Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about DBL Cephalothin Sodium for Injection. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you being given DBL Cephalothin Sodium for Injection against the benefits this medicine is expected to have for you.

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

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

What DBL Cephalothin Sodium for Injection is used for

DBL Cephalothin Sodium for Injection is an antibiotic used to treat infections in different parts of the body caused by bacteria.

This medicine will not work against infections caused by viruses such as colds or the flu.

Cefalotin sodium belongs to a group of antibiotics called cephalosporins (ke-fä-lö-spör-ins).

It works by killing the bacteria causing your infection or by stopping its growth.

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

This medicine is available only with a doctor’s prescription.

There is no evidence that cefalotin sodium is addictive.

Before you are given DBL Cephalothin Sodium for Injection

When you must not be given it

You should not be given DBL Cephalothin Sodium for Injection if you have an allergy to:

• any medicine containing cefalotin sodium
• • any other cephalosporins
• • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue.

• you have had a serious allergic reaction to penicillins
• the packaging is torn or shows signs of tampering
• the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).

If you are not sure whether you should start treatment with cefalotin sodium, 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 any type of allergic reaction to penicillin medicines, cephalosporin medicines or any other antibiotic medicines

You may have an increased chance of being allergic to cefalotin sodium if you are allergic to penicillins or cephalosporins.

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

• kidney disease
• severe bowel conditions/disease.

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

If you have not told your doctor about any of the above, tell them before you are given DBL Cephalothin Sodium for Injection.

Taking other medicines

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

Some medicines and DBL Cephalothin Sodium for Ijection may interfere with each other. These include:

• aminoglycoside antibiotics eg gentamicin, tobramycin; medicines used to treat bacterial infections.
• anticoagulants eg warfarin (Coumadin™, Marevan™), heparin (Calciparine™, Calcihep™), medicines used to prevent blood clots.
• colistin sulfomethate sodium (Coly-Mycin M Parenteral™), a medicine used to treat certain bacterial infections.
• ethacrynic acid (Edecril™), fluid tablets which cause a loss of fluid.
• frusemide (Lasix™, Urex™), fluid tablets which cause a loss of fluid.
• methotrexate (Ledertrexate™, Methoblastin™), used to treat cancer, rheumatoid arthritis or psoriasis.
• piretanide (Not available in Australia), a medicine which causes an increased volume of urine.
• probenecid, a medicine used to treat gout or prolongs the action of certain antibiotics.

These medicines may be affected by cefalotin sodium, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

How DBL Cephalothin Sodium for Injection is given

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

DBL Cephalothin Sodium for Injection can be given in two ways:

• as a slow injection into a vein
• as a deep injection into a large muscle.

DBL Cephalothin Sodium for Injection must only be given by a doctor or nurse. Your doctor will decide what dose you will receive of DBL Cephalothin Sodium for Injection and how long you will receive it for. This depends on your infection and other factors, such as your weight. For most infections, DBL Cephalothin Sodium for Injection is usually given in divided doses throughout the day.

Sometimes only a single dose of DBL Cephalothin Sodium for Injection is required for treatment in certain patients.

If you take too much (overdose)

As DBL Cephalothin Sodium for Injection is most likely to be given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose.

However, if you think you may have received an overdose of cefalotin sodium, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency at your nearest hospital, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are being given DBL Cephalothin Sodium for Injection

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.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after cefalotin sodium has been stopped. Diarrhoea may mean 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 while you are being treated with, or soon after stopping cefalotin sodium, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have fungal infection called thrush. Sometimes the use of cefalotin sodium allows fungi to grow and the above symptoms to occur. Cefalotin sodium does not work against fungi.

If you become pregnant while you are being treated with cefalotin sodium tell your doctor immediately.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are being treated with cefalotin sodium.

If you have to have any blood or urine tests tell your doctor you are being given cefalotin sodium. It may affect the results of some blood and urine tests.

Tell all the doctors, dentists and pharmacists who are treating you that you are receiving DBL Cephalothin Sodium for Injection.

Things you must not do

Do not stop taking DBL Cephalothin Sodium for Injection because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

Do not give DBL Cephalothin Sodium for Injection to anyone else, even if they have the same condition as you.

Do not use DBL Cephalothin Sodium for Injection to treat any other complaints unless your doctor tells you to.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Cephalothin Sodium for Injection.

