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  • Antrolin
    / Super-Pharm


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Cream

    30 g

    not in the basket chart 5162

    Dosage

    For endorectal and perianal applications. Apply the cream twice a day for at least three weeks.
    Pediatric population: the safety and efficacy of ANTROLIN in adolescents and children below 18 years of age have not been established.
    Approximately one centimeter of cream (in one centimeter is contained approximately 2.5-3 g of cream).


    Indications

    Treatment of anal fissures and proctologies generally associated with anal sphincter hypertonia.


    Contra-Indications

    Hypersensitivity to the active ingredients, particularly to Lidocaine (and other local anesthetics with a similar amidic type structure) or to any other excipient.
    Presumed or ascertained pregnancy and breast feeding.


    Special Precautions

    The topical administration of the drug for excessive and/or prolonged periods may cause sensitivity reactions and local reactions of hyperemia and bleeding that disappear when the treatment is stopped. During the clinical trials no adverse reactions resulting from the systemic absorption of the drug were reported.
    Use with caution in patients with severely injured mucosa and phlogosis (inflammation) in the area to treat since this may cause excessive absorption of the active substances. Use with caution in diabetic patients or in those with hepatic and/ or renal insufficiency.
    Use in elderly patients, in patients under eighteen years of age, or in patients being treated with beta-blockers or antihypertensive drugs should be supervised by the physician.
    The arterial pressure should be checked at the beginning and periodically during the treatment.
    In case of failure of the therapy (the absence of improvement or worsening of the symptoms) the treatment must be stopped and a physician must be consulted to take other measures.
    Warning: This cream for rectal use contains sodium methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions, even delayed. It also contains propylene glycol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
    Please refer to the license holder for further details.


    Side Effects

    Pain, a burning sensation, itchiness, hyperemia and Bleeding could occur locally.
    Please refer to the license holder for further details.


    Drug interactions

    Treatment with this rectal cream may increase the effect of antihypertensive drugs due to the presence of Nifedipine. Propranol prolong the plasmatic half-life of Lidocaine and increases the plasmatic levels of Nifedipine. Cimetidine may increase the plasmatic levels of Nifidipine and Lidocaine. The simultaneous administration of this cream for rectal use in patients in treatment with Digoxin may increase the plasmatic levels of Digoxin.
    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Contraindicated during pregnancy and lactation.
    Please refer to the license holder for further details.


    Overdose

    No cases of systemic toxicity from an overdose after the topical application of this  cream for rectal use have been reported. In the eventuality of intoxication after topical application of the medicine, the systemic effects should be similar to those caused by the active ingredients in other routes of administration.
    In cases of severe intoxication from Nifedipine disorders of conscience up to coma, decrease in the arterial pressure, alterations of the heart rate and cardiogenic shock may occur. As regards the treatment, betasympathomimetics may be used for bradycardia and in the case of severe hypotension, Calcium Gluconate 10% solution (10-20 ml, slowly intravenous) and eventually Dopamine or Norepinephrine.
    Most of the toxic reactions to the local anesthetics and to Lidocaine, in humans, affect the central nervous system; “lightheadedness” and dizziness, often followed by visual and auditory troubles such as accommodation difficulties and tinnitus have been reported. In serious cases, depression of the central nervous system and convulsions may occur. The treatment is symptomatic.


    Important notes

    Please refer to the license holder for further details.


    Manufacturer
    NEW FA DEM Farmaceutici e Chimici S.r.l., Italy
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