BENICAR Film-coated tablet (2021)

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BOXED WARNING SECTION

FETAL TOXICITY When pregnancy is detected, discontinue Benicar as soon as possible (5.1, 8.1). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing ...

1. Indications and Usage

Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular ...

2. Dosage and Administration

2.1 Adult Hypertension Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients ...

3. Dosage Forms and Strengths

5 mg yellow, round, film-coated, non-scored tablets debossed with Sankyo on one side and C12 on the other side. 20 mg white, round, film-coated, non-scored tablets debossed with Sankyo on one side and ...

4. Contraindications

Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3)].

5. Warnings and Precautions

5.1 Fetal Toxicity Benicar can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) during the second and third trimesters of pregnancy reduces ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

The following adverse reactions have been reported in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably ...

7. Drug Interactions

7.1 Agents Increasing Serum Potassium Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), ...

8. Use in Specific Populations

8.8 Black Patients The antihypertensive effect of Benicar was smaller in black patients (usually a low-renin population), as has been seen with ACE inhibitors, beta-blockers and other angiotensin receptor ...

8.1. Pregnancy

Risk Summary Benicar can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal ...

8.2. Lactation

Risk Summary There is no information regarding the presence of olmesartan in human milk, the effects on the breastfed infant, or the effects on milk production. Olmesartan is secreted at low concentration ...

8.4. Pediatric Use

The antihypertensive effects of Benicar were evaluated in one randomized, double-blind clinical study in pediatric patients 1 to 16 years of age [see Clinical Studies (14.2)]. The pharmacokinetics ...

8.5. Geriatric Use

Of the total number of hypertensive patients receiving Benicar in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences ...

8.6. Hepatic Impairment

Increases in AUC0-∞ and Cmax were observed in patients with moderate hepatic impairment compared to those in matched controls, with an increase in AUC of about 60%. No initial dosage ...

8.7. Renal Impairment

Patients with renal insufficiency have elevated serum concentrations of olmesartan compared to subjects with normal renal function. After repeated dosing, the AUC was approximately tripled in patients ...

10. Overdosage

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) ...

11. Description

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan ...

12.1. Mechanism of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with ...

12.2. Pharmacodynamics

Benicar doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of Benicar >40 mg giving >90% inhibition at ...

12.3. Pharmacokinetics

Absorption Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Benicar tablets and the suspension formulation ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose tested (2000 mg/kg/day) was, on a mg/m2 basis, about 480 times ...

14. Clinical Studies

14.1 Adult Hypertension The antihypertensive effects of Benicar have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically ...

16.1. How Supplied

Benicar is supplied as yellow, round, film-coated, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated, non-scored tablets containing 20 mg of olmesartan medoxomil, ...

16.2. Storage and Handling

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Benicar during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients ...