Hydrocortisone Sodium Succinate for Injection USP 1000mg Taj Pharma

  1. Name of the medicinal product

Hydrocortisone Sodium Succinate for Injection USP 100mg Taj Pharma
Hydrocortisone Sodium Succinate for Injection USP 500mg Taj Pharma
Hydrocortisone Sodium Succinate for Injection USP 1000mg Taj Pharma

  1. Qualitative and quantitative composition

a) Hydrocortisone Sodium Succinate for Injection USP 100mg
Each vial contains:
Hydrocortisone sodium succinate equivalent to hydrocortisone        100mg

b) Hydrocortisone Sodium Succinate for Injection USP 500mg
Each vial contains:
Hydrocortisone sodium succinate equivalent to hydrocortisone        500mg

c) Hydrocortisone Sodium Succinate for Injection USP 1000mg
Each vial contains:
Hydrocortisone sodium succinate equivalent to hydrocortisone        1000mg

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

White to almost white powder for parenteral use.

  1. Clinical particulars

4.1 Therapeutic indications

Anti-inflammatory agent.

Hydrocortisone is indicated for any condition in which rapid and intense corticosteroid effect is required such as:

  1. Collagen diseases

Systemic lupus erythematosus

  1. Dermatological diseases

Severe erythema multiforme (Stevens-Johnson syndrome)

  1. Allergic states

Bronchial asthma, anaphylactic reactions

  1. Gastro-intestinal diseases

Ulcerative colitis, Crohn’s disease

  1. Respiratory diseases

Aspiration of gastric contents

4.2 Posology and method of administration

Hydrocortisone may be administered by intravenous injection, by intravenous infusion or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.

Dosage usually ranges from 100 mg to 500 mg depending on the severity of the condition, administered by intravenous injection over a period of one to ten minutes. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient’s response and clinical condition.

In general high-dose corticosteroid therapy should be continued only until the patient’s condition has stabilised – usually not beyond 48 to 72 hours. If hydrocortisone therapy must be continued beyond 48 to 72 hours hypernatraemia may occur, therefore it may be preferable to replace Hydrocortisone with a corticosteroid such as methylprednisolone sodium succinate as little or no sodium retention occurs.

Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.

Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.

Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy.

In patients with liver disease, there may be an increased effect (see section 4.4) and reduced dosing may be considered.

Elderly patients: Hydrocortisone is primarily used in acute short-term conditions. There is no information to suggest that a change in dosage is warranted in the elderly.

However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required (See Section 4.4).

Paediatric population: While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily (see Special warnings and special precautions for use).

Preparation of solutions: For intravenous or intramuscular injection prepare the solution aseptically by adding not more than 2 ml of sterile water for injections to the contents of one vial of Hydrocortisone 100 mg, shake and withdraw for use.

For intravenous infusion, first prepare the solution by adding not more than 2 ml of sterile water for injections to the vial; this solution may then be added to 100 ml -1000 ml (but not less than 100 ml) of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction).

When reconstituted as directed the pH of the solution will range from 7.0 to 8.0 and the appearance of the solution is clear and colourless to almost colourless.

4.3 Contraindications

Hydrocortisone is contra-indicated:

– where there is known hypersensitivity to the active substance or any of the excipients listed in section 6.1

– in systemic fungal infection unless specific anti-infective therapy is employed.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.

4.4 Special warnings and precautions for use

Warnings and Precautions:

A Patient Information Leaflet is provided in the pack by the manufacturer.

Undesirable effects may be minimised by using the lowest effective dose for the minimum period. Frequent patient review is required to appropriately titrate the dose against disease activity (see Section 4.2).

Adrenal cortical atrophy develops during prolonged therapy and may persist for months after stopping treatment. In patients who have received more than physiological doses of systemic corticosteroids (approximately 30 mg hydrocortisone) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids, but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose of 30 mg hydrocortisone is reached, dose reduction should be slower to allow the HPA-axis to recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 160 mg hydrocortisone for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

  • Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks.
  • When a short course has been prescribed within one year of cessation of long-term therapy (months or years).
  • Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.
  • Patients receiving doses of systemic corticosteroid greater than 160 mg hydrocortisone.
  • Patients repeatedly taking doses in the evening.

Patients should carry ‘Steroid Treatment’ cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Suppression of the inflammatory response and immune function increases the susceptibility to fungal, viral and bacterial infections and their severity. The clinical presentation may often be atypical and may reach an advanced stage before being recognised.

Chickenpox is of serious concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunization with varicella/zoster immunoglobin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Exposure to measles should be avoided. Medical advice should be sought immediately if exposure occurs. Prophylaxis with normal intramuscular immuneglobulin may be needed.

Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.

The use of Hydrocortisone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculosis regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Rarely anaphylactoid reactions have been reported following parenteral Hydrocortisone therapy. Physicians using the drug should be prepared to deal with such a possibility. Appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of drug allergy.

Care should be taken for patients receiving cardioactive drugs such as digoxin because of steroid induced electrolyte disturbance/potassium loss (see Section 4.8).

Hydrocortisone may have an increased effect in patients with liver diseases since the metabolism and elimination of hydrocortisone is significantly decreased in these patients.

Corticosteroid therapy has been associated with central serious chorioretinopathy, which may lead to retinal detachment.

There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.

Thrombosis including venous thromboembolism has been reported to occur with corticosteroids. As a result corticosteroids should be used with caution in patients who have or may be predisposed to thromboembolic disorders.

Special precautions:

Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

  1. Osteoporosis (post-menopausal females are particularly at risk).
  2. Hypertension or congestive heart failure.
  3. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
  4. Diabetes mellitus (or a family history of diabetes).
  5. History of tuberculosis.
  6. Glaucoma (or a family history of glaucoma).
  7. Previous corticosteroid-induced myopathy.
  8. Liver failure or cirrhosis.
  9. Renal insufficiency.
  10. Epilepsy.
  11. Peptic ulceration.
  12. Fresh intestinal anastomoses.
  13. Predisposition to thrombophlebitis.
  14. Abscess or other pyogenic infections.
  15. Ulcerative colitis.
  16. Diverticulitis.
  17. Myasthenia gravis.
  18. Ocular herpes simplex, for fear of corneal perforation.
  19. Hypothyroidism.
  20. Recent myocardial infarction (myocardial rupture has been reported).
  21. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.

Hydrocortisone can cause elevation of blood pressure, salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 Interaction with Other Medicaments and Other Forms of Interaction that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Paediatric population: Corticosteroids cause growth retardation in infancy, childhood and adolescence, which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time. The use of steroids should be restricted to the most serious indications.

Use in the elderly: The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Systemic corticosteroids are not indicated for, and therefore should not be used to treat traumatic brain injury or stroke because it is unlikely to be of benefit and may even be harmful. For traumatic brain injury a multicenter study revealed an increased mortality at 2 weeks and 6 months after injury in patients administered methylprednisolone sodium succinate compared to placebo. A casual association with methylprednisolone sodium succinate treatment has not been established.

This medicinal product contains 0.3 mmol (6.2 mg) of sodium per vial of 100mg hydrocortisone. This means that sodium content has to be taken into consideration by patients on a controlled sodium diet for dose above 370 mg of hydrocortisone.

4.5 Interaction with other medicinal products and other forms of interaction

  1. Convulsions have been reported with concurrent use of corticosteroids and ciclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse effects associated with the individual use of either drug may be more apt to occur.
  2. Drugs that induce hepatic enzymes, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.
  3. Drugs which inhibit the CYP3A4 enzyme, such as cimetidine, erythromycin, ketoconazole, itraconazole, diltiazem and mibefradil, may decrease the rate of metabolism of corticosteroids and hence increase the serum concentration.
  4. Steroids may reduce the effects of anticholinesterases in myasthenia gravis. The desired effects of hypoglycaemic agents (including insulin), anti- hypertensives and diuretics are antagonised by corticosteroids, and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
  5. The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
  6. The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication. Salicylates and non- steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids in hypothrombinaemia.
  7. Steroids have been reported to interact with neuromuscular blocking agents such as pancuronium with partial reversal of the neuromuscular block.

4.6 Fertility, pregnancy and lactation

Pregnancy

The ability of corticosteroids to cross the placenta varies between individual drugs, however, hydrocortisone readily crosses the placenta.

Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra- uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Breast-feeding

Corticosteroids are excreted in breast milk, although no data are available for hydrocortisone. Doses up to 160 mg daily of hydrocortisone are unlikely to cause systemic systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Fertility

Corticosteroids have been shown to impair fertility in animal studies. Adverse effects on fertility in rats with corticosterone were observed in males only and were reversible (see section 5.3). The clinical relevance of this information is uncertain.

4.7 Effects on ability to drive and use machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as syncope, vertigo, and convulsions are possible after treatment with corticosteroids. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Since Hydrocortisone is normally employed on a short-term basis it is unlikely that side-effects will occur; however, the possibility of side-effects attributable to corticosteroid therapy should be recognised (see Section 4.4).

Undesirable effects are classified into the following categories, according to system organ class, MedDRA terminology and MedDRA frequencies:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000) and

Not known (frequency cannot be estimated from the available data).

Adverse Reactions table
System organ Class Frequency Not Known

(Cannot be estimated from available data)

Infections and infestations Infection masked;

Opportunistic infection

Neoplasms benign, malignant and unspecified (including cysts and polyps) Kaposi’s sarcoma (has been reported to occur in patients receiving corticosteroid therapy)
Immune system disorders Hypersensitivity (including anaphylaxis and anaphylactoid reactions [e.g. bronchospasm, laryngeal oedema, urticaria]);

May suppress reactions to skin tests

Blood and lymphatic system disorders Leucocytosis
Endocrine disorders Cushingoid;

Pituitary-adrenal axis suppression;

WITHDRAWAL SYMPTOMS – Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication where continuous therapy is given (see section 4.4);

A ‘withdrawal syndrome’ may also occur including, fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight

Metabolism and nutrition disorders Sodium retention;

Water retention;

Alkalosis hypokalaemic;

Glucose tolerance impaired;

Increased appetite;

Weight increased

Psychiatric disorders Affective disorders (such as irritable, euphoric, depressed and labile mood psychological dependence and suicidal thoughts);

Psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia); Behavioural disturbances;

Irritability;

Anxiety;

Sleep disturbances;

Cognitive dysfunction including confusion and amnesia

Nervous system disorders Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri) has been reported, usually after treatment withdrawal of hydrocortisone;

Benign intracranial hypertension;

Convulsions;

Epidural lipomatosis

Eye disorders Cataract subcapsular;

Glaucoma;

Exophthalmos;

Increased intra-ocular pressure, with possible damage to the optic nerve;

Corneal or scleral thinning;

Exacerbation of ophthalmic viral or fungal disease;

Central serous chorioretinopathy

Cardiac disorders Cardiac failure congestive (in susceptible patients);

Myocardial rupture following a myocardial infarction

Vascular disorders Hypertension;

Thrombosis including Thromboembolism

Respiratory, thoracic and mediastinal disorders Hiccups;

Pulmonary embolism

Gastrointestinal disorders Peptic ulcer (with possible perforation and haemorrhage);

Gastric haemorrhage;

Pancreatitis;

Abdominal distension;

Oesophageal ulceration;

Oesophageal candidiasis;

Intestinal perforation;

Dyspepsia;

Nausea

Skin & subcutaneous tissue disorders Petechiae;

Telangiectasia;

Ecchymosis;

Skin atrophy;

Skin striae;

Skin hyperpigmentation;

Skin hypopigmentation;

Hirsutism;

Acne;

Hyperhidrosis

Musculoskeletal, connective tissue and bone disorders Myopathy;

Muscular weakness;

Osteonecrosis;

Osteoporosis;

Pathological fracture;

Growth retardation

Reproductive system and breast disorders Menstruation irregular;

Amenorrhoea

General disorders and administration site conditions Impaired healing;

Abscess sterile;

Malaise

Investigations Carbohydrate tolerance decreased;

Increased insulin requirement (or oral hypoglycemic agents in diabetics);

Blood potassium decreased;

Nitrogen balance negative (due to protein catabolism);

Urine calcium increased;

Alanine aminotransferase increased;

Aspartate aminotransferase increased;

Blood alkaline phosphatase increased

Injury, poisoning and procedural complications Spinal compression fracture;

Tendon rupture (particularly of the Achilles tendon)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

There is no clinical syndrome of acute overdosage with Hydrocortisone. Hydrocortisone is dialysable.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticoids

Hydrocortisone sodium succinate has the same metabolic and anti- inflammatory actions as hydrocortisone. It is a glucocorticosteroid. Used in pharmacological doses, its actions supress the clinical manifestations of disease in a wide range of disorders.

5.2 Pharmacokinetic properties

Twelve normal subjects received 100, 200 or 400 mg Hydrocortisone intravenously. Radio-immunoassay results were as follows:-

DOSE (mg) CMAX (mcg/100 ml) TMAX (hr) 12-HR AUC (mG/100 ml x hr)
100 132.3 0.35 418.0
200 231.8 0.25 680.0
400 629.8 0.37 1024.0

In another study, a 1 mg/kg i.m. dose of Hydrocortisone peaked in 30-60 minutes, with a plasma cmax of 80 mg/100 ml.

In analysing hydrocortisone metabolism, a 25 mg IV dose resulted in higher plasma concentrations in females than in males.

5.3 Preclinical safety data

Hydrocortisone was not mutagenic in bacterial assays but induced chromosome aberrations in human lymphocytes in vitro and in mice in vivo. Hydrocortisone did not increase tumor incidences in male and female rats during a limited 2-year carcinogenicity study.

Corticosteroids have been shown to reduce fertility when administered to rats. Adverse effects on fertility in rats with corticosterone were observed in males only and were reversible. Decreased weights and microscopic changes in prostate and seminal vesicles were observed. The numbers of implantations and live fetuses were reduced and these effects were not present following mating at the end of the recovery period.

  1. Pharmaceutical particulars

6.1 List of excipients

Powder for injection:

Sodium hydrogen phosphate buffer

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

3 years.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C and 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Store in the original package in order to protect from light

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature and contents of container

Type III colourless glass vials closed by a grey radiosterilised bromobutyl rubber closure and capped with an aluminium flip cap with blue pastic disk.

Box of 10 vials.

6.6 Special precautions for disposal and other handling

Instructions for reconstitution:

Hydrocortisone should be reconstituted by adding not more than 2ml of sterile Water for injections to the contents of one vial. A homogeneous solution will be obtained by shaking gently. The solution of the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration. The formulation does not contain a preservative and is for single use only. Once opened, the content of a vial should normally be used immediately (see section 6.3).

For instructions on administration, see section 4.2.

For IV infusion, the following solutions can be used: dextrose 5% in water, isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Hydrocortisone Sodium Succinate for Injection USP 100mg Taj Pharma
Hydrocortisone Sodium Succinate for Injection USP 500mg Taj Pharma
Hydrocortisone Sodium Succinate for Injection USP 1000mg Taj Pharma

Hydrocortisone sodium succinate

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

  • Keep this leaflet. You may need to read it
  • If you have any further questions please ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

  1. What Hydrocortisone is and what it is used for
  2. What you need to know before you are given Hydrocortisone
  3. How Hydrocortisone is given to you
  4. Possible side effects
  5. How to store Hydrocortisone
  6. Contents of the pack and other information

1. What Hydrocortisone is and what it is used for

Hydrocortisone 100 mg, powder for solution for injection/infusion contains hydrocortisone as hydrocortisone sodium succinate.

Hydrocortisone 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 such as Hydrocortisone can help when injected by a doctor or nurse to treat shock following surgery, injuries, hypersensitivity (anaphylactic) reactions or other stressful conditions. These include inflammatory or allergic conditions affecting the:

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

You must talk to a doctor if you do not feel better or if you feel worse or are unsure why you have been given this medicine.

2. What you need to know before you are given Hydrocortisone

Hydrocortisone must not be given 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 ingredients in this medicine (listed in section 6). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.
  • you have any fungal infection (such as thrush) which is not being
  • you have recently had, or are about to have any

vaccination.

See your doctor immediately if you have any of the above.

Warnings and precautions

Talk to your doctor or nurse before you are given 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.

• 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 like Hydrocortisone, or having a family history of these illnesses
  • Diabetes (or if there is a family history of diabetes)

• Epilepsy

  • Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.
  • You have recently suffered a heart attack
  • Heart problems, including heart failure or infections
  • Hypertension (high blood pressure
  • Hypothyroidism (an under-active thyroid)
  • 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.

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).

Other medicines and Hydrocortisone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should tell your doctor if you are taking any of the following medicines which can affect the way Hydrocortisone or the other medicine works:

  • Acetazolamide – used to treat glaucoma and epilepsy
  • Aminoglutethimide – used for treating cancer
  • Anticoagulants – used to ‘thin’ the blood such as acenocoumarol, phenindione and warfarin
  • Anticholinesterases – used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine
  • Antibiotics (such as erythromycin)
  • Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain

• Barbiturates, carbamazepine, phenytoin and

primidone – used to treat epilepsy

  • Carbenoxolone and cimetidine – used for heartburn and acid indigestion
  • Ciclosporin – used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant
  • Digoxin – used for heart failure and/or an irregular heart beat
  • Diltiazem or mibefradil – used for heart problems or high blood pressure
  • Diuretics – sometimes called water tablets
  • Ketoconazole or itraconazole – used to treat fungal infections
  • Pancuronium – or other medicines called neuromuscular blocking agents which are used in some surgical procedures
  • Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB)
  • Vaccines – tell your doctor or nurse if you have recently had, or are about to have any You should not have ‘live’ vaccines while being treated with this medicine. Other vaccines may be less effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water retention (oedema), tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

Before you have any operations, tell your doctor, dentist or anesthetist that you are being treated with this medicine.

If you require a test to be carried out by your doctor or in hospital, it is important that you tell the doctor or nurse that you are being treated with

Hydrocortisone. This medicine can affect the results of some tests.

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 you are given this medicine, because it could slow the baby’s growth. 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 being treated with this medicine, your baby will need extra checks to make sure he or she is not being affected by your 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 do not drive nor operate machinery.

Hydrocortisone contains sodium

This medicinal product contains 0.3 mmol (6.2 mg) of sodium per vial of 100 mg hydrocortisone. This means that sodium content has to be taken into consideration by patients on a controlled sodium diet for dose above 370 mg of hydrocortisone.

3. How Hydrocortisone is given to you

Steroid Cards

Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has filled out the details of your medicine, including the dose and how long you will require steroid treatment.

You should show your steroid card to anyone who gives you any medical treatment (such as a doctor, nurse or dentist) while you are receiving this medicine, and for 3 months after your last injection.

If you are admitted to hospital for any reason always tell your doctor or nurse that you are being treated with this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are treated with a steroid if you have an accident or become unconscious.

The recommended dose

Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with

the lowest dose for the shortest possible time to get effective relief of your symptoms.

Adults

Hydrocortisone will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the first dose is given into a vein, especially in an emergency.

It will be given slowly over a period of between 1 – 10 minutes. Depending on your condition a repeat dose may be injected at intervals of between 2 to 6 hours. Large doses should normally be used for only two to three days. The medicine is first dissolved in sterile water for injections. If the medicine is to be given by infusion (using a pump or drip) it is then also mixed with another suitable fluid. No other medicines should be mixed with this medicine.

Elderly patients

Treatment will normally be the same as for younger adults. However your doctor may want to see you more frequently to check how you are getting on with this medicine.

Use in children and adolescents

Corticosteroids can affect growth in children so the doctor will prescribe the lowest dose (should not be less than 25 mg a day) that will be effective for your child.

If you are given more Hydrocortisone than you should have

If you think you have been given too many injections of this medicine please speak to your doctor immediately.

Stopping/reducing the dose of your Hydrocortisone Your doctor will decide when it is time to stop your treatment.

You will need to come off this treatment slowly if you:

  • have been given more than 160 mg of corticosteroids, such as Hydrocortisone, for more than 3 weeks,
  • have been given high doses of corticosteroids, such as Hydrocortisone, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less,
  • have already had a course of corticosteroid tablets or injections in the last year,
  • already have problems with your adrenal glands (adrenocortical insufficiency) before you started this treatment.

You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss.

If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.

Mental problems while taking Hydrocortisone Mental health problems can happen while taking steroids like Hydrocortisone (see also section 4, Possible side effects).

  • These illnesses can be
  • Usually they start within a few days or weeks of starting the
  • They are more likely to happen at high doses.
  • Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases

mental problems have happened when doses are being lowered or stopped.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

In certain medical conditions, medicines like Hydrocortisone (steroids) 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 receiving this 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
  • Acute pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of
  • 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
  • Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender

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
  • Increased numbers of white blood cells (leucocytosis).

Body water and salts

  • Swelling and high blood pressure, caused by increased levels of water and salt
  • Cramps and spasms, due to the loss of potassium from your 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
  • Persistent hiccups, especially when high doses are given.

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
  • 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.

Hormones and metabolic system

  • Slowing of normal growth in infants, children and adolescents which may be
  • Irregular or no periods in
  • Increased hair on the body and face in women (hirsutism).
  • Round or moon-shaped face (Cushingoid facies).
  • Increased appetite.
  • Weight
  • Diabetes or worsening of existing
  • 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.
  • The amount of certain chemicals (enzymes) called alanine transaminase, aspartate transaminase and alkaline phosphatase that help the body digest medicines and other substances 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.

Immune system

  • Increased susceptibility to infections which can hide or change normal reactions to skin tests, such as that for tuberculosis.

Muscles and bones

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

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 having moods that go up and down.
  • Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your
  • 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, 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
  • Poor wound
  • Thinning of skin with stretch
  • Small purple/red patches on the
  • Pale or darker patches on your skin, or raised patches of unusual

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hydrocortisone

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.

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.

6. Contents of the pack and other information

What Hydrocortisone contains

The active substance is hydrocortisone as hydrocortisone sodium succinate.

The other excipient is sodium hydrogen phosphate buffer.

What Hydrocortisone looks like and contents of the pack

Hydrocortisone is a white to almost white powder for parenteral use stored in colourless glass vials with a rubber closure and an aluminum flip cap with plastic disk.

Hydrocortisone is available in packs containing 10 vials.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com