ChlorOph Drops 1%, 1 bottle x 5 ml
Generic Name: Chloramphenicol Chloroph
Manufacturer: Seng Thai
What is Chloroph?
Chloroph belongs to the family of medicines called antibiotics. Chloroph ophthalmic preparations are used to treat infections of the eye. Chloroph may be given alone or with other medicines that are taken by mouth for eye infections.
Chloroph is available only with your doctor’s prescription.
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, Chloroph 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 Chloroph 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
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 Chloroph be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.
How should I use Chloroph?
Use Chloroph as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Chloroph is usually administered as an injection at your doctor’s office, hospital, or clinic. If you are using Chloroph at home, carefully follow the injection procedures taught to you by your health care provider.
- If Chloroph 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 Chloroph 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 Chloroph, 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 Chloroph.
Uses of Chloroph in details
Chloroph is used to treat severe life-threatening infections, particularly those caused by Haemophilus influenzae and typhoid fever. It is also used to treat certain eye infections. It is also used in the treatment of a wide range of bacterial infections of the outer ear.
Each 100 g contains Chloramphenicol 1 g.
Chloroph, 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 Chloroph 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 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).
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.
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.)
There are no known drug interactions arising from the use of topical medication. Vitamin E administered systemically can increase the pharmacological action of insulin and digital. The absorption and accumulation of vitamin A can be reduced respectively by Neomycin sulphate some drugs such corticosteroids administered for prolonged periods, phenobarbital, caffeine and alcohol. And ’demonstrated a significant relationship between vitamin D and phenytoin or phenobarbital.
Among patients treated with these drugs for a long time, it is noted a high incidence of rickets and osteomalacia. Chloroph irreversibly inhibits the enzymes of hepatic microsomal cytochrome P450 complex and this may result in a longer half-lives of drugs metabolized by this system (dicoumarol, phenytoin, chlorpropamide and tolbutamide). Chronic administration of phenobarbital or acute administration of rifampicin shorten the half-lives of Chloroph and subsequent formation of sub-therapeutic concentrations of the drug.
Chloroph side effects
1. Blood Dyscrasias
The most serious adverse effect of Chloroph is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of Chloroph. 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 Chloroph.
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 Chloroph 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 Chloroph. 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 Chloroph 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 Chloroph 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 Chloroph.
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 Chloroph (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.
Chloroph 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.