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Pharmacological properties

hydrocortisone acetate - corticosteroids, when applied topically, has anti-inflammatory, anti-allergic, vasoconstrictive and antipruritic effects. inhibits the release of inflammatory mediators, blocks the metabolism of arachidonic acid.

Zinc sulfate monohydrate promotes healing of wounds and erosion, normalizes the water balance of the skin.

Pharmacokinetics When applied topically, the ingredients of the drug are excreted as mucus or in very small amounts excreted in urine and bile. There are no manifestations of resorptive effects when using the drug in the recommended doses. The components of the drug do not pass into breast milk.

Indications

External and internal hemorrhoids, fissures, fistulas, ulcers, erosion of the perianal region and rectum, accompanied by severe inflammatory phenomena; proctitis, anal itching, eczema, perianal dermatitis.

Application

Wash the skin around the anus with warm water beforehand, clean the affected area with a moistened soft cloth, and carefully dry it with toilet paper or a soft cloth. Before the introduction of the suppository, it is necessary to remove the protective plastic shell from it. insert the suppository into the anus as deep as possible. enter one suppository up to 4 times a day (at night, in the morning and after each bowel movement). the duration of the course of treatment is not more than 7 days.

Children. Safety and Efficiency Relief® Ultra in children under 12 years of age has not been established. No data. The drug can be used in children over the age of 12 years.

Contraindications

Increased individual sensitivity to any component of the drug (allergic reactions), specific (bacterial, fungal, viral, tuberculosis) lesions of the anorectal zone, neoplasm of the anus, thromboembolic disease, intestinal obstruction, abscesses, risk of perforation, peritonitis, common fistulas, fresh intestinal anastomoses or fistulous passages.

Side effects

From the side of the immune system: rarely allergic reactions can occur, including hyperemia (redness), swelling, itching; dry mucous membrane.

Although when using the drug Relief® Ultra was not reported about a systemic effect, with prolonged use in high doses, endocrine disorders are possible: adrenocortical suppression, Cushings syndrome, hyperglycemia, glucosuria, growth retardation, intracranial hypertension.

From the digestive tract: rectal bleeding.

On the part of the skin and subcutaneous tissue: perianal dermatitis, with or without atrophy of the skin; irritation, pain at the site of application, burning, rash, dry skin, pustular acne; “Rebound effect”, which can lead to steroid dependence; slowing the healing of wounds.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (possibly delayed) and, in some cases, bronchospasm.

special instructions

In case of significant bloody discharge from the anus, in the presence of symptoms of the disease within 7 days of treatment or in case of worsening, it is necessary to consult an additional proctologist.

Accidental contact with the eyes should be avoided.

Rectal corticosteroids should be used with caution in patients with severe peptic ulcer and only after proctologic examination due to the risk of intestinal perforation.

When using any topical steroids, one should remember about the possibility of systemic absorption.

In order to minimize systemic effects, the recommended dose should not be exceeded, unless otherwise recommended by the doctor.

Use during pregnancy and lactation. The safety of the drug Relief® Ultra (hydrocortisone acetate, zinc sulfate) during pregnancy has not been studied.

Current data on the safety of the use of topical corticosteroids during pregnancy indicate the absence of a relationship between their use by the mother and the development of the cleft palate, premature birth and fetal death.

Current evidence suggests that the use of strong / very strong topical corticosteroids during pregnancy cannot be associated with placental insufficiency and low birth weight. However, this is the data of one large and small cohort studies. A large population cohort study (84,133 pregnant women from the database of general practice studies) revealed a significant relationship between fetal growth retardation and the use of strong / very strong topical corticosteroids, but not weak / medium strength topical corticosteroids. No connection was found between the use of a pregnant topical corticosteroids of any strength with the development of a cleft palate, premature birth and fetal death. Also, another cohort study conducted in Denmark did not reveal a causal relationship between the use of topical corticosteroids and the cleft palate.

It is not known whether the active substances pass into breast milk® Ultra (hydrocortisone acetate, zinc sulfate). Traces of endogenous hydrocortisone (cortisol) are excreted in breast milk. The amount of corticosteroids in milk ranges from 0.2 to 32 ng / ml with a maximum average concentration (25.5 ng / ml), which is determined in colostrum at the end of pregnancy. The concentration of hydrocortisone in colostrum averages 7.5% of the plasma level.

There are no reports on the excretion of exogenous hydrocortisone or cortisone into breast milk. It is unlikely that these substances can have a negative effect on a breast-fed newborn. Prednisolone, a stronger GCS than hydrocortisone, is excreted in breast milk in minimal quantities and is considered compatible with breastfeeding.

During pregnancy and lactation, the drug can be used if, according to the doctor, the benefits of the use for the mother outweighs the potential risk to the fetus. The drug of this group should not be widely used in pregnant women, especially in high doses or for a long time.

Before using this medication, consult a doctor.

Relief Research® Ultra (hydrocortisone acetate, zinc sulfate) on human fertility was not performed.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. No data available.

Interactions

Use with caution with simultaneous treatment with anticoagulants, hypoglycemic agents, barbiturates, diuretics, cardiac glycosides.

With simultaneous use with other corticosteroids (both topical and oral), the likelihood of developing systemic effects may increase.

With simultaneous use with CYP 3A inhibitors (including drugs containing cobicistat), an increased risk of systemic side effects, including inhibition of adrenal function, is possible. Simultaneous use should be avoided, except in cases where the benefit of using the drug prevails over the risk of developing systemic effects of GCS, and it is necessary to monitor the patients condition.

Overdose

Long-term use in high doses enhances resorption and increases the risk of developing systemic effects of hydrocortisone, such as menstrual irregularities, increased hell, slowing wound healing, muscle weakness, insomnia, increased blood glucose, hirsutism, glaucoma, etc.

In case of accidental swallowing, gastrointestinal tract disorders (nausea, stomach pain) may occur.

Storage conditions

At a temperature not exceeding 25 ° C.

Tags: Relief® [Hydrocortisone, Zinc Sulfate]