Hydrocortisone suspension 125mg/5ml 5ml #1

Hydrocortisone suspension instruction

You can buy Hydrocortisone suspension here

Release form, composition and packaging
Suspension for injection white or almost white, with a characteristic odor.
1 ml of 1 fl.
hydrocortisone acetate 25 mg 125 mg
lidocaine hydrochloride 5 mg 25 mg
Excipients: propyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium chloride, sodium phosphate, sodium dihydrogen phosphate, povidone, polysorbate 80, N, N-dimethylacetamide, water d / i.
5 ml - bottles of colorless glass (1) - packs cardboard.

pharmachologic effect

Hydrocortisone suspension - glucocorticosteroid agent, has anti-inflammatory effect. It inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, reduces the intensity of arachidonic acid metabolism and the synthesis of prostaglandins. Activates steroid receptors, induces the formation of lipocortins, which have anti-edema activity. Reduces inflammatory cell infiltration, prevents the migration of leukocytes and lymphocytes at the site of inflammation. In large doses inhibits the development of lymphoid and connective tissue. Reducing the number of mast cells, reduces the formation of hyaluronic acid; inhibits hyaluronidase, reduces capillary permeability.
Designed for intramuscular injection, intra-and periarticular injection, with the aim of providing systemic or local anti-inflammatory, as well as antiallergic action. With intra-articular administration, the therapeutic effect occurs within 6-24 hours and lasts for several days or weeks.
Lidocaine - a local anesthetic with membrane stabilizing effect, in a short time has an anesthetic effect.

Pharmacokinetics

With intraarticular and periarticular injection, hydrocortisone penetrates the systemic circulation. Communication with protein> 90%. It is metabolized in the liver to tetrahydrocortisone and tetrahydrocortisol, which are excreted by the kidneys in conjugated form. It penetrates the placental barrier.
Absorption of GCS after intra-articular injection or introduction into soft tissues is slow.
After the / m injection, the suspension is absorbed slowly, which provides a prolonged action.
Lidocaine is well absorbed from the mucous membranes and the damaged surface of the skin, has a high affinity with plasma proteins. Metabolized mainly in the liver. T1 / 2 1-2 hours. Penetrates into breast milk and through the placental and blood-brain barriers.

Indications for hydrocortisone suspension

- rheumatic diseases associated with arthritis, incl. osteoarthritis in the presence of synovitis (with the exception of tuberculous, gonorrheal, purulent and other infectious arthritis);
- rheumatoid arthritis;
- humeroscapular periarthritis;
- bursitis;
- epicondylitis;
- tendovaginitis.

Contraindications

- an infected joint;
- Itsenko-Cushing syndrome;
- tendency to thrombosis;
- I trimester of pregnancy;
- systemic infection without specific treatment;
- Achilles tendon disease;
- hypersensitivity to the drug.
Intra-articular administration is contraindicated in:
- transferred arthroplasty;
- pathological bleeding (endogenous or caused by anticoagulants);
- intraarticular bone fracture;
- Infectious (septic) arthritis and periarthricular infection (including a history of);
- general infectious disease;
- pronounced periarticular osteoporosis;
- osteoarthritis without synovitis (the so-called "dry" joint);
- unstable joint;
- Aseptic necrosis of the bone-forming epiphyses;
- severe bone destruction and joint deformity (significant narrowing of the joint space, ankylosis).
With caution: gastric ulcer and duodenal ulcer, herpes simplex, herpes simplex of the eye (the possibility of perforation of the cornea), arterial hypertension, diabetes mellitus including family history, osteoporosis (postmenopausal risk of osteoporosis increases), chronic psychotic reactions, history of tuberculosis, glaucoma, steroid myopathy, epilepsy, measles, chronic heart failure, elderly (> 65 years), pregnancy (I-III). lactation period.

Dosage

Intra- and periarticular. In one day, you can enter no more than 3 joints. Repeated injection is possible with a 3-week interval. Introduction directly into the joint may have an adverse effect on hyaline cartilage, therefore, the same joint can be treated no more than 3 times a year.
In case of tendinitis, the injection should be inserted into the vagina of the tendon - it cannot be inserted directly into the tendon. Not acceptable for systemic treatment and for the treatment of Achilles tendon.
Adults: depending on the size of the joint and the severity of the disease, 5-50 mg intra- and periarticular. V / m adult drug is injected deep into the gluteus muscle at a dose of 125-250 mg / day.
Children: 5-30 mg / day, divided into several doses. Single dose with periarticular administration to children aged 3 months to 1 year: 25 mg, from 1 year to 6 years: 25-50 mg, from 6 to 14 years: 50-75 mg.
In elderly patients, the risk of adverse reactions is higher.

