Olmesartan and HydrochlorothiazideU.S. Brand Names: Benicar HCT™
Synonyms: Hydrochlorothiazide and Olmesartan Medoxomil; Olmesartan Medoxomil and Hydrochlorothiazide
Generic Available: No
Use: Treatment of hypertension (not recommended for initial treatment)
Pregnancy Risk Factor: C/D (2nd and 3rd trimesters)
Pregnancy Implications: The drug should be discontinued as soon as possible when pregnancy is detected. Drugs which act directly on renin-angiotensin can cause fetal and neonatal morbidity and death.
Lactation: Excretion in breast milk unknown/contraindicated
Contraindications: Hypersensitivity to olmesartan, other angiotensin II receptor blockers, hydrochlorothiazide, thiazides, sulfonamide-derived drugs, or any component of the formulation; bilateral renal artery stenosis; anuria; renal failure; pregnancy (2nd and 3rd trimesters)
Warnings/Precautions: Olmesartan: Avoid use or use a smaller dose in patients who are volume depleted; correct depletion first. Deterioration in renal function can occur with initiation. Use with caution in unilateral renal artery stenosis and pre-existing renal insufficiency; significant aortic/mitral stenosis. