Consumer medicine information

Distaph

Dicloxacillin sodium

BRAND INFORMATION

Brand name

Distaph

Active ingredient

Dicloxacillin sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Distaph.

What is in this leaflet

This leaflet answers some common questions about DISTAPH.

It does not contain all 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 DISTAPH against the benefits expected 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 DISTAPH is used for

DISTAPH is used to treat infections in different parts of the body caused by bacteria.

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

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

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

DISTAPH is not recommended for use in newborn infants as its safety and effectiveness have not been established in this age group.

DISTAPH is available only with a doctor's prescription.

There is no evidence that DISTAPH is addictive.

Before you take DISTAPH

When you must not take it

Do not take DISTAPH if you have had an allergic reaction to:

  • medicines containing dicloxacillin or any other penicillin e.g. amoxicillin
  • cephalosporin antibiotics
  • 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, mouth, throat or other parts of the body, shortness of breath, wheezing or troubled breathing.

Check with your doctor or pharmacist if you are not sure about any of the above.

Do not take DISTAPH if the expiry date (EXP.) printed on the bottle has passed If you take this medicine after the expiry date, it may not work as well.

Do not take DISTAPH if the packaging shows signs of tampering or the capsules do not look quite right.

Before you start to take it

Be sure to tell your doctor if you have had any type of allergic reaction to:

  • other penicillins, e.g. amoxicillin
  • cephalosporin antibiotics

You may have an increased chance of being allergic to DISTAPH if you are allergic to cephalosporins.

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

Tell your doctor if you have, or have had, any other health problems or medical conditions, especially the following:

  • stomach problems such as feeling sick (nausea), vomiting, indigestion
  • problems with food absorption
  • liver problems
  • kidney problems
  • cystic fibrosis

Your doctor may want to take special care or adjust your dose if you have any of these conditions.

Tell your doctor if you are over 55 years old. Some side effects occur more frequently in this age group. Your doctor will discuss the risks and benefits of taking DISTAPH with you.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of taking DISTAPH during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Like many other medicines, DISTAPH can pass into breast milk. Your doctor will discuss the risks and benefits of taking DISTAPH when breastfeeding.

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

Taking other medicines

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

Some medicines may be affected by DISTAPH, or may affect how well it works. These include:

  • probenecid, a medicine used to treat gout
  • warfarin, a medicine used to prevent blood clots
  • phenytoin, a medicine used to treat epilepsy

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 DISTAPH.

How to take DISTAPH

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

If you do not understand the instructions on the bottle, ask your doctor or pharmacist.

How much to take

The dose varies from person to person.

Your doctor will tell you how much DISTAPH you need to take each day.

For most infections, the usual dose for adults and children over 12 years is 250 mg to 500 mg every 6 hours.

How to take DISTAPH

Swallow the capsules whole with a glass of water.

Take DISTAPH on an empty stomach, 1 to 2 hours before food. Taking the capsules on an empty stomach means that more of the medicine is absorbed into your body.

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take DISTAPH for

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

Do not stop taking DISTAPH, even if you feel better after a few days, unless advised by your doctor. Your infection may not clear completely if you stop taking your medicine too soon.

If you forget to take DISTAPH

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 it as soon as you remember, and then go back to taking your capsules as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.

If you miss more than one dose, or are not sure what to do, ask your doctor or pharmacist.

If you take too much DISTAPH (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), if you think you or anyone else may have taken too much DISTAPH.

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

While you are taking DISTAPH

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking DISTAPH.

Before starting any new medicine, tell your doctor or pharmacist that you are taking DISTAPH.

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 or pharmacist immediately. Do this even if it occurs several weeks after stopping DISTAPH. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

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

If you develop a yellow discolouration of the skin or eyes, your stools become pale and you feel unwell, tell your doctor immediately. These symptoms may mean that you have a serious problem with your liver. You may need urgent medical care.

If you get a sore, white mouth or tongue while taking or soon after stopping DISTAPH, 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 DISTAPH allows fungi to grow and these symptoms to occur. DISTAPH does not work against fungi.

If you are taking more than one or two courses of DISTAPH, you may need to have tests to check your liver, kidneys or blood. Always follow your doctor's instructions and have the tests performed as directed.

