Active ingredients: Dexamethasone
Soldesam 0.2% Oral drops
Soldesam package inserts are available for packs:- Soldesam 0.2% Oral drops
- Soldesam 0.2% Ointment
- Soldesam 4mg / 1ml Injectable Solution
- Soldesam 8mg / 2ml Injectable Solution
Why is Soldesam used? What is it for?
Pharmacotherapeutic group:
Corticosteroid for systemic use.
Therapeutic indications:
anti-inflammatory and anti-allergic corticotherapy, degenerative and post-traumatic osteoarthritis, chronic developmental polyarthritis, ankylosing spondylarthritis, asthmatic states, dermatitis and allergic dermatoses and in all those cases in which corticoid therapy is required.
Contraindications When Soldesam should not be used
- hypersensitivity to the active substance or to any of the excipients
- systemic fungal infections, systemic bacterial infections, except in cases where specific anti-infective therapy is in progress
- Local injections in the:
- bacteremia
- systemic fungal infections
- unstable joints
- infections at the injection site, for example in septic arthritis secondary to gonorrhea or tuberculosis or tuberculosis,
- peptic ulcer,
- psychosis,
- ocular herpes simplex.
Precautions for use What you need to know before taking Soldesam
The maintenance posology must always be the minimum capable of controlling the symptoms; a dosage reduction must always be done gradually.
Precautions should be taken when treating patients with acute and chronic infections. Corticosteroids can mask some signs of infection and during their use there may be intercurrent infections and the tendency, on the part of infectious processes, not to localize. In these cases, the opportunity to institute adequate antibiotic therapy must always be evaluated.
Additionally, corticosteroids can affect the nitroblutetrazole test for bacterial infections and cause false negative results. Corticosteroids can activate latent amoebiasis. Therefore it is recommended to ascertain that no latent or active amoebiasis is present before initiating corticosteroid therapy in patients who have been in the tropics or in patients with diarrhea.
Corticosteroids can exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless needed to control drug reactions due to "amphotericin B. D". concomitant amphotericin B and hydrocortisone was followed by congestive cardiac hypertrophy.
Suppression of both the inflammatory response and immune function increases susceptibility to infections and their severity. The clinical picture may be unusual and serious infections such as septicemia and tuberculosis may be masked and may reach advanced staging before being diagnosed.
Cases of tumor lysis syndrome have been reported very rarely in patients with malignant haematological diseases following administration of dexamethasone alone or in combination with other chemotherapeutic agents. People at risk of developing tumor lysis syndrome should be monitored closely to prevent such an occurrence
Psychic alterations may occur during treatment with corticosteroids ranging from euphoria, insomnia, mood changes, personality alterations, severe depression, to real psychotic manifestations. When present, psychic instability and psychotic tendencies can be aggravated by corticosteroids. Intra-articular injection of a corticosteroid can cause both systemic and local effects. The presence of fluid in the joints requires appropriate examinations, in order to exclude septic processes. A marked increase in pain - accompanied by local edema, further limitation of joint mobility, fever and general malaise - suggests the presence of "septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, an appropriate" should be instituted. anti-infectious therapy.
The lowest possible dose of corticosteroids should be used to control the disease and, when dose reduction is possible, this should be done gradually. During prolonged therapy, an anti-ulcer regimen including an antacid may be appropriate as a precaution.
Medium or high doses of hydrocortisone or cortisone can cause increased blood pressure, water and salt retention, or excessive potassium depletion. Such effects are less likely to occur with synthetic derivatives unless they are administered in high doses. A low-salt diet and potassium supplements may be needed. All corticosteroids increase calcium excretion.
In patients under corticosteroid therapy exposed to considerable stress, an increase in the dosage of fast-acting corticosteroids is indicated, before, during and after the stressful situation. The slower absorption rate caused by intramuscular administration should be taken into account.
A "secondary adrenocortical insufficiency induced by the drug can be minimized by gradually reducing the posology. This type of relative insufficiency may however persist for a few months after discontinuation of therapy; in any stressful situation that occurs during this period, it is therefore advisable to reinstate the drug. hormonal therapy If the patient is already under steroid treatment, an increase in dosage may be necessary Since the secretion of mineralocorticoids may be inadequate, the simultaneous administration of salts and / or a mineralocorticoid is advisable.
Appropriate antimicrobial therapy should be associated with glucocorticoid therapy when necessary such as in viral and fungal ocular infections.
Chickenpox is of particular concern because this usually mild disease can be fatal in immunosuppressed patients. Patients (or parents of the child) without amnestic confirmation of the disease should avoid contact with people with chickenpox or shingles and should seek urgent medical attention if exposed. Passive immunization with varicella zoster immunoglobulin (VZIG) is required in exposed non-immunized patients who are on systemic treatment with corticosteroids or who have used corticosteroids within the past 3 months; Treatment should be started within 10 days of exposure to the chickenpox virus. Upon confirmation of the diagnosis of chickenpox, the disease requires specialist care and urgent medical therapy. Corticosteroids should not be discontinued and the dosage may also be increased.
Patients should be advised to avoid exposure to measles virus and in case of exposure to obtain appropriate and urgent medical advice; Intramuscular immunoglobulin prophylaxis may be required.
Live vaccines should not be given to individuals with an insufficient immune response. The antibody response to other vaccines may be reduced.
In chronic treatment, adrenal cortical atrophy develops and can persist for years after discontinuation of therapy.
In patients who have received higher than physiological doses of systemic corticosteroids (approximately 1 mg dexamethasone) for more than 3 weeks, treatment discontinuation cannot occur abruptly. Gradual dose reduction depends on the risk of disease recurrence, clinical assessment of disease activity during treatment discontinuation, and the potential and degree of HPA axis suppression. Upon reaching the 1 mg daily dose, dose reduction it must take place more slowly to allow the HPA to recover full efficiency.
Abrupt discontinuation of dexamethasone dosages up to 6 mg / day for treatments lasting up to 3 weeks is unlikely to result in clinically relevant suppression of the HPA axis, however, there are some patient groups in which a gradual discontinuation of therapy is appropriate. also for therapy courses lasting 3 weeks or less. For example, in patients receiving repeated systemic corticosteroid treatments, in patients treated with short-term therapy within one year of cessation of chronic therapy, in patients with other disorders responsible for adrenal insufficiency, in patients treated with daily doses up to 6 mg dexamethasone and in chronically treated patients with evening dosages.
A sudden drop in corticosteroid dosage after prolonged treatment can cause acute adrenal insufficiency, hypotension and death. Withdrawal of corticosteroids after chronic therapy can cause symptoms (corticosteroid withdrawal syndrome) such as fever, myalgia, arthralgia, rhinitis, conjunctivitis, itchy and painful skin nodules and weight loss. These symptoms can occur in patients even without symptoms of adrenal insufficiency.
During chronic treatment, any intercurrent illness, trauma or surgery requires a temporary increase in dosage; if the corticosteroid has been discontinued after prolonged therapy, treatment may need to be temporarily resumed.
Patients must always have with them a health card that reports the steroid therapy in progress in order to have clear guidelines on the precautions to be taken to reduce any risk, with the indication of the prescriber, the medicine, the dosage and the duration of the treatment.
Occasionally there have been reports of anaphylactic reactions in patients treated with systemic cortecosteroids such as edema of the glottis, urticaria and bronchospasm particularly where the patient's clinical history confirms allergic forms to different drugs. When such reactions occur, the following are recommended. procedures: immediate and slow intravenous injection of adrenaline, intravenous administration of aminophylline and, if necessary, artificial respiration.
Corticosteroids should not be used in the management of brain damage or stroke as their clinical usefulness is uncertain and even dangerous for the patient.
Corticosteroids can suppress responses to skin tests. Patients should not be vaccinated against smallpox during corticosteroid therapy. Other immune procedures should not be implemented in patients treated with corticosteroids, especially at high doses, given the danger of neurological complications and a lack of antibody response.
In the presence of hypoprothrombinemia, acetylsalicylic acid should be used with caution during corticosteroid therapy.
In patients with hypothyroidism or with cirrhosis of the liver, the response to corticosteroids may increase.
Steroids should be used with caution in the presence of: non-specific ulcerative colitis with danger of perforation; abscesses or other pyogenic infections; diverticulitis; recent intestinal anastomoses; active or latent gastric ulcer; kidney failure; hypertension; osteoporosis; myasthenia gravis. Air embolism has been described as a possible complication of hypercortisonism.
In hypothyroid and cirrhotic patients the effects of corticosteroids are more marked. In some patients, steroids can increase or decrease mobility and sperm count.
Particular attention should be paid when evaluating the use of systemic corticosteroids in patients suffering from the following diseases that require careful and frequent patient monitoring:
- Osteoporosis (menopausal women are at higher risk)
- Congestive hypertension or heart failure
- History of severe affective disorders (particularly in prior steroid psychosis)
- Diabetes mellitus (or a positive family history of diabetes)
- History of tuberculosis, because glucocorticoids can induce reactivation
- Glaucoma (or family history of glaucoma) with possible damage to the optic nerves
- Previous myopathy induced by corticosteroids
- Hepatic insufficiency
- Kidney failure
- Epilepsy
- Gastro-intestinal ulcerations
- Migraine
- Some forms of intestinal parasites such as amoebiasis
- Incomplete structural growth because glucocorticoids in chronic treatments can accelerate the sealing of epiphyses
- Patients with Cushing's syndrome
- In the treatment of tendonitis or tenosynovitis, care must be taken in injecting into the space between the linings and the tendon itself, as there have been reports of tendon rupture
- Prolonged use of corticosteroids can cause posterior subcapsular cataracts
- It can favor the onset of secondary ocular infections due to fungi or viruses
- in patients or their first degree family members with a history of severe affective disorders including depression or manic depressive illness or steroid psychosis.
- Patients and / or their carers should be advised of the potential risk of serious psychiatric adverse reactions that may arise following systemic steroid therapy. Symptoms typically appear within a few days or weeks of starting treatment. Risks may be greater with higher dosages after systemic exposure, although dosage levels do not allow for the onset, type, severity, or duration of these. reactions. Recovery of most reactions occurs either after dose reduction or upon discontinuation, although specific treatments may be required. In case of depression, suicidal ideation or after any psychological alert symptom seek medical advice. Psychiatric disorders can arise both during and immediately after dose reduction / discontinuation of systemic steroids, although such reactions have only been reported infrequently.
Interactions Which drugs or foods can modify the effect of Soldesam
Drugs that induce cytochrome P450 3A4 (e.g. barbiturates, phenytoin, carbamazepine, diphenylhydantoin, ephedrine, rifampicin, rifabutin, phenobarbital, phenylbutazone, primidone, aminoglutethimide) may increase the metabolism of corticosteroids and require increased corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests, which should be interpreted with caution when administering these drugs.
Drugs that inhibit cytochrome P450 3A4 (e.g. ketoconazole and macrolides such as erythromycin) may increase plasma concentrations of corticosteroids. Dexamethasone is a moderate inducer of CYP 3A4. Concomitant administration with other drugs that are metabolised by CYP3A4 (e.g. indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentrations. Cardiac dilatation and congestive heart failure may occur with concomitant use of amphotericin B and hydrocortisone.
In myasthenia gravis the effects of anticholinesterases are antagonized by corticosteroids.
The efficacy of coumarin anticoagulants can be enhanced by concomitant corticosteroid therapy.
Prothrombin time and INR should be monitored frequently to avoid spontaneous bleeding in patients receiving corticosteroids and coumarin anticoagulants at the same time, as in some cases corticosteroids have altered the response to these anticoagulants. Some studies have shown that the effect caused usually from the addition of corticosteroids is inhibition of the response to coumarin compounds, although there have been some conflicting reports indicating potentiation. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be closely monitored for the development of hypokalaemia.
Patients should not be vaccinated against smallpox during corticosteroid therapy.
Other immunizing procedures should not be undertaken in patients receiving corticosteroids especially at high doses, due to possible risks of neurological complications and insufficient antibody response.
The therapeutic effects of hypoglycemic agents (including insulin), antihypertensives, cardiac glycosides and diuretics are antagonized by corticosteroids, while the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are increased.
Renal clearance of salicylates is enhanced by corticosteroids, steroid withdrawal may lead to "salicylate intoxication. In patients with hypoprothrombinemia there may be" interaction with salicylates. In addition, concomitant use of acetylsalicylic acid (or other NSAIDs) and corticosteroids may increase the risk of gastrointestinal adverse effects Important information about some of the ingredients The oral drops, solution contain sodium benzoate among the excipients which can cause allergic reactions (including delayed).
Warnings It is important to know that:
Use in children
Children and adolescents undergoing chronic corticosteroid therapy should be carefully monitored for growth and development.
Corticosteroids cause irreversible growth retardation in children and adolescents.
In very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
Preterm infants:
Dexamethasone should not be used routinely in preterm infants with respiratory problems.
Use in the elderly
The common adverse effects of systemic corticosteroid therapy may be associated with more serious consequences in the elderly, particularly osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infections and skin thinning. Close clinical supervision is required to avoid fatal reactions.
For those who play sports: the use of the drug without therapeutic need constitutes doping and can in any case determine positive anti-doping tests
Pregnancy
Since adequate studies on corticosteroids in relation to human reproduction are not yet available, the use of these drugs in pregnant women, or in women of childbearing age requires that the possible risks and advantages deriving from the drug for the mother and for the child be carefully evaluated. fetus.
Babies born to mothers who have been treated with substantial doses of corticosteroids during pregnancy must undergo careful checks to ascertain any signs of hypoadrenalism.
As with all medications, corticosteroids should only be prescribed if the benefits to the mother outweigh the risks to the fetus.
The ability of corticosteroids to cross the placenta varies between drug groups, however, dexamethasone readily crosses the placenta.
Feeding time
Corticosteroids have been found in breast milk, although specific data for dexamethasone are not available, and may arrest growth, interfere with the production of endogenous corticosteroids or cause other side effects. Infants of mothers treated with high doses of systemic corticosteroids and for prolonged periods may exhibit some degree of adrenal suppression.
Mothers undergoing corticosteroid therapy should be advised not to breastfeed.
Effects on ability to drive and use machines:
It does not affect the ability to drive and the use of machines.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Dosage and method of use How to use Soldesam: Dosage
Posology, method and frequency of administration
to be adapted according to the case and the therapeutic response.
It should be emphasized that dosage needs are variable and must be individualized on the basis of the disease to be treated and on the basis of the patient's response.
Indicatively, treatment can be started by administering from 2 to 5 mg distributed in 3 daily doses to be taken dissolved in water, shaking before ingesting. As soon as an improvement occurs, gradually decrease the dosage to the minimum therapeutically active dose which can vary from 0.25 to 2 mg per day.
Indicative scheme of dosages:
1 ml = 32 drops = 2 mg 32 drops = mg 2 28 "= mg 1.75 24" = mg1.5 20 "= mg 1.25 16" = mg1 12 "= mg 0.75 8" = mg0.5 4 "= 0.25 mg 2" = 0.125 mg 1 "= 0.0625 mg
Duration of treatment:
constant control and adaptation of the drug dosage is necessary. If, after prolonged therapy, the administration has to be interrupted, the dosage reduction must always be done gradually.
Overdose What to do if you have taken too much Soldesam
in case of overdose the following symptoms occur: obesity, muscle atrophy, osteoporosis, hypertrichosis, purpura, acne (clinical symptoms); excitation, agitation (neuropsychic symptoms), blood glucose, hyperglycemia, hypokalaemia (biological symptoms), Cushing's syndrome, stunting in children. In case of overdose, discontinue administration by progressive dose decreases.
For further information on the use of the medicinal product, contact your doctor or pharmacist
Side Effects What are the side effects of Soldesam
During cortisone therapy, especially for intense and prolonged treatments, some of the following effects may occur:
Metabolism and nutrition disorders: sodium retention; water retention; potassium depletion; hypokalemic alkalosis; impaired tolerance to carbohydrates; patenting of diabetes mellitus; increased need for insulin or oral hypoglycemic agents in diabetic patients. Protein catabolism with negative nitrogen balance, while in prolonged treatments, the protein ratio must be appropriately increased, increase in body weight and increase in appetite. Increase in calcium excretion .
Alterations of the hydro-electrolytic balance which, rarely and in particularly predisposed patients, can lead to hypertension and congestive heart failure;
Cardiac Disorders: In susceptible patients congestive heart decompensation congestive heart failure in predisposed individuals There are reports of cardiac arrhythmias and / or circulatory collapses following rapid administration of high doses of intravenous corticosteroids.
Disorders of the blood and lymphatic system: decrease in lymphatic tissue, leukocytosis.
Vascular disorders: Hypertension, hypotension or shock-like reaction, thromboembolism, hematoma.
Musculoskeletal and connective tissue disorders: muscle asthenia; steroid myopathy; reduction in muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of the femoral head and humerus; growth arrest in children and adolescents. Painless destruction of the joint (reminiscent of Charcots' arthropathy especially after repeated intra-articular injections), premature sealing of the epiphyses, avascular osteonecrosis, proximal myopathy . Growth arrest in children and adolescents. Spontaneous long bone fractures; tendon ruptures, bone fragility, exacerbation after intra-articular injection
Injury, poisoning and procedural complications: Compression fractures of the vertebrae, damage, poisoning and procedural complications such as tendon rupture.
Gastrointestinal pathologies: gastric ulcer with possible perforation and haemorrhage; intestinal perforations, particularly in patients with inflammatory intestinal pathologies; pancreatitis; abdominal distension; ulcerative esophagitis, nausea, malaise, dyspepsia.
Skin and subcutaneous tissue disorders: delayed wound healing; thin and delicate skin; reactions resulting from skin tests can be inhibited; petechiae and bruising; erythema; increased perspiration; burning and itching, especially in the perineal region (after intravenous injection); other skin reactions such as allergic dermatitis, hives, angioneurotic edema, hyperpigmentation or hypopigmentation; hirsutism, telangiectasia, striae and acne, skin and subcutaneous atrophy. sterile abscesses.
Psychiatric disorders: euphoria, insomnia, mood and personality changes, suicidal thoughts, severe depression, mania, delusions, hallucinations and aggravation of schizophrenia, irritability, anxiety, confusion, psychological dependence, symptoms of real psychosis, amnesia. pre-existing emotional instability or psychotic tendencies can be aggravated by corticosteroids.
Nervous system disorders: convulsions; increased intracranial pressure with papilledema in children (pseudotumor cerebri), usually after discontinuation of treatment; cognitive dysfunction, amnesia, aggravation of epilepsy.
Endocrine disorders: Suppression of the hypothalamic-pituitary-adrenal axis; cushingoid state; growth arrest in children; lack of adrenocortical and secondary pituitary response, especially during periods of stress due to trauma, surgery or serious illness.
Reduced tolerance to carbohydrates; manifestations of latent diabetes mellitus; increased need for insulin or oral hypoglycemic agents in diabetic patients, suppression of the hypothalamus-pituitary-adrenal axis; cushingoid state;
Reproductive system and breast disorders: menstrual cycle irregularities and amenorrhea; a momentary burning or tingling sensation in the perineal area after intravenous injection of high doses of phosphate corticosteroids.
Hepatobiliary disorders: increased levels of liver enzymes (in most cases reversible after discontinuation of treatment).
Eye disorders: posterior subcapsular cataract; increased intraocular pressure; glaucoma; exophthalmos, papilledema, corneal or scleral thinning. Rare cases of blindness associated with intra-lesional therapy in the face and head.
Infections and infestations: increased susceptibility and severity of infections (with the suppression of symptoms and clinical signs), opportunistic infections, patent tuberculosis, exacerbation of viral or mycotic ophthalmic diseases, candidiasis.
Blood and lymphatic system disorders: Decreased lymphatic tissue, leukocytosis.
Immune system disorders: Anaphylactic or hypersensitivity reactions, reduced immune response, reduced response to vaccinations and skin tests.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
To be used under the personal supervision of the physician
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store at a temperature not exceeding 30 ° C.
Storage conditions after opening: After first opening the bottle: 60 days. After this period, the residual medicinal product must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Composition and pharmaceutical form
Composition: 100 ml of solution contain:
Active ingredient: dexamethasone sodium phosphate 200 mg
Excipients: sodium benzoate, propylene glycol, sodium dihydrogen phosphate dihydrate, sodium saccharin, hydroxypropylbetacyclodextrin, sodium EDTA, sodium hydroxide, purified water.
Pharmaceutical form and content:
oral drops - solution - glass bottle with dropper of 10 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SOLDESAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION -1 ampoule of 1ml contains: Active ingredient dexamethasone sodium phosphate 4 mg.
SOLDESAM 8MG / 2ML SOLUTION FOR INJECTION -1 ampoule of 2 ml contains: Active ingredient dexamethasone sodium phosphate 8 mg.
SOLDESAM 0.2% ORAL DROPS, SOLUTION -100 ml of oral drops contain: Active ingredient dexamethasone sodium phosphate 200 mg.
EXCIPIENTS: sodium benzoate
SOLDESAM 0.2% Ointment -100 g of ointment contain: Active ingredient: dexamethasone sodium phosphate 200 mg.
EXCIPIENTS: Cetyl alcohol
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
• injectable solution
• oral drops-solution
• ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
SOLDESAM 4MG / 1ML INJECTABLE SOLUTION: anti-inflammatory corticotherapy, degenerative and post-traumatic osteoarthritis, inflammatory arthritis, chronic developmental polyarthritis, ankylosing spondylarthritis, asthmatic attacks.
SOLDESAM 8MG / 2ML INJECTABLE SOLUTION: cerebral edema, cerebral neoplasms, (as adjuvant), various states of emergency and shock: edema of the glottis, posttransfusion reactions, anaphylaxis, etc .; haemorrhagic, surgical, septic, cardiogenic traumas, from burns.
SOLDESAM 0.2% ORAL DROPS: anti-inflammatory and antiallergic corticotherapy, degenerative and post-traumatic osteoarthritis, chronic developmental polyarthritis, ankylosing spondylarthritis, asthmatic states, allergic dermatitis and dermatoses and in all those cases in which corticosteroid therapy is required.
SOLDESAM 0.2% UNGUENTO: atopic dermatitis (allergic eczema, infantile eczema, nummullary eczema, itching with lichenification, eczematous dermatitis, food eczema); contact dermatitis (due to cosmetics, drugs, chemicals, fabrics); itching including anogenital, non-specific; seborrheic dermatitis, intertrigo.
04.2 Posology and method of administration
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION:
• intramuscularly and intravenously: to be adapted according to the case and the therapeutic response: indicatively one ampoule (4 mg) per day, possibly repeated. As soon as a positive result is achieved, gradually decrease the dose.
• intrasynovial route in soft tissues: to be carried out with perfect asepsis and with good injection technique using the following indicative dosages:
SOLDESAM 8MG / 2ML SOLUTION FOR INJECTION:
the dosage of SOLDESAM 8mg / 2ml must be individualized on the basis of the disease to be treated, its severity and the patient's therapeutic response. Indicatively, in the indicated therapies it is recommended to administer 32-96 mg per day divided into 4-6 administrations.
SOLDESAM 0.2% ORAL DROPS: to be adapted according to the case and the therapeutic response.
It should be emphasized that dosage needs are variable and must be individualized on the basis of the disease to be treated and on the basis of the patient's response. Indicatively, treatment can be started by administering from 2 to 5 mg in 3 daily doses to be taken dissolved in water, shaking before ingesting. As soon as an improvement occurs, gradually decrease the dosage to the minimum therapeutically active dose which can vary from 0.25 to 2 mg per day. 1 ml = 32 drops = 2 mg.
SOLDESAM 0.2% OIL: apply a thin layer of ointment, massaging slowly. The operation must be repeated 2-3 times a day. If the use of an occlusive bandage is required, apply the ointment on the part to be treated, cover with a sheet of waterproof material (plastic) and then bandage normally. Repeat the application every 2 or 3 days.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION, SOLDESAM 8MG / 2ML SOLUTION FOR INJECTION, SOLDESAM 0.2% ORAL DROPS :,
• systemic fungal infections, Systemic bacterial infections, except in cases where specific anti-infective therapy is in progress
• Local injections in the:
- bacteremia
- systemic fungal infections
- unstable joints
- infections at the injection site, for example in septic arthritis secondary to gonorrhea or tuberculosis
- tuberculosis,
- peptic ulcer,
- psychosis,
- ocular herpes simplex.
SOLDESAM 0.2% UNGUENTO: cutaneous tuberculosis, herpes simplex, luetic and fungal skin affections; chickenpox, vaccine pustules.
04.4 Special warnings and appropriate precautions for use
SOLDESAM 4MG / 1ML INJECTABLE SOLUTION, SOLDESAM 8MG / 2ML INJECTABLE SOLUTION, SOLDESAM 0.2% ORAL DROPS:
The maintenance posology must always be the minimum capable of controlling the symptoms; a dosage reduction must always be done gradually.
Precautions should be taken when treating patients with acute and chronic infections.
Corticosteroids can mask some signs of infection and during their use there may be intercurrent infections and the tendency, on the part of infectious processes, not to localize. In these cases, the opportunity to institute adequate antibiotic therapy must always be evaluated.
Additionally, corticosteroids can affect the nitroblutetrazole test for bacterial infections and cause false negative results. Corticosteroids can activate latent amoebiasis. Therefore it is recommended to ascertain that no latent or active amoebiasis is present before initiating corticosteroid therapy in patients who have been in the tropics or in patients with diarrhea.
Corticosteroids can exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless needed to control drug reactions due to "amphotericin B. D". concomitant amphotericin B and hydrocortisone was followed by congestive cardiac hypertrophy.
Suppression of both the inflammatory response and immune function increases susceptibility to infections and their severity. The clinical picture may be unusual and serious infections such as septicemia and tuberculosis may be masked and may reach advanced staging before being diagnosed.
