Instructions for use Proctosan Neo rectal suppositories No. 10
Composition
active ingredients: heparin sodium, prednisolone acetate, polidocanol;
1 suppository contains: heparin sodium 120 IU; prednisolone acetate 1.675 mg; polidocanol 30 mg;
excipients: medium chain triglycerides, colloidal anhydrous silicon dioxide, solid fat, glycerol tristearate.
Dosage form
Rectal suppositories.
Main physicochemical properties: white, conical suppositories.
Pharmacotherapeutic group
Means for the treatment of hemorrhoids and anal fissures for topical use. ATC code C05A X03.
Pharmacological properties
Pharmacodynamics. Proctosan® NEO provides effective treatment of the characteristic symptoms and consequences of hemorrhoids. The drug quickly eliminates inflammation in the anorectal area, as well as accompanying sensations such as itching, burning, tingling, pain and a feeling of wetness.
Proctosan® NEO, thanks to pure heparin, prevents blood clot formation in hemorrhoidal plexuses.
Prednisolone has anti-inflammatory and antiallergic effects.
Polidocanol has a local analgesic effect and eliminates itching.
Pharmacokinetics. After topical application, heparin is found in the bloodstream in relatively low concentrations, which does not show systemic effects. In the blood, it binds to plasma proteins (95%). It is metabolized in the liver (partly by the hepatic heparinase enzyme) and in the reticuloendothelial system. It is excreted by the kidneys. From 20% to 50% of the drug is found in the urine in unchanged form. The half-life depends on the dose (increases with increasing dosage).
Prednisolone is contained in the drug and is absorbed in small quantities that are insufficient for systemic action.
Polidocanol has an exclusively local effect.
Indication
For the symptomatic treatment of hemorrhoids and itching in the perianal area for a short period of time.
Contraindication
Hypersensitivity to the components of the drug; infections in the perianal area; tendency to bleeding; specific skin lesions (e.g., syphilis); genital herpes; other viral infections; secondary skin infections in the absence of appropriate antibiotic therapy, I trimester of pregnancy. Tuberculous lesions of the anorectal area.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
CYP3A4 inhibitors, such as erythromycin, clarithromycin, ketoconazole, diltiazem, aprepitant, itraconazole, oleandomycin, and cobicistat, increase the elimination and plasma levels of prednisolone, which increases the therapeutic and side effects of the active substance prednisolone.
Proctosan® NEO is not recommended for use with other rectal medications.
Application features
If skin irritation or allergic reactions occur, the use of the drug should be discontinued immediately and appropriate symptomatic therapy should be initiated. To avoid local or general toxicity of the drug, the drug should not be used for a long time.
Pheochromocytoma crisis, which can be fatal, has been reported following the use of systemic corticosteroids. The drug should be prescribed to patients with suspected or established chromocytoma only after an appropriate risk/benefit assessment.
Visual disturbances have been reported with systemic and topical corticosteroids. If symptoms such as blurred vision or other visual disturbances occur, consideration should be given to referral to an ophthalmologist to rule out possible causes, which may include cataracts, glaucoma, or a rare condition called central serous chorioretinopathy, which has been reported with systemic and topical corticosteroids. Central serous chorioretinopathy may lead to retinal detachment.
The drug should be used with extreme caution in the presence of suppression of the hypothalamic-pituitary system caused by glucocorticoids.
Due to the presence of prednisolone in the composition, you should refrain from long-term use of Proctosan® NEO due to the possibility of causing dryness and microcracks in the anal canal, with infectious diseases of the skin of the perianal area, and during pregnancy.
Use during pregnancy or breastfeeding
The drug is contraindicated for use in the first trimester of pregnancy. Caution is recommended when using it in late pregnancy (second and third trimesters).
It is better not to use the drug during breastfeeding. Corticosteroids penetrate into breast milk. Thus, corticosteroids can affect the function of the adrenal cortex of the newborn and cause growth disorders.
Ability to influence reaction speed when driving vehicles or other mechanisms
Proctozan® NEO rectal suppositories do not affect the reaction speed when driving or working with other mechanisms.
Method of administration and doses
Suppositories should be inserted once a day after defecation into the rectum. With severe symptoms, 1 suppository can be inserted 2-3 times only during the first day of treatment.
The duration of therapy should not exceed 7 days. In the absence of improvement, it is necessary to examine the causes that led to the appearance of symptoms.
Children
There is no clinical experience with the use of the drug in children.
Overdose
With local application of the drug, which can be detected in the systemic circulation in relatively low concentrations, no toxic effects should be expected.
With prolonged use of the drug in large doses, symptoms of hypercorticism may appear.
Symptoms: headache, heart failure, hives, rash, severe itching.
Treatment: symptomatic. The drug should be discontinued and a doctor should be consulted.
In severe cases, emergency medical attention is necessary.
In cases of cutaneous atrophoderma associated with overdose with topical application of the drug, treatment should be discontinued. As a rule, the symptoms regress within 10-14 days.
Adverse reactions
The drug is usually well tolerated, only in rare cases may hypersensitivity reactions and local skin irritation occur (there is a small possibility of allergic reactions to polidocanol).
Topical corticosteroid treatment may cause local adverse reactions such as dermatitis, folliculitis (at the site of application), acne-like eruptions (steroid acne), contact dermatitis; dryness, thinning and fragility of the skin; erythema, rash, urticaria, hirsutism, hyperhidrosis, diaper rash, pruritus, skin atrophy, hypopigmentation, skin irritation, striae, telangiectasia, burning sensation on the skin, purpura, delayed healing of cracks.
With prolonged topical use, suppression of the function of the adrenal cortex, hypercorticism, growth retardation, steroid myopathy, osteonecrosis, osteoporosis (as a manifestation of the resorptive effect of prednisolone), blurred vision, chorioretinopathy are possible.
Expiration date
3 years.
Storage conditions. Store at a temperature not exceeding 25 °C in the original packaging (to protect from light and moisture). Keep out of the reach of children.
Packaging
5 suppositories in blisters; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
"Hemofarm" AD/"Hemofarm" AD,
LLC "FZ "BIOPHARMA", Ukraine.
Location of the manufacturer and its business address
Belgrade Road b/n, 26300, Vrsac, Republic of Serbia/Beogradski put bb, 26300,Vrsac, Republic of Serbia.
Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.
