Lidocaina cloridrato e idrocortisone acetato - haemorrhoid cream 30 g

Product Description

Cream for the treatment of hemorrhoids.

Indications

Lidocaine hydrochloride and hydrocortisone acetate 1.5% / 1% is a cream indicated in cases of:

• Internal and external hemorrhoids;
• Complications of hemorrhoids (eczema, erythema, fissures, itching, burning);
• Pre- or post-operative treatment in anorectal surgery.

Ingredients

Active ingredients: 1 g of rectal cream contains 15 mg of lidocaine hydrochloride and 10 mg of hydrocortisone acetate.
Excipients:Water purified water, white petrolatum, liquid paraffin, cetostearyl alcohol, sorbitan stearate, polysorbate 60, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Directions for use and Dosage

Two or more times a day. 2 applications per day, with gentle massage, in an amount sufficient to cover the affected area.
Instructions for use
For internal applications, use the rectal cannula included in the package.
Before use, pierce the safety seal and screw the cannula.
After administration, remove the cannula from the tube and clean it.

Warnings

The safety of using products containing lidocaine depends on the dosage, a correct application technique and the adoption of precautionary measures.
The medicine should be used at the lowest effective dose, appropriately reducing the dosage in relation to age and physical condition, in the elderly and in acutely ill patients.
Excessive dosage of lidocaine or a short interval between the applications of doses can cause serious side effects. cause high plasma levels and the onset of adverse effects.
The absorption of lidocaine after application to damaged skin and mucous membranes is high.
Therefore, Lidocaine hydrochloride and hydrocortisone acetate rectal cream should be used with caution in patients with severe trauma, sepsis, or extensive skin lesions.
It is good practice to avoid prolonged use of hydrocortisone acetate, particularly on large surfaces.
Local application of corticosteroids for prolonged periods can lead to systemic absorption.
Systemic absorption of corticosteroids for local use can cause systemic absorption. produce reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis, with the possibility of glucocorticosteroid failure after discontinuation of treatment.
Manifestations of Cushing's syndrome may also occur in some patients as a result of systemic absorption of corticosteroids during treatment.
Patients receiving large amounts of highly active steroids applied topically to large areas of skin should be evaluated periodically for HPA axis suppression.
If HPA axis suppression occurs, attempts should be made to discontinue the drug, reduce the frequency of application, or substitute a less potent corticosteroid.
Recovery of HPA axis function is usually rapid and complete after cessation of the drug.
Sometimes, a relapse may occur. manifest withdrawal symptoms, which require supplemental systemic corticosteroids.
As with all highly active local corticosteroid preparations, treatment should be discontinued as soon as the disease is controlled.
Hydrocortisone, like other local corticosteroids, can accentuate an incipient infection.
In this case, appropriate cover therapy must be instituted.
The use of local products, especially if prolonged, can give rise to sensitization or hemorrhagic phenomena; If skin irritation (rash, irritation, or burning sensation) occurs during use of the medicine, treatment should be discontinued and, if necessary, appropriate therapy should be instituted.
Visual disturbances may be reported with the use of systemic and topical corticosteroids.
If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids.
The possibility of specific sensitization to lidocaine should not be underestimated.
Avoid contact with eyes.
Important information about some of the excipients
Lidocaine hydrochloride and hydrocortisone acetate Marco Viti contains:

• Cetostearyl alcohol: may cause localized skin reactions (e.g.
  contact dermatitis);
• Parahydroxybenzoates: may cause allergic reactions (even delayed).

Contraindications

Hypersensitivity to the active ingredients, to amide-type local anesthetics and to corticosteroids in general, or to any of the excipients.
Concomitant manifest or suspected fungal infection.
Concomitant viral infections (e.g. cutaneous tuberculosis, herpes simplex, chickenpox), bacterial and fungal infections.
Children under 12 years of age.
Generally contraindicated in pregnancy and breastfeeding.

