Proctase-P

Proctase-P

Manufacturer:

Meiji

Distributor:

DKSH
Full Prescribing Info
Contents
Proctase, pancreatin.
Description
One PROCTASE-P CAPSULES contain 10 mg of proctase and 50 mg of pancreatin JP.
PROCTASE-P CAPSULES are anti-inflammatory enzyme preparations which contain proctase, a proteolytic enzyme produced by Aspergillus niger and pancreatin.
Action
Pharmacology: Anti-inflammatory Activity: Oral administration of PROCTASE-P CAPSULES showed excellent anti-inflammatory effects on rat foot pad edema due to carrageenan, dextran and antiserum, as well as inflammatory tumors caused by croton oil in rats.
Formation of sarcomas due to embedded cotton pellets after extraction of the anterior maxillary teeth was also inhibited in rats.
Synergistic Action: PROCTASE-P CAPSULES inhibited exudate retention more significantly than either proctase or pancreatin alone in the rat carrageenan granuloma experiments, showing the synergistic action of the two ingredients.
Enhancement of Tissue Penetration of Antibiotics: Oral administration of PROCTASE-P CAPSULES enhanced the tissue penetration of ampicillin and ribostamycin in humans and erythromycin in rabbits.
Toxicology: Non-clinical Tests: Toxicity: Acute Toxicity: Oral LD50 (mg/kg) of PROCTASE-P CAPSULES: >10,000 # in rats and mice.
Chronic Toxicity: 15, 150, 1,500 and 5,000 mg/kg # were orally administered to rats for 6 consecutive months, and the findings were compared with the untreated control. There were no abnormalities in the general condition, body weight, food consumption, urinalysis, hematology, necropsy or histopathology.
Antigenicity: Serum samples were obtained from rabbits treated orally with 600 mg/kg # for 35 consecutive days. All samples were negative with respect to agar gel precipitation and PCA reactions.
General pharmacology: Oral administration of 600 mg/kg # had no effects on the central nervous system (general behavior, anti-convulsive effects, potentiation of anesthetic effects and spontaneous EEG), respiratory and cardiovascular systems (respiration, blood pressure, heart rate and ECG), GI-tract (gastrointestinal transport) or blood coagulation (prothrombin time).
Distribution: In intestinal absorption experiments by the inverted intestine method in rats, both proctase and pancreatin were found to pass through the intestinal wall from the mucosa to the serous membrane without being inactivated.
# A powder mixture containing proctase and pancreatin JP at a ratio of 1:5 was used.
Indications/Uses
Relief of swelling and inflammation.
Dosage/Direction for Use
Usually, one capsule orally administered 3 times a day after meals. The drug should not be administered aimlessly.
Contraindications
Do not administer to the following patients: With a history of hypersensitivity reactions to PROCTASE-P CAPSULES and pancreatin; With a history of hypersensitivity reactions to bovine or porcine proteins.
Special Precautions
General Precautions: Appropriate antibiotics or chemotherapeutic agents should be co-administered to patients with infectious diseases.
Careful Dosage: Administer with caution to patients with the following conditions: Blood coagulation abnormalities; Under treatment with anticoagulants; Serious hepatic or renal diseases.
Side Effects
Hypersensitivity reactions: Hypersensitivity symptoms, such as sneezing, lacrimation and skin eruption may occur. Discontinue treatment upon onset of any such symptom.
Digestive tract: Symptoms, such as anorexia, a feeling of abdominal bloating, nausea or diarrhea, may occasionally occur.
Caution For Usage
Precautions in Application (Pancreatin): Swallow PROCTASE-P CAPSULES immediately. Stomatitis and oral ulcers caused by the retention of large doses in the oral cavity have been reported in children.
Ensure that the powder of PROCTASE-P is not inhaled during administration procedures. Bronchial spasm and rhinitis have been reported due to the inhalation of the powder of this drug.
Storage
Store below 30°C.
ATC Classification
M09AB - Enzymes ; Used in the treatment of musculo-skeletal disorders.
Presentation/Packing
Hard cap (brown cap and ivory body, white or slightly yellow-brown powder with a slightly peculiar taste) 50 x 10's, 500's.
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