POSTERISAN®

Universal drug for the hemorrhoid symptoms treatment.

 

Description

 

Homogeneous white to beige ointment with characteristic phenol odor.

Indications

 

— Anal itching, discharge and burning in the anal area due to hemorrhoids
— Anal fissures
— Eczemas

 

Dosage Regimen

 

Adults
Apply a thin layer of the ointment to the affected area of the skin and mucous membrane in the morning and evening, preferably after defecation.
The duration of treatment is 2–3 weeks.

Children
The safety and efficacy of Posterisan in children aged 0 to 18 years have not been established. No data are available.

 

Method of Administration

 

Apply a thin layer of the ointment to the affected area of the skin and mucous membrane in the morning and evening, as well as after each defecation. For deeper administration of the ointment into the rectum, the screw-on applicator supplied with the package may be used.

Use of the Applicator
Screw the applicator onto the tube and remove the applicator cap. When pressure is applied to the tube, the ointment enters the applicator and is released through the openings on its sides. The applicator should then be carefully inserted fully into the anus.
Lubricating the applicator with the ointment facilitates its insertion into the anus. When pressure is applied to the tube again, the ointment enters the anal canal. Gently rotating the tube ensures even distribution of the ointment. After use, clean the applicator by squeezing a small amount of ointment through the side openings and wiping it with an absorbent tissue, then replace the applicator cap. This will prevent the ointment from drying out.
If the ointment is not used for an extended period, the applicator should be unscrewed and rinsed with water.
Posterisan ointment for rectal and external use may be used in combination with Posterisan rectal suppositories.

Counterindications

 

— Hypersensitivity to the active substance or to any of the excipients
— Children under the age of 18

 

Adverse Reactions

 

Summary of Adverse Reactions

System Organ Class	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1,000 to < 1/100)
General disorders and administration site conditions	Local hypersensitivity reactions (e.g., itching and burning)	Allergic contact dermatitis (due to hypersensitivity to the preservative phenol)

 

Pharmacological Properties

 

Pharmacodynamic Properties
Pharmacotherapeutic group: angioprotectives; agents for the treatment of hemorrhoids and anal fissures for topical use; other agents for the treatment of hemorrhoids and anal fissures for topical use.
ATC code: C05AX

 

Mechanism of Action and Pharmacodynamic Effects
When applied topically to the skin of the anal area and the rectal mucosa, cell wall antigens and metabolic products of a standardized E. coli (Escherichia coli) bacterial culture induce a local immune response. Components of E. coli interact with antigen-presenting Langerhans cells, inducing the release of anti-inflammatory cytokines. This, in turn, reduces the production of histamine and leukotrienes, resulting in anti-inflammatory and antipruritic effects. Vascular exudation is also reduced, while blood vessel permeability and tone are normalized.
In addition, activation of antigen-presenting cells stimulates the regeneration of damaged tissues. Accelerated healing of the rectal mucosa helps reduce bleeding and pain.
Repeated administration of the standardized E. coli culture induces the proliferation of B and T lymphocytes in the regional lymph nodes and stimulates antibody production, thereby enhancing protection against infectious complications of hemorrhoidal disease.

 

Preclinical Safety Data
Preclinical data obtained from conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and reproductive and developmental toxicity revealed no particular hazard for humans. No irritant or toxic effects were identified with prolonged topical administration.