Chloramphenicol (Otic)

Overview

Chloramphenicol is part of a group of medications called antibiotics. It is used in the form of ear drops that are specifically taken to treat infections that arise within the canal of the ear. It can be used alone or alongside similar drugs, which are taken orally. This drug is only available via a prescription from your doctor and is available in the dosage form of a solution.

Condition(s) treated?

• Outer ear inflammation caused by an infection or allergy
• Infection in an area of a mastoidectomy ear operation

Type of medicine?

• Eardrop solution

Side Effects

As with all medications, along with the intended effects, there can be some unwanted side effects associated with taking chloramphenicol. We have ranked these in terms of rare and less common. Remember that you can report any side effects, regardless of their severity, to the FDA at 1-800-FDA-1088.

You should inform your doctor immediately and seek urgent medical attention if you experience any of the following side effects when taking chloramphenicol otic.

Rare - these can also occur weeks or months after you stop taking this medication

• Changes in blood pressure or heart rate
• Bluish tone of the skin
• Eating problems
• Passage of loose green stools
• Pale skin
• Sore fever or throat
• Unusual weakness or tiredness
• Stomach bloating with or without vomiting
• Irregular breathing
• Unusual bruising or bleeding

You should inform your doctor or a health care professional as soon as possible if you experience any of the following side effects when taking chloramphenicol otic:

Less common

• Blindness or changes in vision
• Diarrhea
• Itching, burning, redness, swelling, skin rash, or other sign of irritation not present before use of this medicine
• Fever
• Mental confusion
• Hallucinations
• Headache
• Mild depression
• Stomach pain
• Nausea
• Swollen tongue or mouth
• Vomiting
• An unpleasant taste

Dosage

Your final dosage of any medication will depend on a variety of factors, including your age, weight, height, previous medical conditions, your reaction to the medication and the severity of your condition. Never change or miss a dose without consultation with your doctor or a healthcare professional and do not share this medication with anyone else.

The information below only includes the average doses of this medicine. If your dose is different, don't change it unless your doctor tells or informs you to do so.

The amount of chloramphenicol otic that you take will depend on the strength of the medicine, the time allowed between doses, the number of doses you take each day, the period of time you take the medicine and the medical problem that you are treating.

For chloramphenicol solution in the form of ear drops, the dosage for infections of the ear canal is two to three drops in the affected ear, two or three times each day for adults and children.

Missed dose

If you miss a dose of this medication, you should apply it as soon as you remember. However, if it is close to your next scheduled dose, then skip the missed dose and revert back to your regular dosing schedule.

Proper use

To use:

• Tilt the head or lie down so that the infected ear is facing up.
• Next, pull the earlobe down and back for children and up and back for adults to help straighten the ear canal. However, make sure you do this gently, so as to not cause discomfort or pain.
• Drop the medicine into the ear canal and keep the ear facing up for around two minutes to allow the medicine to find the infection.
• By using a sterile cotton plug, you can prevent some medicine from leaking out.
• To help keep the medicine clean and germ-free, don't rest the dropper on any surface and keep the container closed tightly.
• To help assist your infection in clearing up completely ensure you continue using this medicine for the full time of treatment that has been instructed by your doctor, even if your symptoms begin to clear up after a few days. Failure to complete your full course of medication could mean your symptoms return.

Interactions

Drug interactions can cause your prescribed drug to not work as well or cause unwanted and dangerous side effects. It is important, therefore, that you inform your doctor or physician of all the medication you are taking at the moment, including herbal remedies and vitamins. You should also give them a clear medical history of any illnesses you have experienced, including any that run in the family.

