1. NAME OF THE MEDICINAL PRODUCT

Chloramphenicol Tablets BP 250mg Taj Pharma
Chloramphenicol Tablets BP 500mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION 

    a) Each Tablet contains:
    Chloramphenicol BP………………250mg
    Excipients…………………………….q.s.b) Each Tablet contains:
    Chloramphenicol BP………………500mg
    Excipients…………………………….q.s.

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Tablets

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

To be reserved for the treatment of life-threatening infections, particularly those caused by Haemophilus influenza, and typhoid fever, where other antibiotics will not suffice.

4.2 Posology and method of administration

Posology:

Adults (including the elderly):

The usual dose is 500 mg every 6 hours (50 mg/kg bodyweight daily in 4 divided doses) and treatment should be continued for 2 or 3 days after the patient’s temperature has returned to normal. For severe infections (meningitis, septicaemia) this dose may be doubled initially, but it must be reduced as soon as clinically practical.

Children:

Not recommended

Method of administration: Oral

4.3 Contraindications

Chloramphenicol is contra-indicated in:

  • individuals with a history of hypersensitivity or toxic reaction to chloramphenicol or to any of the excipients listed in section 6.1
  • prophylaxis or treatment of minor infections
  • active immunisation
  • porphyria patients
  • blood dyscrasias including aplastic anaemia
  • patients taking drugs liable to depress bone marrow function (see section 4.5)
  • breast-feeding mothers and during pregnancy or labour, due to a risk of foetal/infant damage (Grey Baby syndrome)

4.4 Special warnings and precautions for use

Dose reduction and plasma level monitoring may be required in patients with hepatic or renal impairment; in the elderly; and in patients concurrently treated with interacting drugs, see section 4.5

Determine routine blood profile before therapy and repeat blood studies at  appropriate intervals, especially during prolonged or repeated therapy. The drug should be withdrawn if evidence of a significant detrimental effect is seen or depression of any of the blood elements appears to be attributable to  chloramphenicol, always weighing these effects against the seriousness and course of the disease under treatment.

Avoid repeated courses of Chloramphenicol and concurrent therapy with other drugs known to cause bone marrow depression. Chloramphenicol should not be used for the treatment of trivial infections. Chloramphenicol should only be used if other treatments are ineffective and its use should always be carefully monitored.

4.5 Interaction with other medicinal products and other forms of interaction Paracetamol: Concurrent administration in patients receiving Paracetamol should be avoided as the half-life of Chloramphenicol is considerably prolonged.

Penicillins and Rifampicin: Complex effects (including reduced/increased plasma levels) requiring monitoring of chloramphenicol plasma concentrations have been reported with co-administration of penicillins and rifampicin.

Anticonvulsants and Anticoagulants: Doses of anticonvulsants and anticoagulants may need to be adjusted if given concurrently.

Warfarin, Phenytoin, Sulphonylureas, Tolbutamide: Chloramphenicol prolongs the elimination, increasing the plasma concentration of drugs including warfarin, phenytoin, sulphonylureas, tolbutamide

Calcineurin Inhibitors (CNIs) Ciclosporin and Tacrolimus: Treatment with chloramphenicol possibly increases the plasma levels of the CNIs ciclosporin and tacrolimus.

Barbiturates: The metabolism of chloramphenicol is accelerated by barbiturates, such as phenobarbitone, leading to reduced plasma concentrations. There is a possible decrease in the metabolism of phenobarbitone with concomitant chloramphenicol administration.

Oestrogens: There is a small risk that chloramphenicol may reduce the contraceptive effect of oestrogens.

Hydroxocobalamin: Chloramphenicol reduces the response to hydroxocobalamin

Drugs causing agranulocytosis: Chloramphenicol is contra-indicated in patients taking drugs liable to suppress bone marrow function (see section 4.3). These include:

  • Carbamazapine
  • Sulphonamides
  • Phenylbutazone
  • Penicillamine
  • Cytotoxic agents
  • Some antipsychotics, including clozapine and particularly depot antipsychotics
  • Procainamide
  • Nucleoside reverse transcriptase inhibitors
  • Propylthiouracil

4.6 Fertility, pregnancy and lactation

Pregnancy:

The use of chloramphenicol is contra-indicated as the drug crosses the placenta Breast-feeding:

The use of chloramphenicol is contra-indicated as the drug is excreted in the milk of the lactating mother, therefore mothers taking this drug should not breast feed their infants.

4.7 Effects on ability to drive and use machines

Chloramphenicol has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The most serious undesirable effects that may arise are:

Blood and lymphatic disorders

  • A reversible dose related bone marrow depression
  • An irreversible aplastic anaemia with an estimated frequency between 1/4000 & 1/100000

Other undesirable effects (of unknown frequency) are: Blood and the lymphatic system disorders

Increase in bleeding time

Immune system disorders

Hypersensitivity reactions including allergic skin reactions Eye disorders

Optic neuritis leading to blindness Ear and labyrinth disorders Ototoxicity

Vascular disorders

Acidotic cardiovascular collapse Gastrointestinal disorders

Nausea, vomiting, glossitis, stomatitis, diarrhoea, enterocolitis Pregnancy, puerperium and perinatal conditions

“Grey” syndrome, particularly in the newborn, which appears to be related to excessively high plasma levels. The Grey baby syndrome consists of abdominal distension, pallid cyanosis, vomiting, progressing to vasomotor collapse, irregular respiration and death within a few hours of onset of symptoms. (These symptoms are thought to be dose related and rapid clearance of chloramphenicol has been associated with recovery).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after the authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

If more than 12 tablets are swallowed, the stomach should be emptied by gastric lavage and symptomatic treatment instituted. There is no antidote to Chloramphenicol.

If an allergy develops, oral antihistamines may be used. In severe overdosage e.g. Grey Baby Syndrome, there is a need for a rapid reduction in plasma levels and it has been reported that resin haemoperfusion (XAD-4) substantially increases chloramphenicol clearance.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Antibacterials for Systemic Use – Amphenicols

Chloramphenicol is a broad spectrum antibiotic which acts by interfering with bacterial protein synthesis. It is bacteriostatic effective against a wide range of gram- negative and gram-positive organisms. Particularly susceptible are S. Typhi, H. Influenzae, Neisseria Meningitides and Bordetella Pertussis. It also has anti-rickettsial activity and is active against Chlamydias.

The most important action on the body tissue is the adverse one of bone marrow depression. There is significant plasma protein binding and the drug is largely inactivated in the liver.

5.2 Pharmacokinetic properties

Chloramphenicol is readily and rapidly absorbed from the G.I. tract when taken orally. Particle size may affect rate of absorption, but will not affect total absorption. Significant serum levels are observable 30 minutes after ingestion and half-life may be 2 – 5 hours. After a single dose of 1 g blood concentrations of about 10 micrograms per ml may be reached after 2 hours.

Blood concentrations above 4 micrograms per ml are usually maintained by a dose of 500 mg every 6 hours.

The drug is widely distributed in body tissues and fluids and enters the cerebro-spinal fluid. Chloramphenicol travels across the placenta into the cerebro-spinal fluid. Chloramphenicol travels across the placenta into the foetal circulation and into breast milk and into the aqueous and vitreous humours of the eye. About 60% in the circulation is bound to plasma protein.

Chloramphenicol is excreted mainly in the urine when 90% is inactivated in the liver mostly by conjugation with glucuronic acid. About 3% is excreted in the bile.

5.3 Preclinical safety data

Not applicable.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25C in a dry place in well closed containers.

6.5 Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts. Pack sizes: 100 and 500.
6.6 Special precautions for disposal

Not applicable.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

CHLORAMPHENICOL TABLETS BP
250MG / 500MG
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions ask your doctor or pharmacist
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

  1. What Chloramphenicol is and what it is used for
  2. What you need to know before you take Chloramphenicol
  3. How to take Chloramphenicol
  4. Possible side effects
  5. How to store Chloramphenicol
  6. Contents of the pack and other information1. WHAT CHLORAMPHENICOL IS AND WHAT IT IS USED FOR

Chloramphenicol belongs to a group of medicines known as antibiotics which are used for the treatment of infections.

Chloramphenicol is used for the treatment of severe infections and typhoid fever, when other antibiotics would not be effective or suitable.

If you are not sure why you are being prescribed Chloramphenicol, then please ask you doctor.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORAMPHENICOL DO NOT TAKE CHLORAMPHENICOL IF YOU:
  • are allergic to chloramphenicol or any of the other ingredients of this medicine (listed in section 6)
  • have recently had or are going to have a vaccination
  • have problems with your blood
  • have porphyria, an inherited iron disorder
  • are taking any other medicines which may cause bone marrow depression
  • are pregnant, or breast feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Chloramphenicol if you:

  • have liver or kidney problems
  • are elderly
  • are taking any of the medicines listed in the next section ‘Other medicines and Chloramphenicol’

Other medicines and Chloramphenicol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • paracetamol for pain and fever
  • penicillins and rifampicin, antibiotics used to treat bacterial infections
  • coumarin anticoagulants, medicines used to thin the blood and prevent clotsting, such as warfarin
  • sulphonylureas, medicines used to treat diabetes, such as tolbutamide and gliclazide
  • anticonvulsants, medicines to treat epilepsy and seizures, such as carbamazepine, phenytoin or phenobarbital
  • ciclosporin and tacrolimus, used to suppress the immune system and prevent the rejection of organs after transplant
  • oestrogens used for contraception or hormone replacement therapy (HRT)
  • hydroxocobalamin, a form of vitamin B12 used to treat conditions caused by vitamin B12 deficiency
  • any medicines that may supress bone marrow function, including:
    • sulfonamide antibiotics
    • phenylbutazone for pain and inflammation
    • medicines used to treat cancer
    • some antipsychotics (such as clozapine, flupentixol, fluphenazine, haloperidol, zuclopenthixol)
    • procainamide to treat irregular or uneven heart beat
    • some antiretrovirals (such as zidovudine, lamivudine, abacavir)
    • propylthiouracil for treating an over-active thyroid

Pregnancy and breast-feeding

Do not use this medicine during pregnancy or while breast feeding, as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Chloramphenicol does not to effect your ability to drive or use machinery.

  1. HOW TO TAKE CHLORAMPHENICOL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses are:

Adults and elderly: Your doctor will decide on the amount of Chloramphenicol to take based on your bodyweight and the severity of your infection, the usual dose is 500 mg (2 capsules) every 6 hours to be taken by mouth.

Children: Not recommended.

If you take more Chloramphenicol than you should

If you take more capsules then you should contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

If you forget to take Chloramphenicol

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Chloramphenicol

Keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking Chloramphenicol and see your doctor or go to the nearest hospital emergency department immediately:

  • an allergic reaction to chloramphenicol, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing
  • suddenly developing failure of the circulatory system symptoms include fatigue, blackouts, fainting, chest pain, shortness of breath, weakness, dizziness, vomiting and palpitations
  • Grey Syndrome – usually in new-born or premature infants, where the skin appears grey, and the infant is listless and weak.

If you get any of the following side effects, tell your doctor straight away:

  • Changes to your blood due to depression of the bone marrow, such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness.

Because of the various blood conditions that may be caused by Chloramphenicol, it is essential that periodic blood counts be undertaken during treatment.

  • inflammation of the nerves of the eye causing blurred vision
  • ear problems such as hearing loss, ringing in the ears, or a feeling of dizziness or “spinning” (vertigo)

Tell your doctor or pharmacist if you get any of the following side effects:

  • nausea, vomiting, inflammation of the mouth and tongue, diarrhoea, inflammation of the small intestine and the colon

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE CHLORAMPHENICOL

Keep this medicine out of the sight and reach of children.

Store your medicine below 25°C, in a dry place. Keep the container closed.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT CHLORAMPHENICOL TABLETS CONTAIN 

    a) Each Tablet contains:
    Chloramphenicol BP………………250mg
    Excipients…………………………….q.s.b) Each Tablet contains:
    Chloramphenicol BP………………500mg
    Excipients…………………………….q.s.

The other ingredients are pregelatinised maize starch, sodium starch glycollate, magnesium stearate, gelatin and titanium dioxide.

What Chloramphenicol Tablets look like and contents of the pack

Chloramphenicol Tablets are white opaque capsules. They are available in pots of 100 and 500.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com