Relief pro rectal cream 10g
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Description
Cream: white, opaque cream.
Active ingredients
Fluocortolone + Lidocaine
Release form
Cream
Composition
1 g of cream contains Active substances: fluocortolone pivalate 1 mg, lidocaine hydrochloride, calculated on the anhydrous substance 20 mg. Excipients: sodium hydrophosphate dodecahydrate 0.7 mg, disodium edetate 1 mg, sodium dihydrophosphate dihydrate 4.5 mg, benzyl alcohol 5 mg, sorbitan stearate 10 mg, polysorbate 60 35 mg, cetostearyl alcohol 60 mg, liquid paraffin 90 mg, vaseline white 100 mg, purified water 672.8 mg.
Pharmacological effect
Fluocortolone Fluocortolone, when exposed to the skin, prevents marginal accumulation of neutrophils, leads to a decrease in lymphokines and inhibition of macrophage migration, contributing to a decrease in the processes of infiltration, exudation and granulation. Fluocortolone suppresses the inflammatory and allergic reactions of the skin and relieves itching, burning and pain; reduces capillary dilatation, interstitial edema and tissue infiltration. Lidocaine is a local anesthetic; Anesthesia is achieved by suppressing the formation and conduction of nerve impulses along afferent nerve fibers through the depolarization of sodium channels.
Pharmacokinetics
Local therapeutic effect is achieved with a low level of active components in the blood plasma. Fluocortolone pivalate After a single rectal application of 1 g of cream or the introduction of a single suppository, the absorption of glucocorticosteroid was maximum 5% of the applied or administered amount of the drug. During the daily administration of 2 suppositories 3 times a day for 4 weeks, the content of fluocortolone in the blood plasma did not reach the level that has a systemic effect. Fluocortolone pivalate is hydrolyzed by esterases, enzymes of the center of inflammation, with the formation of fluocortolone, 11-keto-fluocortolone and trimethylacetic acid. The plasma elimination half-life of fluocortolone and its metabolites after rectal administration was approximately 1.3 and 4 hours, respectively. Fluocortolone is eliminated from the body in the form of metabolites predominantly along with urine. Lidocaine Absorption and bioavailability of lidocaine after rectal administration of the cream and suppository is about 30% and 24%, respectively.The half-life of lidocaine from blood plasma is 1-2 hours. In humans, lidocaine is metabolized by oxidative N-dealkylation, hydrolysis of the amide bond and hydroxylation of the aromatic ring to form 4-hydroxy-2,6-xylidine, which is the main metabolite and 70% of the drug is excreted in the urine with this metabolite.
Indications
- hemorrhoids, - proctitis, - eczema in the area of the anus
Contraindications
- tubercular and syphilitic processes in the field of drug application; - viral diseases (for example, chicken pox, vaccination reaction, shingles) in the area of drug application; - treatment of children and adolescents is not recommended, due to the lack of data on clinical trials; - I trimester of pregnancy; - hypersensitivity to the drug components
Use during pregnancy and lactation
A number of epidemiological studies suggest a possible increased risk of developing a wolf's mouth in newborns whose mothers received glucocorticosteroids orally in the first trimester of pregnancy. Data on the use of local glucocorticosteroids during pregnancy is not enough accumulated, but in this case the probability of adverse effects is very low due to the minimal bioavailability of glucocorticosteroids when applied topically. Relief Pro cream and suppositories should be prescribed with caution in pregnant women. When prescribing to pregnant and lactating women, it is necessary to compare the expected benefit of treatment for the mother with the possible risk to the fetus and infant. When prescribing a drug during pregnancy and lactation by a doctor, it should be used for a short time.
Dosage and administration
Relief Pro is recommended to apply after defecation. Before using the drug should be hygienic anus (anus). The duration of treatment should not exceed 2 weeks. Rectal cream should be applied twice a day: morning and evening. In the first days of treatment, the cream can be applied three times a day. As the symptoms are relieved, it is often sufficient application in a day. Having squeezed a small amount of cream onto a finger (about the size of a pea), it is necessary to lubricate the area around the anus and inside the anal ring.To overcome the resistance of the sphincter need to apply the cream with a fingertip. For the introduction of the cream into the rectum, it is necessary to screw the attached applicator onto the tube and insert it into the anus. Then, slightly pressing the tube, squeeze a small amount of cream into the rectum.
Side effects
With prolonged treatment, both cream and suppositories Relief Pro (more than four weeks), there is a risk of local skin changes, such as atrophy, stretch marks or telangiectasia. Rectal cream: burning sensation: 1-10%, rarely irritation and allergic reactions.
Overdose
If you accidentally take the drug inside (for example, if you swallow a few grams of cream or more than one suppository), the most severe symptoms may occur from the cardiovascular system (cardiac depression, cardiac arrest) and central nervous system (convulsions, respiratory depression, respiratory arrest) dose dependent.
Interaction with other drugs
Patients receiving antiarrhythmic drugs should use lidocaine with caution. With the simultaneous use of lidocaine with antiarrhythmic drugs may prolong the QT interval and, in very rare cases, may develop AV blockade or ventricular fibrillation.
special instructions
In the presence of fungal infections in addition to Relief Pro, appropriate antifungal therapy is required. Avoid getting Relief Pro in or contact with eyes. After applying the cream it is recommended to wash your hands thoroughly. Effect on ability to drive and mechanisms: Not identified.
Storage conditions
At a temperature not higher than 30 ° C. Keep out of the reach of children.