Betnesol Soluble (Betamethasone) Tablets

• Severe allergic reactions, eg anaphylaxis.
• Asthma.
• Rheumatoid arthritis.
• Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
• Inflammatory disorders of the kidney, such as nephrotic syndrome and interstitial nephritis.
• Inflammatory skin disorders, including pemphigus vulgaris, bullous pemphigoid and pyoderma gangrenosum.
• Inflammatory disease of the skin and muscles (dermatomyositis).
• Inflammatory disease called systemic lupus erythematosus, which can affect many organs throughout the body and is caused by the immune system attacking connective tissue in the body.
• Mixed connective tissue disease.
• Rare condition involving inflammation in the walls of arteries (polyarteritis nodosa).
• Sarcoidosis.
• Rheumatic carditis.
• Cancer of the bone marrow (multiple myeloma).
• Acute and lymphatic leukaemia.
• Cancer of the lymph nodes (lymphoma).
• Idiopathic thrombocytopenia purpura.
• Anaemia caused by the immune system attacking red blood cells (autoimmune haemolytic anaemia).
• Helping to prevent the immune system attacking a transplanted organ, eg heart, liver, kidney etc.
• Betamethasone soluble tablets dissolved in water can also be used as a mouthwash to treat mouth ulcers (this is an unlicensed use of the medicine).

How does it work?

• Betamethasone soluble tablets contain the active ingredient betamethasone, 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.
• Betamethasone is a synthetic steroid that has an anti-inflammatory effect. It is used to decrease inflammation in various different diseases and conditions.
• Betamethasone 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 severe allergic reactions, inflammation of the lungs in asthma and inflammation of the joints in arthritis.
• Betamethasone also decreases the numbers of white blood cells circulating in the blood. This, along with the decrease in inflammatory chemicals, can prevent the rejection of organ transplants, as it prevents the body from attacking foreign tissue. It is useful for the treatment of certain types of leukaemia, where there is an abnormally large production of certain white blood cells, and for treating certain diseases that are caused by the immune system attacking tissues in the body (autoimmune diseases).

How do I take it?

• Betamethasone soluble tablets should be taken in the morning to mimic the natural production of corticosteroids by the body.
• The tablets are best taken dissolved in water, but can also be swallowed whole. They should be taken with or after food to minimise irritation to the stomach.
• The dose prescribed by your doctor depends on the condition being treated. It is important to follow the instructions given by your doctor and pharmacist. These will also be found in the printed information you are given with the tablets.

Use with caution in

• Children and adolescents.
• Elderly people.
• Decreased kidney function.
• Liver failure.
• Peptic ulcer.
• Inflammation of the bowel and back passage (ulcerative colitis).
• Painful inflammation of small sacs or pouches in the wall of the gut (diverticulitis).
• People who have recently had a surgical procedure called intestinal anastomosis, which involves the joining together of ends of the intestine after a section has been removed.
• People with a history of blood clots in the blood vessels (thromboembolism).
• Heart failure.
• People who have recently had a heart attack.
• High blood pressure (hypertension).
• Diabetes, or a family history of diabetes.
• Underactive thyroid gland (hypothyroidism).
• Epilepsy.
• Glaucoma, or a family history of glaucoma.
• 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.
• Abnormal muscle weakness (myasthenia gravis).
• People who have previously experienced muscle disorders (myopathy) caused by steroids.
• People with a history of tuberculosis (TB).
• Herpes simplex virus infection of the eye.
• People with a low level of potassium in their blood (hypokalaemia).

Not to be used in

• People with widespread infection, unless this is being treated with specific anti-infectives.
• Corticosteroids should not be used for the management of head injury or stroke because they are unlikely to be of benefit and may even be harmful.
• 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.

• When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of slowed growth in the developing baby. They may also cause the baby to make less of its own steroid hormones after birth, but this usually resolves on its own and rarely causes any problems. When used during pregnancy betamethasone may also temporarily reduce the baby'’s heart rate and body movements. As a result 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. Seek further medical advice from your doctor.
• If you think you could be pregnant while you are taking this medicine you should consult your doctor for advice. It is important that you do not suddenly stop taking the medicine unless your doctor tells you to - see the warnings above.
• This medicine passes into breast milk. It should be used with caution in mothers who are breastfeeding and only if the benefits to the mother outweigh any risks to the nursing infant. Lower doses taken by the mother are unlikely to significantly affect the baby, but if the mother is taking high doses for long periods of time, the medicine could cause the baby's adrenal glands to make less of their own natural steroid hormones. 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.

• 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, change in pigmentation, 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.
• Cushing's syndrome, characterised by a moon face.
• Menstrual disturbances.
• 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.
• Hiccups.
• 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 taking this one, to make sure that the combination is safe.

Betamethasone 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.

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

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

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

The following medicines may increase the removal of betamethasone from the body, thus reducing its effects. You may need a larger dose of betamethasone 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.

Betamethasone 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, shingles, 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.

Corticosteroids can cause fluid and salt retention and so may oppose the effects of antihypertensive medicines used to treat high blood pressure and diuretics, eg furosemide. However, betamethasone is much less likely than other corticosteroids to have this effect.

Corticosteroids can also lower the amount of potassium in the blood, though this is much less likely with betamethasone than with other corticosteroids. However, there may be an increased chance of the level of potassium in the blood falling too low (hypokalaemia) if betamethasone is used in combination with the following medicines:

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

References:

http://www.medicines.org.uk/emc/medicine/10181/PIL/Betnesol+Tablets/

http://patient.info/medicine/betamethasone-soluble-tablets

https://www.drugs.com/uk/betnesol-500-microgram-soluble-tablets-leaflet.html

http://www.netdoctor.co.uk/medicines/a6306/betamethasone-soluble-tablets/