Relief Pro (phenylephrine, lidocaine) rectal suppositories №10

Description

Relief Pro (phenylephrine, lidocaine) rectal suppositories №10

Composition

active substances: 1 suppository contains: 1 mg of fluocortolone pivalate and 40 mg of lidocaine hydrochloride (anhydrous);

excipients: solid fat.

Medicinal form

Rectal suppositories.

Main physicochemical properties: yellowish-white suppositories.

Pharmacotherapeutic group

Means for the treatment of hemorrhoids and anal fissures for local use. Corticosteroids. Fluocortolone.
ATX code C05АА08.

Pharmacological properties

Fluocortolone pivalate suppresses inflammatory and allergic skin reactions, as well as alleviates subjective manifestations such as itching, burning and pain; reduces capillary dilation, interstitial cell edema and tissue infiltration, inhibits capillary proliferation.

Lidocaine hydrochloride is a standard local anesthetic that has been used in medical practice for many years. Due to its analgesic effect, it is effective in the use of suppositories and ointments intended for the treatment of disorders associated with hemorrhoidal pathology. The reduction in pain and itching is associated with the inhibition of afferent nerve impulses.

Indication

For symptomatic treatment of pain and inflammation in the case of:

• hemorrhoids;
• proctitis.

Contraindication

The use of the drug Relief Pro is contraindicated in local infections in the area of ​​introduction, as well as in the presence of clear symptoms in the relevant areas of the following pathological conditions:

• specific skin lesions (syphilis, tuberculosis);
• chickenpox;
• reactions after vaccination;
• genital herpes;
• smallpox;
• other viral infections;
• primary bacterial or fungal infections;
• secondary skin infections in the absence of appropriate antibiotic therapy.

Contraindicated in patients with hypersensitivity to other local amide-type anesthetics (eg bupivacaine, mepivacaine and lidocaine).

Relief Pro should not be used in case of hypersensitivity to the active substances or to any of the excipients.

Method of application and dosage

Apply 1 suppository 2 times a day, morning and evening. After improvement, 1 suppository once a day or once every two days is often enough. It is recommended to use Relief Pro suppositories after defecation. Before inserting the suppository, the anal area should be carefully cleaned.

Insert the suppository deep into the anus. The duration of treatment with Relief Pro suppositories should not exceed 2 weeks.

If the suppositories become soft due to high temperatures, immerse them in cold water before removing the shell.

Children

Not recommended for use in children due to a lack of data on safety and efficacy.

Overdose

Studies of potential acute toxicity associated with the active substances of Relief Pro suppositories indicate no risk of developing symptoms associated with acute toxicity due to accidental overdose from a single rectal administration.
In case of accidental ingestion of the drug (for example, in case of ingestion of several suppositories), mainly systemic symptoms caused by lidocaine hydrochloride are expected. Depending on the dose, they may take the form of severe cardiovascular disorders (low blood pressure, increased sweating, pale skin, bradycardia, arrhythmia, heart failure, shock or, in particularly severe cases, cardiac arrest) or reactions. associated with disorders of the central nervous system (headache, dizziness, blurred vision, diplopia, tinnitus, drowsiness, numbness of the extremities, chills, anxiety, vomiting, convulsions, dyspnea or, in particularly severe cases, respiratory failure). Methemoglobinemia is possible.

Treatment in case of overdose includes careful monitoring of vital signs, supportive actions that provide oxygen levels, as well as symptomatic treatment of disorders of the central nervous system and cardiovascular system, such as short-acting barbiturates, beta-sympathomimetics and atropine. Dialysis does not provide a sufficient effect.

Side effects

Cases of adverse reactions were calculated based on a set of data from clinical trials in 367 patients.
From the skin and subcutaneous tissue, including allergic reactions: common: pain and burning sensation at the site of application; uncommon: irritation at the site of application.

After long-term therapy with Relief Pro suppositories (which exceeds 4 weeks) there is a risk of developing local pathological skin conditions, such as atrophy, stretch marks or telangiectasia.

Adverse reactions due to lidocaine hydrochloride: The development of systemic adverse reactions to lidocaine is unlikely, because with proper use of the drug, the entry of lidocaine into the systemic circulation is negligible.