A. Cetraxal is a 0.2% ciprofloxacin otic solution quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) due to susceptible isolate of P aeruginosa or S aureus. Cetraxal is for ear use only.
Q. Are ear infections contagious?
A. NO. Ear infections are not contagious and can not be spread.
Q. Can you ONLY get an ear infection from lake or ocean water?
A. NO. Ear infections can be caused from bathing water, excessive cleaning with foreign objects, and even excessive moisture in addition to lakes and oceans.
Q. Do I stop use of Cetraxal before 7 days if the pain goes away?
A. Always take your medication based on how your healthcare provider recommends. Cetraxal should be taken for the full 7 days whether your symptoms are resolved or not.
Q. Should I warm Cetraxal before dosing?
A. NO. Cetraxal should be stored at room temperature (59°F to 77°F) which is the correct temperature to dose. If you have slight dizziness try warming Cetraxal in your hands for at least one minute prior to use. Cold solution into the ear canal can cause dizziness.
Q. What if my child appears to have another ear infection?
A. Patients who have not improved from one course of treatment should see their healthcare provider.
Q. What happens if I miss a dose of Cetraxal?
A. Always take your medication based on how your healthcare provider recommends. Cetraxal should be equally spaced from one dose to the next (approximately 12-hrs between doses). If you miss a dose do not double up the next dose. Instead, you should take your next dose as usual as soon as you remember, or, if it is nearly time for the next dose of Cetraxal, skip your dose altogether.
Q. What is Antibiotic Resistance?
Antibiotic resistance occurs when bacteria mutate and make certain medications ineffective in preventing bacterial infections.
The U.S. Department of Health and Human Services offers these suggestions for preventing antibiotic-resistant infections:
Talk to your doctor about whether you actually need an antibiotic to treat a particular illness.
Don’t take antibiotics when they are not helpful. For example, antibiotics will not treat infections caused by viruses, including the common cold and the flu.
Always take antibiotics as prescribed by your doctor. Don’t skip any dose, and don’t stop taking them early, even if you feel better.
Never “save” antibiotics to take later. Never re-use them for a different illness.
Never take an antibiotic that was prescribed to another person.
Managed Care Co Payments
Please use these coupon codes at any retail pharmacy for out of pocket copay assistance: BIN# 600428 GROUP# 06780131 PCN# 0678000 ID# 19062468510.
Indications and Usage
Cetraxal is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.
Dosage and Administration
Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
Dosage Forms and Strengths
Cetraxal is a sterile, preservative-free otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
History of hypersensitivity to ciprofloxacin.
Warnings and Precautions
- Cetraxal is for otic use only.
- Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity.
- Use of Cetraxal may result in overgrowth of nonsusceptible organisms.
The most common adverse reactions reported in 2-3% of patients treated with Cetraxal were application site pain, ear pruritis, fungal ear superinfection, and headache.
Directions for Use
Patients should be advised that Cetraxal is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.
Cetraxal should be given 2 times each day (about 12 hours apart) in each infected ear.
Cetraxal should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on Cetraxal:
Wash their hands before use.
No need to warm the container like other otic antibiotics. Twist off and discard top of container.
Lie with the affected ear upward and then instill the contents of one container into the ear. Maintain this position for at least one minute to facilitate penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear.
Discard used container.
Store unused containers in pouch to protect from light.
Patients should be advised to immediately discontinue Cetraxal at the first appearance of a skin rash or any other sign of hypersensitivity.
Meet Wet Willy
Wet Willy is a tropical fish that wants to help patients with acute otits externa get back in the swim again. Look for Wet Willy swimming into your town soon.
Wet Willy suggests 11 steps to possibly prevent immediate and long term ear infections:
1. Dry Ears. Dry your ears after swimming to prevent moisture build-up.
2. Protection. If you swim frequently you should use a barrier to protect your ears from water. However, impermeable ear plugs act as a local irritant and have been shown to predispose the ear canal to infections.
3. Refrain from cetain activities. If you already have acute otitis externa you should abstain from water sports for at least seven to ten days.
4. Avoid foreign objects. Avoid putting objects in the ear (e.g. fingers, cotton swabs) that may scratch the ear canal and provide a site for infection. Any time the external auditory canal is cleaned and cerumen is removed, the canal becomes more vulnerable to infection.
5. Breast Feeding. Medical literature indicates breast feeding can lower your child’s chances of getting ear infections.
6. Daycare Setting. Continuous exposure to other children increases the risk that your child will catch more colds, and consequently more ear infections.
7. Control Allergies. If you think allergies are contributing to your child’s runny nose and consequently ear infections, ask your healthcare provider how to minimize your child’s allergies.
8. Feed your baby upright. Lying down while bottle-feeding can cause the milk to irritate the Eustachian tube which can contribute to ear infections.
9. Keep the nose clear. When a runny nose and cold start, do your best to keep the nose clear by using steam, saline nose drops, and suctioning. See your healthcare provider for further cold medications.
10. Cigarette smoke. There is strong evidence that cigarette smoke can possibly irritate a baby’s nasal passage, which leads to Eustachian tube dysfunction.
11. Eat more fruits and vegetables. These can boost your child’s immune system and help fight infections.
Please use the below coupon codes at any retail pharmacy for instant out of pocket copay assistance: BIN# 600428 GROUP# 06780131 PCN# 0678000 ID# 19062468510
Ridgeland MS 39157
Phone (601) 605-0664
Fax (601) 605-0135
Ask your Healthcare Provider today about an INSTANT REBATE for your next prescription of Cetraxal®
IMPORTANT SAFETY INFORMATION
CETRAXAL® is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. CETRAXAL® is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. 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. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with CETRAXAL®. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache,each reported in approximately 2-3% of patients.
To report SUSPECTED ADVERSE REACTIONS, contact WraSer Pharmaceuticals at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CETRAXAL® is a registered trademark of Laboratorios Salvat, S.A