Side effects of hydrocortisone suspension

Adverse reactions primarily occur at the injection site, most often in the form of tissue swelling and pain, spontaneously disappear after a few hours. In addition, delayed wound healing, skin atrophy, striae, acne-like rash, itching, folliculitis, hirsutism, hypopigmentation, skin irritation, dry, thin and sensitive skin, telangiectasia are possible.
With long-term treatment and the use of large doses of glucocorticoids and lidocaine, systemic side effects may develop.
On the part of the endocrine system: a decrease in glucose tolerance and an increase in the need for a glucose-lowering drug, manifestation of latent diabetes, steroid diabetes. With long-term treatment - suppression of adrenal function, Itsenko-Cushing syndrome, growth retardation in children and adolescents.
On the part of the digestive system: nausea, vomiting, pancreatitis, peptic ulcer, esophagitis, bleeding and perforation of the gastrointestinal tract, increased appetite, flatulence, hiccups, in rare cases - increased activity of hepatic transaminases and alkaline phosphatase.
Since the cardiovascular system: with significant absorption, lidocaine can cause impaired cardiac conduction and peripheral vasodilation; with large doses of hydrocortisone suspension: increased blood pressure, hypokalemia and its characteristic ECG changes, thromboembolism, heart failure.
On the part of the nervous system: insomnia, irritability, anxiety, agitation, euphoria, epileptiform convulsions, mental disorders, delirium, disorientation, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure with swelling of the optic nerve, dizziness, pseudo sinus, pseudo sinus, pseudo sinus, pseudo mucosal headache.
On the part of the metabolism: increased excretion of potassium, hypokalemia, weight gain, negative nitrogen balance, increased sweating.
On the part of the organ of vision: corneal ulceration, posterior capsular cataract (more likely in children), increased intraocular pressure with possible damage to the optic nerve, secondary bacterial fungal and viral infections of the eye, trophic changes of the cornea, exophthalmos, glaucoma.
On the part of the musculoskeletal system: growth retardation and the process of ossification in children (premature closure of the epiphyseal growth zones), osteoporosis, very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur, rupture of tendons and muscles, steroid myopathy, decrease in muscle mass , arthralgia.
Effects caused by the mineralocorticoid activity of the drug: fluid and sodium retention with the formation of peripheral edema, hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia, muscle spasm, increased weakness, fatigue), hypokalemic alkalosis.
On the part of the immune system: opportunistic infections, exacerbation of latent tuberculosis, hypersensitivity reactions; local and generalized: skin rash, itching, anaphylactic shock, delayed wound healing, a tendency to the development of pyoderma and candidiasis, exacerbation of infections, especially during vaccination and simultaneous treatment with immunosuppressive agents.
Dermatological reactions: petechiae, ecchymosis, hyper- and hypopigmentation, steroid acne, striae, atrophy of the skin and subcutaneous tissue at the injection site (introduction to the deltoid muscle is especially dangerous), folliculitis, hirsutism, hypopigmentation, irritation, telangiectasia.
Other: poor health, withdrawal syndrome (high body temperature, myalgia, arthralgia, adrenal insufficiency), leukocyturia, leukocytosis.
Local reactions: increased pain in the joint when injected into the joint, tissue swelling, burning, numbness, paresthesia at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site.

Overdose

Depending on the dose of GCS and lidocaine, both local and systemic symptoms may appear.
There is no specific antidote. Symptomatic treatment is performed.

Drug interaction

With Addison's disease, simultaneous administration with barbiturates can trigger a crisis. Increases the toxicity of cardiac glycosides (pro-arrhythmic effect of hypokalemia).
Reduces the hypotensive effect of antihypertensive drugs. Accelerates the excretion of acetylsalicylic acid, reducing its concentration in the blood.
With the withdrawal of hydrocortisone suspension, the concentration of salicylates in the blood may increase and lead to the development of adverse reactions. Both drugs have an ulcerogenic effect; their simultaneous use may increase the risk of ulceration and bleeding.
Vaccination with live antiviral vaccines and other types of immunization during treatment with hydrocortisone promote the activation of viruses and the development of infections.
Increases the metabolism of isoniazid, meksiletin, especially in patients with fast acetylators, reducing the plasma concentrations of these drugs.
Enhances the hepatotoxic effect of paracetamol, because induces liver enzymes and the formation of a toxic metabolite of paracetamol.
With prolonged treatment increases the content of folic acid.
Hypokalemia caused by GCS increases the severity and duration of muscle blockade of muscle relaxants.
High doses of hydrocortisone suspension reduce the effect of somatotropin.
Reduces the effectiveness of oral hypoglycemic agents, you may need a dose adjustment.
Reduces or enhances the effect of anticoagulant drugs.
Ergocalciferol and parathyroid hormone prevent the development of glucocorticosteroid osteopathy.
Reduces the concentration of praziquantel in the blood.
Cyclosporine inhibits hydrocortisone metabolism.
Ketoconazole reduces clearance and increases the toxicity of hydrocortisone suspension.
Thiazide diuretics, carbonic anhydrase inhibitors, amphotericin B, theophylline and other corticosteroids increase the risk of hypokalemia.
Sodium-containing drugs contribute to the formation of edema and increase blood pressure.
NSAIDs and ethanol contribute to ulceration of the gastrointestinal mucosa and the development of bleeding. In the treatment of arthritis with hydrocortisone in combination with NSAIDs, the dose of hydrocortisone should be reduced in order to avoid an additive therapeutic effect.
Indomethacin, displacing hydrocortisone suspension from its association with proteins, contributes to the development of side reactions of the latter.
Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.
Phenytoin, barbiturates, ephedrine, theophylline, phenylbutazone, rifampicin, and other inducers of microsomal liver enzymes reduce the effect of hydrocortisone suspension, increasing its metabolism.
With simultaneous use of mitotane and other inhibitors of the adrenal cortex, it may be necessary to increase the dose of hydrocortisone suspension.
Drugs - thyroid hormones increase the clearance of hydrocortisone suspension.
Immunosuppressive drugs increase the risk of developing infections, lymphomas and lymphoproliferative processes caused by Epstein-Barr virus.
Estrogens, including oral estrogen-containing contraceptives, reduce the clearance of hydrocortisone suspension, extending the half-life and enhancing the therapeutic and toxic effects of the latter.
Simultaneous use with other steroid hormonal agents (androgens, estrogens, anabolics, oral contraceptives) contributes to the development of acne and hirsutism.
It is not recommended to use tricyclic antidepressants for the treatment of hydrocortisone-induced depression, since they can aggravate the course of depression.
Simultaneous reception with M-holinoblokatorami, incl. antihistamines, tricyclic antidepressants and nitrates, promotes an increase in intraocular pressure.
The action of corticosteroids weakens when taken with mifepristone.

special instructions for Hydrocortisone suspension

The injection is administered while observing the asepsis rules in order to avoid the development of bacterial contamination.
During treatment, any vaccination is contraindicated, because during treatment with corticosteroids, especially in large doses, can lead to insufficient antibody synthesis.
During treatment, a diet with sodium restriction, a high content of potassium and the provision of a sufficient amount of protein in food is recommended.
It is necessary to control blood pressure, measure blood glucose, blood clotting, monitor urine and feces.
Relative adrenal insufficiency that occurs after the end of the GCS can persist for several months after discontinuation of the drug, therefore, in a state of heightened stress, hormone therapy should be resumed with the simultaneous appointment of mineral corticosteroids and salts.
Children whose mothers received hydrocortisone suspension during pregnancy should be carefully monitored to detect signs of adrenal insufficiency.
In the case of latent tuberculosis and during the turn of tuberculin samples, careful monitoring of the patient’s condition and, if necessary, chemoprophylaxis are necessary.
GCS slow down the growth and development of children and adolescents. It is recommended to prescribe the drug in the least therapeutic doses and, if possible, within the least short term.

Pregnancy and lactation

For pregnant women in the first trimester, the drug is contraindicated due to the lack of sufficient data on the safety of the drug in this group, at a later date - possible only after careful weighing of the intended benefits to the mother and the potential risk to the fetus (the probability of formation of a split palate and intrauterine disorders is small). In the II-III trimesters of pregnancy prescribed with caution. Children whose mothers received hydrocortisone during pregnancy should be carefully monitored to detect signs of adrenal insufficiency.
Use with caution during lactation.
The use of the drug during lactation can lead to dysfunction of the adrenal glands and the development of infants, because glucocorticosteroids and lidocaine enter breast milk.

Use in childhood

Children: 5-30 mg / day, divided into several doses. Single dose with periarticular administration to children aged 3 months to 1 year: 25 mg, from 1 year to 6 years: 25-50 mg, from 6 to 14 years: 50-75 mg.
Possible growth retardation and ossification processes in children and adolescents (premature closure of the epiphyseal growth zones). It is recommended to prescribe the drug in the least therapeutic doses and, if possible, within the least short term.

In case of impaired renal function

Data on the use of the drug in patients with impaired renal function is not provided.

With abnormal liver function

Data on the use of the drug in patients with impaired liver function is not provided.

Use in old age

In elderly patients, the risk of side effects is higher.

Terms and conditions of storage

Store in original packaging at a temperature of 15-30 ° C in a dark place and out of reach of children.
Shelf life - 2 years.
Do not use beyond the expiration date printed on the package.

Terms of sell

You don't need a prescription to buy Hydrocortisone suspension.