Consumer medicine information

Minomycin

Minocycline

BRAND INFORMATION

Brand name

Minomycin 50

Active ingredient

Minocycline

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minomycin.

What is in this leaflet

This leaflet answers some common questions about MINOMYCIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MINOMYCIN against the benefits this medicine is expected to have for you.

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

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

What MINOMYCIN is used for

The name of your medicine is MINOMYCIN. It contains the active ingredient minocycline hydrochloride.

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

MINOMYCIN belongs to a group of antibiotics called tetracyclines. They work by stopping the growth of bacteria.

Your doctor may have prescribed MINOMYCIN for another purpose.

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

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

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

MINOMYCIN is not addictive.

Before you take it

When you must not take it

Do not take MINOMYCIN if:

  1. you have ever had an allergic reaction to:
  • minocycline, or any other tetracycline antibiotics
  • any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction to a tetracycline 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 or difficulty breathing.
  1. you are pregnant or breastfeeding.
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.
If you are a woman of child bearing age, you should avoid becoming pregnant while taking MINOMYCIN.
Your doctor will discuss the risks and benefits of using MINOMYCIN if you are pregnant or breastfeeding.
  1. you have a disease called systemic lupus erythematosus (Lupus).
  2. you have severe kidney disease.
If you are not sure whether you should be taking MINOMYCIN, talk to your doctor.
  1. Do not give MINOMYCIN to children of eight years and under unless directed by the child's doctor.
MINOMYCIN, like other tetracyclines, may cause enamel loss and permanent staining of teeth.
  1. the expiry date (EXP) printed on the pack has passed.
It may have no effect at all, or worse, an entirely unexpected effect, if you take it after the expiry date.
  1. the packaging is torn or shows signs of tampering.
If this is the case, take the tablets back to your pharmacist.

Before you start to take it

You must tell your doctor if:

  1. you are allergic to any foods, dyes, preservatives or any other medicines
  2. you have any other health problems, including kidney disease
  3. you plan to become pregnant.

Taking other medicines

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

There may be interference between MINOMYCIN and some other medicines, including:

  • 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
  • the contraceptive pill (birth control pills). MINOMYCIN 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 if you expect to have surgery or dental work with a general anaesthetic.

These medicines may be affected by MINOMYCIN 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.

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

How to take it

Take MINOMYCIN exactly as your doctor has prescribed.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

For treating infections, the usual dose of MINOMYCIN 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 it

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.

When to take it

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 it

Your doctor may prescribe MINOMYCIN for long periods.

Check with your doctor if you are not sure how long you should be taking it.

For treating infections, MINOMYCIN must be taken for at least 48 hours after you feel well and the fever has gone.

For controlling acne, MINOMYCIN 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 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. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.

Do not try to make up for missed doses by taking more than one dose at a time.

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

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

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency (Casualty) at your nearest hospital if you think you or anyone else may have taken too much MINOMYCIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

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

While you are taking it

Things you must do

Tell all doctors, dentists and pharmacists you visit that you are taking MINOMYCIN.

If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking MINOMYCIN.

If you become pregnant while taking MINOMYCIN, tell your doctor immediately.

If you develop a persistent headache with one or more of the other symptoms you should see your doctor as soon as possible. Minocycline is rarely associated with a serious condition called benign intracranial hypertension which can cause headache, nausea, vomiting, blurred vision, dizziness.

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.

Things you must not do

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

Do not use MINOMYCIN to treat any other medical complaints unless your doctor says to.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how MINOMYCIN affects you. This medicine may cause dizziness or light-headedness in some people.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, dizziness or light-headedness may be worse.

MINOMYCIN 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 outdoors, wear protective clothing and use a SPF 15+ sunscreen.

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

If you get thrush or any other infection while taking, or soon after stopping MINOMYCIN, tell your doctor. Overgrowth of certain organisms not sensitive to MINOMYCIN can sometimes occur.

If you get severe diarrhoea, immediately contact your doctor. Do this even if it occurs several weeks after stopping MINOMYCIN. 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MINOMYCIN. This medicine is effective against some infections and acne in most people, but may have unwanted side effects in some. 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.

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

The more common side effects are:

  • nausea
  • vomiting
  • diarrhoea
  • dizziness, light-headedness, unsteadiness
  • loss of appetite
  • headaches
  • rash or hives
  • allergic reactions such as swelling of face or tongue
  • difficulty in swallowing
  • burning in the throat or food tube

Rare side effects include:

  • increased sensitivity to sunlight
  • infection by other bacteria or organisms resistant to MINOMYCIN (eg intestinal thrush)
  • staining of skin, mouth, teeth or nails

Very rarely:

  • painful joints
  • inflammation of the bowel
  • blurred vision
  • liver, kidney or blood disorders
  • severe allergic reactions
  • drug-induced hepatitis and acute liver failure

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 else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you do not understand anything in this list.

After using it

Storage

Keep this medicine where young 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 MINOMYCIN in a cool, dry place where it stays below 25°C. Do not store it, or any other medicine, in a bathroom or near a sink.

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

Keep your tablets in their container until it is time to take them. If you take the tablets out of their container they may not keep well.

Disposal

If your doctor tells you to stop taking MINOMYCIN, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

MINOMYCIN - 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.

The 50 mg tablets are in blister strips in packs of 4 or 60 tablets. Not all pack sizes are distributed in Australia.

Ingredients

Each MINOMYCIN 50 mg tablet contains minocycline (as hydrochloride) as the active ingredient and the following inactive ingredients:

  • Lactose monohydrate
  • Sodium starch glycollate
  • Povidone
  • Sorbitol
  • microcrystalline cellulose
  • Stearic Acid
  • Magnesium Stearate
  • Opadry Orange YS-1R-2402

Manufacturer

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian Registration Number:

MINOMYCIN 50 mg tablets: AUST R 47054

This leaflet was revised in October 2023.

Published by MIMS December 2023

BRAND INFORMATION

Brand name

Minomycin 50

Active ingredient

Minocycline

Schedule

S4

 

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.

Summary Table of Changes