About Relief Cream for the treatment of hemorrhoids with complications, rectal, ’10, Bayer

Description

Composition
Active substance:
1 g of cream contains: fluocortolone pivalate 1 mg lidocaine hydrochloride based on the anhydrous substance of 20 mg.
Excipients:
Sodium hydrogen phosphate dodecahydrate 0.7 mg Disodium edetate 1 mg sodium dihydrogen phosphate dihydrate 4.5 mg, 5 mg of benzyl alcohol, sorbitan stearate, 10 mg, 35 mg polysorbate 60, cetostearyl alcohol, 60 mg, 90 mg liquid paraffin, white petrolatum 100 mg , 672.8 mg purified water.
Description:
White, opaque cream.
Product form:
Rectal cream 1 mg + 20 mg / g: 10 g of an aluminum tube, sealed with a membrane with a screw cap. Tube with the applicator and instructions for use placed in a cardboard box.
Contraindications
TB and syphilis processes in applying the product.
Viral diseases (e.g., chicken pox, reaction to vaccination, herpes zoster) in the coating formulation.
Treatment of children and adolescents is not recommended due to lack of clinical trial data.
I trimester of pregnancy.
Increased sensitivity to the drug.
Dosage
1 mg + 20 mg / g
Indications
Eczema in the anus (rectal cream). Hemorrhoids. Proctitis.
Interaction with other drugs
Patients receiving antiarrhythmic drugs, lidocaine should be used with caution. When applied simultaneously with lidocaine antiarrhythmic drugs may lengthening QT interval, and, in rare cases, may develop
AV block or ventricular fibrillation.
Overdose
If you accidentally taking the drug administration (eg, by ingestion of several grams of cream or of more than one suppository), the most severe symptoms can occur from cardiovascular (depression of cardiac function, cardiac arrest) and central nervous system (convulsions, respiratory depression, respiratory arrest) in depending on the dose.
pharmachologic effect
Pharmacological group:
Glucocorticosteroid combined for topical use.
Pharmacodynamics:
Fluocortolone.
Fluocortolone when exposed to the skin prevents the accumulation of neutrophils boundary, reduces lymphokines and inhibition of macrophage migration, helping to reduce the infiltration processes of exudation and granulation.
Fluocortolone suppresses inflammatory and allergic reactions of the skin and relieve itching, burning and pain; reduces capillary dilation, interstitial edema, and tissue infiltration.
Lidocaine.
Lidocaine – a local anesthetic; analgesia is achieved by inhibiting the formation and conduction of nerve impulses by afferent nerve fibers by depolarization sodium channels.
Pharmacokinetics:
Local therapeutic effect is achieved at low levels of active ingredients in the blood plasma.
Fluocortolone pivalate.
After a single application of 1 g rectal cream or suppository administration of one, absorption glucocorticosteroid was maximally 5% of the damage or the introduced amount of the drug.
During the daily administration of 2 suppository 3 times a day for 4 weeks fluocortolone content in blood plasma did not reach levels that systemic exposure.
Fluocortolone pivalate hydrolyzed by esterases, enzymes inflammatory focus, to form fluocortolone 11-ketofluokortolona and pivalic acid.
Plasma half-life periods of fluocortolone and its metabolites after a rectal administration was about 1.3 and 4 h, respectively.
Fluocortolone excreted mainly as metabolites in the urine.
Lidocaine. Absorption and bioavailability after rectal administration of lidocaine cream, and a suppository is about 30% and 24% respectively.
The half-life of lidocaine from the blood plasma of 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 major metabolite in urine output and 70% of the drug in the form of this metabolite.
Pregnancy and breast-feeding
A number of epidemiological studies suggest a possible increased risk of cleft palate in newborns whose mothers received corticosteroids into the I trimester of pregnancy. Information on the use of local corticosteroids during pregnancy does not get many, but in this case, the likelihood of adverse effects is very low due to minimal bioavailability of corticosteroids when applied topically.
Relief Of cream and suppositories should be used with caution in pregnant women. In the appointment of pregnant and lactating women must be compared to the potential benefits of treatment for the mother and the possible risk to the fetus and infant.
At a doctor’s appointment of the drug during pregnancy and lactation, it should be used for a short time.
Conditions of supply of pharmacies
On prescription.
side effects
In long-term treatment, like cream and suppositories Relief Pro (more than four weeks), there is the risk of local skin changes, such as atrophy, striae or telangiectasias.
Burning: 1-10%, rare – irritation and allergic reactions.
special instructions
In the presence of fungal infections, in addition to the Relief Pro requires a appropriate antifungal therapy.
Avoid contact with Relief Pro into or contact with eyes. After applying the cream is recommended to wash your hands thoroughly.
Effects on ability to drive and use machines.
Not found.
Storage conditions
Store at a temperature not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Rectally.
Relief Pro is recommended after defecation. Before use, the drug should hold hygiene 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 cream may be applied three times a day. As the relief of symptoms is often enough one application per day.
Extruding a small amount of cream finger (about the size of a pea), lubricate the area around the anus and in the anal ring. To overcome the resistance of the sphincter need to apply the cream with your fingertip.
In order to introduce the cream into the rectum must be screwed into a tube attached applicator and put it into the anus. Then, gently pressing down on the tube, squeeze a small amount of cream into the rectum.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist