• Dosage of Opclor in details
• Opclor interactions
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Dosage of Opclor in details

Opclor Dosage

Generic name: Opclor sodium succinate

Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Opclor, 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 Opclor 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.)

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Professional resources

• Opclor (FDA)
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Opclor interactions

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

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

CefTAZidime: Opclor (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

Opclor (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): Opclor (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Management: Cyclosporine dose reductions will likely be required with initiation of concurrent Opclor. Monitor cyclosporine concentrations and response closely following initiation and/or discontinuation of Opclor. 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 Opclor (Systemic). Fosphenytoin may increase the serum concentration of Opclor (Systemic). Opclor (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 Opclor (Systemic). Phenytoin may increase the serum concentration of Opclor (Systemic). Opclor (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 Opclor (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: Opclor (Systemic) may decrease the metabolism of Sulfonylureas. Monitor therapy

Tacrolimus (Systemic): Opclor (Systemic) may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose reductions will likely be required with initiation of concurrent Opclor. Monitor tacrolimus concentrations and response closely following initiation and/or discontinuation of Opclor. 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: Opclor (Systemic) may diminish the therapeutic effect of Vitamin B12. Monitor therapy

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

Voriconazole: Opclor (Systemic) may increase the serum concentration of Voriconazole. Monitor therapy

References

1. DailyMed. "CHLORAMPHENICOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "66974FR9Q1: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Protein Synthesis Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology