POSTERISAN® FORTE
About the product
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Brand name:
POSTERISAN® FORTE
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Dosage form:
Rectal suppositories
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Composition:
1 suppository contains:
Active pharmaceutical substance: standardized suspension of E. coli bacterial culture (1,00 х 109 inactivated microbial cells) – 387,10 mg, hydrocortisone – 5,00 mg.
Excipients: phenol (liquified)* – 6,60** mg, acetylcysteine – 2,00 mg, α-tocopherol – 0,60 mg, disodium edetate dihydrate – 1,64 mg, macrogol glyceryl hydroxystearate – 57,63 mg, solid fat – 1546,03 mg.
* in composition of standardized suspension of E. coli bacterial culture
** in line with solid phenol content 6,0 mg
Universal drug for the hemorrhoid symptoms treatment. Contains hydrocortisone to treat severe inflammation and itching.
Description
White to beige torpedo-shaped suppositories with characteristic phenol odor.
Indications
— Persistent hemorrhoids
— Anal itching, especially resistant to other medicines
— Anopapillitis
— Anal fissure
Dosage Regimen
Adults
The recommended daily dose is 2 suppositories.
Treatment should be continued until the symptoms disappear. The medicinal product should not be used continuously for more than 10 days.
Children
Posterisan Forte is contraindicated in children under 18 years of age.
Method of Administration
The suppositories should be inserted into the rectum twice daily (morning and evening), preferably after defecation.
Counterindications
— Hypersensitivity to the active ingredients or to any of the excipients
— Children under the age of 18
— Use in bacterial, fungal, or viral diseases in the treatment area
— Specific skin diseases (syphilitic or tuberculous lesions, gonorrhea)
— Vaccination reactions
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) |
Prolonged use of high doses may cause skin atrophy, telangiectasia, striae, and steroid acne.
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.
Код АТХ: C05AX03
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.
Hydrocortisone acetate is a steroid hormone of the adrenal cortex. When applied topically, it has anti-inflammatory, desensitizing, antiallergic, vasoconstrictive, and antipruritic effects. It inhibits the release of inflammatory mediators.
When applied to the affected area, it reduces swelling, redness, and itching.
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.