No initial dosage adjustment is necessary [see DOSAGE AND ADMINISTRATION]. In spite of the effect of candesartan cilexetil on aldosterone secretion, very little effect on serum potassium was observed. DailyMed - CANDESARTAN CILEXETIL tablet See additional information. Candesartan cilexetil is a prodrug suitable for oral use. Check with your physician for additional information about side effects. Candesartan undergoes N-glucuronidation in the tetrazole ring by uridine diphosphate glucuronosyltransferase 1A3 (UGT1A3). What are the possible side effects of ATACAND? Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. Abstract. Candesartan Cilexetil, 16 mg, Provides a Greater - PubMed Incidence not known. fluid and water retention, Curr Med Res Opin. The American College of Cardiology released new guidelines for Candesartan cilexetil (Atacand) is a medication prescribed to treat high blood pressure. Candesartan cilexetil: a new, long-acting, effective angiotensin II They are supplied in bottles of 30 tablets (NDC 62559-641-30). Eur J Pharmacol. life-expectancy for a person with congestive heart failure depends upon the The antihypertensive effects of ATACAND were evaluated in hypertensive children 1 to < 6 years old and 6 to < 17 years of age in two randomized, double-blind multicenter, 4-week dose ranging studies. Drug created at June 13, 2005 13:24 / Updated at June 29, 2023 21:52, Structured drug data for data science & ML, Clinical intelligence tool for your software, Search for drug interactions with our API, Get drug allergy and cross sensitivities info. It's taken by mouth, typically once or twice daily. In hypertensive patients with moderate hepatic impairment, consideration should be given to initiation of ATACAND at a lower dose [see DOSAGE AND ADMINISTRATION]. The metabolism of Acenocoumarol can be decreased when combined with Candesartan cilexetil. Closely monitor blood pressure, renal function and electrolytes in patients on ATACAND and other agents that affect the RAS. In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, hypotension was reported in 22.6% of patients treated with ATACAND versus 13.8% treated with placebo [see DRUG INTERACTIONS]. Several eye diseases are directly or indirectly caused by high blood pressure (hypertension). Tablets should be stored at room temperature, between 15-30 C (59-86 F). This leaflet summarizes the most important information about ATACAND. The tablets can be made into a suspension by a compounding pharmacy for people who have trouble swallowing . Terms of Use. Keep the container of ATACAND closed tightly. Very rarely, it is caused by high blood pressure (HBP) also known as hypertension. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor [see DRUG INTERACTIONS]. Candesartan is an angiotensin-receptor blocker (ARB) that may be used alone or with other agents to treat hypertension. MedicineNet does not provide medical advice, diagnosis or treatment. Triple combination of ATACAND with an ACE-inhibitor and a mineralocorticoid receptor antagonist is generally not recommended. [, Takara K, Kakumoto M, Tanigawara Y, Funakoshi J, Sakaeda T, Okumura K: Interaction of digoxin with antihypertensive drugs via MDR1. The renin-angiotensin system (RAS) plays a critical role in kidney development. Candesartan cilexetil (candesartan) is a drug used for treating high blood pressure (hypertension). Monitor renal function periodically in patients treated with ATACAND. Elimination of candesartan is primarily as unchanged drug in the urine and, by the biliary route, in the feces. Skin and Appendages Disorders: Pruritus, rash and urticaria. A growing number of studies indicate that candesartan cilexetil can produce end organ protection in addition to lowering blood pressure. Inactive ingredients in ATACAND tablets and ATACAND oral suspension are: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Closely observe infants with histories of in utero exposure to ATACAND for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations]. Candesartan cilexetil = 98 HPLC 145040-37-5 - MilliporeSigma It is rapidly converted to the active substance, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract. Atacand (candesartan cilexetil) is a selective AT1 subtype angiotensin II receptor antagonist used to treat high blood pressure (hypertension) in adults and children 1 to less than 17 years of age. Advise female patients of childbearing age should be told about the consequences of exposure to ATACAND during pregnancy. Candesartan has good bioavailibility and is the most potent by weight of the AT-1 . Hypotension may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists, including ATACAND, due to blockade of the renin-angiotensin system. Angiotensin, formed in the blood by the action of angiotensin converting enzyme (ACE), is a powerful chemical that attaches to angiotensin receptors found in many tissues but primarily on smooth muscle cells surrounding blood vessels. You can report side effects to FDA at 1-800-FDA-1088. Candesartan cilexetil | C33H34N6O6 | CID 2540 - PubChem 2009;16(27):3480-675. It is entirely possible and common for physically fit people to have high blood pressure (hypertension). rapid or irregular heartbeats. Nucleic Acids Res. [, Zhou SF, Zhou ZW, Yang LP, Cai JP: Substrates, inducers, inhibitors and structure-activity relationships of human Cytochrome P450 2C9 and implications in drug development. Keep a list of your medications with you to show your doctor and pharmacist when a new medication is prescribed. The volume of distribution of candesartan is 0.13 L/kg. Candesartan cilexetil with its flexible dosage regimen therefore appears to offer an effective and well-tolerated alternative to other established agents in the treatment of a wide range of . Candesartan cilexetil and hydrochlorothiazide tablets, USP, 16 mg/12.5 mg, are peach, capsule shaped, scored, biconvex, non-film coated tablets, engraved "APO" with notch on one side and "16" bisect "12.5" on the other side . It is also used for reducing the chance of death or hospitalization due to heart failure. Renin-angiotensin-aldosterone system. [, Malmqvist K, Kahan T, Dahl M: Angiotensin II type 1 (AT1) receptor blockade in hypertensive women: benefits of candesartan cilexetil versus enalapril or hydrochlorothiazide. Concomitant drugs at baseline were diuretics (85%), digoxin (46%), beta-blockers (55%), and spironolactone (24%). After tablet ingestion, the peak serum concentration (Cmax) is reached after 3 to 4 hours. The overall effect of ARBs is a decrease in blood pressure. If it is almost time for your next dose, skip the missed dose. They are supplied in bottles of 30 tablets (NDC 62559-640-30). Following administration of the candesartan cilexetil prodrug, the absolute bioavailability of candesartan was estimated to be 15%. In heart failure patients, candesartan 8 mg resulted in decreases in systemic vascular resistance and pulmonary capillary wedge pressure. Fifty-six percent had a history of myocardial infarction, 48% had a history of hypertension, and 30% had diabetes. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. differently. An experimental study in rats. The recommended starting dose is 0.20 mg/kg (oral suspension). Candesartan Oral Reviews and User Ratings: Effectiveness, Ease - WebMD When pregnancy is first detected, candesartan should be stopped. It may also be used as an alternative agent for the treatment of heart failure, systolic dysfunction, myocardial infarction and coronary artery disease. 2016 Jan;68(1):168-241. doi: 10.1124/pr.115.011411. measured. Do not co-administer aliskiren with ATACAND in patients with diabetes [see DRUG INTERACTIONS]. Plasma concentrations of angiotensin I and angiotensin II, and plasma renin activity (PRA), increased in a dose-dependent manner after single and repeated administration of candesartan cilexetil to healthy subjects, hypertensive, and heart failure patients. ATACAND can cause harm or death to an unborn baby. Following an intravenous dose of 14C-labeled candesartan, approximately 59% of radioactivity is recovered in urine and approximately 36% in feces. For those > 50 kg the ATACAND doses were 4, 16 or 32 mg once daily. Candesartan Cilexetil. Less commonly, a febrile seizure may only affect one side of the body. Candesartan is mainly excreted unchanged in urine and feces (via bile). Initial dose: 16 mg orally once a day. 1996-2023 MedicineNet, Inc. An Internet Brands company. Candesartan cilexetil produced a slow onset, long-lasting antihypertensive action at a dose range of 0.1-10 mg/kg with no rebound effect upon drug withdrawal. pain or discomfort in the arms, jaw, back, or neck. Candesartan cilexetil is the prodrug form of the potent angiotensin II receptor antagonist, candesartan. An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with ATACAND. Candesartan CILEXETIL - Uses, Side Effects, and More If blood pressure is not controlled by ATACAND alone, a diuretic may be added. Use in Hepatic Impairment: Initiate with 8 mg ATACAND in patients with moderate hepatic insufficiency. It may harm them. Candesartan is an angiotensin II receptor blocker (ARB). Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of candesartan on blood pressure. If you would like more information, talk with your doctor. [, FDA Approved Drug Products: Atacand (candesartan cilexetil) oral tablets [, FDA Approved Drug Products: ATACAND HCT (candesartan cilexetil and hydrochlorothiazide) tablets [, Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Label with an expiry date of 100 days and include the following instructions: are allergic to any of the ingredients in ATACAND. The association between candesartan and exacerbation of the underlying condition could not be excluded. ATACAND can cause you to feel dizzy or tired. nosebleeds. It happens rarely, but some people have serious side effects after taking candesartan. Dosage must be individualized. The effect of ATACAND on labor and delivery in humans is unknown [see WARNINGS AND