Consumer medicine information

Doxycycline Sandoz

Doxycycline

BRAND INFORMATION

Brand name

Doxycycline Sandoz

Active ingredient

Doxycycline

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Doxycycline Sandoz.

SUMMARY CMI

DOXYCYCLINE SANDOZ®

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 Doxycycline Sandoz?

Doxycycline Sandoz contains the active ingredient doxycycline (as monohydrate). Doxycycline Sandoz is an antibiotic used to treat certain types of infections, control acne, prevent some forms of malaria, and treat anthrax infection or for use after exposure to anthrax.

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

2. What should I know before I use Doxycycline Sandoz?

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

Talk to your doctor if you have allergies to any medicines, have any other medical conditions, take any other medicines, work outdoors or are likely to be exposed to strong sunlight or ultra-violet light, are scheduled to have surgery under general anaesthetic, or are pregnant or plan to become pregnant or are breastfeeding.

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

3. What if I am taking other medicines?

Some medicines may interfere with Doxycycline Sandoz 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 Doxycycline Sandoz?

  • Your doctor or pharmacist will tell you how many tablets you will need to take each day.
  • Swallow the tablets whole with a full glass of water or milk while sitting or standing upright

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

5. What should I know while using Doxycycline Sandoz?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking Doxycycline Sandoz.
  • Tell your doctor if your symptoms do not improve or worsen, you get severe diarrhoea, you become pregnant while taking this medicine, or you are about to have any blood tests.
  • If you are taking iron preparations you must take them at least two hours before or two hours after Doxycycline Sandoz.
Things you should not do
  • Do not stop taking your medicine because you are feeling better unless advised by your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not use Doxycycline Sandoz to treat any other 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 Doxycycline Sandoz affects you.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
Looking after your medicine
  • Keep your medicine in the original container.
  • Keep your medicine in a cool dry place where the temperature stays below 25°C.

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

6. Are there any side effects?

Less serious side effects include: oral/vaginal thrush, rash/itching, nail changes, stomach upset/vomiting, mild irritation of the oesophagus, taste loss, ringing in ears. Serious side effects include: depression, feeling anxious/nervous, muscle tenderness/ weakness, painful swollen joints, increased pressure in brain, severe blisters and bleeding in lips, eyes, mouth, nose and genitals, severe skin reactions, difficulty in/pain with swallowing, dizziness, fast heart rate, frequent bruising, passing less urine, yellowing of eyes/skin, severe upper stomach pain often with nausea and vomiting.

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

DOXYCYCLINE SANDOZ®

Active ingredient(s): doxycycline monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Doxycycline Sandoz. 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 Doxycycline Sandoz.

Where to find information in this leaflet:

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

1. Why am I using Doxycycline Sandoz?

Doxycycline Sandoz contains the active ingredient doxycycline (as monohydrate). Doxycycline Sandoz belongs to a group of medicines called tetracyclines.

Doxycycline Sandoz is an antibiotic used to:

  • treat certain types of infections
  • control acne
  • prevent some forms of malaria, sometimes in combination with another antimalarial medicine
  • treat anthrax infection or for use after exposure to anthrax.

It works by killing or stopping the growth of bacteria which cause infections or make acne worse. It also works against parasites that cause malaria.

Tetracyclines will not work against viral infections such as colds or flu.

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

Your doctor may have prescribed it for another reason. This medicine is not addictive.

It is available only with a doctor's prescription

2. What should I know before I use Doxycycline Sandoz?

Warnings

Do not use Doxycycline Sandoz if:

  • you are allergic to doxycycline, other tetracyclines, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine.
  • you are taking preparations containing vitamin A, isotretinoin or etretinate. Ask your doctor or pharmacist if you are not sure if you are taking one of these medicines.
  • if you are more than 18 weeks pregnant or are breast-feeding.

Do not give this medicine to children aged eight years or under (or to children under 50 kg) unless directed by the child's doctor. Doxycycline, like other tetracyclines, may cause enamel loss and staining in developing teeth. It may also cause increased pressure on the brain if used in infants.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be taking Doxycycline Sandoz, talk to your doctor.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes.
  • have any other medical conditions.
  • take any medicines for any other condition.
  • work outdoors or if you are likely to be exposed to strong sunlight or ultra-violet light. Doxycycline may cause your skin to become more sensitive to UV or sunlight, resulting in severe sunburn.
  • are scheduled to have surgery under 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

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

As with many medicines, tetracyclines may harm your developing or breast-feeding baby. Tetracyclines may cause enamel loss and staining of your child's teeth or increase the pressure on your child's brain. High doses of tetracyclines may also cause liver problems in pregnant women.

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 Doxycycline Sandoz may interfere with each other and affect how they work.

These include:

  • preparations containing Vitamin A
  • some medicines used for skin problems, such as isotretinoin or etretinate
  • warfarin, a medicine used to prevent blood clotting
  • another group of antibiotics called penicillins
  • some medicines used in the treatment of epilepsy such as phenytoin, carbamazepine or phenobarbitone
  • methoxyflurane, an anaesthetic
  • acetazolamide, a medicine used to help the body get rid of salt and water
  • the contraceptive pill (birth control pill). Doxycycline may decrease the effectiveness of some birth control pills. Your doctor may advise you to use an additional method of contraception while taking Doxycycline Sandoz and for 7 days after taking Doxycycline Sandoz. Refer to your doctor or pharmacist for advice.

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

If you are taking the following medicines, take them at least two hours before or two hours after taking Doxycycline Sandoz:

  • antacids (containing aluminium, calcium or magnesium) used for indigestion
  • bismuth salts, found in some medicines used to treat stomach ulcers
  • preparations that contain iron including vitamin preparations.

These medicines may interfere with the absorption of Doxycycline Sandoz.

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

4. How do I use Doxycycline Sandoz?

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 pack, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how many tablets you will need to take each day.

  • For treating infections, the usual dose of doxycycline is two 100 mg tablets on the first day, followed by one 100 mg tablet each day from then on.
  • For controlling acne, the usual dose is one 50 mg tablet each day.
  • For the prevention of malaria, the usual dose is one 100 mg tablet each day, commencing two days before entering the malarious area, during the visit, and for four weeks after leaving the area.
  • For the treatment of anthrax infection or after exposure, the usual dose is one 100 mg tablet every 12 hours in adults and 2.2 mg/kg every 12 hours for children (8 years or younger and children weighing 45 kg and less).

Your doctor may ask you to take a different dose, depending on your condition and how you react to the medicine.

Follow the instructions provided when Doxycycline Sandoz was prescribed, including the number of days it should be taken.

Keep taking this medicine for the full time of treatment even if you begin to feel better after a few days.

If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

For treating infections, Doxycycline Sandoz is usually taken for one to two weeks.

For controlling acne, Doxycycline Sandoz is normally taken over a period of 12 weeks.

For preventing malaria, Doxycycline Sandoz is recommended to be taken for up to a maximum of 8 weeks. However, your doctor may prescribe Doxycycline Sandoz for longer periods.

For treating or after exposure to anthrax, Doxycycline Sandoz is usually taken for at least 60 days

If you are not sure how long you should be taking this medicine, talk to your doctor.

How to take Doxycycline Sandoz

If you need to break Doxycycline Sandoz 100 mg tablets, hold tablet with both hands and snap along break line.

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

Do not lie down immediately after swallowing your tablet(s).

It is important to stay upright, for example sitting, standing or walking around for at least half an hour after swallowing your tablet. This is to help avoid irritation to your food pipe (oesophagus).

When to take Doxycycline Sandoz

  • Take your medicine at about the same time each day (usually in the morning). Taking it at the same time each day will have the best effect. It will also help you to remember when to take it.
  • Take your medicine during or immediately after a meal. If taken on an empty stomach, it may cause stomach upset.

If you forget to use Doxycycline Sandoz

Doxycycline Sandoz should be used regularly at the same time each day.

If you miss a dose 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 it as soon as you remember, and then go back to taking your medicine as you would normally.

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

If you 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 Doxycycline Sandoz

If you think that you have used too much Doxycycline Sandoz, 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.

Symptoms of an overdose may include an upset stomach or vomiting.

5. What should I know while using Doxycycline Sandoz?

Things you should do

Call your doctor straight away if you:

  • are taking Doxycycline Sandoz for an infection and your symptoms do not improve within a few days or they become worse
  • get severe diarrhoea. Do this even if it occurs several weeks after Doxycycline Sandoz has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take diarrhoea medicine without first checking with your doctor.

