IDROCORT CR 30G

PROCTORATES 15 MG/G + 10 MG/G

active ingredients

1 g rectal cream contains: active ingredients: Lidocaine Hydrochloride: 15 mg; acetate hydrocortisone: 10 mg. Excipients with known effects: cetostearilic alcohol, parahydroxybenzoates, propylene glycol. For the full list of excipients, see paragraph 6.1.

Excellent

White vaseline, liquid paraffin, methyl parahydroxybenzoate propile parahydroxybenzoate, propylene glycol, dimeticone, cetostearilic alcohol, isottil sterato, PEG-20 monostearate, gliceril monosterato, purified water.

Therapeutic indications

- Internal and external hemorrhoids; - complications of hemorrhoids (eczemas, erythema, ragadi, itching, burning); - pre- or post-operative treatment in abnormal surgery.

Contraindications

Hypersensitivity to active ingredients, amidic local anesthetics and cortisonists in general, or to any of the excipients listed in paragraph 6.1; Concomitant mycotic infection manifests or suspects; Concomitant viral infections (e.g. skin tuberculosis, herpes simplex, chickenpox), bacteria and fungal; Children under 12 years; 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. Instructions for use In case of internal applications, use the rectal cannula included in the package. Before use drill the safety seal and screw the cannula. After administration remove the cannula from the tube and clean it.

Conservation

Store in the original packaging to repair the medicine from light.

Warnings

The safety of use of products containing lidocaine depends on the dosage, correct application technique and the adoption of precautionary measures. The medicinal product must be used at the minimum effective dose, properly reducing the dosage 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, PROCTOZETA rectal cream should be used with caution in patients with severe traumatisms, 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 axis adreno-hypotalamo-hypophysary (HPA), with the possibility of glucocorticosteroid failure after suspension of treatment. In some patients you can also have 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 adreno-hypotalamo-hypophysary axis. If the axis is suppressed, it is necessary to try to suspend the drug, reduce the frequency of the application, or replace it with another less powerful corticosteroid. Restoration of the functionality of the HPA axis 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 products for local use may result in 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. With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the evaluation of possible causes that may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic corticosteroids. The possibility of specific sensitization towards lidocaine should not be underestimated. Avoid contact with eyes. Important information about some excipients: PROCTOZETA contains: - cetosteari alcohol: can cause reactions to localized skin (e.g. contact dermatitis); - parahydroxybenzos: may cause allergic reactions (also delayed); - propylene glycol: this medicine contains 30 mg of glycol propylene for 1 g. may cause skin irritation.

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; moreover in occlusion can induce decrease of urinary excretion of 17-KS and 17-OHCS. 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 bond to plasma proteins, increase its activity. Oral and insulin hypoglycemizers are contrasted in their action by the increase of glycemia induced by the steroid due to its intense glyconeogenetic and glycogenolytic activity. Concurrent treatment with CYP3A inhibitors, including cobicistat-containing medicines, is believed to increase the risk of systemic side effects. The association must be avoided unless the benefit exceeds the greatest risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic side effects due to corticosteroids.

Effects

Below are the undesirable effects of PROCTOZETA rectal 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. PROCTOZETA rectal cream when administered in the intended mode is absorbed only in small quantities 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 Bradycardia, hypotension, myocardial depression until cardiac arrest. Pathologies of the eye Vision, blurred (see also paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 may depress the adreno-hypophysi-surrene axis (HPA), causing secondary adrenal failure. If the HPA 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 hydro-electronic 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. PROCTOZETA rectal 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 are not available during lactation. 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