TEKTURNA HCT TAB(氢氯噻嗪/阿利吉仑复方片剂)-作为新一类药物―直接肾素抑制剂的首个药品,获得美国食品药品监督管理局(FDA)的上市批准。Tekturna每天只需口服一次,以引发高血压产生过程的酶 ― 肾素作为靶向目标。高血压是引发心血管疾病的关键因素,也是全球第一大致死病因。
Generic Name and Formulations:
Aliskiren, hydrochlorothiazide; 150mg/12.5mg, 150mg/25mg, 300mg/12.5mg, 300mg/25mg; tabs.
Company:
Novartis Pharmaceuticals Corp
Indications for TEKTURNA HCT:
Hypertension.
Adult:
Take consistently with regard to meals. ≥18yrs: 1 tab once daily. Add-on or initial therapy and not volume-depleted: initially 150mg/12.5mg; may increase after 2–4 weeks up to max 300mg/25mg. Replacement therapy: may be substituted for the titrated components. Maximum effect usually seen at 4 weeks.
Children:
<18yrs: not established.
Contraindications:
Concomitant ARBs or ACEIs in diabetes. Anuria. Sulfonamide allergy.
Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy or start under close supervision. Discontinue if angioedema or laryngeal edema occurs (have SC epinephrine available). Moderate renal impairment (CrCl <60mL/min): avoid concomitant ARBs or ACEIs. Monitor BP, electrolytes, and renal function periodically. Consider withholding or discontinuing if significant renal dysfunction develops. Renal artery stenosis. Severe HF. Post-MI. Diabetes. Hepatic dysfunction. Asthma. SLE. Gout. Acute myopia. Secondary acute angle-closure glaucoma. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.
Interactions:
Avoid concomitant cyclosporine, itraconazole. Caution with NSAIDs, K+ supplements, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. Potentiates antihypertensives, possibly non-depolarizing muscle relaxants. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs or ACEIs may increase risk of hypotension, hyperkalemia, renal function changes. Concomitant furosemide; monitor. Adjust antidiabetic drugs. Concomitant lithium (risk of toxicity): monitor. Orthostatic hypotension potentiated by alcohol, CNS depressants. Decreased absorption by cholestyramine, colestipol resins (separate dosing by at least 4hrs), high fat meals.
Pharmacological Class:
Direct renin inhibitor + thiazide diuretic.
Adverse Reactions:
Dizziness, flu-like symptoms, diarrhea, cough, vertigo, asthenia, arthralgia, elevated BUN/creatinine, ALT, cholesterol, uric acid; rare: angioedema.
How Supplied:
Tabs—30, 90