Hydrocortisone Acetate Injection B.P.

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125 mg/5 ml

For the use of a Registered Medical Practitioner or a Hospital or a Institution only.

A LONG ACTING ANTI-INFLAMMATORY AND IMMUNOSUPPRESSIVE STEROID

As Adjunctive Therapy in Various Forms of Arthritis

Keloids

Lesions

Alopecia

DESCRIPTION :

Hydrocortisone Acetate is a synthetic adrenocortical steroid. Chemically, Hydrocortisone Acetate is 11ß, 17-dihydroxy-3, 20-dioxopregn-4-en-21-yl acetate, the molecular formula is C₂₃H₃₂O₆ and molecular weight is 404.5.

STRUCTURAL FORMULA :
Its structural formula is :

Hydrocortisone Acetate Injection B.P.

DESCRIPTION OF INJECTION:

Hydrocortisone Acetate Injection B.P. is a sterile aqueous suspension in water for injection, filled in vial of suitable size.

COMPOSITION :
Each ml contains :
Hydrocortisone Acetate B.P. 25 mg
Benzyl Alcohol B.P. 1.0 % w/v
Methyl Hydroxybenzoate B.P. 0.15 % w/v
Propyl Hydroxybenzoate B.P. 0.02 % w/v
(As preservatives)
Water for Injections B.P. q.s.
Carmellose Sodium B.P.
As dispersing agent)

ACTIONS :
Hydrocortisone Acetate has anti-inflammatory and immunosuppressive action. It alters the immune response due to its effects on lymphocyte number and inhibition of their functions. Hydrocortisone Acetate Injection B.P. has a slow onset but long duration of action when compared with more soluble preparations. Because of its insolubility, it is suitable for intra-articular, intralesional, and soft tissue injection where its anti-inflammatory effects are confined mainly to the area in which it has been injected, although it is capable of producing systemic hormonal effects like altering carbohydrate, lipid and protein metabolism.

PHARMACOKINETICS :
The plasma half-life is about 100 minutes. It is more than 90 % bound to plasma proteins. Absorption of hydrocortisone acetate after intra-articular or soft tissue injection is slow but complete. Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. Hydrocortisone readily crosses the placenta.

INDICATIONS :
A. By intra-articular or soft tissue injection : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in :
Synovitis of osteoarthritis
Rheumatoid arthritis
Acute and subacute bursitis
Acute gouty arthritis
Epicondylitis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis, Psoriatic arthritis.
B. By intralesional injection :

Keloids
Localized hypertrophic, infiltrated, inflammatory lesions of : lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis) Discoid lupus erythematosus Necrobiosis lipoidica diabeticorum

Alopecia areata
May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

DOSAGE AND ADMINISTRATION:

Administration :
For Intra-articular, intralesional and soft tissue injection only.

FOR LOCAL ACTION ONLY.
VIAL SHOULD BE GENTLY SHAKEN BEFORE
A DOSE IS WITHDRAWN.

Dosage :
DOSAGE AND FREQUENCY OF INJECTION ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dose varies from 5 to 75 mg depending on the disease being treated and the size of the area to be injected. Frequency of injection depends on symptomatic response and usually is once every two or three weeks. Severe conditions may require injection once a week. Frequent intra-articular injection may result in damage to joint tissues. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Hydrocortisone Acetate injection B.P. and transfer the patient to other therapy. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease and individual drug responsiveness.

For rapid onset of action, a soluble adrenocortical hormone preparation, such as Dexamethasone Sodium Phosphate injection or Prednisolone Sodium Phosphate injection, may be given with Hydrocortisone Acetate Injection B.P. If desired, a local anaesthetic may be used and may be injected before Hydrocortisone Acetate Injection B.P. or mixed in a syringe with Hydrocortisone Acetate Injection B.P. and given simultaneously. If used prior to intra-articular injection of the steroid, inject most of the anaesthetic into the soft tissues of the surrounding area and instill a small amount into the joint. If given together, mixing should be done in the injection syringe by drawing the steroid in anaesthetic. In this way, the anaesthetic will not be introduced inadvertently into the vial of steroid. The mixture must be used immediately and any unused portion discarded.

CONTRAINDICATIONS :

Systemic fungal infections.

Hypersensitivity to any component of this product. Presence of infection at the site of injection.

WARNINGS :

Hydrocortisone acetate injection B.P. contains benzyl alcohol as preservative. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants. Symptoms include a striking onset of gasping syndrome, hypotension, bradycardia and cardiovascular collapse. Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. Corticosteroids may mask some signs of infection and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results.

In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding. Corticosteroids may activate latent amoebiasis. Therefore, it is recommended that latent or active amoebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhoea. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses. Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained.

Patients who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune patients on corticosteroids. In such patients who have not had these diseases, particular care should be taken to avoid exposure. The risk of developing a disseminated infection varies among individuals and can be related to the dose, route and duration of corticosteroid administration as well as to the underlying disease. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.) Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced
immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. 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. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

PRECAUTIONS :

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia and malaise. This may occur in patients even without evidence of adrenal insufficiency. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Asprin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism. When large doses are given, some authorities advise that antacids be administered between meals to help to prevent peptic ulcer. Steroids may increase or decrease motility and number of spermatozoa in some patients.

The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.

Intra-articular injection of a corticosteroid may produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. Corticosteroids should not be injected into unstable joints.A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever and malaise is suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Patients should be impressed strongly with the importance of not overusing joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active. Frequent intra-articular Injection may result in damage to joint tissues.

INFORMATION FOR PATIENTS :

Susceptible patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

PREGNANCY AND LACTATION:

Pregnancy : Pregnancy Category C :
Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or foetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing mothers :
Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

Paediatric Use :
hould be cautiously used in Paediatric patients. Growth and development of paediatric patients on prolonged corticosteroid therapy should be carefully followed.

INTERACTIONS AND INCOMPATIBILITIES :
se of following drugs together with hydrocortisone acetate may accelerate its excertion :
Antiepileptics eg : carbamazepine, phenytoin.
Barbiturates eg : Phenobarbitone.
Rifampicin.
Aminoglutethimide.

Use of hydrocortisone acetate with diuretics like Frusemide, other medications like acetazolamide, amphotericin may increase the
risk of hypokalaemia.
Increases the risk of stomach ulceration and
bleeding when used with NSAIDs.
Live vaccines should not administer to people

taking corticosteroids.
SIDE EFFECTS :
Fluid and electrolyte disturbances :
Sodium retention.
Fluid retention.
Congestive heart failure in susceptible patients.
Potassium loss.
Hypokalaemic alkalosis.
Hypertension.
Musculoskeletal :
Muscle weakness.
Steroid myopathy.
Loss of muscle mass.
Osteoporosis.
Vertebral compression fractures.
Aseptic necrosis of femoral and humeral heads.
Pathologic fracture of long bones.|Tendon rupture.
Gastrointestinal :
Peptic ulcer with possible subsequent perforation and haemorrhage. Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease.
Pancreatitis.
Abdominal distention.
Ulcerative oesophagitis.
Dermatologic :
Impaired wound healing.
Thin fragile skin.
Petechiae and ecchymoses.
Erythema.
Increased sweating.
ay suppress reactions to skin tests.

Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic oedema.

Neurologic :

Convulsions.

Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment.

Vertigo.
Headache.
Psychic disturbances.

Endocrine : Menstrual irregularities. Development of cushingoid state. Suppression of growth in children. Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness. Decreased carbohydrate tolerance.
Manifestations of latent diabetes mellitus. Increased requirements for insulin or oral hypoglycemic agents in diabetics.

Hirsutism.
Ophthalmic :
Posterior subcapsular cataracts. Increased intraocular pressure.

Glaucoma.
Exophthalmos.
Metabolic : Negative nitrogen balance due to protein catabolism.

Cardiovascular : Myocardial rupture following recent myocardial infarction.

Other : Anaphylactoid or hypersensitivity reactions. Thromboembolism. Weight gain. Increased appetite.

Nausea.

Malaise.
The following additional adverse reactions are related to Injection of corticosteroids : Rare instances of blindness associated with intralesional therapy around the face and head.Hyperpigmentation or hypopigmentation. Subcutaneous and cutaneous atrophy. Sterile abscess. Postinjection flare (following intra-articular use). Charcot-like arthropathy.

OVERDOSAGE :
Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare.

TREATMENT OF OVERDOSAGE :
In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.

PHARMACEUTICAL PRECAUTIONS :
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.

STORAGE :
Store below 30°C (86°F), protected from light. Avoid excessive heat. Do not refrigerate.

SHELF LIFE :
24 months from the date of manufacture.

PRESENTATION :
Hydrocortisone Acetate Injection B.P. is supplied as 125 mg of Hydrocortisone Acetate B.P. in 5 ml vial.
Single vial pack.

Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.