Consumer medicine information

Chloromycetin Succinate Injection

Chloramphenicol

BRAND INFORMATION

Brand name

Chloromycetin Succinate

Active ingredient

Chloramphenicol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chloromycetin Succinate Injection.

What is in this leaflet

This leaflet answers some common questions about Chloromycetin Succinate injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of treating you with Chloromycetin Succinate against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Chloromycetin Succinate is used for

Chloromycetin Succinate injection is used to treat serious infections including bacterial meningitis, typhoid fever, rickettsial infections and eye infections.

Chloromycetin Succinate belongs to a group of medicines called antibiotics.

It works by stopping the growth of bacteria causing your infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Chloromycetin Succinate is not addictive.

It is available only with a doctor’s prescription.

Before you are given Chloromycetin Succinate

When you must not be given it

You must not be given Chloromycetin Succinate if you have an allergy to:

  • chloramphenicol
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Chloromycetin Succinate must not be given after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • anaemia, bleeding or any other blood related disorders
  • reduced liver function
  • reduced kidney function

Tell your doctor if you have been recently immunised. Chloromycetin Succinate may interfere with the development of immunity if you have been recently immunised.

Tell your doctor if you are pregnant or plan to become pregnant. It is not recommended that you be treated with Chloromycetin Succinate during the week before giving birth due to possible effects on the baby. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding or plan to breastfeed. Chloromycetin Succinate is not recommended during breastfeeding. The active ingredient passes into breast milk and there is a possibility that your baby may be affected. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are treated with Chloromycetin Succinate injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interact with Chloromycetin Succinate or affect how well it works. These include:

  • medicines that stop you from having fits or seizures, such as phenytoin or phenobarbitone
  • medicines that affect blood clotting, such as warfarin
  • medicines that affect the bone marrow or blood cells
  • other antibiotics, such as erythromycin, clindamycin, lincomycin or rifampicin
  • tolbutamide, a medicine used to treat diabetes
  • oral contraceptives containing oestrogen (“the Pill”)
  • alfentanil, used in anaesthesia and to treat pain
  • tacrolimus, used to prevent rejection after kidney or liver transplant
  • vaccines

These medicines may be affected by Chloromycetin Succinate or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being treated with Chloromycetin Succinate.

How Chloromycetin Succinate is given

How much is given

The dose of Chloromycetin Succinate will vary for different people and depends on your weight and type of infection.

Your doctor will work out how much of this medicine you need.

Adults: The usual dose is 50 mg of chloramphenicol per kilogram of body weight per day. In certain cases, a dose of up to 100 mg per kilogram may be given for a limited time.

Children: After the first two weeks of life, full-term infants can usually receive up to 50 mg per kilogram of body weight per day.

Chloromycetin Succinate should only be given to newborns if it may be life-saving and there is no alternative. When given to newborns, the usual dose is reduced to 25 mg per kilogram of body weight per day.

How the injection is given

Chloromycetin Succinate is given by injection into a vein or muscle by your doctor or a trained nurse.

Chloromycetin Succinate is a powder that is diluted by your hospital pharmacist, doctor or trained nurse by mixing with Water for Injections, sodium chloride 0.9% injection or glucose 5% injection.

When it is given

You will be given four injections per day at intervals of six hours. It does not matter if this medicine is given before or after food.

How long it is given for

The length of time you are given Chloromycetin Succinate will depend on the sort of infection present.

Your doctor will treat you with Chloromycetin Succinate for the shortest duration necessary to effectively treat your condition.

Prolonged use may cause bleeding and increase the risk of other side effects.

Repeated courses of Chloromycetin Succinate should be avoided.

If a dose is missed

It is unlikely that a dose will be missed as Chloromycetin Succinate is given under close medical supervision. However, talk to your doctor or nurse if you have any concerns.

If too much is given (overdose)

Overdose is unlikely as treatment will be given by your doctor or other medical professional. However, tell you doctor or nurse if you do not feel well during or after an injection.

Immediately telephone the Poisons Information Centre (In Australia: 13 11 26, in New Zealand: 0800 POISON or 0800 764 766) for advice if you think that you or anyone else may have been given too much.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

  • feeling sick, vomiting and diarrhoea
  • effects on blood cells and blood clotting

While you are receiving Chloromycetin Succinate

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

Tell your doctor, pharmacist or nurse immediately if you get diarrhoea. Do this even if it occurs several weeks after stopping treatment.

Diarrhoea can be a sign that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue during a treatment course or after stopping Chloromycetin Succinate, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have a fungal infection called thrush. Treatment with Chloromycetin Succinate may result in an overgrowth of fungi which can cause thrush.

Tell any other doctors, dentists, and pharmacists who treat you that you are being given this medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Chloromycetin Succinate.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being given Chloromycetin Succinate. It may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you are being given Chloromycetin Succinate.

Chloromycetin Succinate may interfere with the results of some tests.

Your doctor may recommend that you have blood tests before, during or after treatment.

It is essential that you attend these appointments so your doctor can assess the effects Chloromycetin Succinate is having on you.

Things to be careful of

Be careful driving or operating machinery until you know how Chloromycetin Succinate affects you.

This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Chloromycetin Succinate may cause tiredness in some people. If you are affected, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well during or after treatment with Chloromycetin Succinate.

This medicine helps most people with bacterial infections but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • soreness at the injection site
  • fever
  • skin rash, itching, swelling or hives
  • worsening of your condition
  • headache, depression or confusion
  • nausea or vomiting

Tell your doctor as soon as possible if you notice any of the following:

  • diarrhoea
  • white, furry, sore tongue and mouth
  • sore and itchy vagina and/or white discharge
  • eye pain, numbness, blurred vision or blind spots
  • unusual tiredness, weakness, bleeding or bruising more easily than normal

The above list includes serious side effects, which may require medical attention. Some of these effects can occur several weeks or months after stopping treatment. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Allergic reactions including fever, rash, swelling of the face, lips, mouth or sore throat that may cause difficulty in swallowing or breathing, shortness of breath, swelling of the hands, feet or ankles.
  • In newborn babies, vomiting, refusal to suck, fast irregular breathing, swelling of the stomach, blue discolouration of the skin or green coloured diarrhoea.

The above list includes very serious side effects which require urgent medical attention or hospitalisation. These side effects are very rare.

Other side effects not listed may also occur in some people.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell during or after treatment with Chloromycetin Succinate.

Some side effects (for example, blood disorders) can only be found when your doctor does tests from time to time to check your progress.

After being given Chloromycetin Succinate

Storage

Chloromycetin Succinate vials should be stored in a dry place where the temperature stays below 25°C.

Prepared Chloromycetin Succinate solution should be administered as soon as possible. If storage of prepared solution is necessary, store between 2°C to 8°C for not more than 24 hours.

Chloromycetin Succinate will be stored in the pharmacy or on the hospital ward, out of reach of children.

Disposal

Chloromycetin Succinate is for single use in one patient only. The hospital staff will dispose of any left over or expired Chloromycetin Succinate injection.

Product Description

What it looks like

Chloromycetin Succinate is a white or yellowish-white powder in a glass vial with a rubber stopper and aluminium cap or flip-off cap.

After reconstitution, Chloromycetin Succinate solution should not be cloudy in appearance.

Ingredients

Each vial contains chloramphenicol sodium succinate equivalent to 1g of chloramphenicol. It also contains sodium hydroxide.

Supplier

Chloromycetin Succinate injection is supplied in Australia by:

Link Medical Products Pty Ltd
5 Apollo Street
Warriewood, NSW 2102,
Australia

Chloromycetin Succinate injection is supplied in New Zealand by:

Link Pharmaceuticals Ltd.
Level 31, Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Australian Registration Number:

AUST R 58794

This leaflet was revised in November 2015

Version 3.0

Published by MIMS February 2017

BRAND INFORMATION

Brand name

Chloromycetin Succinate

Active ingredient

Chloramphenicol

Schedule

S4

 

Name of the medicine

Chloramphenicol (as chloramphenicol sodium succinate).

Description

Chloramphenicol sodium succinate.

Chemical name: mixture of variable proportions of sodium (2R,3R)-2-(2,2-dichloroacetamido) -3-hydroxy-3-(4-nitrophenyl) propyl succinate (3-isomer) and sodium (1R,2R)-2-(2,2-dichloroacetamido) -3-hydroxy-1-(4-nitrophenyl) propyl succinate (1-isomer). Molecular formula: C15H15Cl2N2NaO8. MW: 445.2.
Chloramphenicol sodium succinate is a white or yellowish white hygroscopic powder. It is soluble 1 in less than 1 part of water, 1 in 1 part of alcohol; practically insoluble in chloroform and ether. A 25% solution in water has a pH of 6.4 to 7.0.

Pharmacology

Chloramphenicol sodium succinate is a prodrug. After parenteral administration it is hydrolysed in the liver to produce free active chloramphenicol. The rate of hydrolysis is variable in different individuals.
Chloramphenicol is effective in a wide variety of bacterial and rickettsial infections. It possesses high antimicrobial activity, crosses tissue barriers readily and diffuses widely and rapidly through nearly all body tissues and fluids.

Pharmacokinetics.

Interindividual variation exists in determining the pharmacokinetics for a given patient with impaired and/or immature hepatic or renal function (see Dosage and Administration).
Intramuscular chloramphenicol sodium succinate may produce lower blood concentrations than identical intravenous doses. Intramuscular absorption is slow and produces peak blood levels in approximately 2 to 4 hours.

Distribution.

Chloramphenicol has high lipid solubility and diffuses rapidly throughout tissues and body fluids, with highest concentrations in the liver and kidneys. Chloramphenicol enters cerebrospinal fluid even in the absence of meningeal inflammation. Measurable levels are also detectable in pleural and ascitic fluids, saliva and in milk. It diffuses readily into the aqueous and vitreous humours of the eye. Transport across the placental barrier occurs with somewhat lower concentration in cord blood than in maternal blood.

Metabolism and excretion.

Following intravenous or intramuscular administration chloramphenicol sodium succinate must be hydrolysed to free chloramphenicol within the body. Part of the parenterally administered chloramphenicol sodium succinate is excreted by the kidneys prior to hydrolysis. Although serum levels of free chloramphenicol are lower than when a comparable dose of chloramphenicol is given orally, they are clinically effective.
In adults approximately 90% of chloramphenicol is metabolised primarily in the liver by glucuronyl transferase and excreted in the urine. Total urinary excretion ranges from 68% to over 90%, and 30% is excreted as unchanged chloramphenicol. Metabolism and elimination vary widely among patients.
The elimination half-life has been estimated to be in the range 1.6 to 3.3 hours, but is variable in patients with hepatic impairment and prolonged (to 28 hours) in neonates.

Microbiology.

In vitro chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram negative and Gram positive bacteria and is also active against rickettsial organisms and the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of action is through interference with, or inhibition of, protein synthesis in intact cells and in cell free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Development of resistance to chloramphenicol, both experimentally and in man, appears to be low in contrast to other antibiotics.

Susceptibility tests.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of ‘susceptible’ indicates the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of ‘intermediate’ indicates that the result should be considered equivocal and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in the body sites where the drug is physiologically concentrated or in situations where high dosage of the drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of ‘resistant’ indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Indications

Chloromycetin Succinate is specifically indicated for bacterial meningitis, typhoid fever, rickettsial infections, intraocular infections, other serious infections where bacteriological evidence or clinical judgment indicates that chloramphenicol is an appropriate antibiotic.

Contraindications

Chloramphenicol is contraindicated in individuals with a known hypersensitivity and/or toxic reaction to the product or its components.

Precautions

Chloramphenicol is a potent therapeutic agent and should not be used for trivial infections or for prophylaxis. The use of chloramphenicol sodium succinate injection should be reserved for serious infections when other less hazardous antimicrobial agents are ineffective or contraindicated.
Chloramphenicol must be administered according to the instructions of a medical practitioner.

Use in hepatic and renal impairment.

Reduced doses should be given to patients with hepatic impairment. Excessive blood concentrations may also occur following administration of usual doses to patients with severe renal impairment and in premature and full term neonates who have immature metabolic processes. Monitoring of plasma chloramphenicol concentrations may be desirable in patients with risk factors. A suggested range for peak plasma concentrations is 10 to 25 microgram/mL and for trough concentrations 5 to 15 microgram/mL.

Use in premature and full term neonates.

