Properties
What is it?
ANTROLIN® 0.3%+1.5% Rectal Cream ATC Code: C05AX – Nifedipine + Lidocaine 30g tube Composition 100g cream contains: Active substances: Nifedipine 0.3g - Lidocaine hydrochloride 1.5g. Excipients: White petrolatum, propylene glycol, medium-chain triglycerides, polyethylene glycol stearate; cetostearyl alcohol, glyceryl monostearate, sodium methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water. Pharmaceutical form and composition Rectal cream. 30g cream in an aluminum tube, with a cannula, in a cardboard box. Pharmacotherapeutic group This medicine contains nifedipine, a dihydropyridine - calcium channel blocker, which, when applied topically, has a relaxing effect on peripheral smooth muscles and reduces the tone of the internal anal sphincter. The action of nifedipine is integrated in the product by the presence of a surface local anesthetic, lidocaine. Therapeutic indication Treatment of anal fissures and proctalgia, usually associated with anal sphincter hypertonus. Contraindications Hypersensitivity to the active substances and in particular to lidocaine (and other local anesthetics of similar amide structure) or to any of the excipients. Confirmed or suspected pregnancy and lactation (see also "Special warnings"). Severe hypotensive conditions and cardiovascular failure. Precautions for use During clinical studies, no adverse effects due to possible systemic absorption of the preparation were observed. Nevertheless, ANTROLIN rectal cream should be used with particular caution in patients with severe damage to the mucous membranes and inflammation in the area to be treated, as in these situations, excessive absorption of active substances may occur. Furthermore, the medicinal product should be used with caution in diabetic patients or patients with severe hepatic and/or renal insufficiency. Treatment with ANTROLIN rectal cream should be carried out under medical supervision in elderly patients, as well as in patients under 18 years of age and in patients treated with beta-blockers or antihypertensive medications. Blood pressure control is recommended at the beginning of treatment and periodically throughout its duration. In case of treatment failure (lack of improvement or worsening of symptoms), treatment is discontinued and a doctor should be consulted for further measures. Interactions with other medicinal products Due to the presence of nifedipine, the effect of antihypertensive medications may be enhanced when using ANTROLIN rectal cream. Propranolol prolongs the half-life of lidocaine and increases plasma levels of nifedipine. Cimetidine can increase plasma levels of lidocaine and nifedipine. Concurrent use of ANTROLIN rectal cream in patients treated with digoxin may lead to an increase in digoxin plasma levels. Special warnings Topical application of the preparation in excessive doses and/or for prolonged periods may cause sensitization phenomena and local hyperemia and bleeding, which disappear after discontinuation of treatment. Use during pregnancy and breastfeeding Nifedipine and lidocaine cross the placental barrier and are excreted in breast milk. Studies in rats and rabbits have shown that nifedipine causes teratogenic effects. Lidocaine does not show any risk to the fetus, but the use of the product in pregnant and breastfeeding women is not recommended. Warnings related to some excipients ANTROLIN rectal cream contains sodium methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic and also delayed reactions. In addition, ANTROLIN rectal cream contains propylene glycol and cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis). Keep the medicinal product out of the reach and sight of children. Dosage, method of administration and duration For endorectal and perianal applications. Apply the cream 2 times a day for at least three weeks. Method of application - Lie on the bed on your left side; - Unscrew the cap from the tube and screw on the cannula, squeeze out a small amount of cream to lubricate the cannula and insert it into the anus; - Squeeze the end of the tube to extrude approximately one centimeter of cream from the tube (one centimeter of tube content contains approximately 2.5 – 3 g of cream). Overdose No cases of systemic toxicity have been reported with overdose of ANTROLIN rectal cream. In case of poisoning after topical use of the product, systemic effects should be the same as those usually caused by active substances by other routes of administration. In case of severe nifedipine intoxication, disturbances of consciousness, including coma, decreased blood pressure, changes in heart rhythm, and cardiogenic shock may develop. As for treatment, beta-sympathomimetic agents may be used for bradycardia and, in case of severe hypotension, calcium gluconate (10-20 ml of 10% solution intravenously, slowly) and possibly dopamine or noradrenaline. A large part of toxic reactions to local anesthetics and lidocaine affects the central nervous system; "drowsiness" and dizziness occur, often followed by visual and auditory disturbances, such as difficulty with accommodation and tinnitus. In the most severe cases, CNS depression and convulsions may occur. Treatment is symptomatic. Possible side effects Reactions such as pain, burning, itching, hyperemia, and bleeding may occur locally. These effects disappear after discontinuation of treatment. In very rare cases, topical application of preparations containing lidocaine has caused allergic reactions (in the most severe cases, anaphylactic shock). No adverse effects (headache, dizziness, peripheral vasodilation, hypotension, dizziness, and tremor) were observed during the clinical trial phase due to possible systemic absorption of the two active substances. Side effects of unknown frequency: difficulty breathing. Tell your doctor or pharmacist if you notice any side effects not described or explained in these instructions. Expiry date and storage: Check the expiry date indicated on the container. Store in a tightly closed package. Do not store above 25°C. The indicated expiry date refers to a correctly stored, undamaged product. The shelf life of the product after its first opening is 30 days (note the date of first opening in the designated place on the box). Warning: Do not use this medicine after the expiry date indicated on the packaging and after 30 days from the first opening. Keep out of reach of children.