Medications known to interact with chloramphenicol otic

You should let your doctor know if you're taking:

• Cerebyx (fosphenytoin)
• Dilantin (phenytoin)
• Ethotoin
• Di-Phen (phenytoin)
• Fosphenytoin
• Mesantoin (mephenytoin)
• Phenytek (phenytoin)
• Phenytoin Sodium, Extended Release (phenytoin)
• Peganone (ethotoin)
• Phenytoin
• Mephenytoin
• Phenytoin Sodium (phenytoin)
• Phenytoin Sodium, Prompt (phenytoin)

There are two main disease interactions with chloramphenicol:

1. Bone marrow suppression

Chloramphenicol has the potential to cause hematologic toxicities and bone marrow depression, which can be both reversible and irreversible. Bone marrow depression is independent of dose and can result in aplastic anemia, as well as a higher rate of mortality, generally from infection or hemorrhage. It has been reported following the administration of chloramphenicol that an estimated incidence of 1 in 25,000 to 1 in 40,000 occurred in courses of therapy. Therapy that uses chloramphenicol should be administered with caution, if at all, in patients that have bone marrow depression or preexisting blood dyscrasias.

2. Perforated eardrum

The use of chloramphenicol otic preparations is contraindicated when used in patients who have a perforated tympanic membrane. This is because the risk of ototoxicity could be increased if chloramphenicol enters the middle area of the ear.

Warnings

• If you use antibiotics for a prolonged period of time, this can occasionally result in the overgrowth of fungi that belong to a group known as non-susceptible organisms. If you find that new infections are discovered during the course of this medication, you should stop taking the medication and measures should be taken appropriately.
• The possibility of the occurrence of ototoxicity must be considered if this product is allowed to enter the middle ear.

Allergies

You need to inform your doctor if you've ever had any allergic or unusual reactions to chloramphenicol or any other medicines. You should also inform your doctor or health care professional if you've experienced other types of allergies, including allergic reactions to dyes, foods, animals or preservatives. For non-prescription products, you should always ensure that you read the package or label ingredients carefully.

Breastfeeding

There are no adequate studies that have been conducted in women for determining the risk of infants during breastfeeding when the mother is taking this medication. You should work alongside your doctor to weigh up the potential benefits and the risks before commencing with this medication while breastfeeding. In some cases, it may be necessary to stop breastfeeding whilst taking the drug.

Interactions with alcohol/food/tobacco

Some medicines cannot be used at or around the time of eating certain types of food, or eating food in general, since interactions can occur. The use of tobacco and alcohol with certain medicines can also cause interactions. You should speak with your doctor or healthcare professional with regards to taking this antibiotic with alcohol, food or tobacco.

Other medical problems

The presence of other medical problems in your body can potentially affect the use of chloramphenicol. Ensure that you inform your doctor of all current medical problems and past medical problems, especially:

• Sensitivity reaction to chloramphenicol
• Opening in your eardrum - chloramphenicol has the potential to cause unwanted effects if it goes past the eardrum into the middle area of your ear

Use in the pediatric population

Gray syndrome is likely to occur in children because they are usually more sensitive to the effects of chloramphenicol than adults. If any of these side effects are experienced, they should be reported to a doctor: changed in heart rate or blood pressure, blue tone to the skin, eating problems, passage of loose green stools, irregular breathing, stomach bloating and vomiting.

Use in the geriatric population

Adequate studies have not been done between the relationship of this drug used in older people. Therefore, it's unknown whether it works in the same way as it does in younger people.

Storage

• Keep all medicines out of the sight and reach of young children
• Chloramphenicol ear drops must be kept in a fridge between 2°C to 8°C
• Chloramphenicol ear drops need to be stored in a dry, cool place, away from direct light and heat
• Throw away the tube or bottle after you have finished your course of treatment, even if there is some left. Don't leave opened tubes or bottles to use at a later date.

Summary

When used correctly, chloramphenicol otic is successful in treating infections within the ear canal. You should, however, report to your doctor if your symptoms do not begin to improve within a few days of taking this antibiotic, as it may mean that your dose needs to be increased or changed. You should also report to your doctor or a healthcare professional if you have been experiencing any side effects that are bothering your day to day life or putting your health at risk. Your doctor may be able to suggest some things that can help minimise the more common side effects or tips on how to avoid them altogether.

If you have any questions relating to the use of chloramphenicol or its side effects, do not hesitate to contact your local pharmacist, a health care professional or your doctor for further information. To avoid any unwanted interactions, you should inform your doctor of any current drugs you are taking, including any vitamins and herbal remedies. This is to keep you safe when taking chloramphenicol. You should also report your health history and any health issues that may run in the family.