WHO monographs on selected medicinal plants - travolekar.ru

WHO monographs on selected medicinal plants - travolekar.ru WHO monographs on selected medicinal plants - travolekar.ru

20.01.2015 Views

ong>WHOong> ong>monographsong> on selected medicinal plants the placebo was highly significant (–18.0 mm; 95% CI –27.2 to –8.8 mm; p = 0.0002, ANCOVA). The results in the rheumatoid arthritis trial showed that the mean reduction of pain reported using the visual analogue scale was –8 mm (15%) in the group treated with willow bark compared with –2 mm (4%) in the placebo group. The difference was not statistically significant (estimated difference –0.8 mm; 95% CI –20.9 to 19.3 mm; p = 0.93, ANCOVA) (29). Pharmacokinetics The pharmacokinetics of salicin and its major metabolites were determined in humans after oral administration of an extract of the crude drug. The extract, corresponding to 240.0 mg salicin (1360 mg, 838 μmol), was administered to 10 healthy volunteers in two equal doses at times 0 h and 3 h. Over a period of 24 h, levels of salicylic acid and its metabolites in urine and serum, i.e. gentisic acid and salicyluric acid, were determined using reverse-phase high-performance liquid chromatography. Renal excretion rate, elimination half-life and total bioavailability of salicylates were calculated. The results showed that salicylic acid was the major metabolite of salicin detected in the serum (86% of total salicylates), as well as salicyluric acid (10%) and gentisic acid (4%). Peak serum levels were reached within less than 2 h after oral administration. Renal elimination occurred predominantly in the form of salicyluric acid. Peak serum levels of salicylic acid were on average 1.2 mg/l, and the observed area under the serum concentration–time curve of salicylic acid was equivalent to that expected from an intake of 87.0 mg acetylsalicylic acid (30). Adverse reactions Allergic reactions such as pruritus, urticaria, asthma and gastrointestinal symptoms may occur (16). One case of an allergic reaction in a 32-year-old atopic patient who showed a severe anaphylactic reaction after the ingestion of a pollen compound containing the crude drug has been reported (31). One case of anaphylaxis resulting from the use of an extract of the crude drug in a patient with a history of an aspirin allergy has been reported (32). Contraindications Cortex Salicis is contraindicated in cases of hypersensitivity or allergy to the plant material or to salicylates (e.g. asthma, bronchial spasm, rhinitis or urticaria). It is also contraindicated during pregnancy and lactation, in patients with salicylate intolerance and patients with impaired thrombocyte function (7, 27), and in children under the age of 12 years (7). 318

Cortex Salicis Warnings In children under the age of 12 years, Cortex Salicis should only be used on the advice of a health care professional due to the possibility of Reye’s syndrome. In cases of a child or adolescent who has become very ill with severe vomiting, drowsiness or loss of consciousness following a viral infection, Reye’s syndrome should be suspected. This extremely rare, lifethreatening disease requires immediate medical attention. In cases of severe liver or renal dysfunction, coagulation disorders, gastric/duodenal ulcer and glucose-6-phosphate dehydrogenase deficiency, the product should only be taken under medical supervision. Consult a health care professional in cases of fever (> 39 C), lasting longer than 3 days. A health care professional should also be consulted if acute conditions of swelling of joints, redness and impaired mobility persist or worsen during the first week of use of Cortex Salicis. Precautions General The use of Cortex Salicis in patients with hypersensitivity to other nonsteroidal anti-inflammatory drugs is not recommended. Use should be avoided in people with asthma because severe reactions (acute bronchospasms) could be induced (16). Drug interactions Currently there are no data indicating that the crude drug interacts with anticoagulant drugs such as coumarin and heparin. However, Cortex Salicis may increase the effects of anticoagulants. Patients on anticoagulant therapy should not use products containing the crude drug without the supervision of a health care professional (7). Carcinogenesis, mutagenesis, impairment of fertility Oral administration of a 40% ethanol extract of the bark did not disrupt the estrous cycle, or inhibit ovulation or fertility when administered to female rats and rabbits at a dose of 1.6 ml/kg bw (26). Pregnancy: teratogenic effects Oral administration of a 40% ethanol extract of the bark to female rats and rabbits at a dose of 1.6 ml/kg bw during pregnancy was not teratogenic (26). Pregnancy: non-teratogenic effects See Contraindications. 319

Cortex Salicis<br />

Warnings<br />

In children under the age of 12 years, Cortex Salicis should <strong>on</strong>ly be used<br />

<strong>on</strong> the advice of a health care professi<strong>on</strong>al due to the possibility of Reye’s<br />

syndrome. In cases of a child or adolescent who has become very ill with<br />

severe vomiting, drowsiness or loss of c<strong>on</strong>sciousness following a viral infecti<strong>on</strong>,<br />

Reye’s syndrome should be suspected. This extremely rare, lifethreatening<br />

disease requires immediate medical attenti<strong>on</strong>.<br />

In cases of severe liver or renal dysfuncti<strong>on</strong>, coagulati<strong>on</strong> disorders,<br />

gastric/duodenal ulcer and glucose-6-phosphate dehydrogenase deficiency,<br />

the product should <strong>on</strong>ly be taken under medical supervisi<strong>on</strong>.<br />

C<strong>on</strong>sult a health care professi<strong>on</strong>al in cases of fever (> 39 C), lasting<br />

l<strong>on</strong>ger than 3 days. A health care professi<strong>on</strong>al should also be c<strong>on</strong>sulted if<br />

acute c<strong>on</strong>diti<strong>on</strong>s of swelling of joints, redness and impaired mobility persist<br />

or worsen during the first week of use of Cortex Salicis.<br />

Precauti<strong>on</strong>s<br />

General<br />

The use of Cortex Salicis in patients with hypersensitivity to other n<strong>on</strong>steroidal<br />

anti-inflammatory d<strong>ru</strong>gs is not recommended. Use should be<br />

avoided in people with asthma because severe reacti<strong>on</strong>s (acute br<strong>on</strong>chospasms)<br />

could be induced (16).<br />

D<strong>ru</strong>g interacti<strong>on</strong>s<br />

Currently there are no data indicating that the c<strong>ru</strong>de d<strong>ru</strong>g interacts with<br />

anticoagulant d<strong>ru</strong>gs such as coumarin and heparin. However, Cortex Salicis<br />

may increase the effects of anticoagulants. Patients <strong>on</strong> anticoagulant<br />

therapy should not use products c<strong>on</strong>taining the c<strong>ru</strong>de d<strong>ru</strong>g without the<br />

supervisi<strong>on</strong> of a health care professi<strong>on</strong>al (7).<br />

Carcinogenesis, mutagenesis, impairment of fertility<br />

Oral administrati<strong>on</strong> of a 40% ethanol extract of the bark did not dis<strong>ru</strong>pt<br />

the estrous cycle, or inhibit ovulati<strong>on</strong> or fertility when administered to<br />

female rats and rabbits at a dose of 1.6 ml/kg bw (26).<br />

Pregnancy: teratogenic effects<br />

Oral administrati<strong>on</strong> of a 40% ethanol extract of the bark to female rats<br />

and rabbits at a dose of 1.6 ml/kg bw during pregnancy was not teratogenic<br />

(26).<br />

Pregnancy: n<strong>on</strong>-teratogenic effects<br />

See C<strong>on</strong>traindicati<strong>on</strong>s.<br />

319

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