PRECAUTIONS]. Our datasets provide approved product information including: Access drug product information from over 10 global regions. sore throat. Usual Adult Dose for Hypertension. As a result, candesartan relaxes the blood vessels. The prodrug is cleaved by esterases within the intestine to liberate the active molecule. Patients with symptomatic hypotension may require temporarily reducing the dose of ATACAND, diuretic or both, and volume repletion. Keep container tightly closed. The metabolism of Candesartan cilexetil can be decreased when combined with Acetohexamide. The recommended starting dose is 4 to 8 mg. For those greater than 50 kg, the dose range is 4 to 32 mg per day. The most common side effects of candesartan are headache, dizziness, fatigue, abdominal discomfort, diarrhea, and upper respiratory infections. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including candesartan, may result in deterioration of renal function, including possible acute renal failure. No initial dosage adjustment is necessary in patients with mild hepatic impairment. The most common side effects of candesartan are: Rhabdomyolysis (inflammation and 4 mg are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. After repeated dosing, the AUC and Cmax were approximately doubled in patients with severe renal impairment (creatinine clearance <30 mL/min/1.73m2) compared to patients with normal kidney function. As a result blood vessels expand and blood pressure is reduced. Candesartan was effective in reducing blood pressure regardless of race, although the effect was somewhat less in blacks (usually a lowrenin population). Comments: Consider administration of a lower initial dose in volume depleted patients. 32 mg are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. Minor hepatic metabolism of candesartan (<20%) occurs by O-deethylation via cytochrome P450 2C9 to form an inactive metabolite. It is not known whether candesartan is secreted in human milk. The American Academy of Cardiology defines high blood pressure slightly Candesartan cilexetil and hydrochlorothiazide tablets may be administered with or without food. Do not drive, operate machinery, or do other dangerous activities until you know how ATACAND affects you. 8 mg are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. Uses. Store at 20 to 25C (68 to 77F); excursions permitted at 15 to 30C (59 to 86F) [see USP Controlled Room Temperature]. The pharmacokinetics (Cmax and AUC) were not modified by age, sex or body weight. The protein binding is constant at candesartan plasma concentrations well above the range achieved with recommended doses. 1999 Jan;10 Suppl 11:S197-201. In CHARMAdded, 2548 subjects receiving an ACE inhibitor were randomized to ATACAND or placebo. weakness, and I use periodically and it takes only a few days to drop my blood pressure. Candesartan lowers blood pressure by antagonizing the renin-angiotensin-aldosterone system (RAAS); it competes with angiotensin II for binding to the type-1 angiotensin II receptor (AT1) subtype and prevents the blood pressure increasing effects of angiotensin II. Epub 2009 Apr 8. The usual starting dose for hypertension is 16 mg daily, and ATACAND is a type of medicine called angiotensin receptor blocker, which blocks the effect of the hormone angiotensin II, causing the blood vessels to relax. Candesartan is mainly excreted unchanged in urine and feces (via bile). Use our structured and evidence-based datasets to unlock new insights and accelerate drug research. Because candesartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. In these two studies, the benefit of ATACAND in reducing the risk of CV death or heart failure hospitalization (18% p<0.001) was evident in major subgroups (see Figure), and in patients on other combinations of cardiovascular and heart failure treatments, including ACE inhibitors and beta-blockers. There are two types of congestive heart failure, systolic or left-sided heart Candesartan is used to treat high blood pressure (hypertension). Candesartan should not be used during pregnancy or while breastfeeding. It has no agonist activity. unusual tiredness or weakness. High blood pressure during pregnancy may result in decreased blood flow to the placenta. The mean age was 64 years and 21% were female, 24% were NYHA II, 73% were NYHA III, 3% were NYHA IV, and the mean ejection fraction was 28%. stage of the disease. Follow the steps below for preparation of the suspension. Angiotensin II binds to two receptors: type-1 angiotensin II receptor (AT1) and type-2 angiotensin II receptor (AT2). This monograph has been modified to include the generic and brand name in many instances. The recommended dose range of candesartan for adults is 4 to The incidence of hyperkalemia leading to drug discontinuation in ATACAND-treated patients was 2.4% compared with 0.6% in placebo-treated patients. It is practically insoluble in water and sparingly soluble in methanol. Metabolic and Nutritional Disorders: Hyperkalemia, hyponatremia.