The use of SOLDESAM 4mg / 1ml solution for injection and SOLDESAM 8mg / 2ml solution for injection in current tuberculosis should be limited to cases of fulminant or disseminated tuberculosis in which the corticosteroid is used for the treatment of the disease in association with an appropriate antituberculous regimen. .Strict monitoring is required when corticosteroids are indicated in patients with latent tuberculosis or a positive response to tuberculin, as reactivation of the disease may occur.
During prolonged corticosteroid therapy, these patients should undergo chemoprophylaxis.
Cases of tumor lysis syndrome have been reported very rarely in patients with malignant haematological diseases following administration of dexamethasone alone or in combination with other chemotherapeutic agents. People at risk of developing tumor lysis syndrome should be monitored closely to prevent such an occurrence.
Psychic alterations may occur during treatment with corticosteroids ranging from euphoria, insomnia, mood changes, personality alterations, severe depression, to real psychotic manifestations. When present, psychic instability and psychotic tendencies can be aggravated by corticosteroids.
Intra-articular injection of a corticosteroid can cause both systemic and local effects. The presence of fluid in the joints requires appropriate examinations, in order to rule out septic processes. A marked increase in pain - accompanied by local edema, further limitation of joint mobility , fever and general malaise - suggests the presence of a "septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate anti-infective therapy should be instituted. Local injection of a steroid into infected areas should be avoided. Corticosteroids should not be injected into unstable joints. Patients must be clearly emphasized the importance of not abusing the joints where symptomatic improvement has been achieved, as long as the activity of the inflammatory process persists.
Avoid injection of corticosteroids into tendons. Frequent intra-articular injections can cause joint damage.
The lowest possible dose of corticosteroids should be used to control the disease and, when dose reduction is possible, this should be done gradually. During prolonged therapy, an anti-ulcer regimen including an antacid may be appropriate as a precaution.
Medium or high doses of hydrocortisone or cortisone can cause increased blood pressure, water and salt retention, or excessive potassium depletion. Such effects are less likely to occur with synthetic derivatives unless they are administered in high doses. A low-salt diet and potassium supplements may be needed. All corticosteroids increase calcium excretion.
In patients under corticosteroid therapy exposed to considerable stress, an increase in the dosage of fast-acting corticosteroids is indicated, before, during and after the stressful situation. The slower absorption rate caused by intramuscular administration should be taken into account.
A "secondary adrenocortical insufficiency induced by the drug can be minimized by gradually reducing the posology. This type of relative insufficiency may however persist for a few months after discontinuation of therapy; in any stressful situation that occurs during this period, it is therefore advisable to reinstate the drug. hormone therapy. If the patient is already under steroid treatment, an increase in dosage may be necessary. Since mineralocorticoid secretion may be inadequate, concomitant administration of salts and / or a mineralocorticoid is advisable. Appropriate antimicrobial therapy should be performed. be associated with glucocorticoid therapy, when necessary, such as in viral and fungal ocular infections.
Chickenpox is of particular concern because this usually mild disease can be fatal in immunosuppressed patients. Patients (or parents of the child) without amnestic confirmation of the disease should avoid contact with people with chickenpox or shingles and should seek urgent medical attention if exposed. Passive immunization with varicella zoster immunoglobulin (VZIG) is required in exposed non-immunized patients who are on systemic treatment with corticosteroids or who have used corticosteroids within the past 3 months; Treatment should be started within 10 days of exposure to the chickenpox virus. Upon confirmation of the diagnosis of chickenpox, the disease requires specialist care and urgent medical therapy. Corticosteroids should not be discontinued and the dosage may also be increased.
Patients should be advised to avoid exposure to measles virus and in case of exposure to obtain appropriate and urgent medical advice; Intramuscular immunoglobulin prophylaxis may be required.
Live vaccines should not be given to individuals with an insufficient immune response. The antibody response to other vaccines may be reduced.
In chronic treatment, adrenal cortical atrophy develops which can persist for years after discontinuation of therapy. In patients who have received higher than physiological doses of systemic corticosteroids (approximately 1 mg dexamethasone) for more than 3 weeks, treatment discontinuation cannot occur abruptly. Gradual dose reduction depends on the risk of disease recurrence, clinical assessment of disease activity during treatment discontinuation, and the potential and degree of HPA axis suppression. Upon reaching the 1 mg daily dose, dose reduction it must take place more slowly to allow the HPA to recover full efficiency.
Abrupt discontinuation of dexamethasone dosages up to 6 mg / day for treatments lasting up to 3 weeks is unlikely to result in clinically relevant suppression of the HPA axis, however, there are some patient groups in which a gradual discontinuation of therapy is appropriate. also for therapy courses lasting 3 weeks or less. For example, in patients receiving repeated systemic corticosteroid treatments, in patients treated with short-term therapy within one year of cessation of chronic therapy, in patients with other disorders responsible for adrenal insufficiency, in patients treated with daily doses up to 6 mg dexamethasone and in chronically treated patients with evening dosages.
A sudden drop in corticosteroid dosage after prolonged treatment can cause acute adrenal insufficiency, hypotension and death. Withdrawal of corticosteroids after chronic therapy can cause symptoms (corticosteroid withdrawal syndrome) such as fever, myalgia, arthralgia, rhinitis, conjunctivitis, itchy and painful skin nodules and weight loss. These symptoms can occur in patients even without symptoms of adrenal insufficiency.
During chronic treatment, any intercurrent illness, trauma or surgery requires a temporary increase in dosage; if the corticosteroid has been discontinued after prolonged therapy, treatment may need to be temporarily resumed.
Patients must always have with them a health card that reports the steroid therapy in progress in order to have clear guidelines on the precautions to be taken to reduce any risk, with the indication of the prescriber, the medicine, the dosage and the duration of the treatment.
Occasionally there have been reports of anaphylactic reactions in patients treated with systemic corticosteroids such as edema of the glottis, urticaria and bronchospasm particularly where the patient's clinical history confirms allergic forms to different drugs. When such reactions occur, the following are recommended. procedures: immediate and slow intravenous injection of adrenaline, intravenous administration of aminophylline and, if necessary, artificial respiration.
Corticosteroids should not be used in the management of brain damage or stroke as their clinical utility is uncertain and even dangerous for the patient. Corticosteroids can suppress responses to skin tests. Patients should not be vaccinated during corticosteroid therapy. against smallpox Other immune procedures should not be implemented in patients treated with corticosteroids, especially at high doses, given the danger of neurological complications and a lack of antibody response.
In the presence of hypoprothrombinemia, acetylsalicylic acid should be used with caution during corticosteroid therapy. In hypothyroid patients or patients with liver cirrhosis the response to corticosteroids may increase.
Steroids should be used with caution in the presence of: non-specific ulcerative colitis with danger of perforation; abscesses or other pyogenic infections; diverticulitis; recent intestinal anastomoses; active or latent gastric ulcer; kidney failure; hypertension; osteoporosis; myasthenia gravis. Air embolism has been described as a possible complication of hypercortisonism.
In hypothyroid and cirrhotic patients the effects of corticosteroids are more marked. In some patients, steroids can increase or decrease mobility and sperm count.
Care should be taken in evaluating the use of systemic corticosteroids in patients with the following conditions that require careful and frequent monitoring of the patient or in their first degree family members with a history of serious affective disorders including depression or manic depressive illness or steroid psychosis:
• Osteoporosis (women in menopause are at greater risk)
• Hypertension or congestive heart failure
• History of severe affective disorders (particularly in previous steroid psychosis)
• Diabetes mellitus (or a positive family history of diabetes)
• History of tuberculosis, as glucocorticoids can cause it to reactivate
• Glaucoma (or family history of glaucoma) with possible damage to the optic nerves
• Previous myopathy induced by corticosteroids
• Hepatic insufficiency
• Kidney failure
• Epilepsy
• Gastro-intestinal ulcerations
• Migraine
• Some forms of intestinal parasites such as amoebiasis
• Incomplete structural growth because glucocorticoids in chronic treatments can accelerate the sealing of epiphyses
• Patients with Cushing's syndrome
• In the treatment of tendonitis or tenosynovitis, care must be taken in injecting into the space between the linings and the tendon itself, as there have been reports of tendon rupture
• Prolonged use of corticosteroids can cause posterior subcapsular cataracts
• It can favor the onset of secondary ocular infections due to fungi or viruses
• In patients or their first degree relatives with a history of severe affective disorders including depression or manic depressive illness or steroid psychosis.
• Patients and / or their carers should be advised of the potential risk of serious psychiatric adverse reactions that may arise following systemic steroid therapy. Symptoms typically appear within a few days or weeks of starting treatment. Risks may be greater with higher dosages after systemic exposure, although dosage levels do not allow for the onset, type, severity, or duration of these. reactions. Recovery of most reactions occurs either after dose reduction or upon discontinuation, although specific treatments may be required. In case of depression, suicidal ideation or after any psychological alert symptom seek medical advice. Psychiatric disorders can arise both during and immediately after dose reduction / discontinuation of systemic steroids, although such reactions have only been reported infrequently.
Use in children
Children and adolescents undergoing chronic corticosteroid therapy should be carefully monitored for growth and development.
Corticosteroids cause irreversible growth retardation in children and adolescents.
In very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
Preterm infants:
Available evidence suggests the development of long-term adverse events in neurodevelopmental after early treatment (
Dexamethasone should not be used routinely in preterm infants with respiratory problems.
Use in the elderly
The common adverse effects of systemic corticosteroid therapy may be associated with more serious consequences in the elderly, particularly osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infections and skin thinning. Close clinical supervision is required to avoid fatal reactions.
SOLDESAM 0.2% UNGUENTO: the epicutaneous application of cortisone in the treatment of extended dermatoses and for prolonged periods, can cause systemic absorption; this occurrence occurs more easily when an occlusive bandage is used (in newborns the diaper can act as an occlusive bandage) In the presence of a skin infection, appropriate coverage therapy should be instituted. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. Avoid ophthalmic use and application in the external ear canal in case of tympanic perforation.
04.5 Interactions with other medicinal products and other forms of interaction
Drugs that induce cytochrome P450 3A4 (e.g. barbiturates, phenytoin, carbamazepine, diphenylhydantoin, phenobarbital, ephedrine, rifampicin, rifabutin, phenylbutazone, primidone, aminoglutethimide) may increase the metabolism of corticosteroids and require increased corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests, which should be interpreted with caution when administering these drugs.
Drugs that inhibit cytochrome P450 3A4 (e.g. ketoconazole and macrolides such as erythromycin) may increase plasma concentrations of corticosteroids. Dexamethasone is a moderate inducer of CYP 3A4. Concomitant administration with other drugs that are metabolised by CYP3A4 (e.g. indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentrations. Cardiac dilatation and congestive heart failure may occur with concomitant use of amphotericin B and hydrocortisone.
In myasthenia gravis the effects of anticholinesterases are antagonized by corticosteroids.
The efficacy of coumarin anticoagulants can be enhanced by concomitant corticosteroid therapy.
Prothrombin time and INR should be monitored frequently to avoid spontaneous bleeding in patients receiving corticosteroids and coumarin anticoagulants at the same time, as in some cases corticosteroids have altered the response to these anticoagulants. Some studies have shown that the effect caused usually from the addition of corticosteroids is inhibition of the response to coumarin compounds, although there have been some conflicting reports indicating potentiation. When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be closely monitored for the development of hypokalaemia.
Patients should not be vaccinated against smallpox during corticosteroid therapy.
Other immunizing procedures should not be undertaken in patients receiving corticosteroids especially at high doses, due to possible risks of neurological complications and insufficient antibody response.
The therapeutic effects of hypoglycaemic agents (including insulin), antihypertensives, cardiac glycosides and diuretics are antagonized by corticosteroids, while the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.
Renal clearance of salicylates is enhanced by corticosteroids, steroid withdrawal may lead to "salicylate intoxication. In patients with hypoprothrombinemia there may be" interaction with salicylates. Furthermore, concomitant use of acetylsalicylic acid (or other NSAIDs) and corticosteroids may increase the risk of gastrointestinal adverse effects.
The oral drops, solution contain sodium benzoate among the excipients which can cause allergic reactions (even delayed)
The ointment contains cetyl alcohol as an excipients which can cause local skin reactions (eg contact dermatitis).
04.6 Pregnancy and lactation
Pregnancy
Since adequate studies on corticosteroids in relation to human reproduction are not yet available, the use of these drugs in pregnant women, or in women of childbearing age requires that the possible risks and advantages deriving from the drug for the mother and for the child be carefully evaluated. fetus.
Babies born to mothers who have been treated with substantial doses of corticosteroids during pregnancy must undergo careful checks to ascertain any signs of hypoadrenalism. Administration of corticosteroids to pregnant animals can cause fetal development abnormalities including cleft palate, intrauterine growth retardation, and effects on brain growth and development. There is no evidence that corticosteroids cause an increased incidence of congenital abnormalities, such as cleft lip and palate in humans.When given for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation.
As with all medications, corticosteroids should only be prescribed if the benefits to the mother outweigh the risks to the fetus.
See also section 5.3.
The ability of corticosteroids to cross the placenta varies between drug groups, however, dexamethasone readily crosses the placenta.
Feeding time
Corticosteroids have been found in breast milk, although specific data for dexamethasone are not available, and may arrest growth, interfere with the production of endogenous corticosteroids or cause other side effects. Infants of mothers treated with high doses of systemic corticosteroids and for prolonged periods may exhibit some degree of adrenal suppression.
Mothers undergoing corticosteroid therapy should be advised not to breastfeed.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive and the use of machines.
04.8 Undesirable effects
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION, SOLDESAM 8MG / 2ML SOLUTION
INJECTABLE, SOLDESAM 0.2% ORAL DROPS:
in the course of cortisone therapy, especially for intense and prolonged treatments, some of the following effects may occur:
Metabolism and nutrition disorders: sodium retention; water retention; potassium depletion; hypokalemic alkalosis; impaired tolerance to carbohydrates; patenting of diabetes mellitus; increased need for insulin or oral hypoglycaemics in diabetic patients. Protein catabolism with negative nitrogen balance, while in prolonged treatments, the protein ratio must be appropriately increased, body weight increase and appetite increase.
Increased calcium excretion
Alterations of the hydro-electrolyte balance which, rarely and in particularly predisposed patients, can lead to hypertension and congestive heart failure.
Cardiac pathologies: In patients susceptible to congestive heart decompensation congestive heart failure in predisposed individuals. There are reports of cardiac arrhythmias and / or circulatory collapses following rapid administration of high doses of intravenous corticosteroids.
Disorders of the blood and lymphatic system: decrease in lymphatic tissue, leukocytosis.
Vascular pathologies: Hypertension, hypotension or shock-like reaction, thromboembolism, hematoma
Musculoskeletal and connective tissue disorders: muscle asthenia; steroid myopathy; reduction in muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of the femoral head and humerus; growth arrest in children and adolescents. Painless destruction of the joint (reminiscent of Charcots' arthropathy especially after repeated intra-articular injections), premature sealing of the epiphyses, avascular osteonecrosis, proximal myopathy . Growth arrest in children and adolescents. Spontaneous long bone fractures; tendon ruptures, bone fragility, exacerbation after intra-articular injection.
Injury, poisoning and procedural complications: Compression fractures of the vertebrae, damage, poisoning and procedural complications such as tendon rupture.
Gastrointestinal disorders: gastric ulcer with possible perforation and hemorrhage; intestinal perforations, particularly in patients with inflammatory intestinal pathologies; pancreatitis; abdominal distension; ulcerative esophagitis, nausea, malaise, dyspepsia.
Skin and subcutaneous tissue disorders: delayed wound healing; thin and delicate skin; reactions resulting from skin tests can be inhibited; petechiae and bruising; erythema; increased perspiration; burning and itching, especially in the perineal region (after intravenous injection); other skin reactions such as allergic dermatitis, hives, angioneurotic edema, hyperpigmentation or hypopigmentation; hirsutism, telangiectasia, striae and acne. Skin and subcutaneous atrophy. sterile abscesses.
Psychiatric disorders: euphoria, insomnia, mood and personality changes, suicidal thoughts, severe depression, mania, delusions, hallucinations and aggravation of schizophrenia, irritability, anxiety, confusion, psychological dependence, symptoms of real psychosis, amnesia, a pre-existing instability emotional or psychotic tendencies can be aggravated by corticosteroids.
Nervous system disorders: convulsions; increased intracranial pressure with papilledema in children (pseudotumor cerebri), usually after discontinuation of treatment; cognitive dysfunction, aggravation of epilepsy.
Endocrine disorders: Suppression of the hypothalamic-pituitary-adrenal axis; cushingoid state; growth arrest in children and adolescents; lack of adrenocortical and secondary pituitary response, especially during periods of stress due to trauma, surgery or serious illness.
Reduced tolerance to carbohydrates; manifestations of latent diabetes mellitus; increased need for insulin or oral hypoglycaemics in diabetic patients.
Diseases of the reproductive system and breast: menstrual cycle irregularities and amenorrhea; a momentary burning or tingling sensation in the perineal area after intravenous injection of high doses of corticosteroid phosphates.
Hepatobiliary disorders: increased levels of liver enzymes (reversible in most cases after stopping treatment).
Eye disorders: posterior subcapsular cataract; increased intraocular pressure; glaucoma; exophthalmos, papilledema, corneal or scleral thinning.
Rare cases of blindness associated with intra-lesional therapy in the face and head.
Infections and infestations: increased susceptibility and severity of infections (with the suppression of symptoms and clinical signs), opportunistic infections, patent tuberculosis, exacerbation of viral or fungal ophthalmic diseases, candidiasis.
Disorders of the blood and lymphatic system: Decreased lymphatic tissue, leukocytosis.
Immune system disorders: Anaphylactic or hypersensitivity reactions, reduced immune response, reduced response to vaccinations and skin tests.
SOLDESAM 0.2% UNGUENTO: during epicutaneous cortisone therapy, especially if intense and prolonged, some of the following effects may arise:
- sensations of burning, itching, irritation, dryness of the skin, skin atrophy, acne rash and hypopigmentation;
- atrophies and striae localized to the intertriginous areas treated for a long time with occlusive dressings.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
In case of overdose, the following symptoms occur: obesity, muscle atrophy, osteoporosis, hypertrichosis, purpura, acne (clinical symptoms); excitation, agitation (neuropsychic symptoms), blood glucose, hyperglycemia, hypokalaemia (biological symptoms), Cushing's syndrome, stunting in children. In case of overdose, discontinue administration by progressive dose decreases.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
SOLDESAM 4MG / 1ML SOLUTION INJECTABLE, SOLDESAM 8MG / 2ML SOLUTION INJECTABLE, SOLDESAM 0.2% ORAL DROPS
Pharmacotherapeutic group: Unassociated systemic corticosteroids, glucocorticoids
ATC code: H02AB02
SOLDESAM 0.2% OIL
Pharmacotherapeutic group: Corticosterorides for topical use for the treatment of skin conditions.
ATC code: D07AB19
Glucocorticoids are produced and secreted by the adrenal cortex and are an integral part of the hypothalamus pituitary adrenal axis (HPA).
Both natural (cortisol) and synthetic (eg dexamethasone, triamcinolone) glucocorticoids are easily absorbed from the gastrointestinal tract, exert various metabolic effects and modify the body's immune responses to various stimuli.
Glycocorticoids are mainly used for their anti-inflammatory effects in disorders of many organs.
