Descrizione Clinica
LIDOCAINE CHLORIDE AND HYDROCORTISONE ACETATE SELLA 1.5% / 1% CREMA
active ingredients
100 g cream contain: Active ingredients: lidocaine hydrochloride 1.5 g; hydrocortisone acetate 1 g. For the full list of excipients, see paragraph 6.1.Excellent
Gliceril monostearate, hamamelis fluid extract, cetilstearilic alcohol, macrogol cetostearil ether, octildodecanol, methyl parahydroxybenzoate (E218), imidurea, purified water.Therapeutic indications
– Internal and external hemorrhoids; – complications of hemorrhoids (eczemas, erythma, ragadi, itching, burning); – pre or post-operative treatment in anorectal surgery.Contraindications
Hypersensitivity to active ingredients, local anaesthetics of amidic type and cortisonists in general, or to any of the excipients. Concomitant mycotic infection manifests or suspects. Concomitant viral infections (e.g. skin tuberculosis, herpes simplex, chickenpox), bacteria and fungal. Children under 12 years of age. Generally contraindicated in pregnancy and nursing (see paragraph 4.6).Population
Two or more applications a day, with mild massage, in enough quantity to cover the sliced part. For the internal application use the special cannula provided inside the case.Conservation
Store in the original packaging to repair the medicine from light and away from direct sources of heat. Store at temperature not exceeding 30 ° C.Warnings
The safety of use of products containing lidocaine depends on the dosage, correct application technique and the adoption of precautionary measures. The medicine must be used at the minimum effective dose, reducing the dosage appropriately in relation to age and physical condition, in the elderly and in the sick in acute form. The excessive dosage of lidocaine or a narrow interval between the application of doses can cause high plasma levels and the manifestation of unwanted effects. The absorption of lidocaine after application on the skin and on the mucous membranes is high. Therefore, lidocaine ointment should be used with caution in patients with severe traumatism, sepsis or extensive skin lesions. It is good to avoid prolonged use of acetate hydrocortisone, especially on large surfaces. The local application of cortisonists and for prolonged periods may result in systemic absorption. Systemic absorption of corticosteroids for local use can produce a reversible suppression of the adrene–hypothalamus–hypophysary (HPA), with the possibility of glucortiosteroid failure after suspension of treatment. In some patients there may also be manifestations of Cushing syndrome following systemic absorption of corticosteroids during treatment. Patients, who receive high amounts of particularly active steroids applied locally on large skin areas, must be evaluated periodically in order to detect the suppression of the adrene–hypotalamoipophysary axis. If the axle suppression occurs – hypothalamus–hypophysary, it is necessary to try to suspend the drug, to reduce the frequency of the applications or to replace it with another less powerful corticosteroid. Restoration of the HPA axis functionality is generally rapid and complete once the drug has ceased. Sometimes depreciation symptoms may occur, which requires a systemic corticosteroid supplement. As with all courteous preparations for local use with high activity, the treatment should be interrupted as soon as the pathology is checked. Hydrocortisone, like other corticosteroids for local use, can accentuate an incipient infection. In this case it is necessary to establish suitable coverage therapy. Prolonged use of local products may lead to awareness-raising or hemorrhagic phenomena; if, during the use of the medicinal product, skin irritation occurs (skin rashes, irritation phenomena and burning), it is necessary to stop treatment and, if necessary, to establish suitable therapy. The possibility of specific sensitization towards lidocaine should not be underestimated. Avoid contact with eyes. For those who carry out sports activities: the use of the drug without therapeutic need constitutes doping and can still determine positivity to anti-doping tests. Important information about some excipients: – Parahydroxybenzoate (E218): may cause allergic reactions (also delayed). – Cetilstearilic alcohol: can cause local skin reactions (e.g. contact dermatitis)Interactions
The cimetidine and beta-blockers (such as propanolol) slow the liver catabolism of local anesthetics; tyretics increase the risk of brachycardia and auricle–vestibular conduction disorders. Using high doses of lidocaine should be considered the risk of increased systemic toxicity in patients treated with other local anesthetics or with agents structurally related to them, e.g. tocainide. The local administration of acetate hydrocortisone, especially for applications on large areas or for long periods, can cause phenomena of systemic activity such as glycosuria and postprandial hyperglycemia; furthermore, in occlusion, the urinary excretion of 17–KS and 17–OHCS may decrease. Interaction phenomena with other drugs can also occur, mainly through mechanisms of enzymatic induction, scaling or activity contrapposta.Barbiturici, antihistamines and difenilidantoin, causing an increase in steroid metabolization, reduces drug activity. Anti-inflammatory drugs, such as salicylates and phenilbutazone, smoothing the steroid from the links to plasma proteins, increase its activity. Oral and insulin hypoglycemizers are counteracted in their action by the increase of glycemia induced by the steroid due to its intense glyconeogenetic and glycogenolytic activity.Effects
Below are the side effects of Lidocaine Hydrochloride and Hydrocortisone Acetate Cream, organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue Irritation, dryness, atrophy of the skin and mucosa, burning sensation, itching. Immune system disorders Following the local administration of amidic-type local anaesthetics, allergic reactions (and severe anaphylactic shocks) are reported. Lidocaine Hydrochloride and Hydrocortisone Acetate cream when administered in the intended mode is absorbed only in small amounts with minimal systemic effects. The following are however listed adverse reactions due to a systemic effect of the medicinal product. Diseases of the nervous system Excitement or depression events associated with dizziness, drowsiness, vision, anxiety, tremors followed by changes in the state of consciousness, seizures and respiratory arrest. Heart disease Bradicardia, hypotension, myocardial depression until cardiac arrest.Overdosing
Due to high systemic levels due to rapid absorption or overdosing, lidocaine hydrochloride can cause acute toxic effects. The symptoms of overdose are characterized by neuroeccitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and cardiovascular alterations with hypotension and bradycardia. Treatment is symptomatic. Any seizures may be controlled by short-acting barbituric or benzodiazepine administration. The excessively prolonged use of locally administered corticosteroids can depress the hypophysi–surrene axis (HPE), causing secondary adrenal failure. If the HPE axis is suppressed, try to suspend the drug, reduce the frequency of the application, or replace it with another less powerful corticosteroid. Syntomatology from hypercorticoidism is in fact spontaneously reversible. Treatment is symptomatic. If necessary, rebalance the hydroelectronic budget. In case of chronic toxicity, it is necessary to slowly remove corticosteroid from the body.Pregnancy
Clinical data on the safety of use of lidocaine in pregnancy are not available. Glucocorticoids, of which hydrocortisone is part, have harmful pharmacological effects on pregnancy and/or on fetus/neonate. As in the case of all locally applied glucocorticoids it must be taken into account the possibility that the growth of the fetus is influenced by the passage of hydrocortisone through the placental barrier. Lidocaine Hydrochloride and Hydrocortisone Acetate Cream, therefore, should not be used in pregnancy if not in case of absolute necessity.Food
Clinical data on the safety of use of lidocaine during lactation are not available. Glucocorticoids are excreted in breast milk; therefore, it is necessary to decide whether to stop breastfeeding or treatment with the medicinal product, taking into account the importance of the drug for the mother.Source: Farmadati
