Chloramphenicol + Fluorometholone

Usage

This combination medication is primarily used for ophthalmic (eye) infections and inflammations. Chloramphenicol is a broad-spectrum antibiotic effective against a wide range of bacteria, while Fluorometholone is a corticosteroid that reduces inflammation. This combined action makes it suitable for treating bacterial eye infections where inflammation is also present, such as bacterial conjunctivitis, blepharitis, and keratitis.

• Pharmacological Classification:

  • Chloramphenicol: Antibiotic
  • Fluorometholone: Corticosteroid, anti-inflammatory, glucocorticoid

• Mechanism of Action:

  • Chloramphenicol: Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation.
  • Fluorometholone: Binds to glucocorticoid receptors, modulating gene expression to suppress inflammation by inhibiting inflammatory mediators.

Alternate Names

There are no internationally recognized alternate names for the combination “Chloramphenicol + Fluorometholone” itself. However, each component has its own variations:

• Chloramphenicol may be listed as chloramphenicol palmitate (oral suspension) or chloramphenicol sodium succinate (injectable).
• Fluorometholone may appear in some databases under its chemical name, oxylone. Brand names for combination preparations containing these two drugs vary regionally. Some examples include:
• Chloromycetin Plus (various manufacturers)
• FML-Chloramphenicol

How It Works

• Pharmacodynamics:

  • Chloramphenicol: Bacteriostatic effect, inhibiting bacterial growth and replication.
  • Fluorometholone: Suppresses the inflammatory cascade, reducing redness, swelling, pain, and other symptoms of inflammation.

• Pharmacokinetics:

  • Chloramphenicol: When administered as eye drops/ointment, systemic absorption is minimal. With other routes of administration, it is widely distributed in the body, including the central nervous system. Metabolized primarily in the liver and excreted mainly in the urine.
  • Fluorometholone: After ophthalmic application, some systemic absorption can occur. It is metabolized primarily in the liver and excreted in urine and bile.

• Mode of Action: (already described in Usage - Mechanism of action)

• Elimination Pathways:

  • Chloramphenicol: Primarily renal excretion, some biliary excretion.
  • Fluorometholone: Hepatic metabolism, excretion in urine and bile.

Dosage

Standard Dosage

Adults:

Ophthalmic: 1-2 drops of solution or a thin ribbon of ointment in the affected eye(s) every 2-4 hours, or as directed by the physician. The frequency may be reduced as the condition improves.

Children:

Ophthalmic use in children should be carefully considered and used under strict medical supervision. Dosage is generally the same as for adults, but the duration of treatment might be shorter.

Special Cases:

• Elderly Patients: No specific dosage adjustments are typically necessary, but monitoring for adverse effects is crucial.
• Patients with Renal Impairment: For ophthalmic use, no adjustment is necessary due to minimal systemic absorption. Systemic chloramphenicol requires dose adjustment.
• Patients with Hepatic Dysfunction: For ophthalmic use, caution is advised. Systemic chloramphenicol warrants dose adjustment.
• Patients with Comorbid Conditions: Evaluate patient’s specific conditions and adjust or avoid treatment if necessary, particularly for patients with glaucoma, herpes simplex keratitis, or fungal infections of the eye.

Clinical Use Cases

The dosages mentioned above are applicable in most clinical settings where topical ophthalmic antibiotic and corticosteroid combinations are indicated. Systemic Chloramphenicol might be used in specific cases:

• Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, Emergency Situations: Systemic Chloramphenicol is generally avoided in these scenarios unless other antibiotic options are unsuitable. If used, careful monitoring is required, and dose adjustments may be needed depending on the patient’s condition and renal/hepatic function.

Dosage Adjustments

For ophthalmic use, dosage adjustments based on renal or hepatic impairment are not typically necessary. However, for systemic Chloramphenicol administration, adjustments are needed based on individual patient parameters.

Side Effects

Common Side Effects:

• Ocular: Transient stinging or burning, blurred vision (especially with ointment), eye irritation.
• Systemic (rare with ophthalmic use): Nausea, vomiting, diarrhea.

Rare but Serious Side Effects:

• Ocular: Increased intraocular pressure (IOP), glaucoma, optic nerve damage, cataracts, secondary ocular infections.
• Systemic: Bone marrow suppression (aplastic anemia, leukopenia, thrombocytopenia), gray baby syndrome (in neonates), hypersensitivity reactions.

Long-Term Effects:

Prolonged use of topical corticosteroids like Fluorometholone can lead to increased IOP, glaucoma, cataract formation, and thinning of the cornea.

Adverse Drug Reactions (ADR):

Any signs of blood dyscrasias (e.g., unusual bleeding, bruising, fatigue), severe allergic reactions, or vision changes require immediate medical attention.

Contraindications

• Hypersensitivity to Chloramphenicol or Fluorometholone.
• Most viral infections of the cornea and conjunctiva, including herpes simplex keratitis.
• Mycobacterial infections of the eye.
• Fungal diseases of the eye.
• Untreated purulent eye infections.
• Systemic Chloramphenicol: Bone marrow suppression, hepatic impairment, renal impairment, hypersensitivity.

Drug Interactions

• Topical ophthalmic administration: Clinically significant drug interactions are unlikely.
• Systemic Chloramphenicol administration: Interacts with numerous medications, including anticoagulants (warfarin), antidiabetic drugs, and other drugs metabolized by the liver. Consult a drug interaction database for specific interactions.

Pregnancy and Breastfeeding

• Pregnancy: Ophthalmic: Use with caution and only if the potential benefit outweighs the risk to the fetus. Systemic: Contraindicated, especially near term.
• Breastfeeding: Ophthalmic: Use with caution, monitor infant for adverse effects. Systemic: Avoid if possible.

Drug Profile Summary

See sections above.

Popular Combinations

As this is already a combination product, it is typically not combined with other ophthalmic agents. The physician might alternate it with lubricating drops if needed.

Precautions

See Side Effects and Contraindications sections.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Chloramphenicol + Fluorometholone?

A: Ophthalmic: 1-2 drops or a small amount of ointment every 2-4 hours, or as directed by the physician.

Q2: Can this combination be used in children?

A: It can be used cautiously under strict medical supervision. The dosage is generally the same as for adults, but the treatment duration may be shorter.

Q3: What are the common side effects?

A: Common side effects are usually limited to the eye and include transient stinging, burning, blurred vision, and irritation.

Q4: Are there any serious side effects?

A: Yes, though rare with ophthalmic use, serious side effects can include increased intraocular pressure, glaucoma, and secondary infections. Systemic use carries risks of bone marrow suppression and gray baby syndrome in neonates.

Q5: Can this be used during pregnancy and breastfeeding?

A: Ophthalmic use should be approached with caution, and only if the potential benefit justifies the potential risk to the fetus or nursing infant. Systemic use is generally contraindicated.

Q6: What conditions is this combination used to treat?

A: It is typically prescribed for bacterial eye infections accompanied by inflammation, like bacterial conjunctivitis, blepharitis, and keratitis.

Q7: How does Chloramphenicol work?

A: It’s an antibiotic that inhibits bacterial protein synthesis.

Q8: How does Fluorometholone work?

A: It’s a corticosteroid that reduces inflammation in the eye.

Q9: Are there any drug interactions I should be aware of?

A: Clinically significant interactions are rare with topical application. For systemic Chloramphenicol administration, multiple drug interactions exist. Consult a drug interaction database before concurrent use with other medications.

Q10: What should I do if a patient experiences side effects?

A: Discontinue use and consult an ophthalmologist. For serious side effects like signs of blood dyscrasias or vision changes, seek immediate medical attention.