125494-59-9 Two foreign studies have been carried out on the possibility of heart valve disease: In one study, 210 patients (mean age of 54) using 2 - the color doppler echocardiographic instrument, observing the patients during the period of up to 2 weeks to 16 months 15 mg per day sibutramine hydrochloride or placebo, and no cases of heart valve disease, the results of sibutramine hydrochloride group of heart valve disease incidence is 3/132 (2.3%), All three cases had mild aortic insufficiency, compared with 2/77 (2.6%) in the placebo group, with one mild aortic insufficiency and one severe aortic insufficiency.
In another study, no heart valve disease was observed in 25 patients treated with sibutramine hydrochloride 5 to 30mg daily for 3 months using 2 and color doppler echocardiography. Certain central weight-loss drugs that cause the release of serotonin from nerve endings can induce pulmonary hypertension (PPH), a rare but fatal condition. No similar cases have been found in the clinical study of this product before marketing, but it is not certain whether this product can cause this disease due to the low incidence of this disease in the population. Patients with severe hepatic or renal insufficiency should not take this product.
Since weight loss can increase and aggravate the formation of gallstones, patients suffering from gallstones should use this product with caution. This product can cause pupil dilation, so it is used in patients with angle-closure glaucoma. Use with caution in patients with a history of epilepsy. Discontinue use in patients with epileptic seizures.
Although sibutramine hydrochloride did not affect psychomotor and thought behavior in healthy volunteers, any drug that acts on the central nervous system has the potential to affect judgment, thinking, or motor skills. Teratogenic effect of sibutramine hydrochloride was observed in animal tests, but carcinogenic and mutagenic effect was not observed. It is recommended that women who are pregnant, preparing for pregnancy and lactation should not take this product. Sibutramine hydrochloride is not recommended for children under 16 years of age because the safety and efficacy of sibutramine hydrochloride in children under 16 years of age has not been established. Due to reduced cardiac, kidney, and liver function or the increased likelihood of treatment for other diseases, the elderly should be carefully selected for dosage.
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