Like other medicines, cefalotin sodium can cause some side effects. 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 list of side effects. You may not experience any of them.

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

While you are being given it

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

• oral thrush - white, furry, sore tongue and mouth
• vaginal thrush - sore and itchy vagina and/or discharge
• mild stomach upsets, such as feeling sick
• diarrhoea
• pain, swelling, redness, a hard lump or tenderness at the site of injection
• skin rash
• itchiness.

These are all mild side effects of cefalotin sodium.

Tell your doctor or nurse immediately if you notice any of the following:

• severe blisters and bleeding in the lips, eyes, mouth, nose or genitals
• itchy spots accompanied by fever and feeling unwell

The above list includes serious side effects. You may need urgent medical attention.

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

• fever
• skin rashes which may be itchy
• vomiting
• severe diarrhoea
• swelling or clotting of a vein
• faster heart rate.
• fitting
• life threatening allergic reaction which may include skin rash, itching, difficulty breathing, swelling of face, lips or tongue
• skin rash with joint pain and fever
• decrease in urine output or decrease in urine concentrating ability.

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

After finishing treatment with it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with DBL Cephalothin Sodium for Injection:

• severe abdominal cramps or stomach cramps
• watery and severe diarrhoea, which may also be bloody
• fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Cefalotin sodium can cause bacteria, which is normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. However, this side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

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

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

After being given DBL Cephalothin Sodium for Injection

Storage

DBL Cephalothin Sodium for Injection will generally be stored in the pharmacy or on the ward.

If stored at home, keep your cefalotin sodium vials in their original packs until it is time to use them. If you take the vials out of the pack they may not keep well.

Keep them in a cool, dry place where the temperature stays below 25°C.

Do not store DBL Cephalothin Sodium for Injection or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Product description

What it looks like

DBL Cephalothin Sodium for Injection is a white to off white, almost odourless, crystalline powder.

DBL Cephalothin Sodium for Injection comes in a single strength:

• Cefalotin sodium equivalent to cefalotin 1 g.

It is available in 10 mL vials in packs of 10.

Ingredients

DBL Cephalothin Sodium for Injection contains cefalotin sodium as the active ingredient.

It also contains:

• sodium bicarbonate.

DBL Cephalothin Sodium for Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

DBL Cephalothin Sodium for Injection is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au
™ = Trademark
© Copyright

This leaflet was prepared in June 2019

AUST R 63203

Published by MIMS August 2019

1 Name of Medicine

Cefalotin sodium.

6.7 Physicochemical Properties

Cefalotin sodium is sodium (6R,7R)-3-acetoxymethyl-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. The molecular formula of cefalotin sodium is C₁₆H₁₅N₂NaO₆S₂ and the molecular weight is 418.4.

Chemical structure.

CAS number.

Cefalotin.

Cefalotin sodium.

2 Qualitative and Quantitative Composition

DBL Cephalothin Sodium for Injection contains the active ingredient cefalotin sodium and sodium bicarbonate. A 10% or 25% solution of cefalotin sodium in water has a pH of 4.5 to 7. However, precipitation may occur in solutions with a pH of less than 5. Therefore, sodium bicarbonate has been added to result in reconstituted solutions having a pH ranging between 6 and 8.5.
1.06 g of cefalotin sodium is approximately equivalent to 1 g of cefalotin. Each gram of cefalotin sodium represents 2.39 mmol of sodium. The total sodium content is approximately 63 mg (sodium ion 2.8 mEq) per gram of DBL Cephalothin Sodium for Injection.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Cephalothin Sodium for Injection is a powder for injection that occurs as a white to off white, almost odourless, crystalline powder. The drug is freely soluble in water, sodium chloride 0.9% solution and in glucose solutions. It is slightly soluble in dehydrated alcohol, and practically insoluble in ether and most other organic solvents.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Note.

Susceptibility plate tests.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Cephalothin Sodium for Injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility studies should be performed. However, therapy may be instituted before results of susceptibility studies are obtained (see Section 5.1 Pharmacodynamic Properties).

Respiratory tract.

Skin and soft tissue.

Genitourinary tract.

Septicaemia, including endocarditis.

Bone and joint.

Note.

4.3 Contraindications

DBL Cephalothin Sodium for Injection is contraindicated in patients with a known hypersensitivity to cephalosporin antibiotics or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use), or any other ingredients in the DBL Cephalothin Sodium for Injection preparation.

4.4 Special Warnings and Precautions for Use

Before cefalotin therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillin and other beta-lactam antibiotics. There is some clinical and laboratory evidence of partial cross allergenicity of the penicillins and the cephalosporins. Patients have been reported to have had severe reactions, including anaphylaxis, to both drugs. Cephalosporin C derivatives should be given cautiously in penicillin sensitive patients. Any patient who has demonstrated some form of allergy, particularly to drugs, should receive antibiotics cautiously and then only when absolutely necessary. No exception should be made with regard to cefalotin. If an allergic reaction to cefalotin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline, or other pressor amines, antihistamines or corticosteroids).
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefalotin. 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 such as oral antibacterial agents effective against C. 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.
Prolonged use of cefalotin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Although cefalotin rarely produces alteration in kidney function, evaluation of renal status is recommended, especially in seriously ill patients receiving maximum doses.
An increased incidence of nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Since cefalotin may cause a low white blood cell count and neutropenia, it is advisable that patients receiving cefalotin treatment for one week or more should have a white blood cell count (see Section 4.8 Adverse Effects (Undesirable Effects), Haemic and lymphatic system).
When intravenous doses of cefalotin larger than 6 g daily are given by infusion for periods longer than three days, they may be associated with thrombophlebitis, and the veins may have to be alternated. The addition of hydrocortisone 10 to 25 mg to intravenous solutions containing cefalotin 4 to 6 g may reduce the incidence of thrombophlebitis. The use of small intravenous needles in the larger available veins may be preferred.
Cefalotin should not be used in the treatment of meningitis due to its unpredictable cerebrospinal fluid levels (see Section 5.2 Pharmacokinetic Properties).
Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected.

Severe cutaneous adverse reactions.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Antiglobulin test.

Creatinine.

Theophylline.

Urinary glucose.

Urinary protein.

Urinary steroids.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Aminoglycosides.

Anticoagulants.

Colistin sulfomethate sodium.

Ethacrynic acid.

Frusemide.

Gentamicin.

Methotrexate.

Nephrotoxic drugs.

Platelet aggregation inhibitors, other.

Probenecid.

Tobramycin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

Body as a whole.

Cardiovascular system.

Digestive system.

Haemic and lymphatic system.

Metabolic and nutritional disorders.

Skin and other subcutaneous tissue disorders.

Urogenital system.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

Dosage.

Treatment.

Adults.

Infants, children.

Prophylaxis.

Adults.

Children.

Method of administration.

Intramuscular.

Intravenous.

Intermittent intravenous administration.

Intermittent intravenous infusion with Y-type administration set.

Continuous intravenous infusion.

Dosage adjustments.

Renal impairment.

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.

4.9 Overdose

The administration of inappropriately large doses of parenteral cephalosporins may cause seizures, particularly in patients with renal impairment. Dosage reduction is necessary when renal function is impaired (see Section 4.2 Dose and Method of Administration). If seizures occur, the drug should be promptly discontinued; anticonvulsant therapy may be administered if clinically indicated. In cases of overwhelming overdosage, haemodialysis may be considered. A maintenance dose of cefalotin should be administered following haemodialysis, however there is an absence of data from well controlled studies to make more specific recommendations.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand, call 0800 764 766.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium bicarbonate.

6.2 Incompatibilities

Cefalotin sodium has been reported to be incompatible with aminoglycosides and with many other agents.

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.
To minimise the risk of microbial contamination and growth, use the reconstituted product as soon as practical after reconstitution/preparation and discard any remaining residue. If storage is necessary, hold at 2 to 8°C for no longer than 24 hours.
Reconstituted solutions may precipitate following refrigeration; they can be redissolved by being warmed to room temperature with constant agitation. Kept at room temperature, solutions for intramuscular injection should be given within six hours after being mixed. Intravenous infusions should be started within six hours and completed within 24 hours. For prolonged infusions, replace with a freshly prepared solution at least every 24 hours.
The concentrated solution will darken, especially at room temperature. Slight discolouration of the solution is permissible.

6.4 Special Precautions for Storage

DBL Cephalothin Sodium for Injection should be stored below 25°C. Protect from light.

6.5 Nature and Contents of Container

10 mL vials containing 1 g powder for reconstitution.
Packs of 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes