Chloramphenicol (Otic)

Chloramphenicol is an antibiotic. Chloramphenicol otic drops are used to treat infections in the ear canal. This medicine can be used by itself or along with other medicines taken by mouth for ear canal infections.

Chloramphenicol is available only with your doctor's prescription.

If your symptoms do not get better in a few days, or if they worsen, contact your doctor.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it can provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or ingredients carefully.

Pediatric

Gray syndrome may be more likely to happen in children, who are generally more sensitive than adults to the effects of chloramphenicol. Report any of the following effects to your healthcare professional: blue skin tone, changes in blood pressure or heart rate, problems with eating, irregular breathing, loose green stools, or stomach bloating with or without vomiting. Your healthcare professional should monitor blood levels of chloramphenicol if possible.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way as they do in younger adults or if they cause different side effects or issues in older adults. There is no specific information comparing the use of this medicine in the elderly with other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily complete.

Using this medicine with any of the following medicines is generally not recommended, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Cholera Vaccine, Live
• Tacrolimus
• Voriconazole

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Ceftazidime
• Chlorpropamide
• Cyanocobalamin
• Cyclosporine
• Dicumarol
• Fosphenytoin
• Phenytoin
• Rifampin
• Rifapentine
• Tetanus Toxoid
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Opening in your ear drum—This medicine may cause unwanted effects if it passes through the ear drum into the middle ear
• Sensitivity reaction to chloramphenicol

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

may also occur weeks or months after you stop using this medicine

• Bluish tone to the skin
• changes in blood pressure or heart rate
• eating problems
• irregular breathing
• pale skin
• passage of loose green stools
• sore throat and fever
• stomach bloating with or without vomiting
• unusual bleeding or bruising
• unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Blindness or changes in vision
• burning, itching, redness, skin rash, swelling, or other signs of irritation not present before using this medicine
• diarrhea
• fever
• hallucinations
• headache
• mental confusion
• mild depression
• nausea
• stomach pain
• swollen mouth and tongue
• unpleasant taste
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In Canada

• Chloromycetin
• Sopamycetin

Chemical Class: Chloramphenicol (class)

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 1 or 2 minutes to allow the medicine to come into contact with the infection. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic solution (ear drops) dosage form: For infections of the ear canal: Adults and children—Use 2 or 3 drops in the affected ear two to three times a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.