Due the risk of ‘grey baby syndrome’ (see Adverse Effects), neonates should not be given chloramphenicol systemically, unless it is potentially life saving and there is no alternative.

Use during immunisation.

Chloramphenicol may interfere with the development of immunity and should not be used during active immunisation.

Use in pre-existing haematological disorders.

Use with caution in patients with pre-existing haematological disorders or who are receiving other bone marrow depressants.
Blood dyscrasias including aplastic anaemia are known to occur after administration of chloramphenicol. If facilities are available, it is well to determine the routine blood profile before therapy, and blood studies should be repeated at appropriate intervals especially during prolonged or intermittent therapy. Consideration should be given to discontinuing the drug if evidence of depression of any of the blood elements appears attributable to chloramphenicol, weighing these effects against the seriousness and course of the disease under treatment. Repeated courses of chloramphenicol and concurrent therapy with other drugs known to cause bone marrow depression or aplastic anaemia should be avoided.
There have been reports of aplastic anaemia attributed to chloramphenicol which later terminated in leukaemia (see Adverse Effects). Treatment should not be continued longer than to produce a cure with little or no risk of relapse. Aplastic anaemia usually occurs after treatment has been completed. Patients should be informed of the importance of having blood counts followed closely during therapy.

Prolonged use.

Prolonged use of chloramphenicol may induce bleeding, either by bone marrow depression or by reducing intestinal flora with consequent inhibition of vitamin K synthesis. Prolonged use may also cause haemolytic episodes in individuals with glucose 6-phosphate dehydrogenase (G-6-PD) deficiency.
Optic and peripheral neuritis have been reported usually following long-term dosage (see Adverse Effects).

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including chloramphenicol. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
As with other antibiotics, the use of chloramphenicol may result in an overgrowth of nonsusceptible organisms including fungi. If infections caused by nonsusceptible organisms occur during therapy, appropriate measures should be taken.

Use in pregnancy.

(Category A)
There are no studies to establish the safety of this drug in pregnancy.
Chloramphenicol enters the foetal circulation and, if given to the mother shortly before parturition, may cause ‘grey baby syndrome’, with cyanosis and hypothermia, owing to the limited glucuronidating capacity of the newborn infant's liver. It may also cause bone marrow suppression in the neonate. Chloramphenicol treatment should therefore be avoided during the week before parturition.

Use in lactation.

Due to the possibility of toxic effects on the nursing infant (see Use in pregnancy) the use of chloramphenicol is not recommended during breastfeeding.

Interactions

In those patients who are concurrently receiving anticoagulants or anticonvulsants, dosage adjustment of these agents may be necessary. Chloramphenicol has been shown to retard the biotransformation of tolbutamide, phenytoin and dicoumarol in man. Chloramphenicol should be used with caution if administered concomitantly with lincomycin, clindamycin or erythromycin. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur.

Alfentanil.

Chronic preoperative or perioperative use of chloramphenicol may decrease the plasma clearance and prolong the duration of action of alfentanil.

Oral contraceptives containing oestrogen.

Concurrent long-term use of chloramphenicol may result in reduced contraceptive reliability and increased incidence of breakthrough bleeding.

Hepatic enzyme induction and inhibition.

Concurrent use of chloramphenicol with hepatic microsomal enzyme producing drugs, including phenobarbitone and rifampicin, can increase the metabolism of chloramphenicol, decreasing chloramphenicol concentrations. Other medications metabolised by mixed function oxidase system (inhibition of cytochrome P450 system) by chloramphenicol may cause a decrease in the hepatic metabolism of these medications, resulting in delayed elimination and increased blood concentrations.

Tacrolimus.

Chloramphenicol has been shown to increase the serum concentrations of tacrolimus when these drugs are administered concurrently. Dose reductions and careful monitoring of tacrolimus levels are recommended to avoid toxicity.

Adverse Effects

Blood and lymphatic system disorders.

Blood dyscrasias including aplastic anaemia, hypoplastic anaemia, thrombocytopenia and granulocytopenia have been attributed to the administration of chloramphenicol (see Precautions). A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterised by vacuolisation of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of chloramphenicol. An irreversible type of marrow suppression leading to aplastic anaemia, with a high mortality rate, is characterised by the appearance weeks or months after therapy of bone marrow aplasia or hypoplasia. The incidence of fatal aplastic anaemia has been estimated as 1 in 40,000 to 1 in 100,000 based on two dosage levels. Peripherally, pancytopenia is observed most often, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed. Paroxysmal nocturnal haemoglobinuria has also been reported.