Things you must not do

Do not stop taking DISTAPH, even if you feel better after a few days, unless advised to by your doctor. If you stop taking DISTAPH too soon, your infection may not clear completely and your symptoms may return.

Do not use DISTAPH to treat any other conditions unless advised to by your doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DISTAPH. DISTAPH 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.

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

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

While you are taking DISTAPH

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

  • nausea (feeling sick), vomiting, stomach upset, wind, loose stools
  • oral thrush (white, furry sore tongue and mouth)
  • vaginal thrush (sore and itchy vagina, vaginal discharge)

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

  • watery and severe diarrhoea, which may also be bloody
  • blood in the urine
  • excess protein in the urine
  • severe stomach cramps
  • yellowing of the skin or eyes (jaundice), pale stools
  • kidney problems

Stop taking DISTAPH and tell your doctor immediately or go to casualty at the nearest hospital if any of the following happen:

  • any type of skin rash, itching or hives
  • swelling of the face, lips, mouth, throat or other parts of the body
  • shortness of breath, wheezing or difficulty breathing

After you have finished taking DISTAPH

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

  • watery and severe diarrhoea, which may also be bloody
  • severe stomach cramps

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything that is making you feel unwell while you are taking, or soon after you have finished taking DISTAPH, even if it is not on this list.

After taking DISTAPH

Storage

Keep DISTAPH 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.

Keep your capsules in the bottle until it is time to take them. If you take the capsules out of the bottle they will not keep well.

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

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

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

Disposal

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

Product description

What it looks like

DISTAPH comes in two strengths of capsules:

  • DISTAPH 250 - Size 2 capsule with white opaque body and cap, printed 'DX' on the cap and ‘250’ on the body in black
  • DISTAPH 500 - Size 0 capsule with white opaque body and cap, printed 'DX' on the cap and '500' on the body in black

Each bottle contains 24 capsules.

Ingredients

The active ingredient in DISTAPH is dicloxacillin (as dicloxacillin sodium)

  • each DISTAPH 250 capsule contains 250 mg of dicloxacillin
  • each DISTAPH 500 capsule contains 500 mg of dicloxacillin

The capsules also contain:

  • colloidal anhydrous silica
  • magnesium stearate
  • gelatin
  • titanium dioxide
  • purified water
  • TekPrint SW-9008 Black Ink (ARTG PI No: 2328)

DISTAPH 250 tablets contains sulfites and 21.2 mg of sodium per dose.

DISTAPH 500 tablets contains sulfites and 42.5 mg of sodium per dose.

Supplier

DISTAPH is supplied by:

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond30 - 34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in November 2022.

Australian registration numbers:

DISTAPH 250: AUST R 226506

DISTAPH 500: AUST R 226508

DISTAPH® is a Viatris company trade mark

DISTAPH_cmi\Nov22/00

Published by MIMS December 2022

BRAND INFORMATION

Brand name

Distaph

Active ingredient

Dicloxacillin sodium

Schedule

S4

 

1 Name of Medicine

Dicloxacillin (as dicloxacillin sodium).

2 Qualitative and Quantitative Composition

Each capsule contains dicloxacillin sodium equivalent to 250 mg or 500 mg dicloxacillin as the active ingredient.

Excipients with known effect in Distaph 250 capsules.

Sulfites and 21.2 mg of sodium per dose.

Excipients with known effect in Distaph 500 capsules.

Sulfites and 42.5 mg of sodium per dose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Distaph 250.

Dicloxacillin 250 mg capsule: Size 2 capsule with white opaque body and cap, printed 'DX' on the cap and '250' on the body in black

Distaph 500.

Dicloxacillin 500 mg capsule: Size 0 capsule with white opaque body and cap, printed 'DX' on the cap and '500' on the body in black.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).
Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin.
Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.

Important note.

When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase resistant penicillin.

4.2 Dose and Method of Administration

Microbiological studies to determine the causative organism and its susceptibility to the penicillinase resistant penicillins should be performed. The duration of treatment varies with the type and severity of infection as well as the overall condition of the patient. Therefore, treatment duration should be determined by the clinical and bacteriological response of the patient. Treatment should be continued for at least 48 to 72 hours after the patient has become asymptomatic and cultures are negative. In severe staphylococcal infections, treatment with penicillinase resistant penicillins should be continued for at least 14 days. The treatment of endocarditis and osteomyelitis requires a longer term of therapy.
Infections caused by group A beta-haemolytic Streptococci should be treated for at least 10 days to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.
The capsules should be administered on an empty stomach, one to two hours before food.
For mild to moderate infections:

Adults and children more than 12 years of age.

250 mg 6 hourly.
In more severe infections the dosage may be doubled.

Dosage adjustment in hepatic impairment.

Adequate data are not available on the use of dicloxacillin in such patients. It may be prudent, however, to reduce the dicloxacillin dose in patients with significant liver disease.

Dosage adjustment in renal impairment.

As dicloxacillin is excreted primarily by the kidneys, the half-life in patients with renal failure is increased (see Section 5.2 Pharmacokinetic Properties, Excretion). Limited clinical data suggest that in severe renal impairment the dosing interval may be increased to 8 hourly but no change in the individual dose is needed.

4.3 Contraindications

A history of a previous hypersensitivity reaction to any penicillins, or to any component of the formulation.

4.4 Special Warnings and Precautions for Use

Anaphylaxis.

Serious, and occasionally fatal, hypersensitivity (anaphylactoid) reactions have occurred in patients receiving penicillin. Serious anaphylactic reactions require immediate emergency treatment with adrenaline (epinephrine). Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins.
Before commencing therapy with any penicillin, a careful enquiry about sensitivity or allergic reactions to penicillins, cephalosporins or other allergens should be made before dicloxacillin is prescribed. There is clinical and laboratory evidence of cross allergenicity among bicyclic β-lactam antibiotics including penicillins, cephalosporins, cephamycins, 1-oxa-β-lactams and carbapenems. Should an allergic reaction occur during therapy, the drug should be discontinued and appropriate measures taken.

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including dicloxacillin. 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 (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.

Cholestatic hepatitis.

Dicloxacillin has been associated with cholestatic hepatotoxicity and jaundice. The patterns of liver function test results and biopsy histology are similar to those with flucloxacillin.
In the period 1981 to 1994, the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) received 20 reports of adverse hepatic reactions which were possibly or probably related to dicloxacillin. During this period, 10.7 million defined daily doses (DDD) of dicloxacillin were prescribed in Sweden, giving a frequency of 1.8 reactions per million DDD. Over the same period, SADRAC received 127 adverse hepatic reaction reports (77 possible, 47 probable, 3 unclassified) related to flucloxacillin, giving a frequency of 4.3 reactions per million DDD. Although the limitations of retrospective data reliant on spontaneous physician reporting are obvious, the SADRAC figures suggest that adverse hepatic events occur, or at least are reported, less frequently with dicloxacillin than with flucloxacillin.
Despite the reduced frequency of hepatic reactions to dicloxacillin, dicloxacillin should only be used in older patients (55 years or more) when such use is clearly justifiable on clinical grounds.
Bacteriological studies to determine the causative organisms and their susceptibility to the penicillinase resistant penicillins should be performed. In the treatment of suspected staphylococcal infections, therapy should be changed to another active agent if culture tests fail to demonstrate the presence of staphylococci.
As with any potent drug, periodic assessment of organ system function, including hepatic, renal and haematopoietic, should be made during prolonged therapy. White blood cell counts and differential cell counts should be obtained prior to initiation of therapy with dicloxacillin.
Periodic urinalysis should be performed, and serum urea, creatinine, AST and ALT concentrations should be determined during therapy with dicloxacillin. Dosage alterations should be considered if these values become elevated. Dicloxacillin should be discontinued if abnormal liver function tests develop whilst on therapy.
The use of antibiotics may result in the overgrowth of nonsusceptible organisms. Should superinfection occur, appropriate treatment should be initiated and discontinuation of dicloxacillin therapy should be considered.
This oral preparation should not be relied upon in patients with severe illness or with nausea, vomiting, gastric dilatation, cardiospasm, intestinal hypermotility.
Rare reports have been received during postmarketing surveillance of oesophageal burning, oesophagitis and oesophageal ulceration, particularly after ingestion of dicloxacillin capsules with an insufficient quantity of water and/or before going to bed. To minimise the risk of developing such events, dicloxacillin should be taken with at least 120 mL of water and should not be taken in the supine position or immediately before going to bed.
High doses (2 to 4 g/day) of dicloxacillin administered prophylactically to geriatric patients undergoing arthroplasties have been reported to be associated with elevations of serum creatinine and nephrotoxicity. Renal function should be assessed prior to starting dicloxacillin and doses appropriately reduced in the presence of kidney dysfunction when high doses are considered (see Section 4.2 Dose and Method of Administration, Dosage adjustment in renal impairment).