Remind any doctor, dentist or pharmacist you visit that you are taking Doxycycline Sandoz.

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

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

If you are taking iron preparations, including vitamin preparations containing iron, bismuth salts or antacids (containing aluminium, calcium or magnesium), you must take them at least two hours before or two hours after Doxycycline Sandoz to make sure there is no problem with absorption.

Things you should not do

  • Do not stop taking your medicine because you are feeling better unless advised by your doctor. If you do not complete the full course, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not use Doxycycline Sandoz to treat any other complaints unless your doctor tells you to.

Things to be careful of

  • Protect your skin when you are in the sun, especially between 10am and 3pm. If outdoors, wear protective clothing and use a 30+ sunscreen. Doxycycline 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 a severe sunburn. If your skin does appear to be burning, see your doctor as soon as possible. You may need alternative treatment.
  • If you get thrush (a fungal infection which can affect the mouth and/or vagina) or any other infection while taking, or soon after stopping Doxycycline Sandoz, tell your doctor. Sometimes the use of this medicine allows fungi to grow as they are not killed by doxycycline.

Driving or using machines

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep your medicine in the original container. If you take it out of its original container it may not keep well.
  • Keep your medicine in a cool dry place where the temperature stays below 25°C.
  • Keep your medicine where it is protected from light.

Store it in a cool dry place 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 effectsWhat to do
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina with or without discharge
  • rash or itching
  • nail changes
  • stomach upset or vomiting
  • mild irritation of the oesophagus (food-pipe)
  • taste loss
  • ringing or other persistent noise in the ears
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
  • depression
  • feeling anxious or nervous
  • muscle tenderness or weakness, not caused by exercise
  • painful swollen joints
  • increased pressure in the brain (headache, blurred vision, vomiting)
  • severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
  • severe skin reactions starting as painful red areas then large blisters and ends with peeling layers of skin
  • difficulty in/pain with swallowing
  • flaking of the skin
  • dizziness
  • fast heart rate
  • frequent bruising
  • passing less urine
  • yellowing of the eyes or skin (jaundice)
  • severe upper stomach pain often with nausea and vomiting (pancreatitis)
  • symptoms of an allergic reaction such as shortness of breath, wheezing or troubled breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin
  • a rare, potentially life-threatening, drug-induced sensitivity reaction that includes skin rashes, blood changes, fever and dysfunction of internal organs (e.g. liver, kidney, lung) • a reaction that can happen after starting doxycycline therapy for a particular bacterial infection (spirochete infections, e.g. Lyme disease); symptoms include fever, chills, muscle pain and worsening of skin rash.
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.

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

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Doxycycline Sandoz:

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

These are rare but serious side effects. You may have a serious condition affecting your bowel. Doxycycline Sandoz may cause the bacteria which are normally harmless and present in the bowel to multiply, resulting in the above symptoms. Therefore you may need urgent medical attention.

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

Ask your doctor or pharmacist to answer any questions you may have about the side effects.

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 Doxycycline Sandoz contains

Active ingredient
(main ingredient)		doxycycline (as monohydrate)
Other ingredients (inactive ingredients)
  • microcrystalline cellulose
  • sodium starch glycollate type A
  • hydrogenated castor oil
  • povidone
  • colloidal anhydrous silica
  • magnesium stearate.
Potential allergensThis medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

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

What Doxycycline Sandoz looks like

Doxycycline Sandoz comes in two types of tablets:

Doxycycline Sandoz 50 mg - dull yellow, round, biconvex tablet. Available in blisters of 25 tablets (Aust R 69049).

Doxycycline Sandoz 100 mg - dull yellow, round, biplane tablet with a single sided score notch. Available in blisters of 7 tablets (Aust R 66302).

Who distributes Doxycycline Sandoz

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369

This leaflet was prepared in March 2025.

® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.

Published by MIMS May 2025

BRAND INFORMATION

Brand name

Doxycycline Sandoz

Active ingredient

Doxycycline

Schedule

S4

 

1 Name of Medicine

Doxycycline monohydrate.

