Ak-Chlor

Name: Ak-Chlor

Descriptions

Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol ophthalmic preparations are used to treat infections of the eye. This medicine may be given alone or with other medicines that are taken by mouth for eye infections.

Chloramphenicol is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Solution
  • Ointment
  • Powder for Solution

Commonly used brand name(s)

In the U.S.

  • Ocu-Chlor

In Canada

  • Ak-Chlor
  • Chloromycetin
  • Chloroptic
  • Fenicol
  • Isopto Fenicol
  • Minims Chloramphenicol 0.5%
  • Ophtho-Chloram
  • Pentamycetin Ophthalmic Solution 0.25%
  • Pentamycetin Ophthalmic Solution 0.5%
  • Pms-Chloramphenicol
  • Sopamycetin

Available Dosage Forms:

  • Solution
  • Ointment
  • Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Chloramphenicol (class)

Before Using Ak-Chlor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholera Vaccine, Live
  • Citalopram
  • Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of chloramphenicol

This section provides information on the proper use of a number of products that contain chloramphenicol. It may not be specific to Ak-Chlor. Please read with care.

For patients using the eye drop form of chloramphenicol:

  • Although the bottle may not be full, it contains exactly the amount of medicine your doctor ordered.
  • To use:
    • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to come into contact with the infection.
    • If you think you did not get the drop of medicine into your eye properly, use another drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.

To use the eye ointment form of chloramphenicol:

  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using chloramphenicol eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube 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 eye infection:
    • For ophthalmic ointment dosage form:
      • Adults and children—Use every three hours.
    • For ophthalmic solution (eye drops) dosage form:
      • Adults and children—One drop every one to four hours.

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.

Ak-Chlor Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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
  • Pale skin
  • sore throat and fever
  • 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
  • Itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Burning or stinging

After application, eye ointments may be expected to cause your vision to blur for a few minutes.

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.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Chloramphenicol Levels and Effects while Breastfeeding

Summary of Use during Lactation

Adverse reactions such as vomiting, excessive intestinal gas and falling asleep at the breast have been reported in breastfed infants whose mothers were taking oral chloramphenicol. Milk concentrations are not sufficient to induce "gray baby" syndrome, but since chloramphenicol-induced aplastic anemia is not dose-related, this might occur, but has not been reported. An alternate drug is preferred to chloramphenicol during breastfeeding, especially while nursing a newborn or preterm infant. If the mother must receive chloramphenicol during nursing, monitor the infant for gastrointestinal disturbances and adequacy of nursing. Monitoring of the infant's complete blood count and differential is advisable. In some cases, discontinuation of breastfeeding might be preferred.

Drug Levels

Maternal Levels. Milk concentrations reported vary somewhat apparently due to the use of older assay techniques in early studies.[1][2][3]

Peak milk levels in 10 breastfeeding women were 1.7 to 2.8 mg/L during therapy with 250 mg orally 4 times daily and 3.6 to 6.1 mg/L during therapy with 500 mg orally 4 times daily.[1]

Four women were given a single dose of chloramphenicol 500 mg orally. The average peak milk concentration of 3.24 mg/L (range 2.5 to 4.5 mg/L) occurred 2 hours after the dose. By 8 hours after the dose, the milk concentration averaged 0.31 mg/L. In 5 other women given chloramphenicol 500 mg 3 times daily by mouth at 7-hour intervals for 2 days, breastmilk chloramphenicol levels were 1.72 and 0.66 mg/L at 24 and 48 hours after the first dose. The average half-life in milk was 1.77 hours.[2]

After a single oral dose of 500 mg of chloramphenicol in 2 women, the drug was first measurable in milk in a concentration of 3.3 mg/L 2 hours after the dose. At 4 and 6 hours after the dose, milk concentrations averaged 4.1 mg/L at both times.[3]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

One study reported 50 breastfed infants whose mothers were give oral chloramphenicol beginning 2 to 12 days postpartum in dosages of 1 (n = 20), 2 (n = 20)or 3 grams (n = 10) daily. All of the infants refused to suck, and 50 to 60% fell asleep during nursing. Vomiting occurred after feeding in 10%, 25%, and 90% of infants with daily maternal dosages of 1, 2 and 3 grams, respectively. All infants had excessive intestinal gas and abdominal distention, with severe problems in 0.5%, 20% and 100% of infants with daily maternal dosages of 1, 2 and 3 grams, respectively.[4]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Havelka J, Hejzlar M, Popov V et al. Excretion of chloramphenicol in human milk. Chemotherapy (Basel). 1968;13:204-11. PMID: 5750653

2. Plomp TA, Thiery M, Maes RAA. The passage of thiamphenicol and chloramphenicol into human milk after single and repeated oral administration. Vet Hum Toxicol. 1983;25:167-72. PMID: 6868331

3. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy Perinatol. 1984;5:57-60. PMID: 6743732

4. Havelka J, Frankova A. [Adverse effects of chloramphenicol in newborn infants]. Cesk Pediatr. 1972;27:31-3. PMID: 5010584

Administrative Information

LactMed Record Number

606

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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