AFATISON® Hydrocortisone (as sodium succinate) 100mg

AFATISON®

Hydrocortisone

Powder for injection 100mg

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

AFATISON®  belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. Boosting your body with extra corticosteroid can help when injected by a doctor or nurse if your body cannot produce enough corticosteroid due to problems with your adrenal glands (e.g. adrenal insufficiency). Corticosteroids can also help treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inflammatory or allergic conditions affecting the:

• bowel and gut e.g. Crohn’s disease (inflammation of the gut) or ulcerative colitis (inflammation of the lower bowel)
• lungs e.g. bronchial asthma or inflammation caused by breathing in (aspirating) vomit or stomach contents
• skin e.g. Stevens-Johnson syndrome (an autoimmune disorder in which an immune system causes the skin to blister and peel), or systemic lupus erythematosus (lupus)

AFATISON®  may be prescribed to treat conditions other than those listed above, such as adrenal insufficiency and other medical emergencies like treatment of shock associated with this.

 

Before use this drug, ask your doctor:

• If you think you have ever suffered an allergic reaction, or any other type of reaction after being given Hydrocortisone, or any other medicine containing a corticosteroid, or any of the other ingredients of this medicine. An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.
• If you have any fungal infection (such as thrush) which is not being treated.
• If you have recently had, or are about to have any vaccination.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, because it could slow the baby’s growth. Corticosteroids can cross the placenta which is a risk associated with low birth weight of the baby. Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy. Tell your doctor if you are breast-feeding as small amounts of corticosteroid medicines may get into breast milk. If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.

 

Warnings and precautions

Talk to your doctor or nurse before taking this medicine if you have any of the following conditions.

Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine.

• You are suffering from a traumatic brain injury or stroke.
• Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines, or having a family history of these illnesses.
• If you suffer from mood swings, sleeplessness and personality changes
• If you are under unusual stress.
• If you develop adrenal insufficiency.
• Diabetes (or if there is a family history of diabetes).
• Cushing’s disease (a hormone disorder caused by high levels of cortisol in the blood).
• Epilepsy, fits or seizure
• Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.
• Cataract
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Fluid retention in the body.
• Hypothyroidism (an under-active thyroid).
• Pancreatitis (Inflammation of the pancreas which causes severe pain in the abdomen and back).
• Peritonitis (Inflammation of the thin lining (peritoneum) around the gut and stomach).
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness) have happened while taking steroid medicines in the past.
• Myasthenia gravis (a condition causing tired and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal glands are located above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or intestinal problems.
• Thrombophlebitis – vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered tuberculosis in the past.

Caution should be exercised with corticosteroids as they can cause an eye condition (central serous chorioretinopathy) where a collection of fluid forms under the light-sensitive layer of tissue at the back of the inner eye (retina) causing visual impairment and may lead to retinal detachment.

Contact your doctor if you experience blurred vision or other visual disturbances.

Long term therapy of corticosteroids in high doses can cause an abnormal amount of fat deposition on or outside the lining of the spine (epidural lipomatosis).

Tell your doctor if you suspect an infection has occurred, as corticosteroids can make infections more likely and may mask their signs.

This medicine is not recommended for injection via the spinal cord (intrathecal or epidural). Serious side effects have been reported with this use on occasions.

Before you have any operation tell your doctor, dentist or anaesthetist that you are taking this medicine

 

Driving and using machines

The effect of this class of medicines on the ability to drive or use machinery has not been studied. There are undesirable effects observed with the use of this medicine such as syncope (fainting), vertigo (sensation of rotation or movement of oneself or the surrounding), and convulsions (seizures). If you are affected by any of them, you should not drive or operate machinery.

 

Medical Tests

May increase glucose and cholesterol levels.

May decrease potassium and calcium levels.

Method of administration

• Intramuscular and Intravenous administration

100mg Hydrocortisone should be dissolved in 2ml of bacteriostatic water and injected in 30 second.

• For i.v. infusion

Reconstituted solutions must be diluted with 100-1000 ml diluent with one of the following infusion solutions: sodium chloride 0.9%, dextrose 5%, sodium chloride 0.9% + dextrose 5%.

The infusion should be given over 20-30 minutes.

The recommended dose

Hydrocortisone Injection will be given by a doctor or nurse. Your doctor will decide upon the most suitable dose for your condition. The injection can be given in the following ways:

Adults:

• For soft tissue conditions: 100 mg to 200 mg injected into or around the soft tissue daily. This daily dose may be repeated on up to three occasions. For other conditions: 100 mg to 500 mg injected into a muscle, or injected slowly into a vein over at least 30 seconds (through a ‘drip’ into the vein), up to four times a day.

