Instructions Posterizan ointment tube 25 g
Composition
active ingredient: 1 g of ointment contains 166.70 mg of standardized bacterial culture suspension (containing 3.3 × 108 E. coli killed and preserved in 3.3 mg of liquefied phenol);
excipients: lanolin, yellow soft paraffin.
Dosage form
Ointment.
Main physicochemical properties: homogeneous ointment from white to beige color with a characteristic odor of phenol.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for topical use. ATX code C05A X.
Pharmacological properties
Pharmacodynamics. The active substance of the drug is a standardized bacterial culture suspension (SBS) obtained from E. coli.
To produce SKB, bacteria are inactivated with phenol. The aqueous suspension is then processed into a galenic form. Therefore, the finished preparation contains intact cells, cell breakdown products, and metabolites, but does not contain live bacteria.
After rectal administration (in rats and dwarf piglets), SKB is rapidly absorbed through the intestinal mucosa. After application to the skin and mucosa, SKB stimulates nonspecific and specific immune mechanisms. In vitro tests and animal models have shown that SKB induces T-lymphocyte proliferation and the production of immunoglobulins (IgA and IgG). This triggers a polyclonal stimulation of the immune response, enhances natural immune defenses, and reduces the susceptibility of affected tissues to infections.
In an in vitro model on human cell systems, lymphocyte proliferation is induced in an antigen-specific manner by antigen-presenting Langerhans cells. In vitro, SKB lyophilizates have an inhibitory effect on the provoked release of histamine from mast cells and basophilic granulocytes, demonstrating anti-inflammatory properties. In vitro induction of various cytokines indicates a possible involvement in tissue regeneration and, accordingly, promotes wound healing.
Animal and human experiments also demonstrate an immunogenic effect on inflammatory skin changes, as well as a wound-healing effect. Swelling decreases more quickly when therapy includes SKB.
Pharmacokinetics.
Absorption, blood presence, and excretion studies cannot be performed after topical application of SKB. However, penetration of immunogenic components of SKB has been determined in immunohistological studies on the rectal mucosa of animals (rats and dwarf piglets).
Indication
Topical treatment of symptoms of hemorrhoids, eczema and anal fissures.
Contraindication
Hypersensitivity to the active substance or to any component of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
In case of fungal infections, a topical antifungal medication should be used simultaneously.
During treatment with Posterisan ointment, the tensile strength of condoms may decrease due to the content of the yellow soft paraffin component, which may negatively affect the quality of the condom.
Posterisan contains wool wax (lanolin). May cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
There are no contraindications for using the drug during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data is missing.
Method of administration and doses
Before use, it is necessary to carry out hygienic procedures of the anal area.
Adults should apply the ointment to the affected area of the skin and mucous membranes twice a day (morning and evening), if possible after defecation, and gently rub in with a finger.
To introduce the ointment into the anal canal and rectum, you can use the applicator with side holes, which is included in the package.
The duration of treatment is determined by the doctor depending on the nature and course of the disease. Usually the duration of use is 5–7 days.
Children.
Do not use on children.
Overdose
No cases of overdose or intoxication have been reported. In case of accidental oral administration of the ointment (e.g. by children), gastrointestinal disorders (abdominal pain, nausea) are possible.
Side effects
In some cases, patients with hypersensitivity to the components of Posterizan ointment may experience hypersensitivity reactions, including itching and burning.
May cause contact dermatitis (e.g. due to hypersensitivity to phenol).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children and in a dry place, protected from light.
Packaging
25 g in an aluminum tube with an applicator.
1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
Dr. Kade Pharmaceutical Factory GmbH.
Address
Rigistrasse 2, 12277 Berlin, Germany.
