Cefixime Tablets USP 400mg Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Cefixime Tablets USP 200mg Taj Pharma
Cefixime Tablets USP 400mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

a) Each film-coated tablet contains:
Cefixime (as trihydrate)       200mg
Excipients                             q.s

b) Each film-coated tablet contains:
Cefixime (as trihydrate)     400mg
Excipients                            q.s

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Film-coated tablets.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Cefixime is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.

It is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:

Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.

Lower Respiratory Tract Infection: e.g. bronchitis.

Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.

Clinical efficacy has been demonstrated in infections caused by commonly occuring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Kliebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta- lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.

Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and meticillin- resistant strains) are resistant to Cefixime. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Cefixime.

4.2 Posology and method of administration

The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Posology

Adults and Children over 10 Years or weighing more than 50 kg:

The recommended adult dosage is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.

Elderly:

Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment (See “Dosage in Renal Impairment”).

Children under 10 Years:

Cefixime Tablets 200 mg are not recommended for use in children under 10 years old.

The safety and efficacy of cefixime has not been established in children less than 6 months.

Renal Impairment:

Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.

Method for administration

For oral administration.

Absorption of Cefixime is not significantly modified by the presence of food.

4.3 Contraindications

Hypersensitivity to cephalosporin antibiotics or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Encephalopathy

Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

Severe cutaneous adverse reactions

Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens- Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy and/or measures should be taken.

Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs.

Hypersensitivity to penicillins

As with other cephalosporins, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.

Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.

Haemolytic anaemia

Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of haemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime) –associated haemolytic anaemia has also been reported.

Acute renal failure

As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, cefixime should be discontinued and appropriate therapy and/or measures should be taken.

Renal impairment

Cefixime should be administered with caution in patients with markedly impaired renal function (See section 4.2).

Paediatric use

Safety of cefixime in premature or newborn infant has not been established.

Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea.

Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.

Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic- associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.

4.5 Interaction with other medicinal products and other forms of interaction

Anticoagulants

In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.

Cefixime should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.

Other forms of interaction

A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the drug.

4.6 Fertility, pregnancy and lactation

Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

4.7 Effects on ability to drive and use machines

In the case of side effects such as encephalopathy (which may include convulsion, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.

4.8 Undesirable effects

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.

The following adverse reaction (Preferred term# or equivalent) will be considered listed:

Blood and lymphatic system disorders: Eosinophilia

Hypereosinophilia

Agranulocytosis

Leucopenia

Neutropenia

Granulocytopenia

Haemolytic anaemia

Thrombocytopenia

Thrombocytosis

Gastrointestinal disorders: Abdominal pain

Diarrhoea*

Dyspepsia

Nausea

Vomiting

Flatulance

Hepatobiliary disorders: Jaundice
Infections and infestations: Pseudomembranous colitis
Investigations: Aspartate aminotransferase increased

Alanine aminotransferase increased

Blood bilirubin increased

Blood urea increased

Blood creatinine increased

Nervous system disorders: Dizziness

Headache

Cases of convulsions have been reported with cephalosporins including cefixime (frequency not known)**

Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment (frequency not known)**

Respiratory, thoracic and mediastinal disorders: Dyspnoea
Renal and urinary disorders: Renal failure acute including tubulointerstitial nephritis as an underlying pathological condition
Immune system disorders, administrative site conditions, skin and subcutaneous tissue disorders: Anaphylactic reaction

Serum sickness-like reaction

Drug rash with eaosinophilia and systemic symptoms (DRESS)

Pruritus

Rash

Drug Fever

Arthralgia

Erythema multiforme

Stevens-Johnson syndrome

Toxic epidermal necrolysis

Angio-oedema

Urticaria

Pyrexia

Face oedema

Genital pruritus

Vaginitis

The above mentioned listed adverse reactions have been observed during clinical studies and/or during marketed use.

# Preferred term in MedDRA (v.14.0)

*Diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhoea occurs

** Cannot be estimated from available data

Reporting of suspected adverse reactions

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

4.9 Overdose

There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including cefixime, particularly in case of overdose or renal impairment.

Adverse reactions seen at dose levels up to 2 g Cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses.

Cefixime is not removed from the circulation in significant quantities by dialysis.

No specific antidote exists. General supportive measures are recommended.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: third generation cephalosporin.

Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.

Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta- lactamase positive and negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.

Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and meticillin- resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.

5.2 Pharmacokinetic properties

The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals.

From in vitro studies, serum or urine concentrations of 1 mcg/mL or greater were considered to be adequate for most common pathogens against which cefixime is active. Typically, the peak serum levels following the recommended adult or paediatric doses are between 1.5 and 3 mcg/mL. Little or no accumulation of cefixime occurs following multiple dosing.

The pharmacokinetics of cefixime in healthy elderly (age > 64 years) and young volunteers (11-35) compared the administration of 400 mg doses once daily for 5 days. Mean Cmax and AUC values were slightly greater in the elderly. Elderly patients may be given the same dose as the general population.

Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of cefixime have not been isolated from human serum or urine.

Serum protein binding is well characterised for human and animal sera; cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of cefixime is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.

Transfer of 14C-labelled cefixime from lactating rats to their nursing offspring through breast milk was quantitatively small (approximately 1.5% of the mothers’ body content of cefixime in the pup). No data are available on secretion of cefixime in human breast milk. Placetal transfer of cefixime was small in pregnant rats dosed with labelled cefixime.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet cores: microcrystalline cellulose, pregelatinised starch, calcium hydrogen phosphate dihydrate and magnesium stearate.

Tablet coating: hypromellose, Macrogol and titanium dioxide.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25° C.

6.5 Nature and contents of container

PVC/aluminium foil blister packs.

Pack sizes of: 7, 14, 28, 30, 50, 60, 90, 100, 200 & 250 Tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

7.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

Cefixime Tablets USP 200mg, 400mg
(Cefixime)

Package Leaflet: Information for the user

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 signs of illness 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 Cefixime is and what it is used for
    2. What you need to know before you take Cefixime
    3. How to take Cefixime
    4. Possible side effects
    5. How to store Cefixime
    6. Contents of the pack and other information

 

  1. WHAT CEFIXIME IS AND WHAT IT IS USED FOR

Cefixime 200mg Tablets (called Cefixime in this leaflet) contains a medicine called cefixime. This belongs to a group of antibiotics called ‘cephalosporins’.

Cefixime is used to treat infections caused by bacteria.

These include infections of the:

  • Ear
  • Nose, sinuses (such as sinusitis)
  • Throat (such as tonsillitis, pharyngitis)
  • Chest and lungs (such as bronchitis, pneumonia)
  • Urinary system (such as cystitis and kidney infections)
  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFIXIME

Do not take Cefixime:

  • if you are allergic to cefixime, any other cephalosporin antibiotics including penicillin or to any of the other ingredients of this medicine (listed in section 6).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.

Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Cefixime.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefixime:

  • if you have ever had colitis
  • if you have kidney problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Cefixime

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Cefixime can affect the way some other medicines work. Also some medicines can affect the way Cefixime works.

In particular, tell your doctor if you are taking the following:

  • Medicines to thin the blood such as warfarin

Pregnancy and breast-feeding

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 this medicine.

Driving and using machines

This medicine can cause symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. If you experience any of these effects don’t drive or use machinery.

Medical Tests

If you require any tests (such as blood or urine tests) while taking this medicine, please make sure your doctor knows that you are taking Cefixime.

  1. HOW TO TAKE CEFIXIME

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

  • Take this medicine by mouth
  • Swallow tablets whole with a drink of water
  • If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

Carefully read the label from the pharmacist. Ask your pharmacist if you are not sure about the dose to take. The medicine should be taken for the prescribed number of days.

The recommended dose is:

Adults, Elderly and Children over 10 years or weighing more than 50kg

  • 1-2 tablets each day given as a single or divided dose

People with kidney problems

  • Your doctor may prescribe a lower dose

Children under 10 years old

  • Cefixime should not be given to children under 10 years old

If you take more Cefixime than you should

If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Cefixime

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

If you stop taking Cefixime

Do not stop taking this medicine without talking to your doctor. You should not stop taking Cefixime just because you feel better. This is because the infection may come back or get worse again.

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.

Tell your doctor straight away or go to the nearest hospital casualty department if you notice any of the following serious side effects – you may need urgent medical treatment:

  • You have an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson’ syndrome.
  • Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’
  • You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’
  • You get infections more easily than usual. This could be because of a blood disorder. This normally gets better after stopping the medicine
  • You bruise or bleed more easily than normal. This could be because of a blood disorder. This normally gets better after stopping the medicine
  • If your child gets nose bleeds, bleeding gums, chills, tiredness, pale skin (often with a yellow tinge), shortness of breath. This may be due to haemolytic anaemia.
  • Changes in the way the kidneys are working or blood in your child’s urine
  • Fits (convulsions) – Frequency not known
  • A brain condition with symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. This may be something called encephalopathy. This side effect is more likely if you have taken an overdose or you already have a problem with your kidneys

Stop taking this medicine and contact your doctor without delay if you get:

  • Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called ‘Pseudomembranous colitis’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Feeling sick (nausea) or being sick (vomiting)
  • Stomach pains, indigestion or wind
  • Headaches
  • Feeling dizzy
  • Feeling itchy in the genital or vaginal area

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

Blood tests

Cefixime can cause blood clots or small changes to the way the liver and kidney work. This would be shown up in blood tests. This is not common and goes back to normal after stopping this medicine.

Reporting of side effects

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

  1. HOW TO STORE CEFIXIME

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

Do not use this medicine after the expiry date which is stated on the label and blister pack after EXP:.

Store below 25°C.

Do not throw away 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 Cefixime Tablets contain

  1. a) Each film-coated tablet contains:
    Cefixime (as trihydrate) 200mg
    Excipients s.
  2. a) Each film-coated tablet contains:
    Cefixime (as trihydrate) 400mg
    Excipients s.

The other ingredients are microcrystalline cellulose, pregelatinised starch, calcium hydrogen phosphate dihydrate, magnesium stearate, hypromellose, macrogol and titanium dioxide.

What Cefixime Tablets look like and content of the pack

Cefixime is available as an off-white, convex, film coated tablet.

PVC/aluminium foil blister packs.

Pack sizes of: 7, 14, 28, 30, 50, 60, 90, 100, 200 & 250 Tablets.

Not all pack sizes may be marketed.

7.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

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