Consumer medicine information

Keflor

Cefaclor

BRAND INFORMATION

Brand name

Keflor

Active ingredient

Cefaclor

Schedule

What is in this leaflet

This leaflet answers some common questions about Keflor.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Keflor against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

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

What Keflor is used for

Keflor is used to treat infections in different parts of the body caused by bacteria. Keflor can be used to treat infections of the:

ear, nose, throat and tonsils (upper respiratory tract)
chest and lungs (lower respiratory tract)
bladder and kidneys (urinary tract)
skin.

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

Keflor is an antibiotic that belongs to a group of medicines called cephalosporins. These medicines work by killing the bacteria that are causing your infection.

Keflor will not work against infections caused by viruses, such as colds or flu.

Keflor is available only with a doctor's prescription.

There is no evidence that Keflor is addictive.

Before you take Keflor

When you must not take it

Do not take Keflor if you are allergic to medicines containing:

cefaclor monohydrate
any other cephalosporin
any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take Keflor if you have had a severe allergic reaction to penicillin.

Do not give this medicine to a child under the age of 1 month. Safety and effectiveness in children younger than 1 month have not been established.

Do not take Keflor after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have had any type of allergic reaction to penicillin antibiotics. You may have an increased chance of being allergic to Keflor if you are allergic to penicillins.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

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

kidney disease
liver disease
bowel disease
bleeding problems.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Keflor.

Taking other medicines

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

Some medicines may be affected by Keflor or may affect how well Keflor works. These include:

anticoagulants, medicines used to prevent blood clots
salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain or inflammation
probenecid, a medicine used to treat gout
antacids, medicines used to treat heartburn and indigestion.
Antacids may interfere with the absorption of Keflor. To make sure there is no problem with absorption, do not take antacids within one hour of taking Keflor.

Talk to your doctor about the need for additional contraception while taking Keflor. Some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with Keflor.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Keflor.

How to take Keflor

How much to take

Your doctor will tell you how much Keflor you need to take.

This will depend on the type of infection you have.

Adults: The usual adult dose is 250 mg every 8 to 12 hours.

Children: The dose for children will depend on the child's weight. Your doctor and pharmacist will tell you how much Keflor your child should take.

How to take Keflor

Always shake the bottle well before measuring the correct amount to take.

When to take it

Take Keflor at about the same time each day. This will allow Keflor to have its best effect and also help you remember when to take it.

Keflor can be taken with or without food.

How long to take it for

Keep taking Keflor until you finish the bottle, or for as long as your doctor recommends.

Keep taking Keflor for the full time of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, your infection may not clear completely or your symptoms may return.

If you forget to take

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking Keflor as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much Keflor. 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, upset stomach or diarrhoea.

While you are taking Keflor

Things you must do

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

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Keflor, especially if you are being started on any new medicines.

Tell your doctor, surgeon, or dentist that you are taking Keflor if you are about to undergo surgery or an operation. It may affect other medicines used during surgery.

Tell your doctor if you become pregnant while you are taking this medicine.

If you have to have any blood tests, tell your doctor that you are taking Keflor. Keflor may affect the results of some tests.

If you develop itching with swelling or skin rash or difficulty breathing while you are taking Keflor, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after stopping Keflor. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medicines for diarrhoea without first checking with your doctor.

If you get a sore, white mouth or tongue while taking or soon after stopping Keflor, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Keflor allows fungi to grow and the above symptoms to occur. Keflor does not work against fungi.

If you are diabetic, check with your doctor or pharmacist before using urine sugar tests. Keflor may cause false test results with some urine sugar tests.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not stop taking Keflor or lower the dose because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, your infection may not clear completely or your symptoms may return.

Do not take Keflor to treat any other complaints unless your doctor tells you to.

Do not give Keflor to anyone else, even if they have the same condition as you

Things to be careful of

Be careful driving or operating machinery until you know how Keflor affects you. Keflor generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Keflor may cause dizziness or drowsiness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Children should be careful when riding bicycles or climbing trees.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Keflor. Keflor treats infections in most people, 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 treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

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

diarrhoea
itchy rash
oral thrush (white, furry sore tongue and mouth)
vaginal thrush (sore and itchy vagina and/or vaginal discharge).

The above list includes the more common side effects of Keflor. They are usually mild and short-lived.

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

nausea (feeling sick)
vomiting
drowsiness
headache
hyperactivity, nervousness, insomnia, confusion, dizziness, hallucination (seeing, feeling, or hearing things that are not there)
severe muscle stiffness
swelling or pain in the joints, with or without fever
itchy or swelling of the skin
yellowing of the skin or eyes
frequent infections such as fever, severe chills, sore throat or mouth ulcers
bleeding or bruising more easily than normal
difficulty swallowing or breathing
stomach (abdominal) pain or discomfort
nosebleed
unusual tiredness or weakness
watery and severe diarrhoea, which may also be bloody
fever, cough, sore throat, feeling generally unwell, skin rash (in some instances it can develop over 2 to 7 days), rashes can be painful and itchy, blistering or peeling of the skin, facial swelling, sore/red eyes or lips, in some instances reactions can be delayed by up to 3 or 4 weeks.

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

sudden signs of allergy such as rash, itching, hives on the skin, with swelling of the face, lips, tongue or other parts of the body, which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

The above list includes very serious side effects which are very rare. You may need urgent medical attention or hospitalisation.

After you have finished taking Keflor

Tell your doctor immediately if you notice any of the following, even if they occur several weeks after stopping treatment with Keflor:

watery and severe diarrhoea, which may also be bloody
severe stomach cramps
fever, in combination with one or both of the above.
fever, cough, sore throat, feeling generally unwell, skin rash (in some instances rash can develop over 2 to 7 days), rashes can be painful and itchy, blistering or peeling of the skin, facial swelling, sore/red eyes or lips, in some instances reactions can be delayed by up to 3 or 4 weeks.

Do not take any diarrhoea medicine without first checking with your doctor. You may have a serious condition affecting your bowel, requiring urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people. Some of these side effects can only be found when your doctor does tests from time to time to check your progress. These include:

swelling of the liver
inflammation of the kidney.

After using Keflor

Storage

Keep your medicine where children cannot reach it.

Keep the suspension in the bottle until it is time to take it.

Keep Keflor suspension in the refrigerator but not in the freezer, and keep the bottle tightly closed. Do not use any mixture that is left in the bottle after 14 days.

Do not keep Keflor or any other medicine in the bathroom or near a sink.

Do not leave Keflor in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Keflor, or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Keflor suspensions comes in two strengths:

Keflor 125 mg/5 mL
Keflor 250 mg/5 mL.

Both strengths of Keflor Suspension are pink and have a strawberry taste.

Each bottle of Keflor 125 mg/5 mL contains 100 mL of mixture.

Each bottle of Keflor 250 mg/5 mL contains 75 mL of mixture.

Ingredients

The active ingredient in Keflor suspensions is cefaclor (as cefaclor monohydrate).

each 5 mL of Keflor 125 mg/5 mL contains 125 mg of cefaclor
each 5 mL of Keflor 250 mg/5 mL contains 250 mg of cefaclor.

The suspensions also contain the following inactive ingredients:

sucrose
erythrosine CI45430 (E 127)
methylcellulose
sodium lauryl sulfate
artificial strawberry flavour
dimeticone 350
xanthan gum
pregelatinised starch.

Keflor suspensions contain sugars.

Keflor suspensions are gluten free.

Supplier

Keflor is supplied by:

Alphapharm Pty Ltd
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration numbers:

Keflor 125 mg/5 mL - AUST R 58651

Keflor 250 mg/5 mL - AUST R 58653

This leaflet was prepared in October 2020.

Keflor_cmi\Oct20/00

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Keflor

Active ingredient

Cefaclor

Schedule

1 Name of Medicine

Cefaclor monohydrate.

2 Qualitative and Quantitative Composition

Each bottle of Keflor 125 mg/5 mL powder for oral suspension upon reconstitution contains 125 mg of cefaclor (as monohydrate) as the active ingredient, per 5 mL of suspension.
Each bottle of Keflor 250 mg/5 mL powder for oral suspension upon reconstitution contains 250 mg of cefaclor (as monohydrate) as the active ingredient, per 5 mL of suspension.

Excipients with known effect.

Sugars.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Keflor 125 mg/5 mL is a powder for oral suspension. The powder is a pink free-flowing dry powder. After reconstitution, it is a red coloured suspension with a characteristic strawberry odour.
Keflor 250 mg/5 mL is a powder for oral suspension. The powder is a pink free-flowing dry powder. After reconstitution, it is a red coloured suspension with a characteristic strawberry odour.

4 Clinical Particulars

4.1 Therapeutic Indications

Keflor is indicated for the treatment of the following types of infections caused by or likely to be caused by susceptible organisms.
Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis.
Upper respiratory infections, including pharyngitis, tonsillitis and otitis media.
Skin and skin structure infections.
Urinary tract infections, including pyelonephritis and cystitis.

Note.

1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflor appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

4.2 Dose and Method of Administration

Keflor is administered orally.

Directions for reconstitution of Keflor for oral suspension.

125 mg/5 mL.

Add 60 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

250 mg/5 mL.

Add 45 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.
Reconstituted Keflor for oral suspension should be stored under refrigeration (2 - 8°C) and may be kept for 14 days without significant loss of potency.

Adults.

The usual adult dosage is 250 mg every 8 to 12 hours. For bronchitis and pneumonia, the dosage is 250 mg administered 3 times daily. For more severe infections or those caused by less susceptible organisms, doses may be doubled (500 mg 8 hourly). Doses of 2 g/day should not be exceeded.
For skin and skin structure infections the dosage is 250 mg 2-3 times a day.

Children.

The usual recommended daily dosage for children with mild to moderate infections is 20 mg/kg/day in divided doses every 8 hours (maximum 1 g/day).
For streptococcal pharyngitis/tonsillitis and impetigo, 12 hourly administration appears equally effective.
In more serious infections, otitis media, and infections caused by less susceptible organisms, the recommended dosage is 40 mg/kg/day in divided doses every 8 to 12 hours (maximum 2 g/day). For otitis media, 12 hourly administration appears equally effective.
Keflor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see Section 4.4 Special Warnings and Precautions for Use).
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage of Keflor should be administered for at least 10 days.

4.3 Contraindications

Keflor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics or who have previously experienced a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use) or any of the excipients.
Keflor is also contraindicated in infants under the age of one month as safety and efficacy of this product has not been established in prematures and infants under one month of age.

4.4 Special Warnings and Precautions for Use

As with antibiotic therapy in general, administration of Keflor should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained. A minimum of ten days of treatment is recommended in infections caused by group A beta-haemolytic Streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis.
Prolonged use of Keflor may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Except under special circumstances, this medication should not be used when the following medical problem exists:

Allergic reaction (anaphylaxis).

In penicillin-sensitive patients, cephalosporin antibiotics should be administered cautiously. There is clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins and there are instances in which patients have had reactions, including anaphylaxis, to both drug classes. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin/cephalosporin hypersensitivity who have experienced severe reactions when treated with a penicillin/cephalosporin.
Past history of a severe allergic reaction to penicillin/cephalosporin is a contraindication to the use of Keflor. Before initiating therapy with any cephalosporin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Keflor should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline (epinephrine). Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Risk-benefit should be considered when the following medical problems exist:

History of colitis or gastrointestinal disease.

Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis.

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefaclor. A toxin produced with 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 Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

History of bleeding disorders.

All cephalosporins may cause hypoprothrombinemia and, potentially, bleeding.

Neurotoxicity.

There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus (see Section 4.8 Adverse Effects (Undesirable Effects)). Risk factors for developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment, central nervous system disorders and intravenous administration. Withdrawal of the medicine should be considered if there are signs of neurotoxicity.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, Keflor should be discontinued immediately and an alternative treatment should be considered.

Use in renal impairment.

Many cephalosporins are excreted renally. Keflor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuria is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are usually not required. Clinical experience with cefaclor under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made.

Use in hepatic impairment.

Keflor should be used with caution in patients with liver disease, as documented clinical experience in this group of patients is lacking.

Dental.

Long-term therapy with cephalosporins may allow for the overgrowth of Candida albicans, resulting in oral candidiasis.

Use in the elderly.

Cephalosporins have been used in the geriatric population and no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage and/or dosing interval in patients receiving cephalosporins.

Paediatric use.

Safety and effectiveness of this product for use in infants less than one month of age have not been established. Serum sickness-like reactions including arthritis and arthralgia have been reported more frequently in children than in adults.

Effects on laboratory tests.

Glucose, urine.

Administration of Keflor may result in a false-positive reaction for glucose in the urine. This phenomenon has been seen in patients taking cephalosporin antibiotics when the test is performed using Benedict's and Fehling's solutions and also with Clinitest tablets but not with Tes-Tape (Glucose Enzymatic Test Strip, USP).

