Consumer medicine information

Minomycin

Minocycline

BRAND INFORMATION

Brand name

Minomycin 50

Active ingredient

Minocycline

Schedule

SUMMARY CMI

MINOMYCIN 50 tablets

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using MINOMYCIN 50?

MINOMYCIN 50 tablet contains the active ingredient minocycline hydrochloride dihydrate. MINOMYCIN 50 is used to treat acne, which is resistant to other antibiotics. It is also used to treat various other infections.

For more information, see Section 1. Why am I using MINOMYCIN 50? in the full CMI.

2. What should I know before I use MINOMYCIN 50?

Do not use if you have ever had an allergic reaction to minocycline, any other tetracycline antibiotics or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use MINOMYCIN 50? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MINOMYCIN 50 and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use MINOMYCIN 50?

For treating infections: the usual dose is 200 mg to start with, followed by 100 mg every 12 hours.
For controlling acne: the usual dose is 100 mg daily, preferably in two separate doses of 50 mg each.

More instructions can be found in Section 4. How do I use MINOMYCIN 50? in the full CMI.

5. What should I know while using MINOMYCIN 50?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using MINOMYCIN 50. If you become pregnant while taking MINOMYCIN 50, tell your doctor immediately. If you are being treated for an infection, take the full course of tablets prescribed, even if you feel better after a few days. Before starting any new medicine, tell your doctor or pharmacist that you are taking MINOMYCIN 50. If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking MINOMYCIN 50. Tell your doctor, if you get thrush or any other infection while taking, or soon after stopping MINOMYCIN 50.
Things you should not do	Do not stop using this medicine suddenly or lower the dosage without checking with your doctor. Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Do not use MINOMYCIN 50 to treat any other medical complaints unless your doctor says to
Driving or using machines	Be careful before you drive or use any machines or tools until you know how MINOMYCIN 50 affects you. MINOMYCIN 50 may cause dizziness or light-headedness in some people.
Drinking alcohol	If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine	Store below 25°C.

For more information, see Section 5. What should I know while using MINOMYCIN 50? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

MINOMYCIN 50 tablets

Active ingredient: minocycline hydrochloride dihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using MINOMYCIN 50. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MINOMYCIN 50.

Where to find information in this leaflet:

1. Why am I using MINOMYCIN 50?
2. What should I know before I use MINOMYCIN 50?
3. What if I am taking other medicines?
4. How do I use MINOMYCIN 50?
5. What should I know while using MINOMYCIN 50?
6. Are there any side effects?
7. Product details

1. Why am I using MINOMYCIN 50?

MINOMYCIN 50 contains the active minocycline hydrochloride dihydrate. MINOMYCIN 50 belongs to a group of antibiotics called tetracyclines. They work by stopping the growth of bacteria.

MINOMYCIN 50 is used to treat acne, which is resistant to other antibiotics. It is also used to treat various other infections.

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

MINOMYCIN 50 is not addictive.

Your doctor may have prescribed MINOMYCIN 50 for another purpose.

2. What should I know before I use MINOMYCIN 50?

Warnings

Do not use MINOMYCIN 50 if:

you are allergic to minocycline, any other tetracycline antibiotics or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- rash, itching or hives on the skin
- swelling of the face, lips, tongue or other parts of the body
- shortness of breath, wheezing
- difficulty breathing
Always check the ingredients to make sure you can use this medicine.
you are pregnant or breastfeeding.
you have systemic lupus erythematosus (Lupus).
you have severe kidney disease.
The expiry date (EXP) printed on the pack has passed.
the packaging is torn or shows signs of tampering.

Use in children

Do not give MINOMYCIN 50 to children of eight years and under unless directed by the child's doctor.

MINOMYCIN 50, like other tetracyclines, may cause enamel loss and permanent staining of teeth.

Check with your doctor if you:

are allergic to any foods, dyes, preservatives or any other medicines.
have any other health problems, including kidney disease.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant, breastfeeding, intend to become pregnant or breastfeed.

As with many medicines, tetracyclines may harm the developing or breastfeeding baby. This may include enamel loss and staining of the child's teeth.

High doses of tetracyclines may also cause liver problems in pregnant women.

Your doctor will discuss the risks and benefits of using MINOMYCIN 50 if you are pregnant or breastfeeding.

