Generic Drug for Benicar: Olmesartan / Hydrochlorothiazide
Benicar contains olmesartan medoxomil, a prodrug which gets converted into the active drug olmesartan in the gastrointestinal tract. Olmesartan, classified as an angiotensin 2 receptor antagonist, works independently of angiotensin 2 synthesis pathways. Benicar keeps the blood vessels dilated which results in reduced blood pressure and improved blood flow. Used as a treatment for high blood pressure, Benicar can be used as combination therapy with other antihypertensive medications. Available by prescription only.
Indication/Usage: Benicar is used in the treatment of high blood pressure (hypertension) in adults and children over 6 years old. It can be used as monotherapy or as combination therapy with other antihypertensive medicines. By lowering high blood pressure, Benicar helps reduce the risk of fatal and nonfatal cardiovascular events, mainly strokes and myocardial infarctions (MI). When Benicar alone is insufficient to control blood pressure, a diuretic therapy may be added to achieve the required beneficial effects.
Dose, Administration and Dosage Forms: Benicar is available in film-coated tablet formulation in varying strengths with distinct shapes and colors for easy identification. The formulations vary as follows: 5mg (round and yellow), 20mg (round and white), and 40mg (oval and white). The starting dose for Benicar is 20mg once daily for the adult population and 10mg - 20mg once daily for 6- to 16- year-old patients. The recommended adult maintenance dosage is 20mg to 40mg once daily. The maintenance dose for 6- to 16-year-olds is 10mg to 40mg daily. Benicar can be taken with or without food and should be stored at room temperature between 20 C to 25 C (68 F to 77 F).
Mechanism of Action: Angiotensin 2 is the principal pressor agent of the renin-angiotensin system (RAS). It is responsible for vasoconstriction, cardiac stimulation, aldosterone synthesis and release, and sodium re-absorption at the kidney level. AT2 is synthesized from AT1 via the angiotensin converting enzyme, kininase 2. Benicar contains the prodrug olmesartan medoxomil, which gets hydrolyzed into the active drug olmesartan in the GI tract. Olmesartan works by preventing angiotensin 2 from binding to the AT1 receptor sites in vascular muscles; therefore, it is independent of angiotensin 2 synthesis pathways. Olmesartan inhibits the negative regulatory feedback on renin secretion by blocking AT2 binding, thus reducing vasoconstriction and aldosterone secretion. This curtailment of vasoconstriction reduces peripheral resistance, thereby suppressing the blood pressure as is required in hypertension patients.
Side-effects and Safety Profile: Patients experiencing any allergic reactions to Benicar, such as hives, dyspnea, rashes, swelling of the face, lips, tongue, or throat, etc., should immediately report to the emergency room.
Benicar may be associated with various serious side-effects such as: faintness, altered urination (volume and frequency), joint pain, chest pain, rapid heart rate, slow/irregular heartbeat, swelling of the hands or feet, fainting, severe dizziness, etc.
Mild to moderately-serious side-effects associated with Benicar include: lightheadedness, myalgia, back pain, itching, skin rash, nausea, vomiting, stomach pain, diarrhea, weakness, etc.
Various post-marketing side-effects reported in Benicar studies include: acute renal failure, alopecia, angioedema, asthenia, hyperkalemia, increased blood creatinine levels, pruritus, rhabdomyolysis, urticaria, etc.
Warnings and Contraindications:
- Pregnant women should avoid taking Benicar as it contains the black box warning of injury or even death to the developing fetus. Benicar is categorized as a pregnancy category C drug during the first trimester and category D during the second and third trimesters.
- Nursing women: Since Benicar has not been studied in nursing women it should not be used in that population. Preclinical trials show that olmesartan is secreted in lactating rats; therefore, in order to avoid potential adverse effects to the nursing infant, Benicar must not be prescribed to nursing women.
- Benicar has been contraindicated in patients with biliary obstruction (BNF).
- Benicar must not be prescribed for hypertension to children less than 1 year of age as it can affect the development of immature kidneys.
- Volume or salt-depleted patients may experience symptomatic hypotension when taking Benicar.
- Benicar has been associated with oliguria, progressive azotemia, and acute renal failure in patients with congestive heart failure.
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Benicar (Olmesartan) - also known as Olmetec
