U.S.Food and Drug Administration FDA has approved Striant Testosterone patches can be used to relieve oral including male hypogonadism testosterone deficiency. The patch was developed by the production company Columbia Laboratories, size as an aspirin, can be quickly adhered to the gums and upper lip junction, to the oral mucosa in 12 hours to slowly release testosterone.
Because without going through the digestive tract directly into the superior vena cava, so the effect of the corresponding increase testosterone, as testosterone skin patch, cream or injection of local than another option. According to experts, Striant containing 30mg of testosterone a day, morning and evening can be affixed to a body's testosterone levels to maintain normal and stable
FDA to change Striant, Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS, AndroGel to the safety labeling
Feb. 9, 2005 - The U.S. Food and Drug Administration (FDA) last December approved safety labeling of several drugs, including male breast cancer patients with suspected or identified and prostate cancer, may not use testosterone buccal system; Naproxen (suspension, tablets, casings release tablets) and naproxin sodium (tablets, two tablets) may cause anaphylactoid reactions; testosterone gel will burn when dry, it may cause harm; the case to the safety labeling changes , is released for health professionals.
Testosterone buccal system (Striant) may not be used in male breast cancer or prostate cancer patients Nov. 3, FDA approval for a testosterone buccal system (Striant oral mucosa adhesive, Columbia Laboratories, Inc manufacturing) to the safety labeling, whether male or suspected carcinoma of the breast and prostate, are not use Striant.
FDA said that elderly patients, clinical and demographic characteristics that have of prostate cancer, the use of testosterone replacement therapy, they must first assess the malignancy; being testosterone-treated patients, treatment should continue to gonads guidelines for monitoring.
Testosterone buccal system for testosterone replacement therapy as treatment for congenital and acquired endogenous testosterone deficiency.
Naproxen and Naproxen Sodium (Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS) may cause anaphylactoid reactions In the November 10, FDA approved safety labeling revisions for the case of naproxen, and suspension dosage forms include tablets (Naproxyn), sustained-release tablets casing (EC-Naprosyn), and naproxen sodium regular and double strength tablets (Anaprox, Anaprox; chosen by Roche Palo Alto Manufacturing); FDA proposed the use of these drugs warnings and contraindications.
Patients for Yin Asi aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) and lead to asthma, rhinitis and nasal polyps (aspirin triad) and other potentially fatal symptoms, not to use naproxen and naproxen sodium; FDA stressed that the symptom complex typically occurs in asthmatic patients, these patients have symptoms of rhinitis, nasal polyps, but the phenomenon; or taking aspirin or other NSAIDs drugs, potentially fatal bronchospasm .
FDA warned that patients with no drugs used NSAIDs, naproxen may cause anaphylactoid reactions; so the patients before treatment should be carefully questioned to determine asthma, nasal polyps, urticaria, and hypotension side effect of NSAIDs; if found that the phenomenon described, one should immediately stop treatment.
In addition, severe kidney disease, do not recommend the use of naproxen therapy; can not avoid the use of naproxen in the case of kidney function should be monitored.
As with other NSAID drugs, should be avoided in late pregnancy naproxen, because the arterial catheter may be premature closure.
Naproxen and naproxen sodium are indicated for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis.
In addition to sustained-release tablets than naproxen, Naproxen and naproxen sodium, signs and symptoms of tendonitis, bursitis, acute gout and primary dysmenorrhea.
Attention! Testosterone gel 1% (AndroGel) will burn when dry November 19, FDA approved a testosterone gel 1% (AndroGel, Solvay Pharmaceutical, Inc) to the safety labeling case, the drug is the alcohol gel as the base agent with a flammability, patients should stay away from fire.
1% testosterone gel for testosterone replacement therapy as treatment for congenital and acquired endogenous testosterone deficiency.
通用名称STRIANT 睾酮30毫克;粘附颊标签。
法律分类: CIII
药理班STRIANT 雄激素。
制造商STRIANT 哥伦比亚实验室
适应症STRIANT 睾酮替代疗法。
成人剂量STRIANT 不要咀嚼或吞咽标签。 ≥18yrs:30毫克应用于口香糖(上门牙),每12小时(上午及下午),在30秒的地方举行,旋转应用网站。
儿童剂量为STRIANT 不推荐。
禁忌的STRIANT 乳腺癌或前列腺癌。不适合于女性使用。妊娠(Cat.X)。哺乳的母亲。
警告/注意事项的STRIANT 定期检查牙龈地区。心脏,肾脏或肝脏疾病。睡眠呼吸暂停。监测血红蛋白,红细胞压积,肝功能,前列腺特异抗原,胆固醇,高密度脂蛋白胆固醇,血清睾酮。老年人(前列腺增生症的风险增加)。五月的亚临床前列腺癌而成长。如果停止水肿,心衰,或出现黄疸。
互作STRIANT 口服抗凝血剂,会增强,oxyphenbutazone。可能会影响胰岛素的需求。糖皮质激素,促肾上腺皮质激素水肿增加风险。
不良反应为STRIANT 局部刺激,味觉倒错,口干,牙痛,水肿,肝紫斑病,前列腺肥大,胃肠不适,黄疸,多毛,痤疮,红细胞增多症,头痛,焦虑,抑郁,高血压,血清胆固醇增加或PSA,乳房发育。
Our patented delivery system used in STRIANT is the first-ever buccal system for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (primary or secondary hypogonadism).
In a 12-week, U.S. multicenter, open-label, single-arm, Phase 3 trial in 98 hypogonadal men, STRIANT returned 86.6% of patients to normal physiologic testosterone levels. STRIANT achieved these results without dose titration.
In another 7-day, European multicenter, open-label, parallel study, 96.6% of patients achieved normal testosterone levels, again without dose titration.
Also, STRIANT attains maximum serum testosterone concentrations within 10 to 12 hours after the first dose. This was shown in a phase I, prospective, randomized, double-blind, placebo-controlled cross-over study. Steady state was achieved after the second dose. This was shown in a phase 1, open-label pharmacokinetic study in 12 hypogonadal men.
STRIANT achieved testosterone concentration-time curves that were consistent when evaluated across a 12-week, multicenter, open-label, single-arm, Phase 3 study in 98 hypogonadal men (study 1), and a 7-day, multicenter, open-label, parallel study comparing STRIANT and an approved testosterone transdermal system in 29 hypogonadal men (study 2).
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