3. What if I am taking other medicines?

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

Some medicines may interfere with MINOMYCIN 50 and affect how it works. These include:

preparations containing vitamin A and some medicines used for skin problems such as isotretinoin or etretinate
warfarin, a medicine used to stop blood clotting
antacids used for indigestion
preparations containing iron
another group of antibiotics called penicillins
contraceptive pill (birth control pills). MINOMYCIN 50 may decrease the effectiveness of some birth control pills. Your doctor may advise you to use an additional method of contraception.
Some tetracyclines may interact with a general anaesthetic called Penthrane. Tell the doctor or dentist that you are taking MINOMYCIN 50 if you expect to have surgery or dental work with a general anaesthetic.

These medicines may be affected by MINOMYCIN 50 or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MINOMYCIN 50.

4. How do I use MINOMYCIN 50?

Take MINOMYCIN 50 exactly as your doctor has prescribed.

How much to take

For treating infections: the usual dose is 200 mg to start with, followed by 100 mg every 12 hours.
For controlling acne: the usual dose is 100 mg daily, preferably in two separate doses of 50 mg each.

How to take MINOMYCIN 50

Swallow the tablets whole with a full glass of water or milk. This medicine may be taken with food.
Do not take it immediately before lying down.

How long to take MINOMYCIN 50

Your doctor may prescribe MINOMYCIN 50 for long periods.
Check with your doctor if you are not sure how long you should be taking it.
For treating infections, MINOMYCIN 50 must be taken for at least 48 hours after you feel well and the fever has gone.
For controlling acne, MINOMYCIN 50 is normally taken for a few months.
Visit your doctor regularly. They may do blood tests to check your progress.
Continue taking it until your doctor tells you to stop.

If you forget to use MINOMYCIN 50

MINOMYCIN 50 should be used regularly at 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.

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

Do not take a double dose to make up for the dose 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 use too much MINOMYCIN 50

If you think that you have used too much MINOMYCIN 50, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much MINOMYCIN 50 you may experience the following symptoms: nausea, vomiting, stomach pain, fall in blood pressure, tiredness.

5. What should I know while using MINOMYCIN 50?

Things you should do

If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking MINOMYCIN 50.
If you become pregnant while taking MINOMYCIN 50, tell your doctor immediately.
If you are being treated for an infection, take the full course of tablets prescribed, even if you feel better after a few days.
If you do not complete the full course, the bacteria may still be present and your infection may return.

Call your doctor straight away if you:

develop a persistent headache with one or more of the other symptoms. Minocycline is rarely associated with aserious condition called benign intracranial hypertension which can cause headache, nausea, vomiting, blurred vision, dizziness.
If you get thrush or any other infection while taking, or soon after stopping MINOMYCIN 50.
Overgrowth of certain organisms not sensitive to MINOMYCIN 50 can sometimes occur.
If you get severe diarrhoea. Do this even if it occurs several weeks after stopping MINOMYCIN 50.
This may be a sign of a serious side effect that affects the bowel.
Do not take any medicines to treat this diarrhoea unless directed by your doctor.

Remind any doctor, dentist or pharmacist you visit that you are using MINOMYCIN 50.

Things you should not do

Do not stop using this medicine suddenly or lower the dosage without checking with your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use MINOMYCIN 50 to treat any other medical complaints unless your doctor says to.

Things to be careful of

If outdoors, wear protective clothing and use a SPF 15+ sunscreen.
MINOMYCIN 50 may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn.
If your skin does appear to be burning, stop taking MINOMYCIN 50 and tell your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MINOMYCIN 50 affects you.

MINOMYCIN 50 may cause dizziness or light-headedness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol, dizziness or light-headedness may be worse.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 25°C away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

dizziness, lightheadedness, unsteadiness
headache
blurred vision, hearing loss
feeling sick (nausea), vomiting, diarrhoea
loss of appetite
sore mouth or tongue
difficulty in swallowing
oral thrush (white, furry sore tongue and mouth)
vaginal thrush (sore and itchy vagina, vaginal discharge)
swelling and itching in the anal and genital areas
heartburn, which may be due to irritation and ulceration of the oesophagus (food pipe).

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

symptoms of a rare condition called benign intracranial hypertension (increased pressure within the skull) such as persistent headache along with one or more of the following - nausea, vomiting, blurred vision or dizziness
severe diarrhoea, usually with blood and mucus, stomach pain and fever
severe upper stomach pains, often with nausea and vomiting
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
bruising or bleeding more easily than normal
being short of breath when exercising, often with tiredness, headaches, dizziness and looking pale and yellowing of the skin and/or eyes
swollen, stiff or painful joints
passing less urine than normal
signs of liver disease such as feeling generally unwell, loss of appetite, yellowing of the eyes or skin (jaundice), fever, itching and dark coloured urine skin rash, itching, redness, flaking or blistering
symptoms of severe sunburn (such as redness, itching, swelling, blistering) that may occur more quickly than normal
convulsions or seizures

Allergy-related:

rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Contact your doctor if you notice any staining of your skin, teeth, tongue, lips, gums or nails.

Slight blue-black colour staining of the skin, teeth, nails, inside of the mouth, eyes, tears, breast milk or sweat has been reported. Staining may appear at any time during MINOMYCIN 50 therapy but is more common during long-term treatment. Inform your doctor without delay if you notice any staining so that your treatment can be reviewed.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What MINOMYCIN 50 contains

Active ingredient (main ingredient)	minocycline hydrochloride dihydrate, 50 mg
Other ingredients (inactive ingredients)	Lactose monohydrate Sodium starch glycollate Povidone Sorbitol microcrystalline cellulose Stearic Acid Magnesium Stearate Opadry Orange YS-1R-2402

Do not take this medicine if you are allergic to any of these ingredients.

What MINOMYCIN 50 looks like

MINOMYCIN 50 is round, convex, orange film coated tablet with a scoreline on one side, and plain on the other (AUST R 47054).

The cosmetic scoreline serves no function. Do not break or split the tablet in half.

MINOMYCIN 50 is available in blister strips in packs of 4 or 60 tablets.

(Not all pack sizes are distributed in Australia.)

Who distributes MINOMYCIN 50

Aspen Pharma Pty Ltd
34-36 Chandos Street,
St Leonards NSW 2065
Australia
www.aspenpharmacare.com.au

This leaflet was prepared in December 2023.

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Minomycin 50

Active ingredient

Minocycline

Schedule

1 Name of Medicine

Minocycline hydrochloride dihydrate.

2 Qualitative and Quantitative Composition

Each Minomycin 50 tablet contains minocycline hydrochloride dihydrate equivalent to 50 mg of minocycline.

Excipients of known effect.

Lactose monohydrate and sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Minomycin 50: round, convex, orange film coated tablet, with a score line on one side, and plain on the other.
The cosmetic score line serves no function. Do not break or split the tablet in half.

4 Clinical Particulars

4.1 Therapeutic Indications

Minocycline may be used for the treatment of infections caused by any of the following organisms, provided that they have been shown by bacteriological testing to be susceptible to minocycline: Escherichia coli, Enterobacter aerogenes, Haemophilus influenzae, Klebsiella and Proteus.
It may also be used in the treatment of infections due to Streptococcus pyogenes (group A β-haemolytic) and Streptococcus faecalis, but because a large proportion of these organisms are resistant to tetracyclines, minocycline should be used only if the organisms have been shown to be definitely sensitive.
Tetracyclines, including minocycline, are not the drugs of choice in the treatment of staphylococcal infections. Minocycline may be considered for the treatment of such infections only if other suitable agents are not available and the organism has been shown to be sensitive to minocycline.
Minocycline may be used in the treatment of tetracycline resistant acne.

4.2 Dose and Method of Administration

The usual dosage of minocycline for adults is 200 mg initially, followed by 100 mg every 12 hours. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.
In tetracycline resistant acne, the dosage is 100 mg daily, given preferably as 50 mg twice daily. Most cases are likely to resolve within 3 months.

Renal impairment.

Patients with renal impairment: (see Section 4.4 Special Warnings and Precautions for Use).
Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.

Treatment of streptococcal infections.

If tetracycline is used for streptococcal infections, therapeutic doses should be administered for at least 10 days.

4.3 Contraindications

In persons who have shown hypersensitivity to any of the tetracyclines.
Severe renal insufficiency.
Systemic lupus erythematosus.
Rare cases of benign intracranial hypertension have been reported after tetracyclines and after vitamin A or retinoids such as isotretinoin or etretinate. Concomitant treatment of tetracyclines and vitamin A or retinoids is therefore contraindicated.

4.4 Special Warnings and Precautions for Use

As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted.
Use with caution in the following circumstances:

Use in renal impairment.

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. As with all tetracyclines, other than doxycycline, minocycline should be avoided in patients with renal failure.
The antianabolic action of the tetracyclines may cause an increase in BUN. This effect may be enhanced by diuretics.
In patients with significantly impaired function, higher serum levels of tetracyclines may lead to azotaemia, hyperphosphataemia and acidosis.

Discolouration of teeth.

The use of tetracyclines during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discolouration of the teeth (yellow/grey/brown). This adverse reaction is more common during long-term use of the drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracyclines also accumulate in the growing skeleton. Tetracycline drugs, therefore, should not be used in this age group unless other drugs are not likely to be effective or are contraindicated.

Hyperpigmentation.

Minocycline use has been associated with blue-black cutaneous hyperpigmentation. Most areas of the body may be affected, including the face. It has also been reported in nails, mucous membranes, hard palate and bone. The incidence varies but appears more likely to occur in patients with certain immunological conditions (rheumatoid arthritis, pemphigus and pemphigoid in particular), acne vulgaris and with prolonged use and/or higher doses. In many cases the cutaneous pigmentation is reversible or partially reversible on discontinuation of minocycline. Complete resolution may take several months or years.

Photosensitivity.

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs and treatment should be discontinued at the first evidence of skin erythema.
Patients should be advised to avoid direct sunlight or UV light exposure if possible. Some reports suggest that, as compared to other tetracyclines, minocycline may be less likely to produce photosensitivity.

Central nervous system (CNS) effects.

CNS side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.

Other CNS.

Pseudotumour cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines including minocycline. The usual clinical manifestations are headache and blurred vision. Bulging fontanelles have been associated with the use of tetracyclines in infants. While both of these conditions are related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists. Headache (not related to pseudotumour cerebri) has also been reported. Decreased hearing has been reported in patients on minocycline therapy.

Electrocolitis.

The use of tetracyclines can cause severe enterocolitis due to resistant Staphylococci.

Colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including minocycline. A toxin produced by 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 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.

Staphylococcal infection.

Tetracycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Streptococcal infection.

If a tetracycline is used for the treatment of infections due to group A β-haemolytic Streptococci (Strep. pyogenes) (see Section 4.1 Therapeutic Indications), treatment should continue for 10 days.

Anticoagulant therapy.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. In long-term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.

Syphilis.

In venereal diseases when coexistent syphilis is suspected, darkfield examination should be done before treatment is started and the blood serology repeated monthly for at least 4 months.

Hepatotoxicity.

Hepatotoxicity has been reported with minocycline, therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

Use in the elderly.

No data available.

Paediatric use.

(See Section 4.4 Special Warnings and Precautions for Use about use during tooth development).
All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticoagulants.

Since tetracyclines may depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Aluminum, calcium, magnesium, iron.

Antacids containing aluminium, calcium or magnesium and preparations containing iron impair absorption and should not be given to patients taking oral tetracycline.

Etretinate and isotretinoin.

Administration of etretinate and isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumour cerebri (see Section 4.4 Special Warnings and Precautions for Use).

Methoxyflurane.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Food and dairy products.

Absorption of minocycline does not appear to be notably influenced by food and dairy products.

Penicillin.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

Oral contraceptives.

Reduced efficacy and increased incidence of breakthrough bleeding has been suggested with concomitant use of tetracycline and oral contraceptive preparations. Consideration should therefore be given to using an additional mechanical form of contraception whilst on Minocycline therapy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Safe use in pregnancy has not been established. Tetracyclines are safe for use during the first 18 weeks of pregnancy after which they cause discolouration of the baby's teeth.
These products should be avoided during the second and third trimesters of pregnancy.
Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

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 adverse reactions profile of minocycline is generally similar to that of tetracyclines, except for a significantly higher incidence of vestibular adverse effects, e.g. dizziness, vertigo and ataxia.

Gastrointestinal.

Anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia, enterocolitis, pancreatitis and inflammatory lesions (with monilial overgrowth) in the anogenital region. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rarely, oesophagitis and oesophageal ulceration.

Hepatic.

Increases in liver enzymes, hepatitis and acute liver failure have been reported. Autoimmune hepatitis with lupus-like symptoms and acute hypersensitivity hepatitis associated with eosinophilia and exfoliative dermatitis have been reported rarely.

Skin.

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Lesions occurring on the glans penis have caused balanitis. Fixed drug eruptions, erythema multiforme and Stevens-Johnson syndrome have been reported. Pigmentation of the skin and mucous membranes, as well as nail discolouration, have been reported. Photosensitivity is discussed above.

Dental.

Discolouration of teeth (yellow/grey/brown) and/or enamel hypoplasia have been reported in infants and children to the age of 8 years. Tooth discolouration has been reported in adults.

Renal toxicity.

Rise in BUN has been reported and is apparently dose related. Tetracyclines may aggravate pre-existing renal failure. Nephrotoxicity has also occurred in association with "acute fatty liver" related to the use of tetracycline in high doses. Degraded tetracycline may result in renal tubular damage and a "Fanconi-like" syndrome. Reversible acute renal failure has been reported.

Hypersensitivity reactions.

Urticaria, angioneurotic oedema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, pulmonary infiltrates with eosinophilia and *exacerbation of systemic lupus erythematosus have been reported. A reversible lupus-like syndrome has been reported.

Blood.

Agranulocytosis, haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have been reported.

CNS.

Convulsions, hypaesthesia, dizziness, paraesthesia, sedation, and vertigo. Bulging fontanelles in infants and benign intracranial hypertension (the usual clinical manifestations are headache and blurred vision) in adults have been reported. Decreased hearing and headache (not related to benign intracranial hypertension) have also been reported (see Section 4.4 Special Warnings and Precautions for Use).

Other.

When given over prolonged periods, tetracyclines have been reported to produce brown/black microscopic discolouration of thyroid glands. No abnormalities of thyroid function studies are known to occur, but the potential for such an effect cannot be excluded.

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

Maximum dosage should not exceed 400 mg/day.

Symptoms and signs of acute overdosage.

May include nausea, vomiting, abdominal pain, hypotension, lethargy, coma, acidosis and azotaemia without a concomitant rise in creatinine.

Treatment of acute overdose.

No specific antidote. General supportive care includes maintenance of clear airway, adequate respiration, circulation and renal function.
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.

Microbiology.

Minocycline, like other tetracyclines, is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis.
Minocycline, like other tetracyclines, is also active against a wide range of Gram negative and Gram positive organisms. It is active against a proportion of Staphylococcus aureus organisms that are resistant to other tetracyclines. Except for this difference, it shares the antimicrobial spectra and cross resistance common to other tetracyclines.
Because many strains of the Gram negative and Gram positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended. Resistance levels in an individual may also be influenced by previous antibiotic exposure.

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.

Following oral administration of a single 200 mg dose of minocycline, mean peak serum levels of approximately 2.5 microgram/mL were achieved in 2-4 hours. With oral doses of 100 mg twice daily, steady state levels were achieved in approximately 5 days; mean peak levels were higher in women (3.4 microgram/mL) than in men (2.45 microgram/mL). The plasma half-life of minocycline is approximately 13 hours.
When minocycline was given concomitantly with a meal which included dairy products, the extent of absorption of minocycline was not noticeably influenced. The peak plasma concentrations were slightly decreased and delayed by one hour when administered with food, compared to dosing under fasting conditions.
In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and faecal recovery of minocycline when administered to 12 normal volunteers is one-half to one-third that of other tetracyclines.

Distribution.

Minocycline is widely distributed in body tissues. Less than 10% of the administered dose is excreted in the urine.

Excretion.

Minocycline is excreted in the bile and undergoes enterohepatic circulation. Approximately 35% of an administered dose is excreted in the faeces. An unknown proportion is metabolised in the body. Approximately 75% of the minocycline in plasma is protein bound.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Minomycin 50 tablets contains lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry Orange YS-1R-2402 (PI 3306), povidone, sodium starch glycollate, sorbitol, stearic acid.

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. Protect from light.

6.5 Nature and Contents of Container

Minomycin 50 tablets are available in blister packs of 4 or 60 tablets.
Not all pack sizes are distributed in Australia.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Minocycline hydrochloride dihydrate is a semisynthetic derivative of the broad-spectrum antibiotic, tetracycline. It is a yellow crystalline powder that is soluble in water. Minocycline hydrochloride dihydrate has the following structure:

Chemical structure.

CAS number.

13614-98-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

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