Faktu

Faktu

Manufacturer:

Takeda

Distributor:

Zuellig
Full Prescribing Info
Contents
Policresulen, cinchocaine hydrochloride.
Description
Suppository: 1 suppository contains 100 mg of Policresulen and 2.5 mg of Cinchocaine hydrochloride.
Ointment: 1 g of ointment contains 50 mg of Policresulen and 10 mg of Cinchocaine hydrochloride.
The principal active component of Policresulen + Cinchocaine HCl (Faktu) is a polycondensation product consisting of methylene-bridged metacresolsulfonic acids buffered for proctologic use. In addition, it contains the local anesthetic cinchocaine hydrochloride.
Action
Antihemorrhoidal.
Pharmacology: Pharmacodynamics: Actions: Policresulen + Cinchocaine HCl (Faktu) has multiple actions predominantly attributable to policresulen. It arrests to bleeding by coagulating blood protein and inducing the muscle fibers of small blood vessels to contract. The coagulating properties and the acid pH brings out the antimicrobial action against Escherichia coli, staphylococci and streptococci, Pseudomonas aeruginosa, Proteus vulgaris, candida and other bacteria. Thus, the wound is protected against infection. In vitro periodic investigations on the different pathogens have revealed no change in sensitivity. The coagulation of necrotic and pathologically altered tissues cleans the wound and promotes wound healing. Cinchocaine has local anesthetic action which relieves pain and itching.
Pharmacokinetics: General pharmacokinetics: After oral administration of policresulen about 10% of the dose was absorbed in animal experiments. The absorption after local intravaginal or intrarectal application was slightly less with 6-8%. Absorbed policresulen constituents were eliminated with a half-life between 4 and 5 hours. No biotransformation was detected. Intravenously administered policresulen was eliminated mainly via urine, and less than 10% were excreted through feces, whereas orally or rectally administered drug was excreted mainly in the feces due to its low absorption, and less than 10% were eliminated via urine.
After dermal application of cinchocaine, 15.3% of the applied dose was absorbed by rats within 12 h. The terminal elimination half-life of the unchanged drug was 12 min after intraperitoneal administration in rats. The drug is largely metabolised by different species and excreted in urine and bile in nearly equal amounts by rats. Because of these findings and based on long-term human experience only minor amounts are expected to be absorbed after local administration on skin and mucous membranes.
Indications/Uses
For hemorrhoids and other anorectal disorders (external and internal hemorrhoids associated with inflammatory symptoms or superficial bleeding, anal fissures, anal rhagades, incised or spontaneously perforated perianal thrombosis, anitis, cryptitis, anal eczema, pruritus and postoperative wound treatment following proctological operations).
Dosage/Direction for Use
Ointment: The ointment is applied 2-3 times daily to the affected area. Rectal insertion of ointment requires prior evacuation of bowel. Use enclosed applicator for introduction.
Suppositories: 1 suppository 2-3 times daily following evacuation. After cessation of symptoms, treatment may be maintained with one suppository daily or as prescribed by the physician.
Overdosage
Unknown.
Contraindications
Policresulen + Cinchocaine HCl (Faktu) must not be used in patients with hypersensitivity to policresulen, cinchocaine hydrochloride or to any of the excipients.
Policresulen + Cinchocaine HCl (Faktu) suppositories contain soy lecithin. If the patient is allergic to soya or peanut, do not use Faktu suppositories.
Like any drug, it is generally not advisable to use Policresulen + Cinchocaine (Faktu) during the first trimester of pregnancy.
Use In Pregnancy & Lactation
Pregnancy: During pregnancy, policresulen must only be used when strictly indicated, with due assessment of the risks to the mother and child. Studies in animals have not shown any evidence of malformations. No studies are available on the risk of use during human pregnancy.
Lactation: It is not known whether the active ingredient passes into milk.
Adverse Reactions
Mild local discomfort such as burning sensation or itching associated with the therapeutic mechanism of preparation may sometimes be noted at the beginning of treatment, usually subsiding rapidly. Discontinuation of medication, therefore, is generally not required.
Very Rare: Anaphylactic reactions, including skin reactions (angioneurotic oedema, laryngeal oedema, urticaria and others) and generalized reactions up to anaphylactic shock.
Drug Interactions
Coadministration of other topical medications and policresulen, cinchocaine hydrochloride may lead to local interaction with other drugs. Hence, other topical medications should not be used in the affected region during the application of the policresulen, cinchocaine hydrochloride.
Storage
Store at room temperatures not exceeding 25°C.
MIMS Class
Anorectal Preparations
ATC Classification
C05AD04 - cinchocaine ; Belongs to the class of local anesthetics. Used in the topical treatment of hemorrhoids and anal fissures.
C05AX - Other agents for treatment of hemorrhoids and anal fissures for topical use ; Used in the topical treatment of hemorrhoids and anal fissures.
Presentation/Packing
Rectal oint (white to brownish) 20 g. Supp (cream-coloured to reddish-brown of identical appearance and with an intact surface) 10's.
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