Use in the elderly.

No data available.

Paediatric use.

Penicillinase resistant penicillins (especially methicillin) may not be completely excreted in newborn infants because of incompletely developed renal function. This may result in abnormally high blood levels. Frequent blood level determinations and dosage adjustments when necessary are advisable in these patients. All newborn infants treated with penicillins should be monitored closely for clinical and laboratory evidence of toxic or adverse effects. Experience in the neonatal period is limited. Therefore, a dose for newborn is not recommended at this time.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid increases and prolongs serum penicillin concentrations. Probenecid administered concomitantly with penicillins slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.
Dicloxacillin may reduce the anticoagulant effects of warfarin. Careful monitoring of prothrombin time is suggested during concomitant therapy, and adjustment of the anticoagulant dose may be necessary.
Concurrent administration of oxacillin with phenytoin resulted in decreased phenytoin serum concentrations due possibly to impaired phenytoin absorption.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Safety for use in pregnancy has not been established.
 Dicloxacillin is distributed into milk. Therefore, caution should be exercised when dicloxacillin 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)

The following adverse reactions to dicloxacillin have, where possible, been grouped by frequency according to the following criteria. Very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1000; very rare: < 1/10,000.

Gastrointestinal.

Common: gastrointestinal disturbances such as nausea, vomiting, epigastric discomfort, flatulence and loose stools. Rare: pseudomembranous colitis, oesophageal ulcer, oesophageal pain, oesphagitis (see Section 4.4 Special Warnings and Precautions for Use).

Hypersensitivity and skin.

Common: skin rashes, urticaria and pruritus. Very rare: laryngospasm, bronchospasm, angioedema. Frequency unknown: anaphylactic reactions laryngeal edema, serum sickness, wheezing, sneezing.

Hepatobiliary.

Very rare: cholestatic hepatitis (see Section 4.4 Special Warnings and Precautions for Use). Frequency unknown: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, liver function test abnormal.

Renal.

Uncommon: renal failure, renal impairment, renal tubular disorder, nephritis interstitial, nephropathy, haematuria, proteinuria. Frequency unknown: transient, generally minor deterioration in the renal function of elderly patients given high doses of dicloxacillin intravenously.

Haematological.

Uncommon: eosinophilia. Frequency unknown: agranulocytosis or neutropenia. Haematolytic anaemia, leukopenia, granulocytopenia, thrombocytopenia and bone marrow depression have been associated with the use of penicillinase resistant penicillins.

Neurological.

Frequency unknown: generalised epileptic convulsion, myoclonus, confusional state, neurotoxicity, lethargy. Neurotoxicity similar to that observed with benzylpenicillin (e.g. seizures) may occur with large intravenous doses of the penicillinase resistant penicillins, especially in patients with impaired renal function.

Vascular disorders.

Uncommon: phlebitis, thrombophlebitis. Very rare: circulatory collapse, hypotension.

Musculoskeletal, connective tissue and bone disorders.

Frequency unknown: myalgia, arthralgia, muscle twitching*.

General disorders.

Very rare: death in the context of hypersensitivity. Uncommon: pain. Frequency unknown: malaise, pyrexia.
*These events may occur with large intravenous doses of penicillinase resistant penicillins, especially in patients with renal insufficiency.

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

Treatment of dicloxacillin overdosage should be symptomatic and supportive. There is no specific antidote. Dicloxacillin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Dicloxacillin sodium is a semisynthetic penicillin that resists inactivation by staphylococcal β-lactamase (penicillinase). Penicillinase resistant penicillins exert a bactericidal action against penicillin-susceptible microorganisms during active multiplication. All penicillins inhibit the biosynthesis of the bacterial cell wall.
Dicloxacillin is a narrow spectrum antibiotic with activity against the following Gram-positive organisms: susceptible staphylococci, Streptococcus pyogenes, "Viridans" group streptococci, Streptococcus pneumoniae. Because of its resistance to the enzyme penicillinase, it is active against penicillinase producing staphylococci.
Dicloxacillin is not active against methicillin-resistant Staphylococcus aureus.

Disc susceptibility tests.

The most precise estimates of antibiotic susceptibility are given by quantitative methods that require measurement of zone diameters. The results of agar diffusion sensitivity tests for methicillin determined in accordance with NCCLS^ M100-S6, M2-A5, can be applied to other β-lactamase resistant penicillins including dicloxacillin. The NCCLS "Zone Interpretative Standards and Equivalent Minimum Inhibitory Concentrations (MIC) Breakpoints for organisms other than Haemophilus spp, Neisseria gonorrhoea, and Streptococcus," gives sensitivity results for methicillin against various staphylococcal bacteria, which are shown in Table 1.
^ Available from NCCLS, Lancaster avenue, Villanova, Pennsylvania 19085, USA
A report of 'susceptible' indicates the infecting organism is likely to response to therapy. A report of 'intermediate' suggests the organism would be susceptible if high dosage is used or if the infection is confined to tissues in which high concentrations of dicloxacillin are obtained, for example in urine. A report of 'resistant' indicates that the infection is unlikely to response to therapy with the antibiotic.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Dicloxacillin is resistant to destruction by acid. Absorption from the gastrointestinal tract is rapid, in fasting adults, 50% to 94% of an oral dose was absorbed with peak levels occurring 0.5 to 2 hours. The bioavailability of dicloxacillin is decreased in the presence of food.
Serum levels after oral administration are directly proportional to dosage at unit doses of 125 mg, 250 mg, and 500 mg as measured at the 2 hour level. Single oral doses of dicloxacillin 500 mg produced peak serum concentrations of 10 to 18 microgram/mL.

Distribution.

Dicloxacillin is 95-99% bound to serum proteins, mainly albumin. Dicloxacillin is distributed into bone, bile, pleural fluid and synovial fluid. Only minimal concentrations are attained in the cerebrospinal fluid.

Metabolism.

The elimination half-life of dicloxacillin is approximately 0.7 hours. Dicloxacillin is partially metabolised to microbiologically active (5-hydroxymethyl derivative of dicloxacillin) and inactive metabolites.

Excretion.

Dicloxacillin and its metabolites are rapidly excreted in the urine by glomerular filtration and tubular secretion, approximately 50% of the absorbed dose is excreted unchanged in the urine. The drug is also partially excreted in the faeces via biliary elimination.
Reduced plasma concentrations have been reported in patients with cystic fibrosis. This is attributed to enhanced elimination of the drug in these patients.
In patients with severe renal impairment, the half life of dicloxacillin has been reported to increase two to threefold, however, extra renal elimination prevents significant drug accumulation in these patients (see Section 4.2 Dose and Method of Administration).
Dicloxacillin is not dialysable. Only minimal amounts are removed by haemodialysis or peritoneal dialysis.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients present are colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide, purified water and TekPrint SW-9008 Black Ink (ARTG PI No: 2328).

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

Store below 25°C.

6.5 Nature and Contents of Container

Container type: HDPE bottles with HDPE screw caps.
Pack sizes: 24 and 30 capsules.
Some pack sizes may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

AUST R 226506 - Distaph 250 dicloxacillin 250 mg (as sodium) capsule bottle.
AUST R 226508 - Distaph 500 dicloxacillin 500 mg (as sodium) capsule 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

Dicloxacillin sodium is an antibiotic and a member of the isoxazolyl penicillins. Dicloxacillin sodium is a white or almost white, crystalline powder. It is hygroscopic, freely soluble in water, soluble in alcohol and in methanol.

Chemical structure.

Chemical name: (6R)-6-[3-(2, 6-dichlorophenyl)-5-methylisoxazole-4-carboxamido]-penicillanate. Structural formula:
Molecular Formula: C19H16Cl2N3NaO5S,H2O. Molecular Weight: 510.3.

CAS number.

13412-64-1.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes