Elase-Chloromycetin

In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicolmust be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. However, Elase-Chloromycetin may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of Elase-Chloromycetin rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.

1. Acute infections caused by Salmonella typhi*

It is not recommended for the routine treatment of the typhoid carrier state.

2. Serious infections caused by susceptible strains in accordance with the concepts expressed above:

a) Salmonella species

b) H. influenzae, specially meningeal infections

c) Rickettsia

d) Lymphogranuloma-psittacosis group

e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections

f) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.

3. Cystic fibrosis regimens

*In treatment of typhoid fever some authorities recommend that Elase-Chloromycetin be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.

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

Elase-Chloromycetin is available only with your doctor's prescription.

Elase-Chloromycetin, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Administration of 50 mg/kg/day in divided doses will produce blood levels of the magnitude to which the majority of susceptible microorganisms will respond.

As soon as feasible an oral dosage form of another appropriate antibiotic should be substituted for intravenous Elase-Chloromycetin sodium succinate.

The following method of administration is recommended:

Intravenously as a 10% (100 mg/mL) solution to be injected over at least a one-minute interval. This is prepared by the addition of 10 mL of an aqueous diluent such as water for injection or 5% dextrose injection.

Adults

Adults should receive 50 mg/kg/day in divided doses at 6-hour intervals. In exceptional cases patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels inhibiting the pathogen, but these high doses should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques (information available on request).

Pediatric Patients

Dosage of 50 mg/kg/day divided into 4 doses at 6-hour intervals yields blood levels in the range effective against most susceptible organisms. Severe infections (eg, bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired liver or kidney function may retain excessive amounts of the drug.

Neonates

A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in blood and tissues adequate to control most infections for which the drug is indicated. Increased dosage in these individuals, demanded by severe infections, should be given only to maintain the blood concentration within a therapeutically effective range. After the first two weeks of life, full-term neonates ordinarily may receive up to a total of 50 mg/kg/day equally divided into 4 doses at 6-hour intervals. These dosage recommendations are extremely important because blood concentration in all premature and full-term neonates under two weeks of age differs from that of other infants neonates. This difference is due to variations in the maturity of the metabolic functions of the liver and the kidneys.

When these functions are immature (or seriously impaired in adults), high concentrations of the drug are found which tend to increase with succeeding doses.

Pediatric Patients with Immature Metabolic Processes

In young infants and other pediatric patients in whom immature metabolic functions are suspected, a dose of 25 mg/kg/day will usually produce therapeutic concentrations of the drug in the blood. In this group particularly, the concentration of the drug in the blood should be carefully followed by microtechniques. (Information available on request.)

See also:
What is the most important information I should know about Elase-Chloromycetin?

Elase-Chloromycetin Lotion is contraindicated for premature neonates because their skin may be more permeable than full term infants and their liver enzymes may not be sufficiently developed. It is also contraindicated for patients with Norwegian (crusted) scabies due to possible increased absorption. It is also contraindicated for patients with known seizure disorders and for individuals with a known sensitivity to the product or any of its components.

Use Elase-Chloromycetin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Elase-Chloromycetin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Elase-Chloromycetin at home, carefully follow the injection procedures taught to you by your health care provider.
• If Elase-Chloromycetin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• To clear up your infection completely, continue using Elase-Chloromycetin for the full course of treatment even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Elase-Chloromycetin, use it as soon as possible. Then use your doses at evenly spaced times as directed by your doctor. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Elase-Chloromycetin.

Use: Labeled Indications

Serious infections: Treatment of serious infections, including cystic fibrosis exacerbations, bacterial meningitis, and bacteremia, caused by Chlamydiaceae, Haemophilus influenzae, Rickettsia, Salmonella spp. (acute infections), and other organisms when other less toxic agents are ineffective or contraindicated.

Guideline recommendations: Elase-Chloromycetin may be considered for use as an alternative agent to doxycycline in the treatment of tickborne rickettsial diseases (eg, Rocky Mountain spotted fever [RMSF]); however, epidemiologic studies suggest that Elase-Chloromycetin-treated patients with RMSF are at a higher risk of death compared to tetracycline-treated patients. In addition, Elase-Chloromycetin is not effective in the treatment of human ehrlichiosis or anaplasmosis, therefore, use with caution in the empiric treatment of tickborne rickettsial diseases (CDC [Biggs 2016]).

Alcohol (Ethyl): Elase-Chloromycetin (Systemic) may enhance the adverse/toxic effect of Alcohol (Ethyl). Monitor therapy

Barbiturates: Elase-Chloromycetin (Systemic) may decrease the metabolism of Barbiturates. Barbiturates may increase the metabolism of Elase-Chloromycetin (Systemic). Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Carbocisteine: Elase-Chloromycetin (Systemic) may enhance the adverse/toxic effect of Carbocisteine. Specifically, Elase-Chloromycetin may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Monitor therapy

CefTAZidime: Elase-Chloromycetin (Systemic) may diminish the therapeutic effect of CefTAZidime. Management: Consider using a different combination of antimicrobials, especially if bactericidal activity is desired. If these agents are combined, monitor for reduced antimicrobial effectiveness and/or therapeutic failure. Consider therapy modification

Elase-Chloromycetin (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

CycloSPORINE (Systemic): Elase-Chloromycetin (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Management: Cyclosporine dose reductions will likely be required with initiation of concurrent Elase-Chloromycetin. Monitor cyclosporine concentrations and response closely following initiation and/or discontinuation of Elase-Chloromycetin. Consider therapy modification

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Fosphenytoin: May decrease the serum concentration of Elase-Chloromycetin (Systemic). Fosphenytoin may increase the serum concentration of Elase-Chloromycetin (Systemic). Elase-Chloromycetin (Systemic) may increase the serum concentration of Fosphenytoin. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Phenytoin: May decrease the serum concentration of Elase-Chloromycetin (Systemic). Phenytoin may increase the serum concentration of Elase-Chloromycetin (Systemic). Elase-Chloromycetin (Systemic) may increase the serum concentration of Phenytoin. Monitor therapy

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

RifAMPin: May increase the metabolism of Elase-Chloromycetin (Systemic). Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Sulfonylureas: Elase-Chloromycetin (Systemic) may decrease the metabolism of Sulfonylureas. Monitor therapy

Tacrolimus (Systemic): Elase-Chloromycetin (Systemic) may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose reductions will likely be required with initiation of concurrent Elase-Chloromycetin. Monitor tacrolimus concentrations and response closely following initiation and/or discontinuation of Elase-Chloromycetin. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin B12: Elase-Chloromycetin (Systemic) may diminish the therapeutic effect of Vitamin B12. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Elase-Chloromycetin (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Elase-Chloromycetin (Systemic) may increase the serum concentration of Vitamin K Antagonists. Monitor therapy

Voriconazole: Elase-Chloromycetin (Systemic) may increase the serum concentration of Voriconazole. Monitor therapy

See also:
What are the possible side effects of Elase-Chloromycetin?

1. Blood Dyscrasias

The most serious adverse effect of Elase-Chloromycetin is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of Elase-Chloromycetin. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastic or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.

A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of Elase-Chloromycetin.

An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.

In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.

There have been reports of aplastic anemia attributed to Elase-Chloromycetin which later terminated in leukemia.

Paroxysmal nocturnal hemoglobinuria has been reported.

2. Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

3. Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving Elase-Chloromycetin. Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.

4. Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.

5. "Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received Elase-Chloromycetin during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with Elase-Chloromycetin had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of Elase-Chloromycetin.

c) The symptoms appeared in the following order:

(1) abdominal distension with or without emesis;

(2) progressive pallid cyanosis;

(3) vasomotor collapse, frequently accompanied by irregular respiration;

(4) death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e)Preliminary blood serum level studies revealed unusually high concentrations of Elase-Chloromycetin (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

Each 100 g contains Chloramphenicol 1 g.