Interactions

Cimetidine and beta-blockers (such as propranolol) slow the hepatic catabolism of local anesthetics; Digitalis increases the risk of bradycardia and auriculovestibular conduction disorders.
When using high doses of lidocaine, the risk of increased systemic toxicity must be considered in patients treated with other local anesthetics or with agents structurally related to them, e.g.,
tocainide.
Local administration of hydrocortisone acetate, especially when applied over large areas or for long periods, can cause systemic effects such as glycosuria and postprandial hyperglycemia. Furthermore, under occlusion, it can cause systemic toxicity. induce a decrease in urinary excretion of 17-KS and 17-OHCS.
Interactions with other drugs may also occur, which are mainly expressed through mechanisms of enzyme induction, displacement, or opposing activity.
Barbiturates, antihistamines, and diphenylhydantoin, by inducing an increase in the metabolism of the steroid, reduce its pharmacological activity.
Anti-inflammatories, such as salicylates and phenylbutazone, by displacing the steroid from binding to plasma proteins, increase its activity.
Oral hypoglycaemic agents and insulin are counteracted in their action by the increase in blood glucose induced by the steroid due to its intense gluconeogenic and glycogenolytic activity.
Concomitant treatment with CYP3A inhibitors, including medicinal products containing cobicistat, is believed to increase the risk of systemic side effects.
/>The combination should be avoided unless the benefit outweighs the increased risk of systemic side effects due to corticosteroids; In this case, patients must be monitored for systemic side effects due to corticosteroids.

Undesirable effects

The following are the undesirable effects of lidocaine hydrochloride and hydrocortisone acetate rectal cream, organized according to the MedDRA system organ classification.
There are insufficient data to establish the frequency of the individual effects listed.
Skin and subcutaneous tissue disorders
Irritation, dryness, atrophy of the skin and mucous membranes, burning sensation, itching.
Immune system disorders
Allergic reactions (and in the most severe cases, anaphylactic shock) have been reported following the local administration of amide-type local anaesthetics.
Lidocaine hydrochloride and hydrocortisone acetate rectal cream, when administered as directed, is absorbed only in small quantities with minimal side effects. systemic.
Adverse reactions due to a systemic effect of the drug are listed below.
Nervous system disorders
Manifestations of excitation or depression associated with dizziness, drowsiness, visual disturbances, anxiety, tremors followed by changes in the state of consciousness, convulsions and respiratory arrest.
Cardiac disorders
Bradycardia, hypotension, myocardial depression up to cardiac arrest.
Eye disorders
Blurred vision.

Overdose

Due to the achievement of high systemic levels, due to rapid absorption or overdose, lidocaine hydrochloride may cause serious side effects. cause acute toxic effects.
Symptoms of overdose are characterized by neuroexcitatory manifestations (tremors, convulsions followed by depression, respiratory failure and coma) and cardiovascular alterations with hypotension and bradycardia.
Treatment is symptomatic.
Possible convulsions can be controlled with the administration of barbiturates or short-acting benzodiazepines.
Excessively prolonged use of locally administered corticosteroids can depress the adrenal-pituitary-adrenal (HPA) axis, causing secondary adrenal insufficiency.
If suppression of the HPA axis occurs, it is necessary to attempt to suspend the drug, reduce the frequency of its applications or replace it with another less potent corticosteroid.
The symptoms of hypercorticoidism are virtually spontaneously reversible.
Treatment is symptomatic.
If necessary, rebalance the fluid and electrolyte balance.
In case of chronic toxicity, it is necessary to slowly remove the corticosteroid from the body.

Pregnancy and breastfeeding

Pregnancy
There are no clinical data available on the safety of the use of lidocaine during pregnancy.
Glucocorticoids, of which hydrocortisone is a part, have harmful pharmacological effects on pregnancy and/or the fetus. fetus/newborn.
As with all locally applied glucocorticoids, the possibility that fetal growth may be affected by the passage of hydrocortisone across the placental barrier must be taken into account.
Lidocaine Hydrochloride and Hydrocortisone Acetate rectal cream should therefore not be used during pregnancy unless clearly necessary.
Breastfeeding
There are no clinical data available on the safety of lidocaine use during breastfeeding.
Glucocorticoids are excreted in breast milk; Therefore, a decision should be made whether to discontinue breastfeeding or treatment with the medicine, taking into account the importance of the medicine for the mother.

Storage

Store in the original package to protect from light.

Format

30 g tube with rectal cannula