Consumer medicine information

Akamin

Minocycline

BRAND INFORMATION

Brand name

Akamin

Active ingredient

Minocycline

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Akamin.

SUMMARY CMI

AKAMIN®

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 taking AKAMIN?

AKAMIN contains the active ingredient minocycline (as hydrochloride dihydrate). AKAMIN is used to treat certain infections caused by bacteria and to control acne which is resistant to other antibiotics. For more information, see Section 1. Why am I using AKAMIN? in the full CMI.

2. What should I know before I take AKAMIN?

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 take AKAMIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AKAMIN 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 take AKAMIN?

  • 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 50mg twice a day.

More instructions can be found in Section 4. How do I take AKAMIN? in the full CMI.

5. What should I know while taking AKAMIN?

Things you should do
  • Remind any doctor, dentist or pharmacist that you visit that you are using AKAMIN.
  • If you become pregnant while you are taking AKAMIN, 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 AKAMIN.
  • If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking AKAMIN.
  • Tell your doctor, if you get thrush or any other infection while taking, or soon after stopping AKAMIN.
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 AKAMIN to treat any other medical complaints unless your doctor tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how AKAMIN affects you.
  • AKAMIN 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.
  • Heat and dampness can destroy some medicines.

For more information, see Section 5. What should I know while taking AKAMIN? 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

AKAMIN®

Active ingredient(s): [minocycline (as hydrochloride dihydrate)]

Consumer Medicine Information (CMI)

This leaflet provides important information about using AKAMIN. 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 AKAMIN.

Where to find information in this leaflet:

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

1. Why am I taking AKAMIN?

AKAMIN contains the active ingredient minocycline (as hydrochloride dihydrate). AKAMIN is an antibiotic that belongs to a group of medicines called tetracyclines. They work by stopping the growth of bacteria which cause infections or make acne worse.

AKAMIN is used to treat certain infections caused by bacteria, and to control acne, which is resistant to other antibiotics.

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

Ask your doctor if you have any questions about why AKAMIN has been prescribed for you.

Your doctor may have prescribed AKAMIN for another reason.

There is no evidence that AKAMIN is addictive.

2. What should I know before I take AKAMIN?

Warnings

Do not use AKAMIN if:

  • you are allergic to medicines containing minocycline (e.g. Minomycin), any other tetracycline antibiotics (e.g. Doryx, Doxylin, Vibramycin, Vibra-Tabs) or 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, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing.
  • you are taking preparations containing:
    - vitamin A
    - retinoids, which are medications used to treat:
    -- skin problems such as isotretinoin (e.g., Roaccutane, Oratane) and acitretin (Neotigason)
    -- a certain type of leukaemia such as tretinoin (Vesanoid)
    Taking AKAMIN with any of these preparations may lead to serious unwanted side effects.
    Ask your doctor or pharmacist if you are not sure if you are taking one of these medicines.
  • you are pregnant or breastfeeding.
  • you have systemic lupus erythematosus (Lupus).
  • you have severe kidney disease.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Use in Children

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

Tetracycline medicines, including AKAMIN, may cause permanent staining and enamel loss in developing teeth, and reduced bone growth.

Check with your doctor if you:

  • have allergies to any other medicines, foods, dyes or preservatives.
  • have any other health problems, including kidney or liver problems.
  • plan to have surgery, including dental surgery, especially if it requires a general anaesthetic.

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 take AKAMIN if you are pregnant, breastfeeding or if you intend to become pregnant or breastfeed.

AKAMIN is not recommended in the second and third terms of pregnancy as it may harm your developing baby. This may include enamel loss and staining of your baby's teeth.

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

AKAMIN passes into breast milk and may cause enamel loss and staining of your baby's teeth.

Your doctor will discuss the risks and benefits of using AKAMIN 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 and AKAMIN may interfere with each other and affect how it works. These include:

  • preparations containing vitamin A including vitamin supplements
  • retinoids used for skin problems, such as isotretinoin (Roaccutane, Oratane), acitretin (Neotigason) or for leukaemia such as tretinoin (Vesanoid)
  • medicines used to prevent blood clots, such as warfarin (Coumadin, Marevan)
  • penicillins, another group of antibiotics (e.g. Amoxil)
  • diuretics, also called fluid or water tablets (e.g. Lasix, Moduretic, Aldactone)
  • methoxyflurane (Penthrax), an inhalation general anaesthetic
    Tell the doctor or dentist that you are taking AKAMIN if you expect to have surgery or dental work with a general anaesthetic.
  • the contraceptive pill (birth control pill).
    Talk to your doctor about the additional need for a barrier method of contraception (e.g. condom or diaphragm) while taking AKAMIN. AKAMIN may decrease the effectiveness of some birth control pills.

You may need to take different amounts of your medicine, or you may need to take different medicines.

Medicines which interfere with the absorption of AKAMIN include:

  • antacids (containing aluminium, calcium or magnesium) used for indigestion
  • preparations containing iron including vitamin supplements.

You can still take these medicines while you are taking AKAMIN. However, you must take AKAMIN at least 2 hours before or 2 hours after taking any of these medicines to make sure there is no problem with absorption.

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

4. How do I take AKAMIN?

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

  • For treating infections, the usual dose for adults is 200 mg initially, followed by 100 mg every 12 hours.
  • For controlling acne, the usual dose is 50 mg twice a day.

However, depending on your condition and your response to this medicine, your doctor may ask you to take a different dose.

People with kidney problems may require smaller doses.

When to take AKAMIN

Take AKAMIN during or immediately after a meal.

This will reduce the chances of stomach upset.

Take AKAMIN 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 to take AKAMIN

Swallow the tablets whole with a full glass of water or milk while sitting or standing upright.

Stay upright for at least 30 minutes. Do not lie down immediately after taking AKAMIN.

This is to help avoid irritation to your oesophagus (food pipe), which you may feel as heartburn or indigestion.

How long to take AKAMIN for

Keep taking AKAMIN until you finish the tablets or for as long as your doctor recommends. Your doctor may prescribe AKAMIN for long periods.

For treating infections, your doctor will tell you when to stop taking AKAMIN, as the length of treatment varies depending on the condition you have. This is usually 24 to 48 hours after the fever and signs of infection have gone.

Do not stop taking AKAMIN, 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.

For controlling acne, AKAMIN is normally taken for a few months.

If you forget to use AKAMIN

AKAMIN 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 you miss your dose at the usual time, and 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 your tablets as you would normally.

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 take too much AKAMIN

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

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, 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 AKAMIN you may experience the following symptoms: nausea, vomiting, stomach pain, fall in blood pressure, tiredness.

5. What should I know while taking AKAMIN?

Things you should do

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

Call your doctor straight away if you:

  • develop a persistent headache with one or more of the following symptoms - nausea, vomiting, blurred vision or dizziness.
    These may be signs of a rare condition associated with the use of minocycline called benign intracranial hypertension (increased pressure within the skull).
  • are taking AKAMIN for an infection and your symptoms do not improve within a few days, or if they become worse.
  • become pregnant while you are taking AKAMIN.
  • develop symptoms of thrush (a sore, white mouth or tongue, vaginal itching or discharge) while taking or soon after stopping AKAMIN.
    Sometimes the use of AKAMIN allows fungi to grow and the above symptoms to occur. AKAMIN does not work against fungi.
  • If you get severe diarrhoea. Do this even if it occurs several weeks after you have stopped taking AKAMIN.
    Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medicines for the diarrhoea without checking with your doctor.

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

If you are taking AKAMIN for a long time, visit your doctor regularly so that they can check on your progress.

Your doctor may want you to have some blood tests from time to time.

Things you should not do

  • Do not stop taking AKAMIN or change the dose, without checking with 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. Your infection may not clear completely or may return.
  • Do not use AKAMIN to treat any other conditions unless your doctor tells you to.
  • Do not let yourself run out of AKAMIN over the weekend or on holidays.
  • Do not give AKAMIN to anyone else, even if they have the same condition as you.

Things to be careful of

Protect your skin when you are in the sun, especially between 10 am and 3 pm. If outdoors, wear protective clothing and use a SPF 30+ sunscreen.

AKAMIN may cause your skin to be much more sensitive to sunlight than it is normally. This may cause a skin rash, itching, redness or severe sunburn.

If your skin does appear to be burning, stop taking AKAMIN and tell your doctor.

Driving or using machines

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

AKAMIN may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

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. Keep your tablets in the original container until it is time to take them.

If you take the tablets out of the bottle they may not keep well.

Store AKAMIN in a cool dry place that stays below 25°C. Protect 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.

Heat and dampness can destroy some medicines.

Keep your medicine 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 effectsWhat 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 effectsWhat 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
  • sudden signs of allergy such as 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.

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

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 AKAMIN 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.

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

After finishing AKAMIN

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

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

These may be signs of a serious condition affecting your bowel.

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 AKAMIN 50 tablets contain

Active ingredient
(main ingredient)		minocycline 50 mg (as hydrochloride dihydrate)
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • sodium starch glycollate
  • povidone
  • microcrystalline cellulose
  • sodium lauryl sulfate
  • magnesium stearate
  • Opadry Orange OY-23022
Potential allergenscontains sulfites and sugars as lactose.

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

What AKAMIN looks like

AKAMIN 50 are a gold coloured, convex, film coated tablet, 6mm in diameter, debossed with "MC" on one side and the Greek alpha symbol on the other (AUST R 70852).

Who distributes AKAMIN

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

This leaflet was prepared in May 2024.

AKAMIN® is a Viatris company trade mark.

AKAMIN_cmi\May24/01

Published by MIMS June 2024

BRAND INFORMATION

Brand name

Akamin

Active ingredient

Minocycline

Schedule

S4

 

1 Name of Medicine

Minocycline hydrochloride dihydrate.

2 Qualitative and Quantitative Composition

Each Akamin 50 tablet contains minocycline hydrochloride dihydrate equivalent to 50 mg of minocycline as the active ingredient.

Excipients with known effect.

Sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Akamin 50 tablets.

Gold coloured, convex, film coated tablet 6 mm in diameter, debossed with "MC" on one side and the greek alpha symbol on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Infections due to 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. In addition, infections due to Streptococcus pyogenes (group A β-haemolytic) and Streptococcus faecalis, however, because a large proportion of these organisms are resistant to tetracyclines, minocycline should be used only if the organisms have definitely been shown to be 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 twelve 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.

Impaired renal function.

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.

Streptococcal infections.

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

4.3 Contraindications

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 (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

4.4 Special Warnings and Precautions for Use

As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted.

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 unlikely 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 prone to exposure 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 ultraviolet light exposure if possible. Some reports suggest that, compared with other tetracyclines, minocycline may be less likely to produce photosensitivity.

Enterocolitis.

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 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.

Central nervous system effects.

Central nervous system 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 and 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.

Anticoagulant therapy.

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage, because tetracyclines have been shown to depress plasma prothrombin activity. 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.

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 (S. pyogenes) (see Section 4.1 Therapeutic Indications), treatment should continue for 10 days.

Use in hepatic impairment.

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 renal impairment.

If renal impairment exists, even usual doses may lead to excessive systemic accumulation of the drug and possible hepatic toxicity. As with all tetracyclines, (except doxycycline), minocycline should be avoided in patients with renal failure.
The antianabolic action of tetracyclines may cause an increase in serum urea. This effect may be enhanced by diuretics.
In patients with significantly impaired renal function, higher serum levels of tetracyclines may lead to azotaemia, hyperphosphatemia and acidosis.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use; Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy 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 premature infants given oral tetracycline in doses of 25 mg/kg every six 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.

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage, as tetracyclines have been shown to depress plasma prothrombin activity.

Aluminium, 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.

Food and dairy products do not appear to significantly influence the absorption of minocycline.

Penicillin.

It is advisable to avoid giving tetracyclines concomitantly with penicillin, as bacteriostatic drugs may interfere with the bactericidal action of 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 the patient using an additional mechanical form of contraception whilst on Akamin 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.
Australian categorisation definition of Category D. Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
 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 (see Section 4.4 Special Warnings and Precautions for Use).

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. Oesophagitis and oesophageal ulceration have been reported rarely.

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 dermatitis have been reported rarely.

Dermatological.

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity (see Section 4.4 Special Warnings and Precautions for Use). 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 (see Section 4.4 Special Warnings and Precautions for Use).

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 also been reported in adults.

Renal.

Rise in serum urea has been reported, and is apparently dose related (see Section 4.4 Special Warnings and Precautions for Use). 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.

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

Haematological.

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

Central nervous system.

Convulsions, hypesthesia, dizziness, paresthesia, 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.

Minocycline hydrochloride dihydrate is a semisynthetic derivative of the broad spectrum antibiotic tetracycline.
Microbiology. Like other tetracyclines, minocycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by protein synthesis inhibition.
Minocycline is active against a wide range of Gram-negative and Gram-positive organisms. It is active against a proportion of Staphylococcus aureus organisms which 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.
Microbiology, susceptibility tests.

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 minocycline 200 mg dose, mean peak plasma levels of approximately 4 microgram/mL were achieved in one to four hours.
With oral doses of 100 mg twice daily, it has been reported that steady state levels were achieved in approximately five days; mean peak serum levels were higher in women (3.4 microgram/mL) than in men (2.45 microgram/mL).

Distribution.

Minocycline is widely distributed in body tissues. Approximately 75% of the minocycline in plasma is protein bound.

Metabolism.

A number of metabolites of minocycline have been isolated from urine. Therefore, metabolism appears to be a significant mechanism of clearance of minocycline in contrast to other tetracycline derivatives.
The plasma half-life of minocycline is approximately 13 hours.

Excretion.

Less than 10% of the administered dose is excreted in the urine. Minocycline is excreted in the bile and undergoes enterohepatic circulation. Approximately 35% of an administered dose is excreted in the faeces.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, sodium starch glycollate, povidone, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate and Opadry Orange OY-23022 (ARTG PI No. 2215).

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 bottle, PP screw cap.

Australian register of therapeutic goods (ARTG).

AUST R 70852 - Akamin 50 minocycline (as hydrochloride) 50 mg tablet 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

Minocycline hydrochloride dihydrate is a yellow crystalline powder which is sparingly soluble in water, slightly soluble in alcohol. It dissolves in solutions of alkali hydroxides and carbonates.

Chemical structure.

Chemical name: (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.
Structural formula:
Molecular formula: C23H27N3O7.HCl.
Molecular weight: 493.95.

CAS number.

13614-98-7.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes