| Ingredients | Amount Per Serving |
|---|---|
|
(Acacia catechu )
(herb)
(Extraction rate: about 1/3-4 (up to 333 mg of dry raw material per 1 ml of extract))
|
983 mg |
Alcohol, Water, Glycerin
Below is general information about the effectiveness of the known ingredients contained in the product Catechu. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Catechu. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Catechu has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of catechu when used orally in medicinal amounts. A specific product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been associated with an increased risk for liver and lung injury. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination. There is insufficient reliable information available about the safety of catechu when used topically.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
Catechu has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912). There is insufficient reliable information available about the safety of catechu when used orally in medicinal amounts or when used topically during pregnancy and lactation.
Below is general information about the interactions of the known ingredients contained in the product Catechu. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, concomitant use with antihypertensive drugs might increase the risk of hypotension.
 Details
Catechu might lower blood pressure (14144).
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Theoretically, black catechu may increase the levels and clinical effects of CYP1A2 substrates.
Details
Animal research shows that black catechu can increase theophylline concentrations in the blood, possibly by inhibiting CYP1A2 (94560). Theophylline is a CYP1A2 substrate.
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Theoretically, catechu might interfere with immunosuppressant therapy.
Details
Animal and in vitro studies suggest that catechu has immunomodulating effects (103271).
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Theoretically, black catechu may increase the levels and clinical effects of theophylline.
Details
Animal research shows that black catechu can increase theophylline concentrations in the blood, possibly by inhibiting cytochrome P450 1A2 (94560).
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Below is general information about the adverse effects of the known ingredients contained in the product Catechu. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General ...There is limited reliable information available about the adverse effects of catechu when used orally or topically as a single ingredient. A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavonoid extracts of catechu and Baikal skullcap has been associated with serious adverse effects, including liver and lung injury.
Hepatic
...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been linked to several reports of acute liver damage.
In a case series, four reports of liver damage were described in patients taking this product. The patients involved were females aged 54-68 years taking doses of 250-500 mg twice daily for 1-3 months. Signs and symptoms included jaundice, pruritus, abdominal pain, fever, rash, and elevated serum and liver transaminase levels. All patients fully recovered and levels normalized within 3 months after discontinuation (18009,18011). In addition to these published case reports, approximately 30 liver-related adverse events have been reported to the manufacturer of this product (18009). The mechanism of hepatotoxicity is unclear (18009,18010); it is estimated that the incidence of hepatotoxicity with this product is around 1 in 10,000, although the actual incidence is unknown (18010). In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination.
More recently, in another case report, a 54-year-old female reported to the emergency room with acute hepatitis possibly due to taking a preparation of catechu and Baikal skullcap for 2-4 weeks. Causation was unable to be established. After discontinuing the supplements and supportive treatment, liver function returned to normal (94563). It was unclear if the catechu product was the same specific combination product (Limbrel, Primus Pharmaceuticals) associated with previous reports of liver damage.
Pulmonary/Respiratory ...A specific combination product (Limbrel, Primus Pharmaceuticals) containing flavocoxid, a mixture of flavonoid extracts from catechu and Baikal skullcap, has been linked to several reports of hypersensitivity pneumonitis. Symptoms include fever, chills, headache, cough, chronic bronchitis, shortness of breath, weight loss, and fatigue. In 2017, the US Food and Drug Administration (FDA) formally requested the recall of all non-expired lots of this product due to the risk for liver and lung injury (106042). It is unclear if these effects were due to catechu, Baikal skullcap, or the combination.