Dexamethasone is a synthetic adrenocorticoid that possesses the actions and effects of other basic glucocorticoids and is among the most active compounds in its class.
Adrenocorticoids act on specific receptors of the HPA axis located on the cell membrane. In other tissues, adrenocorticoids diffuse through the cell membrane by means of cytoplasmic receptors that enter the cell nucleus and stimulate protein synthesis. Adrenocorticoids have antiallergic, antitoxic, antishock properties. , antipyretic and immunosuppressive.
Dexamethasone has an anti-inflammatory power 7 times that of prednisolone and about 30 times that of hydrocortisone.
Dexamethasone has little propensity to promote renal retention of sodium and water, therefore it does not offer complete replacement therapy and must be supplemented with salt or deoxycorticosterone.
SOLDESAM contains the soluble derivative of dexamethasone, namely the 21 ester phosphoric disodium salt.
The action of SOLDESAM 4mg / 1ml solution for injection and SOLDESAM 8 mg / 2ml solution for injection is of rapid effect and is therefore recommended for the treatment of acute diseases sensitive to corticosteroid therapy. The form in drops allows you to establish a dosage as much as possible. possible adequate to the single morbid forms to be treated, in relation to the severity and reactivity of the individual subject. Furthermore, it is possible to establish a regularly decreasing dosage in order to administer the optimal dose and then carry out a progressive "weaning". in 0.2% ointment possesses good local therapeutic activity.
TOXICOLOGICAL DATA: acute toxicity: LD50 (in rat per os): 40.81 mg / kg of dexamethasone sodium phosphate.
05.2 Pharmacokinetic properties
Absorption:
Corticosterorides are generally absorbed through the gastrointestinal tract. They are also absorbed when administered locally. Corticosteroids can be absorbed and give systemic effects after topical use, particularly under an occlusive dressing or in case of skin injury, or when used rectally (enema). Forms of water-soluble corticosteroids are administered intravenously to have a rapid response; by using fat-soluble forms of corticosterorides intramuscularly, effects that last longer over time are obtained.
Parenteral absorption of dexamethasone (IM or IV)
After administration of the dexamethasone solution for injection, dexamethasone sodium phosphate is rapidly hydrolyzed to dexamethasone. After an intravenous dose of 20 mg dexamethasone, the plasma peak is achieved within 5 minutes. Dexamethasone is bound (approximately 77%) to plasma proteins, mainly albumin.
Absorption of dexamethasone by the oral route
Glucocorticoids are well absorbed following oral administration and have a bioavailability of 60-100%. The% fraction available systemically after administration of dexamethasone is 61-86%
Absorption of dexamethasone topically
No data are available on the absorption of dexamethasone after topical application
Distribution
Corticosterorides are generally absorbed through the gastrointestinal tract. Corticosteroids are rapidly distributed to all tissues of the body. Corticosteroids cross the placenta to varying degrees and can be distributed in small amounts through breast milk (or pass into breast milk).
Most corticosteroids in the circulation bind to plasma proteins, mainly globulin and less to albumin. Corticosteroid-binding globulin (transcortin) has high affinity and low binding capacity while albumin has high binding and low affinity . Synthetic corticosteroids compared to natural corticosteroids (cortisol) bind less to proteins and have a longer half-life.
Metabolism
Corticosteorides are metabolised mainly in the liver but also in other tissues and are excreted in the urine. The lower metabolic activity of synthetic corticosteroids and the low affinity of binding with proteins determines a greater potency of the latter compared to natural corticosteroids.
The plasma half-life is 3.5-4.5 hours but since the effects of corticosteroids last longer than the significant plasma concentration of steroids, the plasma half-life becomes of little relevance while the use of the biological half-life is more significant.
The biological half-life of dexamethasone is 36 "." 54 hours; therefore the action of dexamethasone is suitable in conditions where the continuous action of glucocorticoids is desired.
05.3 Preclinical safety data
In animal studies, cleft palate was observed in rats, mice, hamsters, rabbits, dogs and primates, not horses and sheep. In some cases these anomalies were associated with central nervous system and heart defects. In primates, effects on the brain were observed after exposure to the drug. However, intrauterine growth may be retarded. All of these effects were seen at high dosages.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
SOLDESAM 4MG / 1ML INJECTABLE SOLUTION, SOLDESAM 8MG / 2ML INJECTABLE SOLUTION: phenol, sodium citrate dihydrate, anhydrous citric acid, water for preparations
injectable
SOLDESAM 0.2% ORAL DROPS: sodium benzoate, propylene glycol, sodium dihydrogen phosphate dihydrate, sodium saccharin, hydroxypropyl beta-cyclodextrin, sodium EDTA, sodium hydroxide, purified water
SOLDESAM 0.2% OIL: polyethylene glycol 400, polyethylene glycol 4000, cetyl alcohol
06.2 Incompatibility
Incompatibilities with other medicines are unknown
06.3 Period of validity
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION: 5 years
SOLDESAM 8MG / 2ML SOLUTION FOR INJECTION: 4 years
SOLDESAM 0.2% ORAL DROPS 3 years. After first opening the bottle: 60 days.
After this period, the residual medicinal product must be discarded
SOLDESAM 0.2% UNGUENTO: 5 years.
06.4 Special precautions for storage
SOLDESAM 0.2% ORAL DROPS: store at a temperature not exceeding 30 ° C
06.5 Nature of the immediate packaging and contents of the package
SOLDESAM 4MG / 1ML SOLUTION FOR INJECTION: 3 vials of 4mg / ml in glass
SOLDESAM 8MG / 2ML SOLUTION FOR INJECTION: 3 vials of 8 mg / 2ml in glass
SOLDESAM 0.2% ORAL DROPS: a glass bottle with dropper of 10 ml
SOLDESAM 0.2% UNGUENTO: a 30 g aluminum tube
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations
07.0 MARKETING AUTHORIZATION HOLDER
MILANESE PHARMACOLOGICAL LABORATORY s.r.l.
Via Monterosso 273, 21042 Caronno Pertusella (VA)
08.0 MARKETING AUTHORIZATION NUMBER
• SOLDESAM 4MG / 1ML INJECTABLE SOLUTION: AIC n.019499019
• SOLDESAM 8MG / 2ML INJECTABLE SOLUTION: AIC n.019499084
• SOLDESAM 0.2% ORAL DROPS: AIC n.019499072
• SOLDESAM 0.2% UNGUENTO: AIC n.019499060
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
first authorization: 21/12/1961; last renewal: November 2009
10.0 DATE OF REVISION OF THE TEXT
AIFA Resolution no.74 / 2015 of 12 March 2015
