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Chloroxylenol, hydrocortisone, and pramoxine (otic)

Generic names: chloroxylenol, hydrocortisone, and pramoxine (otic) [KLOR-oh-ZYE-le-nol, HYE-droe-KOR-ti-sone, pra-MOX-een].
Brand names: Cortane-B, Cortane-B Aqueous, Cortane-B Otic, Pramox-hcotic, Zoto-HC Drops,… Show all 19 brands
Forms of dosage: otic lotion (0.1%–1%) and otic solution (0.1%–1%).
Otic steroids with antibiotics

What is Chloroxylenol, hydrocortisone, and pramoxine (otic)?

Chloroxylenol is an antibacterial used to treat infections caused by bacteria and fungi. Hydrocortisone is a type of steroid. It inhibits the action of chemicals that cause inflammation in the body. Pramoxine works as a topical anesthetic. It interferes with the pain signals that are sent by the nerves from the skin to the brain. The combination of chloroxylenol and hydrocortisone (for the ears) is used to treat infections and relieve symptoms such as swelling or itching. The combination of chloroxylenol and hydrocortisone will not work to treat inner ear infections, also known as medial otitis. The FDA has not approved the use of this product as a medicine to treat ear infections. It is not recommended that you use hydrocortisone or pramoxine as a substitute for medication prescribed by your doctor. This medication guide does not list all possible uses for chloroxylenol.

Side effects of Chloroxylenol, hydrocortisone, and pramoxine (otic)

If you experience any of the following signs and symptoms of an allergic reaction: difficulty breathing, hives or swelling to lips, face, tongue or throat - please seek medical help immediately! Hydrocortisone can cause side effects, even though it is only used on the ears. Steroids absorbed through your skin in your ears may cause side effects in other parts of your body. These include thin skin, easy bruises, changes in body shape (especially your neck, back, and waist), acne or facial hair growth, menstrual issues, impotence, or loss of interest in a sexual relationship. If you experience severe burning or irritation in your ears after using these drops, stop using them and contact your doctor immediately. Some common side effects include mild burning or stinging after the first application. There may be other side effects. Call your physician immediately if experiencing symptoms that seem unusual; alternatively, for more assistance regarding side effects contact 1-800-FDA-1088 and report any adverse reactions directly.

Warnings

The FDA has not approved the use of this product as a medicine to treat ear infections. If you have cowpox or chickenpox, you should not take chloroxylenol or hydrocortisone.

Before you take this drug

This medicine should not be used if:

  • A hole in the eardrum (eardrum rupture);
  • Chickenpox and cowpox are both contagious diseases.

Inform your doctor of any of the following to make sure this medication is appropriate:

  • An inner ear infection
  • Severe ear pain
  • Hearing problems or other hearing disorders
  • Fever.

There is no way to know if chloroxylenol or hydrocortisone will harm an unborn child. If you plan to get pregnant or are currently pregnant, tell your doctor. It is unknown whether this medication passes into breast milk and whether its effects could harm a baby who was breastfeeding at the same time. You should tell your doctor if you're breastfeeding a child. This medicine should not be given to children without consulting a doctor. This medicine can be absorbed more readily by children through their ear canals, and they may experience side effects.

How to take Chloroxylenol, hydrocortisone, and pramoxine (otic)?

Follow the directions on the prescription label. Use chloroxylenol and hydrocortisone in smaller or larger amounts, or for a longer time than prescribed. Remove any earwax or other debris prior to using this medication. Ask your doctor for safe ways to remove earwax.

How to use the eardrops:

  • If you are lying down, tilt your head upward with your ear up. When giving the medicine to a young child, gently pull your ear back or pull downward on the earlobe.
  • Drop the correct amount of drops in your ear by holding the dropper upside-down over your ear.
  • For at least five minutes, lie down with your head tipped back. Use a piece of cotton to block the ear canal and prevent the medication from leaking out.
  • You can also put a piece of gauze in your ear and drop enough medicine inside to soak it.
  • Keep the cotton moistened by adding a few drops to the medicine every four hours.
  • You can then put the drops in your ear directly after removing the gauze. Do this 3 to 4 times a day. Only use the prescribed number of drops.
  • You should follow your doctor's advice about the length of time you can use chloroxylenol ear drops, hydrocortisone ear drops, or pramoxine.

Avoid touching the tip of the dropper or placing it directly into your ears. It could become contaminated. Do not use soap or water to wash the tip. Instead, wipe it with a tissue. If your symptoms persist after 10 days, call your doctor. If you have not had your ear checked by a doctor, do not use hydrocortisone or pramoxine. Store away from heat and moisture at room temperature.

What happens if I miss the dose?

As soon as you recall, take the missed dose. If your next scheduled dosage is approaching, skip the missed dose. You should not take extra medicine to compensate for a missed dose.

What happens if I overdose?

Overdoses of hydrocortisone and pramoxine are not dangerous. If anyone accidentally swallows the medication, seek emergency medical care or call Poison Help at 1-800-222-1222.

What should be avoided?

The medicine should only be used in the ears. Avoid getting the medication in your mouth, nose, eyes, or lips. If this medicine has gotten into or on any of these areas, rinse with water. You should only use this medication if your doctor prescribes it.

Interaction with other drug

Other drugs that you may take orally or even inject are unlikely to have any effect on the chloroxylenol, hydrocortisone, or pramoxine that are used in your ears. Many drugs interact with each other. Inform your healthcare provider about the medicines you take, including vitamins and herbal remedies.