Children:

• 25 mg to 100 mg injected into a vein. This may be repeated up to four times a day depending on the patient response.

People with liver and kidney problems

Systemic dosage may need adjustment depending on the degree of hepatic insufficiency, but quantitative recommendations are not available.

 

If you are given more Hydrocortisone for injection than you should

If you accidentally receive more than your prescribed dose, contact your doctor as soon as possible.

 

If you forget to use Hydrocortisone for injection

If you miss a dose, take it as soon as you can. If it’s close to the time for your next dose, contact your doctor or pharmacist. You might need to miss a dose or take an extra dose, depending on your condition.

If you stop using Hydrocortisone for injection

If you’ve been on hydrocortisone injection for long-term therapy and suddenly stop receiving it, you may have withdrawal reactions. These can include changes in the hormone levels in your body. These changes can cause serious conditions called adrenal insufficiency or Cushing syndrome. If you don’t receive this drug at all, your condition won’t be treated and may get worse.

Adverse reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious.

In certain medical conditions, medicines like Hydrocortisone should not be stopped abruptly. If you suffer from any of the following symptoms seek IMMEDIATE medical attention. Your doctor will then decide whether you should continue taking your medicine:

• Allergic reactions, such as skin rash, swelling of the face or wheezing and difficulty breathing. This type of side effect is rare, but can be serious.
• Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness.
• Ulcers or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood.
• This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a flare up of a previous TB infection could be coughing up blood or pain in the chest. This medicine may also make you more likely to develop a severe infection.
• Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood.
• Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side effect usually occurs after treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away.

The frequency of the side effects is not known. The frequency cannot not be estimated from the available data.

Blood, heart and circulation

• Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse.
• ncreased numbers of white blood cells (leucocytosis).
• Low blood pressure.

Body water and salts

• Swelling and high blood pressure, caused by increased levels of water and salt content.
• Swelling of the extremities of the body e.g.ankles.
• Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).

Digestive system

• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Bloated stomach.
• Abdominal pain.
• Persistent hiccups, especially when high doses are taken.

Ears

• A feeling of dizziness or spinning (vertigo).

Eyes

• Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).
• Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance).
• Damage to the optic nerve or cataracts (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.
• Eye condition (central serous chorioretinopathy) where a collection of fluid forms under the light-sensitive layer of tissue at the back of the inner eye (retina) causing visual impairment and may lead to retinal detachment.

General disorders

• Feeling tired or unwell.
• Skin reactions at the site of injection.

Hormones and metabolic system

• Slowing of normal growth in infants, children and adolescents which may be permanent.
• Irregular or no periods in women.
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite.
• Weight increased.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of some hormones which in turn can cause low blood pressure and dizziness. This effect may persist for months.
• Blood urea increased.
• The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest drugs and other substances in your body may be raised after treatment with a corticosteroid. The change is usually small and the enzyme levels return to normal after your medicine has cleared naturally from your system. You will not notice any symptoms if this happens, but it will show up if you have a blood test.
• Drug withdrawal syndrome includes symptoms like runny nose, fever, headache, loss of appetite, tiredness, joint pain, peeling of skin, weight loss and low blood pressure.
• Abnormal level of fats e.g. cholesterol in the blood.
• Abnormal fat deposition in the body.

Immune system

• More likely to get infections, which can hide or change normal reactions to skin tests, such as that for tuberculosis.

Muscles and bones

• Muscle pain.
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone and joint due to poor circulation of blood, this causes pain in the hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.

Nerves and mood issues

Steroids, including Hydrocortisone, can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hydrocortisone.

• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
• Other nervous system side effects may include breathing problems, convulsions, dizziness, drowsiness, difficulty breathing, irritability, sensation of cold, heat or numbness, tinnitus or unconsciousness.
• Abnormal amount of fat deposition on or outside the lining of the spine (epidural lipomatosis).

Skin

• Abscess, especially near injection sites.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Stretch marks (skin striae).
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an unusual colour.
• Excessive growth of bodily and facial hair.
• Rash, itching, hives.
• Increased sweating.

 

Special precautions for storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• This medicine must be stored below 25°C.
• Once the medicine has been mixed with sterile water for injections the solution should be used straight away.
• Any unused liquid should be disposed of safely.
• Your doctor will check that the solution contains no particles and is not discoloured before using it.

 

AFATISON®

Each vial contains:

Hydrocortisone (as sodium succinate) 100mg

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.