Published March 10, 1994.
List of German Commission E Monographs (Phytotherapy)
Bromelain (EC 126.96.36.199) is the genuine mixture of bromelin A and B, the proteolytic enzymes of pineapple fruit, Ananas comosus (L.) Merrill [Fam. Bromeliaceae], in effective dosage.
In various animal experiments (egg white-, carrageen-, dextran-, and yeast-induced edemas, traumatic edema, adrenalin-caused edema of the lungs), an edema-inhibiting effect was demonstrated with high dosages of bromelain upon oral and intraperitoneal administration. Upon oral intake, bromelain can prolong prothrombin and bleeding time, as well as inhibit the aggregation of thrombocytes. There is no information available on the absorption of the compound in humans after oral ingestion.
Only older data are known regarding acute and chronic toxicity of the compound. The LD50 after parenteral application is 85.2 mg/kg for rats, 30 - 35 mg/kg for mice, and for rabbits greater than 20 mg/kg of body weight. There are no data for mutagenicity and carcinogenicity.
With rats and rabbits, there were no indications of embryotoxic or teratogenic effects.
Clinical Data 1. Uses Acute postoperative and post-traumatic conditions of swelling, especially of the nasal and paranasal sinuses.
Hypersensitivity to bromelain.
Occasionally gastric disturbances or diarrhea. Sometimes allergic reactions.
No data available.
An increased tendency for bleeding in the case of simultaneous administration of anticoagulants and inhibitors of thrombocytic aggregation cannot be excluded. The levels of tetracyclines in plasma and urine are increased by simultaneous intake of bromelain.
Unless otherwise prescribed:
80 - 320 mg of bromelain (200 - 800 FIP units) in 2 or 3 doses. Mode of Administration Solid preparations for oral use.
8 - 10 days. If necessary, administration may be prolonged.