Immune system disorders.

Anaphylaxis, Herxheimer reactions have occurred during therapy for typhoid fever.

Psychiatric disorders.

Delirium, mental confusion, mild depression (see Precautions).

Nervous system disorders.

Headache; peripheral neuritis has been reported, usually following long-term dosage. If this occurs, the drug should be promptly withdrawn.

Eye disorders.

Optic neuritis has been reported, usually following long-term dosage. If this occurs the drug should be promptly withdrawn.

Gastrointestinal disorders.

Nausea, vomiting, glossitis and stomatitis, diarrhoea and enterocolitis may occur; incidence is low.

Cardiac disorders.

Toxic reactions including fatalities have occurred in premature and newborn infants; the signs and symptoms associated with these reactions are known as the ‘grey baby syndrome’. Although ‘grey baby syndrome’ has been reported in neonates born to mothers who have received chloramphenicol during labour, in most cases therapy with chloramphenicol has been instituted within the first 48 hours of life and symptoms first appeared after 3 to 4 days of continued treatment with high doses of chloramphenicol.
The manifestations in the first 24 hours are vomiting, refusal to suck, irregular and rapid respiration and abdominal distension, periods of cyanosis and passage of loose green stools. After 24 hours the infant develops flaccidity, an ashen grey colour, a decrease in temperature followed by circulatory collapse.
Mechanisms responsible for this effect are the inadequate development of hepatic and renal function.

Skin and subcutaneous tissue disorders.

Angioedema, macular and vesicular rashes, urticaria.

General disorders and administration site conditions.

Fever.

Dosage and Administration

A dosage of 50 mg/kg/day in divided doses at six hourly intervals is recommended for the average patient. In exceptional cases, such as patients with infections due to moderately resistant organisms or suffering from infections such as septicaemia or meningitis, dosage schedules up to 100 mg/kg/day may be prescribed. However, these high doses should be decreased as soon as clinically indicated.
Chloramphenicol in the form of chloramphenicol sodium succinate may be administered intravenously or intramuscularly in seriously ill patients.
In instances of impaired hepatic or renal function, the ability to metabolise or excrete chloramphenicol may be reduced and the medical practitioner should adjust the dose accordingly.
Premature, newborn infants and children with immature metabolic processes. (See Adverse Effects, Cardiac disorders regarding ‘grey baby syndrome’.) A total of 25 mg/kg/day, divided into four doses and administered at six hour intervals usually produces and maintains a concentration of chloramphenicol in blood and tissues adequate to control most infections in premature and newborn infants and children with immature metabolic processes.
After the first two weeks of life, full term infants ordinarily may receive up to a total of 50 mg/kg/day equally divided into four doses at six hour intervals. Precise control of serum blood levels, when in doubt, may be achieved through analytical methods.

Preparation for use.

This product contains no additional antimicrobial agent. It is for single use in one patient only. Discard any residue.
The powder in the vial is prepared for injection by the addition of an aqueous diluent such as water for injection, 0.9% sodium chloride injection or 5% dextrose injection. Although Chloromycetin Succinate freeze dried powder is highly soluble, the rate of solution is somewhat slower in the more highly concentrated solutions. Gentle shaking of the vial hastens solution or solubility. The following dilution table may be used as a guide for preparing solutions for injection. (See Table 1.)

Overdosage

Levels exceeding 25 microgram/mL are frequently considered toxic. Chloramphenicol toxicity can be evidenced by serious haemopoietic effects such as aplastic anaemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhoea. In the case of serious overdosage, charcoal haemoperfusion may be effective in removing chloramphenicol from plasma. Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.

Presentation

Powder for injection, chloramphenicol sodium succinate ≡ chloramphenicol 1 g (freeze dried powder): 1's (clear glass vial sealed with rubber stopper, aluminium or flip-off cap).

Storage

Store below 25°C. Cloudy solutions of Chloromycetin Succinate should not be used. To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary, hold at 2 to 8°C for not more than 24 hours.

Poison Schedule

S4.