How does it work?

Hydrocortistab injection contains the active ingredient hydrocortisone acetate, which is a type of medicine known as a corticosteroid. Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions in the body, including control of inflammatory responses. Corticosteroid medicines are man-made derivatives of the natural hormones. They are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.

Hydrocortisone is a synthetic steroid that has an anti-inflammatory effect. It is used to decrease inflammation in various different diseases and conditions.

Hydrocortisone works by acting within cells to prevent the release of certain chemicals that are important in the immune system. These chemicals are normally involved in producing immune and allergic responses, resulting in inflammation. By decreasing the release of these chemicals in a particular area, inflammation is reduced. This can help control a wide number of disease states characterised by excessive inflammation. These include inflammation of the joints in arthritis.

Hydrocortistab injection is administered directly into inflamed joints, or inflamed soft tissue, in conditions such as arthritis or tenosynovitis, to decrease inflammation and pain in that particular area and increase mobility of the affected joint.

What is it used for?

• Local injection into or around a joint in inflammatory diseases of the joints such as rheumatoid arthritis or osteoarthritis.
• Local injection into inflamed bursae, which are fibrous sacs containing joint fluid that aid movement between tendons and bones, skin and bones, and muscles (bursitis).
• Local injection into inflamed tendon sheaths (tenosynovitis).

Warning!

• Injections administered into joints are associated with a risk of introducing infection into the joint. Before the injection is given, the fluid found in the joint should be examined to make sure there is not an existing infection that could be made worse. Joint injections should only be given under sterile conditions.
• After having a joint injection it is important to let your doctor know if you experience a distinct increase in pain accompanied by swelling, further restriction of joint movement, fever and feeling generally unwell, as these symptoms could suggest that the joint is infected. If this is the case, antimicrobial treatment will be needed.
• It is important not to overuse joints that feel better after joint injection, as the inflammatory process may remain active.
• No more than three joints should be treated in one day. The injection may be repeated at intervals of about three weeks.
• Although Hydrocortistab is given as a local injection, if injections are given at high doses for a prolonged period, the hydrocortisone can be absorbed into the bloodstream. This may result in side effects of the hydrocortisone on other parts of the body. These are known as systemic side effects.
• Systemic corticosteroid treatment, especially with high doses, can alter mood and behaviour early in treatment. People may experience confusion, irritability, nightmares, difficulty sleeping, mood changes and depression, and suffer from delusions and suicidal thoughts. In a few cases these effects have also occured when corticosteroid treatment is being withdrawn. If this medicine is absorbed into the bloodstream after joint injection it is possible that these types of side effects could happen. For this reason, it is important to let your doctor know if you notice any change in your mood or behaviour during or after treatment, particularly if you begin to feel depressed, or have any disturbing thoughts or feelings. Most of these problems go away if the dose is lowered or the medicine is stopped. However if problems do happen they might need treatment.

Use with caution in

• Children and adolescents.
• Elderly people.
• Diabetes, or a family history of diabetes.
• High blood pressure (hypertension).
• Glaucoma, or a family history of glaucoma.
• Epilepsy.
• Current severe psychiatric illness, or a personal or family history of psychiatric illness, including depression, manic depression or schizophrenia.
• History of psychiatric illness caused by the use of a corticosteroid.
• Osteoporosis.
• Women who have passed the menopause.
• People who have previously experienced muscle disorders (myopathy) caused by steroids.
• Peptic ulcer.
• History of tuberculosis.

Not to be used in

• People with widespread infection, unless this is being treated with specific anti-infectives.
• Infected joints, tendons, bursae or surrounding tissue.
• Injection into spinal joints and other joints without a large range of movement (non-diarthrodial joints).
• Injection directly into tendons.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the developing baby. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of slowed growth in the developing baby. Seek further medical advice from your doctor.
• This medicine may pass into breast milk. It should be used with caution in breastfeeding mothers and only if the expected benefit to the mother is greater than any possible risk to the nursing infant. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

The principal side effects following injection into or around a joint are a temporary increase in pain and swelling.

In some circumstances, particularly after high or prolonged local dosage, the medicine may be absorbed into the bloodstream in amounts sufficient to produce effects on other parts of the body, such as those listed below (systemic effects).

• Raised blood sugar level.
• Increased appetite and weight gain.
• Increased susceptibility to infections and increased severity of infections.
• Effects on the gut, such as indigestion or abdominal bloating, nausea, ulceration in the stomach or intestine, inflammation of the pancreas (pancreatitis).
• Ulceration or thrush infection in the throat.
• Muscle weakness or wasting.
• Thinning of the bones (osteoporosis) and increased risk of breaking a bone.
• Effects on the skin, such as skin thinning, impaired healing, acne, bruising, stretch marks, increased sweating, increased hair growth (hirsutism).
• Psychiatric reactions, such as mood changes (including irritability, depression and suicidal thoughts), psychotic reactions (including mania, delusions and hallucinations), anxiety, confusion, memory loss, sleep disturbances (see warning above).
• Cushing's syndrome, characterised by a moon face.
• Menstrual disturbances.
• Sodium and water retention.
• Increase in blood pressure (hypertension).
• Decrease in the level of potassium in the blood.
• Decrease in the production of natural steroids by the adrenal glands.
• Effects on the eyes, such as raised pressure inside the eye (glaucoma), cataracts.
• Slowed growth in children and adolescents.
• Blood clots in the blood vessels (thromboembolism).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while being treated with this one, to ensure that the combination is safe.

In some circumstances, particularly after high or prolonged local dosage, the medicine may be absorbed into the bloodstream in amounts sufficient to affect other medicines, such as those listed below.

Hydrocortisone can cause fluid and salt retention and so may oppose the effects of the following medicines:

• antihypertensive medicines used to treat high blood pressure
• diuretics, eg furosemide.

Hydrocortisone may increase blood sugar levels and so may oppose the blood sugar lowering effects of antidiabetic medicines. People with diabetes may need an increase in their dose of insulin or antidiabetic tablets.

There may be an increased chance of the level of potassium in the blood falling too low (hypokalaemia) if hydrocortisone is used in combination with any of the following medicines, which can also lower the amount of potassium in the blood:

• acetazolamide
• amphotericin
• beta agonists, eg salbutamol, salmeterol, terbutaline
• carbenoxolone
• potassium-losing diuretics, eg furosemide, bendroflumethiazide
• theophylline.

If the level of potassium in your blood falls during treatment, this can increase the risk of side effects on the heart caused by a medicine called digoxin.

Hydrocortisone may enhance the anti-blood-clotting effect of anticoagulant medicines such as warfarin. People taking anticoagulant medicines in combination with hydrocortisone should have their blood clotting time (INR) regularly monitored, particularly after starting or stopping treatment with hydrocortisone and after any dose changes.

If hydrocortisone is used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) eg ibuprofen, there may be an increased risk of side effects on the gut, such as stomach ulceration and bleeding.

Hydrocortisone may decrease the blood levels of salicylates such as aspirin. When hydrocortisone is stopped, this may result in excessive levels of the salicylate, unless the dose is readjusted.

The following medicines may increase the removal of hydrocortisone from the body, thus reducing its effects. You may need a larger dose of hydrocortisone if you are also taking any of these medicines:

• barbituates, eg amobarbital, phenobarbital
• carbamazepine
• phenytoin
• primidone
• rifabutin
• rifampicin.

The effect of corticosteroids may be reduced in the three to four days following use of mifepristone.

The following medicines may reduce the removal of hydrocortisone from the body and so may increase its effects or side effects:

• ciclosporin (hydrocortisone may also increase the blood level and risk of side effects of ciclosporin)
• itraconazole
• ketoconazole
• macrolide-type antibiotics, eg erythromycin
• protease inhibitors such as ritonavir.

Hydrocortisone may decrease the body's immune response. This means that vaccines may be less effective if given during treatment, because the body does not produce sufficient antibodies. Live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, chickenpox, oral polio, oral typhoid and yellow fever. These should not be given to people whose immune system is underactive due to treatment with this medicine.

Other medicines containing the same active ingredient

Hydrocortisone has many different uses and comes in many different forms. The factsheets below contain information about hydrocortisone used in various areas of the body.