2 Qualitative and Quantitative Composition

Each Doxycycline Sandoz 50 mg tablets contains 50 mg doxycycline (as monohydrate).
Each Doxycycline Sandoz 100 mg tablets contains 100 mg doxycycline (as monohydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Doxycycline Sandoz 50 mg tablets - dull yellow, round, biconvex tablets.
Doxycycline Sandoz 100 mg tablets - dull yellow, round, biplane tablets with a single-sided score notch.

4 Clinical Particulars

4.1 Therapeutic Indications

Infections caused by the following micro-organisms: Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis).
(Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline, or in combination with topical agents.)
Borreliae (relapsing fever); Calymmatobacterium (Donovania) granulomatis (granuloma inguinale).
Doxycycline Sandoz is indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (see Section 4.2 Dose and Method of Administration).
Infections caused by the following Gram negative micro-organisms: Vibrio sp. (cholera); Brucella sp. (brucellosis; in conjunction with streptomycin); Yersinia pestis (plague); Francisella tularensis (tularaemia); Bartonella bacilliformis (bartonellosis); Bacteroides sp.
When penicillin is contraindicated, doxycycline is an alternative medicine in the treatment of infections due to: Treponema pallidum (syphilis); Treponema pertenue (yaws); Neisseria gonorrhoea (see Section 4.2 Dose and Method of Administration).

Note.

Doxycycline Sandoz is not the medicine of choice in the treatment of any type of staphylococcal infection or infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. Doxycycline Sandoz should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual medicine of choice.
In acute intestinal amoebiasis Doxycycline Sandoz may be a useful adjunct to amoebicides.
In severe acne, doxycycline may be a useful adjunctive therapy.
Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by Plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by Plasmodium vivax. Doxycycline is only able to suppress malaria caused by Plasmodium vivax. As there are relatively few locations where P. vivax does not coexist to some extent with P. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine.

4.2 Dose and Method of Administration

Dosage.

The usual dosage and frequency of administration of doxycycline differs from that of other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects. Therapy should be continued at least 24 to 48 hours after symptoms and fever have subsided.
Tetracyclines are not the medicines of choice for the treatment of streptococcal infections (see Section 4.1 Therapeutic Indications). However, when used, therapy should be continued for ten days.
Adults, children over 8 years (and > 50 kg). The usual dose of doxycycline is 200 mg on the first day of treatment (administered as 100 mg every twelve hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every twelve hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every twelve hours is recommended.

Acute uncomplicated gonococcal infections.

100 mg twice daily for five to seven days.
Resistance to tetracyclines is not uncommon amongst gonococci. The use of tetracycline in the treatment of gonorrhoea should, therefore, be accompanied by monitoring of efficacy.

Primary and secondary syphilis.

300 mg/day in divided doses for at least ten days.

Louse borne typhus.

This has been successfully treated with a single oral dose of 100 or 200 mg according to severity.

Prevention of scrub typhus.

200 mg as a single dose.
Children over 8 years (and < 50 kg, without skeletal growth retardation). The adult dose of 100 mg should be recalculated on a weight basis as 2 mg/kg (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.

Severe acne.

Some efficacy has been demonstrated in some individuals at a dose of 50 mg/day over a period of 12 weeks. No data showing efficacy beyond 12 weeks have been submitted.
Malaria chemoprophylaxis. 100 mg once a day; commencing two days prior to entering malarious areas, while in the malaria area and for two weeks after leaving the malarious area. A maximum of 100 mg daily for eight weeks is recommended, as safety after eight weeks has not been clearly established (see Section 5 Pharmacological Properties; Section 4.1 Therapeutic Indications about combination with other antimalarial agents for prophylaxis against P. vivax).
Anthrax due to Bacillus anthracis including inhalational anthrax (post exposure).

Adults.

The recommended dose for adults is 100 mg every 12 hours.

Children 8 years or younger and children weighing 45 kg and less.

The recommended dose is 2.2 mg/kg every 12 hours.

Duration of treatment.

It is recommended that treatment be continued for at least 60 days.
Therapy should be modified in light of antimicrobial susceptibility testing results.

Method of administration.

Administration of adequate amounts of fluid with the tablets is recommended to reduce the risk of oesophageal irritation and ulceration. Morning (rather than late night) dosing may be preferable. As the recumbent posture may delay oesophageal transit of the tablets, the patient should not lie down for some time after taking the tablets. To reduce the possibility of gastric irritation, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Antacids containing aluminium, calcium or magnesium and preparations containing iron impair absorption and should not be given to patients taking doxycycline.

4.3 Contraindications

Hypersensitivity to doxycycline, any of the excipients in Doxycycline Sandoz or to any of the tetracyclines. Rare cases of benign intracranial hypertension have been reported after tetracyclines and oral retinoids such as isotretinoin or etretinate and vitamin A. Concomitant treatment is therefore contraindicated (see Section 4.8 Adverse Effects (Undesirable Effects)).
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

The use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline medicines and treatment should be discontinued at the first evidence of skin erythema.

Concomitant diseases.

In venereal disease when coexistent syphilis is suspected, proper diagnostic measures including a dark field examination should be done before treatment is started and the blood serology repeated monthly for at least four months.

Long-term treatment.

In long-term therapy, periodic laboratory evaluation of organ systems, including haemopoietic, renal and hepatic studies, should be performed.
If doxycycline is used to treat infections due to group A beta-haemolytic streptococci, treatment should continue for at least 10 days.

Gastrointestinal disease.

History of colitis.

Antibiotics should be prescribed with care for individuals with a history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or antibiotic associated colitis.

Pseudomembranous colitis.

Clostridium difficile associated diarrhoea (CDAD) and antibiotic associated pseudomembranous colitis have been reported with nearly all antibacterial agents including doxycycline, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile and C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Mild cases usually respond to medicine 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. Medicines, which delay peristalsis, e.g. opiates and diphenoxylate with atropine may prolong and/or worsen the condition and should not be used.
Rarely, oesophagitis and oesophageal ulceration have been reported in patients receiving doxycycline tablets. Most of these patients took medication immediately before going to bed. Patients should be instructed to take doxycycline with plenty of water (at least 100 mL), remain upright and not take their treatment before going to bed. Withdrawal of doxycycline and investigation of oesophageal disorder should be considered if symptoms such as dyspepsia or retrosternal pain occur. Caution is required in the treatment of patients with known oesophageal reflux disorders. To reduce the possibility of gastric irritation it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

Bacillus anthracis infection.

In the treatment of severe disease due to Bacillus anthracis initial IV therapy is recommended. Doxycycline should not be used as a single agent for treatment of severe disease due to Bacillus anthracis, including meningitis. Doxycycline may be less effective in anthrax meningitis due to poor CNS penetration.

Use in hepatic impairment.

Abnormal hepatic function has been reported rarely and has been caused by both the oral and parenteral administration of tetracyclines, including doxycycline.

Use in renal impairment.

The anti-anabolic action of the tetracyclines may cause an increase in serum urea. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.

Use in the elderly.

No data available.

Paediatric use.

As with other tetracyclines, doxycycline forms 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 effect was shown to be reversible when the medicine was discontinued.
Tetracyclines also interfere with tooth development (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy). The use of the medicines of the tetracycline class, including Doxycycline Sandoz, during tooth development (latter half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discolouration of the teeth (yellow-grey-brown). This effect is more common during long-term use of the medicines but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Therefore, doxycycline should not be used in children younger than 8 years of age unless other medicines are not likely to be effective or are contraindicated.
The use of tetracyclines in infants, even in the usual therapeutic doses, may cause increased intracranial pressure and bulging of the fontanelles. Discontinuation of therapy results in prompt return of the pressure to normal.