Coombs' (antiglobulin) tests.

Positive direct Coombs' tests have been reported during treatment with cefaclor. In haematologic studies or in transfusion cross-matching procedures when anti-globulin tests are performed on the minor side, or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognised that a positive Coombs' test may be due to the drug.

Prothrombin time (PT).

May be prolonged.

Creatinine, serum.

Concentrations may be increased.

Carnitine or haematocrit.

Values may decrease during therapy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticoagulants, coumarin- or indandione-derivative, or heparin or thrombolytic agents.

Because all cephalosporins can inhibit vitamin K synthesis by suppressing gut flora, prophylactic vitamin K therapy is recommended when any of these medications is used for prolonged periods in malnourished or seriously ill patients.

Platelet aggregation inhibitors.

Hypoprothrombinemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or haemorrhagic potential of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfinpyrazone may increase the risk of haemorrhage.

Antacids.

The extent of absorption of cefaclor is diminished if aluminium hydroxide- or magnesium-containing antacids are taken within 1 hour of administration.

Probenecid.

Probenecid decreases renal tubular secretion of those cephalosporins excreted by this mechanism, resulting in increased and prolonged cephalosporin serum concentrations, prolonged elimination half-life and increased risk of toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Adequate and well-controlled studies in humans have not been done. However, studies in animals have not shown that cefaclor causes impaired fertility.
(Category B1)
The oral administration of high dose cefaclor (500 mg/kg) in pregnant rats and mice has resulted in a slight increase of minor skeletal malformations. Safety of this product for use during pregnancy has not been established. Cefaclor should not be used in women of childbearing potential unless, in the judgement of the treating clinician, its use is considered essential to the welfare of the patient and the expected benefits outweigh potential risks.
Small amounts of cefaclor have been detected in mother's milk following administration of single 500 mg doses. Average levels were 0.18, 0.20, 0.21 and 0.16 microgram/mL at 2, 3, 4 and 5 hours respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not known. Caution should be exercised when Keflor is administered to a nursing woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal disorders.

The most frequent side effect has been diarrhoea.
Nausea and vomiting have been reported rarely. Colitis, including rare instances of pseudomembranous colitis, has been reported in conjunction with therapy with cefaclor (see Section 4.4 Special Warnings and Precautions for Use).

Immune system disorders.

Allergic reactions, such as urticaria and morbilliform eruptions, have been observed, as have pruritus and positive Coombs' tests. These reactions usually subsided upon discontinuation of the drug. Angioedema and fever have been reported rarely.
Cases of serum-sickness-like reactions have been reported with the use of cefaclor. These have been reported more frequently in children than in adults with an overall occurrence ranging from 0.5% (1 in 200) in one trial, to 0.024% (2 in 8,346) in overall clinical trials (with an incidence in children in clinical trials of 0.055%). The worldwide reporting rate for serum-sickness-like reactions in adults is very rare (< 0.01%). Serum-sickness-like reactions are characterised by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. While further investigation is ongoing, serum sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy; occasionally these reactions have resulted in hospitalisation usually of short duration (median hospitalisation = 2 to 3 days, based on postmarketing surveillance studies). In those requiring hospitalisation, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in children. Antihistamines and glucocorticoids appear to enhance resolution of the signs and symptoms. No serious sequelae have been reported. More severe hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely. Anaphylaxis may be more common in patients with a history of penicillin allergy. The worldwide reporting rate for anaphylaxis in the total population is very rare (< 0.01%).

Infections and infestations.

Genital pruritus, moniliasis or vaginitis.

Nervous system disorders.

Rare: reversible hyperactivity, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations, headache or somnolence have been reported.
Transitory abnormalities in clinical laboratory test results for hepatobiliary, blood and renal disorders have been reported, but their clinical significance is uncertain.

Hepatobiliary disorders.

Transient hepatitis and cholestatic jaundice have been reported rarely.
Slight elevations in AST, ALT, or alkaline phosphatase values have also been reported.

Blood and lymphatic system disorders.

Eosinophilia, transient lymphocytosis, leukopenia and, rarely, thrombocytopenia, thrombocytosis, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance.
There have been rare reports of increased prothrombin time with or without clinical bleeding in patients receiving cefaclor and warfarin concomitantly.
There have also been reports of transient fluctuations in leukocyte count, predominantly lymphocytosis in infants and young children.

Renal and urinary disorders.

Reversible interstitial nephritis, slight elevations in serum urea or serum creatinine or abnormalities of urinalysis (haematuria, pyuria).

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.

Post-marketing experience.

Nervous system disorders.

Frequency not known: seizures, encephalopathy and/or myoclonus.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Signs and symptoms.

The toxic symptoms following an overdose of Keflor may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction or the effects of other intoxication.

Treatment.

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient.
Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.
Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefaclor.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Keflor (cefaclor monohydrate) is a semisynthetic cephalosporin antibiotic for oral administration.

Microbiology.

In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell-wall synthesis. Cefaclor is stable in the presence of bacterial β-lactamases; consequently, β-lactamase-producing organisms resistant to penicillins and some cephalosporins may be susceptible to cefaclor. Cefaclor has been shown to be active against most strains of the following organisms both in vitro and in clinical infections:
Staphylococci, including coagulase-positive and penicillinase-producing strains (but not methicillin-resistant strains of Staph. aureus); Streptococcus pyogenes (group A beta-haemolytic streptococci); Streptococcus (Diplococcus) pneumoniae; Escherichia coli; Proteus mirabilis; Klebsiella sp.; Haemophilus influenzae; Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase producing strains); Moraxella (Branhamella) catarrhalis.

Note.

Pseudomonas species, Acinetobacter calcoaceticus, enterococci, Enterobacter, indole-positive Proteus, and Serratia species are resistant to cefaclor. Methicillin resistant strains are also resistant to cefaclor.
Susceptibility testing. 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 that 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 body sites where the drug is physiologically concentrated or in situations where high dosage of 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.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Keflor is well absorbed after oral administration, whether taken with food or while fasting; however, when it is taken with food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasting subjects and generally appears from 45 minutes to 1 hour later. The presence of food in the gastrointestinal tract does not alter the total amount of cefaclor absorbed. Following administration of 250 mg, 500 mg, and 1 g doses to fasting subjects average peak plasma levels of antibacterial activity (expressed as microgram/mL of cefaclor) of 7, 13 and 23 microgram/mL, respectively, were obtained at 30 to 60 minutes. The reduced peak serum levels resulting from the administration of cefaclor with food should be considered with reference to the sensitivity of the infecting organism, severity of illness, the dose being administered and the variability in the peak plasma levels which occur with cefaclor.

Metabolism.

There is no evidence of metabolism of cefaclor in humans.

Excretion.

The plasma half-life in healthy subjects is independent of dosage form and averages 40-60 minutes. In elderly subjects (over age 65) with normal serum creatinine values, a higher peak plasma concentration and AUC are effects resulting from mildly diminished renal function and are not expected to have clinical significance. Therefore, dosage changes are not necessary in elderly subjects with normal renal function.

5.3 Preclinical Safety Data

Genotoxicity.

Long-term studies in animals to evaluate the mutagenic potential of cefaclor have not been done.

Carcinogenicity.

Long-term studies in animals to evaluate the carcinogenic potential of cefaclor have not been done.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sucrose, erythrosine, methylcellulose, sodium lauryl sulfate, strawberry flavour 52312 AP0551 (ARTG PI No: 274), dimeticone 350, xanthan gum and pregelatinised starch.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

For the dry powder.

Store below 25°C.

After reconstitution.

The suspension should be stored under refrigeration (2 - 8°C) and may be kept for 14 days without significant loss of potency.

6.5 Nature and Contents of Container

Container type: (HDPE) bottle with child resistant/tamper evident screw cap.
Pack sizes: 75 mL (250 mg/5 mL), 100 mL (125 mg/5 mL).
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 58651 - Keflor cefaclor 125 mg/5 mL (as monohydrate) powder for oral liquid bottle.
AUST R 58653 - Keflor cefaclor 250 mg/5 mL (as monohydrate) powder for oral liquid bottle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 3-chloro-7- D-(2-phenylglycinamido)- 3-cephem-4-carboxylic acid monohydrate.
Structural formula:

Molecular formula: C₁₅H₁₄ClN₃O₄S.H₂O.
Molecular weight: 385.83.
Cefaclor monohydrate is a white to off white crystalline powder, slightly soluble in water, but is insoluble in alcohol and chloroform.

CAS number.

53994-73-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

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