Olmesartan

Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide. …

• The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy
• Dose can be titrated up to 40 /25 mg if necessary
• The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide
• Dose can be titrated up to 40 /25 mg if necessary
• Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide
• Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide

Olmesartan medoxomil and hydrochlorothiazide is supplied as film-coated, non-scored tablets: 20 mg/12.5 mg reddish-yellow, circular, debossed with Sankyo on one side and C22 on the other side 40 mg/12.5 mg reddish-yellow, oval, debossed with Sankyo on one side and C23 on the other side 40 mg/25 mg pink, oval, debossed with Sankyo on one side and C25 on the other side Tablets: (olmesartan medoxomil …

• Neonates with a history of in utero exposure to olmesartan medoxomil and hydrochlorothiazide: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function
• Safety and effectiveness of olmesartan medoxomil and hydrochlorothiazide
• In pediatric patients have not been established

Clinical studies of olmesartan medoxomil and hydrochlorothiazide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Pregnancy: Advisefemale patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible [see Use in Specific Populations ]
• Symptomatic h ypotension and s yncope : Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider
• Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. …

Olmesartan medoxomil and hydrochlorothiazide is contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide [see Adverse Reactions ( 6.1 , 6.2 )] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [ s ee Drug Interactions (7.4) ]. …

Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise …

Hypotension: Correct volume-depletion prior to administration. ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for signs of fluid or electrolyte imbalance. ( 5.4 ) Acute angle-closure glaucoma ( 5.5 ) Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide in cases where no other etiology is found ( 5.7 ) 5.1 Fetal Toxicity Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Electrolyte and Metabolic Imbalances [see Warnings and Precautions (5.5) ] Acute Myopia and Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6) ] Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Sprue-Like Enteropathy [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and …

8.1 Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity, and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. …

Olmesartan medoxomil Limited data are available related to overdosage of olmesartan medoxomil in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown. No lethality was observed in acute toxicity studies in mice and rats given single oral doses up to 2000 mg/kg olmesartan medoxomil. …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.