Effects on laboratory tests.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There have been reports of prolonged prothrombin time in patients taking warfarin and doxycycline. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Antacids containing aluminium, calcium or magnesium or other medicines containing these cations, bismuth salts, and preparations containing iron impair absorption and should not be given to patients taking doxycycline.
Since bacteriostatic medicines may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin.
Plasma levels of doxycycline are reduced by the ingestion of alcohol or the administration of barbiturates, anticonvulsants (phenytoin, carbamazepine), disodium hydrogen edetate, sodium bicarbonate, sodium lactate, acetazolamide and ethoxzolamide.
There are anecdotal reports that concurrent use of tetracyclines may render oral contraceptives less effective. Unplanned pregnancy may occur with this combination. A barrier method of contraception should be used while taking doxycycline and for seven days following completion of the course of Doxycycline Sandoz.
The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Tetracyclines are safe for use during the first 18 weeks of pregnancy, after which they cause discolouration of the baby's teeth.
During the period of mineralisation of a child's teeth (the last half of pregnancy, the neonatal period and the first 8 years of life), tetracyclines may induce hypoplasia of the enamel and discolouration of the teeth. Tetracyclines also accumulate in the growing skeleton. These products should be avoided during the latter half of pregnancy.
There are no adequate and well controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS (the Teratogen Information System) concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk. A case control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. Sixty three (0.19%) of the controls and fifty six (0.30%) of the cases were treated with doxycycline. This association was not seen when the analysis was confined to maternal treatment during the period organogenesis (i.e. in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases.
A small prospective study of 81 pregnancies describes 43 pregnant women treated for ten days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age.
Results in animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
Large doses of tetracyclines have caused acute fatty necrosis of the liver in pregnant women, especially those with pyelonephritis. Large doses of the medicine should not be used in pregnant women, or those likely to become pregnant.
 Doxycycline is present in the milk of lactating women. It forms a stable calcium complex in bone-forming tissue and a decrease in the fibula growth has been observed in prematures. The uses of medicines of the tetracycline class during tooth development may also cause permanent discolouration of the teeth. Doxycycline should not be given to nursing mothers.

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)

Doxycycline is generally well tolerated. Due to its virtually complete absorption, side effects of the lower bowel, particularly diarrhoea, have been infrequent. The following adverse effects have been observed in patients receiving doxycycline.

More common effects.

Dermatological.

Photosensitive skin reactions (see Section 4.4 Special Warnings and Precautions for Use), erythematous rash, maculopapular rash, morbilliform rash, pustular rash, urticaria, photo-onycholysis and discolouration of the nails.

Gastrointestinal.

Nausea, anorexia, vomiting, dysphagia, diarrhoea, oesophagitis, oesophageal ulceration, abdominal pain, glossitis, black hairy tongue.

Hypersensitivity.

Urticaria, exacerbation of systemic lupus erythematosus and Jarisch-Herxheimer reaction has been reported in the setting of spirochete infections treated with doxycycline.

Hepatic.

Cholestatic hepatitis, fatty liver degeneration.

Renal.

Dose related increase in serum urea (see Section 4.4 Special Warnings and Precautions for Use).

Musculoskeletal.

Tooth discolouration, enamel hypoplasia.

Nervous system disorders.

Dizziness.

Others.

Bulging fontanelles have been reported in young infants following full therapeutic dosage. The sign disappeared rapidly when the medicine was discontinued.
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.

Less common effects.

Gastrointestinal.

Enterocolitis (see Section 4.4 Special Warnings and Precautions for Use), inflammatory lesions (with monilial overgrowth) in the ano-genital region; dyspepsia and pseudomembranous colitis (see Section 4.4 Special Warnings and Precautions for Use), C. difficile diarrhoea, hepatotoxicity, hepatitis. Abnormal hepatic function has been reported rarely (< 1/1,000), pancreatitis.

Dermatological.

Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).

Musculoskeletal.

Arthralgia, myalgia.

Genitourinary.

Acute renal failure.

Hypersensitivity.

Angioneurotic oedema, anaphylaxis, anaphylactic shock, anaphylactic reaction, anaphylactoid purpura, pericarditis, serum sickness, hypotension, dyspnoea, peripheral oedema, tachycardia, erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS).

Haematological and reticuloendothelial.

Phlebitis associated with intravenous administration; leucopenia; thrombocytopenic purpura; increase in prothrombin time; haemolytic anaemia; eosinophilia, neutropenia.

Nervous system.

Flushing, malaise, headache, confusion, taste loss, stupor, hypoaesthesia, paraesthesia, somnolence, benign intracranial hypertension in adults, increased intracranial pressure in infants. In relation to benign intracranial hypertension, symptoms included blurring of vision, scotomata and diplopia. Permanent visual loss has been reported.

Ocular.

Conjunctivitis, periorbital oedema.

Hearing/ vestibular.

Tinnitus.

Psychiatric.

Depression, anxiety, hallucination.

Respiratory.

Bronchospasm.

Hepatic.

Hepatotoxicity.

Rare reactions.

Retrosternal pain.

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

Tetracyclines, including doxycycline, generally have low toxicity.

Symptoms.

Severe toxicity following acute overdosage is unlikely, with nausea and vomiting being the most common effects after ingestion of therapeutic and overdose amounts.

Treatment.

Treatment may include immediate discontinuation of medication, dilution with water or milk and general supportive care. Antacids may be useful in managing gastric irritation. In most cases, gastrointestinal decontamination is not required. Plasma levels are not clinically useful and specific laboratory monitoring is not needed unless otherwise indicated.
In case of an oral overdose with doxycycline, gastric lavage should be considered to remove unabsorbed portions of the substance. Remaining residues of doxycycline should be minimised by administering antacids or calcium or magnesium salt in order to produce non-absorbable chelates.
Doxycycline is not sufficiently dialysable. Thus, haemodialysis or peritoneal dialysis is not very effective.
In massive overdose, there is a risk of liver damage sometimes accompanied by pancreatitis.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Doxycycline is a broad spectrum antibiotic synthetically derived from oxytetracycline.

Mechanism of action.

Microbiology. Doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect through inhibition of protein synthesis. It is active against a wide range of Gram-positive and Gram-negative organisms (see Section 4.1 Therapeutic Indications).
Strains of Bacillus anthracis isolated from the environment are generally sensitive to doxycycline. Because of the potential for laboratory manipulation of B. anthracis, in the treatment of anthrax, clinical isolates should be tested for antibiotic susceptibility by validated test methods. Therapy should be modified in light of antimicrobial susceptibility testing results.

Susceptibility testing.

Medicines in the tetracycline class have closely similar antimicrobial spectra, and cross resistance among them is common. Microorganisms may be considered susceptible if the MIC (minimum inhibitory concentration) is less than 1.0 microgram/mL, and intermediate if the MIC is 1.0 to 5.0 microgram/mL.
A tetracycline disc may be used to determine microbial susceptibility to medicines in the tetracycline class. If the Kirby-Bauer method of disc susceptibility is used, a 30 microgram tetracycline disc should give a zone of at least 19 mm when tested against a tetracycline susceptible bacterial strain.

Disc 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 the alternative, clinically feasible drugs, the tests 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 reached 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.

Tetracyclines are readily absorbed though to a varying extent. Doxycycline is virtually completely absorbed after oral administration. Its absorption is not significantly affected by the presence of food or milk. Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 microgram/mL of doxycycline at 2 hours decreasing to 1.45 microgram/mL at 24 hours.

Distribution.

There is limited diffusion of doxycycline into CSF after oral administration.

Metabolism.

The metabolism of doxycycline in the human body has not been investigated. In vitro serum protein binding of doxycycline varies from 23 to 93%.

Excretion.

They are concentrated by the liver in the bile, and excreted in the urine and faeces at high concentrations and in a biologically active form. Excretion of doxycycline by the kidney is about 40% in 72 hours in individuals with normal function (creatinine clearance above 75 mL/minute). This percentage excretion may fall as low as 1 to 5% in 72 hours in individuals with severe renal insufficiency creatinine clearance below 10 mL/minute). Studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severely impaired renal function.
The fraction of drug that is not eliminated with urine is mainly excreted in the faeces. More than 90% of an oral dose of doxycycline is eliminated from the body within 72 hours of drug administration.
Haemodialysis does not alter serum half-life.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, sodium starch glycollate type A, hydrogenated castor oil, povidone, colloidal anhydrous silica and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Doxycycline Sandoz 50 mg tablets are available in PP/Al blister packs of 25 tablets.
Doxycycline Sandoz 100 mg tablets are available in PP/Al blister packs of 7 tablets.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Doxycycline is a light yellow crystalline powder, which has a high lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. It will not degrade into an epianhydro form.
Chemical formula: (4S,4aR,5S,5aR,6R,12aS)- 4-(dimethylamino)-3,5,10,12,12a- pentahydroxy-6-methyl-1,11-dioxo- 1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide monohydrate.
Molecular formula: C22H24N2O8.H2O.
Molecular weight: 462.5.

Chemical structure.


CAS number.

17086-28-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes