The instruction for medical use
the Hydrocortisone Richter
the Trade name
the Hydrocortisone Richter
the International unlicensed name
Is not present
the Dosage form
Suspension microcrystalline for injections, 5 ml
One bottle contain
active agents – Hydrocortisoni acetas of 125 mg,
lidocaine of a hydrochloride of 25 mg
excipients: propilparagidroksibenzoat, methyl – parahydroxybenzoate, sodium chloride, phosphate dinatrium dodecahydrate, dihydrophosphate sodium a dihydrate, povidone, polysorbate 80, N, N-dimetilatsetamid, water for injections.
White or almost white, easily resuspended when stirring, suspension with a characteristic smell
of Kortikoida for system use. Glucocorticoids a combination for system use.
The ATX H02BX code
Pharmacokinetics At properties local use, a hydrocortisone can be soaked up and have systemic action. In a system blood-groove of 90% of a hydrocortisone is in the state connected with proteins. The hydrocortisone gets through a placental barrier. The hydrocortisone is metabolized in a liver with formation of a tetrahydrocortisone and tetrahydrocortisol, these derivatives are allocated with urine in the form of conjugates.
In researches of reproductive toxicity the fetotoksichesky effect of drug, development of malformation (crevice of a hard palate) and growth delay is established. In spite of the fact that at clinical use of drugs the toxic action was not noted, long reception of corticosteroids can be connected with increase in risk of a delay of pre-natal development.
Lidocaine is quickly soaked up from mucous membranes and the injured skin. In a system blood-groove drug actively contacts proteins, time of semi-removal of drug is 1 – 2 hour. Lidocaine is metabolized mainly in a liver. Drug gets through a placental and blood-brain barrier and is emitted with breast milk.
the Hydrocortisone is steroid hormone with low glucocorticoid and anti-inflammatory action. Lidocaine – local anesthetic of membrane stabilizing action with fast development of anesthesia.
– osteoarthroses with damage of several joints (knee, elbow, coxofemoral), monoarthroses
– rheumatic arthritises and arthritises of other genesis (except for tubercular and gonorrheal)
– a humeroscapular periarthrosis
– a bursitis, an epicondylitis, a tendovaginitis
– preoperative preparation of the ankylosed joints, addition to system therapy with corticosteroids
the Route of administration and doses
Adult: from 5 to 50 mg intra- and periartrikulyarno, depending on the size of a joint and disease severity.
Children: from 5 to 30 mg a day in several introductions.
Elderly: prescribing of steroids at elderly patients requires special attention, in view of increase in a likelihood of development of side reactions on drug with age.
In one day it is possible to administer the drug no more, than in 3 joints, repeated administration of drug is possible at observance of a 3-week interval. Intra articulate administration of drug can cause injury of a hyaline cartilage, the maximum frequency of introduction to one joint is 3 times a year. Administration of drug directly in a sinew is contraindicated, in a tendinitis, the drug has to be administered in a tendinous vagina. Drug should not be used for treatment of damages of the Achilles tendon. Drug is not shown for system introduction.
The side effects
Given about the frequency of development of side reactions are not available.
– pain, puffiness (these reactions regress independently within several hours)
– slow healing of wounds of skin, an atrophy of skin, a striya, acneform rash, peeling, a folliculitis, a hirsutism, hypopigmentation, irritation, dryness, thinning and hypersensitivity of skin, a telangiectasia
– when using high doses and/or at long introduction, a hydrocortisone and lidocaine can be soaked up in the quantities sufficient for development of system effects
– oppression of bark of adrenal glands (when assigning in high doses and/or long use)
– disorders of food and disbolism
– disturbance of tolerance to glucose and increase in a necessary dose of oral glucose-lowering drugs
– a delay of sodium and water, decrease in potassium concentration, a gipokaliyemichesky alkalosis, a leukocytosis
– osteoporosis, a growth inhibition at children, development of a steroid myopathy and an aseptic osteonecrosis
– increase in appetite, nausea, the general weakness, development of round ulcers (in some cases with perforation and bleeding), gastric bleedings, pancreatitis, an esophagitis
– increase in intracranial pressure with the subsequent edematization of a nipple of an optic nerve, spasms, dizzinesses, a headache, insomnia, mental disturbances
– a keratohelcosis, increase in intraocular pressure, glaucoma, an exophthalmos, increase in risk of a cataract at patients of children’s age
– development of disturbances of intracardial conductivity and peripheral vasodilation, hypertensia, heart failure
– a thrombembolia
– opportunistic infections, exacerbation of latent tuberculosis
After the termination of administration of steroids develop cancellation symptoms: fever, myalgia, arthralgia, adrenal insufficiency.
– hypersensitivity to active ingredient or excipients of drug
– intra articulate infections
– Cushing’s Syndrome
– predisposition to venous fibrinferments
– sepsis without adequate antibiotic treatment
– treatment of injury of the Achilles tendon
– pregnancy and the period of a lactation
In the Adissonovy disease is contraindicated co-administration of a hydrocortisone and barbiturates as it can provoke adrenal crisis.
The special attention at co-administration with the following drugs is required:
– barbiturates, phenylbutazone, Phenytoinum, rifampicin – these drugs can reduce efficiency of corticosteroids
– oral glucose-lowering drugs (for correction of hyper glycemic action of kortikostreroid the modification of a dose of drug can be required)
– the concomitant use of corticosteroids can both raise, and to reduce efficiency of anticoagulants
– at cancellation of corticosteroids the increase in concentration of salicylates, in some cases with development of intoxication can be noted. As salicylates and corticosteroids possess ulcerogenic action, their concomitant use increases risk of formation of ulcers and development of gastrointestinal bleeding
– a combination with Amphotericinum, diuretics, theophylline, digoxin, cardiac glycosides – can increase risk of development of a hypopotassemia,
– reception of oral contraceptives can increase serumal concentration of corticosteroids
– antihypertensive drugs – glucocorticoids reduce efficiency of antihypertensive therapy
– mifepristone reduces efficiency of corticosteroids
Intra articulate introduction of corticosteroids is followed by significant increase in risk of the inflammatory answer of tissues of joint, including development of a bacterial infection at infection. Therefore, especially careful observance of rules of an asepsis at intra articulate administration of steroid drugs is required.
During treatment by corticosteroids (especially in a high dose) performing vaccination, in connection with a possibility of insufficient products of antibodies and increase in risk of neurologic complications is contraindicated. These states can lead to decrease in immunity. Introduction can lead the Hydrocortisone Richter in usual or high doses to increase in arterial blood pressure, a delay of salt and water, and can increase potassium excretion. All corticosteroids increase calcium clearance rate. In latent tuberculosis the Hydrocortisone Richter can be appointed only in a combination with antitubercular drugs. At development of system infections the Hydrocortisone Richter can be appointed only in a combination with specific drugs (for example, antibiotics). Dose adjustment of oral glucose-lowering drugs and anticoagulants at a concomitant use with corticosteroids is necessary. When assigning in a combination with diuretics the control of water and electrolytic balance is required. For prevention of a hypopotassemia the prescribing of drugs of potassium can be required, the absolute indication is long therapy. Purpose of corticosteroids slows down growth at children and teenagers. Therefore purpose of a minimal effective dose and use of courses of the minimum duration is necessary. Drug withdrawal should be carried out after a gradual dose decline. When performing therapy it is necessary to carry out monitoring of arterial blood pressure, the general analysis of urine and to carry out tests a calla on the occult blood. Big frequency of development of undesirable reactions is characteristic of elderly.
When assigning corticosteroids, obligatory monitoring is required in the following cases:
– diabetes (or the family anamnesis of diabetes)
– osteoporosis (especially high risk of a disease characterizes women in a postmenopause)
– chronic psychotic reactions
– tuberculosis in the anamnesis
– glaucoma, a steroid myopathy
– ulcer of stomach or duodenum
– a herpes simplex or eye herpes (in connection with risk of perforation of a cornea), chicken pox.
Pregnancy and the period of a lactation
Reception can be followed by small risk of the birth of the child with a crevice of a hard palate and a delay of pre-natal development.
The hydrocortisone and lidocaine get into breast milk. Corticosteroids can have negative impact on function of adrenal glands and cause growth disorder.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Hydrocortisone Richter suspension for injections does not affect ability to run vehicles and to work with mechanisms.
Symptoms: depending on quantity of the soaked-up corticosteroids and lidocaine, both local, and system disturbances can develop.
Treatment: there is no specific antidote. Symptomatic treatment is shown.
The form of release and packing
On 5 ml of drug place in the bottle of the I type from transparent colourless glass which is hermetically corked by a gray rubber brombutilovy bung, pressed out by the combined aluminum cap with a polypropylene disk (flipp-off).
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature from 15 °C to 30 °C in the place protected from light.
To store out of children’s reach!
not to use a period of storage after expiry date.
According to the prescription
the Name and the country
of the JSC Gideon Richter manufacturing organization,
1103 Budapest, Dyomryoi St., 19-21, Hungary
the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Representative office of JSC Gideon Richter in RK E-mail: firstname.lastname@example.org: 8 (727) 258-26-22, 8 (727) 258-26-23
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