GIDROKOR-LM [Hydrocortisone] 100 mg Powder for solution for intramuscular administration
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instructions for the medical use of
the medicinal product
GIDROKOR-LM
Tradename: Gidrokor-LM,
Гидрокор-LM
International non-proprietary name
or generic name: hydrocortisone,
гидрокортизон
Dosage form: powder for
the preparation of a solution with a solvent for intramuscular administration.
Composition
Each vial contains:
hydrocortisone sodium succinate equiv. hydrocortisone 100 mg
Ampule of solvent contains:
lidocaine hydrochloride 1%
Pharmacotherapeutic
group: Corticosteroid for systemic use. Glucocorticoids (GCS). Hydrocortisone.
Code АТХ: H02AB09
Pharmacological
properties
Pharmacodynamics
Hydrocortisone
acetate belongs to the group of glucocorticosteroids of natural origin. It has
anti-shock, antitoxic, immunosuppressive, anti-exudative, antipruritic,
anti-inflammatory, desensitizing, anti-allergic effects. It inhibits
hypersensitivity reactions, proliferative and exudative processes in the
inflammation focus. The action of hydrocortisone acetate is mediated through
specific intracellular receptors. The anti-inflammatory effect is based on
inhibition of all phases of inflammation: stabilization of cellular and
subcellular membranes, reduction of proteolytic enzyme release from lysosomes,
inhibition of superoxide anion formation and other free radicals.
Hydrocortisone inhibits the release of inflammation mediators, including
interleukin-1 (IL-1), histamine, serotonin, bradykinin, etc., reduces the
release of arachidonic acid from phospholipids and the synthesis of
prostaglandins, leukotrienes, thromboxane. Reduces inflammatory cellular
infiltrates, reduces the migration of leukocytes and lymphocytes to the site of
inflammation. Inhibits connective tissue reactions during the inflammatory
process and reduces the intensity of scar tissue formation. Reduces the number
of mast cells that produce hyaluronic acid, inhibits the activity of
hyaluronidase and helps reduce capillary permeability. Inhibits collagenase production
and activates the synthesis of protease inhibitors. Reduces synthesis and
enhances the catabolism of proteins in muscle tissue. By stimulating steroid
receptors, it induces the formation of a special class of proteins -
lipocortins, which have an anti-edematous effect. It has a counter-insular
effect, increasing the level of glycogen in the liver and causing the
development of hyperglycemia. It retains sodium and water in the body, thereby
increasing the volume of circulating blood and increasing blood pressure
(anti-shock effect).
Stimulates the
excretion of potassium, reduces the absorption of calcium from the digestive
tract, and reduces bone mineralization.
Like other
glucocorticoids, hydrocortisone reduces the number of T-lymphocytes in the
blood, thereby reducing the effect of T-helpers on B-lymphocytes, inhibits the
formation of immune complexes, reducing the manifestations of allergic
reactions.
Pharmacokinetics
Hydrocortisone, which is applied
locally, can be absorbed and exhibit systemic action. It is absorbed from the
injection site relatively slowly. Up to 90% of the drug binds to blood proteins
(80% to transcortin, 10% to albumins), about 10% is a free fraction. Metabolism
occurs in the liver. Unlike synthetic derivatives, an insignificant amount of
the drug penetrates the placenta (up to 67% is destroyed in the placenta itself
to inactive metabolites). Hydrocortisone metabolites are excreted mainly by the
kidneys.
Indications for use
For
conditions in which it is desirable to obtain a rapid and intense effect from
the action of corticosteroids.
Endocrine
disorders:
•
primary or secondary adrenal cortex insufficiency;
•
acute adrenal cortex insufficiency; use in the preoperative period, in case of
severe trauma or illness in patients with adrenal cortex insufficiency or in
case of doubts regarding the reserve functions of the adrenal cortex;
•
shock, unresponsive to conventional therapy, when adrenal cortex insufficiency
is present or suspected;
•
congenital adrenal hyperplasia; non-suppurative thyroiditis; hypercalcemia
associated with malignancy.
Non-endocrine
disorders
Rheumatic
diseases, as adjuvant therapy for short-term use (to help the patient survive
an acute episode or exacerbation) in the following diseases:
•
acute and subacute bursitis, acute gouty arthritis acute non-specific
tenosynovitis; ankylosing spondylitis;
•
epicondylitis; post-traumatic osteoarthritis;
•
psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid
arthritis (individual cases may require maintenance therapy with low doses of
the drug) synovitis in osteoarthritis.
Collagenoses
During
an exacerbation or as maintenance therapy in individual cases of the following
diseases:
•
acute rheumatic carditis;
•
systemic dermatomyositis (polymyositis) systemic lupus erythematosus.
Dermatological
diseases:
•
bullous herpetiform dermatitis exfoliative dermatitis fungal mycosis,
pemphigus;
•
severe erythema multiforme (Stevens-Johnson syndrome) severe psoriasis; severe
seborrheic dermatitis.
Allergic
conditions: control of severe allergic conditions or allergic
conditions that lead to loss of ability to work and do not respond to
traditional treatment, in the following diseases:
•
acute non-infectious laryngeal edema atopic dermatitis bronchial asthma;
contact dermatitis hypersensitivity reactions to drugs;
•
seasonal or perennial allergic rhinitis serum sickness, transfusion reactions
such as urticaria.
Ophthalmological
diseases: severe acute and chronic allergic and inflammatory processes with eye
damage, such as:
•
allergic conjunctivitis allergic marginal corneal ulcers inflammation of the
anterior segment of the eye;
•
chorioretinitis, diffuse posterior uveitis and choroiditis;
•
ocular herpes zoster;
•
iritis and iridocyclitis;
•
keratitis, optic neuritis sympathetic ophthalmia.
Gastrointestinal
diseases, to help the patient survive the critical period in the following
diseases:
• ulcerative
colitis (systemic therapy);
•
regional enteritis (systemic therapy).
Respiratory
diseases:
•
aspiration pneumonitis;
•
berylliosis, fulminant or disseminated pulmonary tuberculosis, when used
concomitantly with appropriate anti-tuberculosis chemotherapy;
•
Löffler's syndrome, refractory to other treatments;
•
sarcoidosis.
Hematological
diseases:
•
acquired (autoimmune) hemolytic anemia congenital (erythroid) hypoplastic
anemia erythroblastopenia (erythrocyte anemia);
•
idiopathic thrombocytopenic purpura of adults (only intravenous intramuscular
use is contraindicated) secondary thrombocytopenia of adults.
Neoplastic
diseases, palliative treatment of such diseases:
Acute
leukemia in children, leukemia and lymphoma in adults.
Conditions accompanied by
edema: to induce diuresis or remission of proteinuria in nephrotic syndrome
without uremia, idiopathic or due to lupus erythematosus.
Emergencies:
•
shock due to adrenal cortex insufficiency, or shock unresponsive to conventional
therapy, in case of possible adrenal cortex insufficiency;
•
acute allergic conditions (asthmatic status, anaphylactic reactions, insect
bites, etc.), which do not resolve after the use of epinephrine.
Other:
Trichinellosis
with involvement of nerves or myocardium, tuberculous meningitis with
subarachnoid block or threat of blockade, in which it is used in combination
with appropriate anti-tuberculosis chemotherapy.
Contraindications
• hypersensitivity to hydrocortisone;
• systemic fungal infections, acute viral and
bacterial infections;
• peptic ulcer of the stomach and duodenum;
• renal failure;
• arterial hypertension;
• osteoporosis;
• vaccination period;
• idiopathic thrombocytopenic purpura;
• acute and subacute myocardial infarction;
• children under 2 years of age.
Method of administration
and dosage
The drug is administered as an
intramuscular injection.
For
adults, the initial dose is 100 mg. Depending on the severity
of the patient's condition, the dose may be increased. High doses of GCS should
be prescribed only until the patient's condition stabilizes, but not longer
than 48-72 hours. The dose of the drug is re-prescribed every 2, 4 or 6 hours,
depending on the patient's response and the clinical picture of the disease.
Children
should be administered lower doses (but not less than 25 mg / day), however,
when choosing a dose, the severity of the condition and the patient's response
to therapy are primarily taken into account, and not age and body weight.
Preparation
of the solution
1. Add 3.5 ml of lidocaine
hydrochloride to the vial.
2. Gently shake the vial until the
powder dissolves.
3. Use only a clear solution.
Special instructions and precautions
Consult a physician before
using the drug.
When prescribing high doses
of hydrocortisone for a period longer than 48-72 hours, hypernatremia may
develop. In this case, it is recommended to replace Solu-Cortef with another
GCS, for example, methylprednisolone sodium succinate, which causes little or
no sodium retention in the body.
Patients who may be exposed
to stress while taking GCS are shown to have their dose increased before,
during, and after the stressful situation. Such patients should be under strict
medical supervision due to the possible development of adrenal insufficiency.
During GCS therapy, some
infections may be latent, and new infections may develop. When taking GCS,
resistance to infections may decrease, and the body's ability to localize the
infectious process may decrease. The development of infections caused by
various pathogenic organisms, such as viruses, bacteria, fungi, protozoa or
helminths, which are localized in various systems of the human body, can be
associated with the use of GCS, both as monotherapy and in combination with
other immunosuppressants that affect cellular immunity, humoral immunity or
neutrophil function. These infections may not be severe, but in some cases they
may be severe and even fatal. The higher the doses of GCS used, the higher the
likelihood of developing infectious complications.
The use of hydrocortisone in active tuberculosis should be limited to
cases of fulminant and disseminated tuberculosis, when GCS are used to treat
the disease in combination with appropriate anti-tuberculosis chemotherapy. If
GCS is prescribed to patients with latent tuberculosis or with positive
tuberculin tests, then treatment should be carried out under strict medical
supervision, since reactivation of the disease is possible. During long-term
therapy with the drug, such patients should receive appropriate preventive
treatment. Patients receiving immunosuppressant doses of GCS are
contraindicated from receiving live or live-attenuated vaccines, but killed or
inactivated vaccines may be administered, although the response to such
vaccines may be reduced. Patients receiving non-immunosuppressant doses of GCS
may be immunized as indicated.
Hydrocortisone administration may result in increased blood pressure,
water and salt retention, and increased potassium excretion. It may be
necessary to limit dietary salt intake and administer additional potassium
supplements. All GCS increase calcium excretion. Since anaphylactoid reactions
(eg, bronchospasm) may rarely occur in patients receiving parenteral GCS
therapy, appropriate preventive measures should be taken before administration,
especially if the patient has a history of allergic reactions to any drugs.
With prolonged daily therapy with GCS in children, growth retardation may
occur, so this dosage regimen should be prescribed to children only if there
are serious indications. Acute myopathy most often develops with the use of
high doses of GCS in patients with impaired neuromuscular transmission (eg,
myasthenia gravis), or in patients receiving concomitant treatment with
peripheral muscle relaxants (eg, pancuronium). Such acute myopathy is
generalized in nature, can affect the muscles of the eye and respiratory
system, and lead to the development of tetraparesis. Increased creatine
phosphokinase levels are possible. However, improvement or recovery after
discontinuation of GCS may occur only after many weeks or even several years.
Influence on the ability to drive vehicles and machinery
After treatment
with corticosteroids, adverse effects such as visual impairment, muscle
weakness, syncope, vertigo, mood changes (euphoria and depression) and seizures
may develop, which may affect the ability to drive vehicles and operate other
mechanisms. If the above effects are present, patients should not drive
vehicles or operate other mechanisms.
Use during pregnancy and
breastfeeding
Contraindicated in the first
trimester of pregnancy. Subsequently, the drug is prescribed only in cases
where the benefit of use for the mother outweighs the risk of negative
consequences for the fetus.
Corticosteroids are excreted in
milk, so breastfeeding should be discontinued during treatment.
Interaction with
other medicinal products
Caution is required when co-administering:
with barbiturates, phenylbutazone,
phenytoin and rifampicin (the effect of corticosteroids may decrease);
with oral antidiabetic agents
(their dose must be adjusted taking into account the hyperglycemic effect of
corticosteroids);
with anticoagulants (increased or
decreased anticoagulant effect);
with salicylates (may decrease the
level of salicylates in plasma, causing latent gastrointestinal bleeding or the
possibility of ulcers);
with amphotericin, diuretics,
theophylline, cardiac glycosides (increased risk of hypokalemia);
with oral contraceptives (increased
concentration of corticosteroids in the blood);
with antihypertensive drugs
(corticosteroids reduce the effectiveness of antihypertensive drugs); with mephipristone (the effectiveness of corticosteroids decreases).
Side effect
Infections and infestations: opportunistic infections, latent infections,
infectious diseases (exacerbations of infection, including reactivation of
tuberculosis).
Neoplasms benign, malignant and unspecified
(including cysts and polyps): Kaposi's sarcoma,
pheochromocytoma crisis.
From the blood and lymphatic system: leukocytosis.
From the immune system: hypersensitivity reactions, anaphylactic
reactions, anaphylactoid reactions.
From the endocrine system: Cushing's syndrome, panhypopituitarism, steroid
withdrawal syndrome.
From metabolism and nutrition: metabolic acidosis, sodium retention, fluid
retention, hypokalemic alkalosis; dyslipidemia, impaired glucose tolerance;
increased need for insulin (or oral antidiabetic drugs in diabetes mellitus),
worsening of existing diabetes mellitus, lipomatosis, increased appetite (which
may lead to weight gain).
From the psyche: affective disorders (including depression,
euphoria, affective lability, drug dependence, suicidal ideation), psychotic
disorders (including mania, delusions, hallucinations and schizophrenia),
mental disorders, personality changes, anxiety, confusion, mood swings;
pathological behavior, insomnia, irritability, exacerbation of existing
psychotic behavior.
From the nervous system: epidural lipomatosis, increased intracranial
pressure, benign intracranial hypertension, seizures, amnesia, cognitive
impairment, dizziness, headache.
From the visual organs: central serous chorioretinopathy; cataract,
glaucoma, exophthalmos, blurred vision (see section "Features of
use").
From the organs of hearing and balance: vertigo.
From the cardiovascular system: congestive heart failure (in patients with a
tendency to it), thrombosis, arterial hypertension and hypotension.
From the respiratory system, organs of the chest
and mediastinum: pulmonary embolism,
gasping syndrome, hiccups.
From the gastrointestinal tract: peptic ulcer disease (with possible perforation
and bleeding), intestinal perforation, gastric bleeding, pancreatitis,
esophagitis, bloating, abdominal pain, diarrhea, dyspepsia, nausea.
From the skin and subcutaneous tissue: angioedema, hirsutism, petechiae, ecchymosis,
skin atrophy, erythema, hyperhidrosis, striae on the skin, rash, itching,
urticaria, acne, skin pigmentation.
From the musculoskeletal system and connective
tissue: muscle weakness,
myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fractures,
neuropathic arthropathy, arthralgia, growth retardation.
From the reproductive system and mammary glands:
irregular menstrual
cycle.
General disorders and reactions at the injection
site: impaired recovery,
peripheral edema, fatigue, weakness, reactions at the injection site.
If any of the side effects listed in the
instructions worsen, or you notice any other side effects not listed in the
instructions, tell your doctor.
The clinical syndrome of acute drug overdose has not
been described. Repeated frequent use of the drug (daily or several times a
week) over a long period of time may lead to the development of Cushing's
syndrome.
In case of overdose, symptomatic and supportive
treatment should be carried out.
There is no specific antidote. Hydrocortisone is
removed by dialysis.
Storage conditions
Store in a dry place at a temperature not exceeding
30°C.
Keep out of reach of children!
Shelf life
3 years. Do not use after the expiration date stated
on the package.
Vacation conditions
By prescription.
Release form
1 bottle with powder for solution preparation and 1 ampoule with solvent together with instructions for use in a cardboard box.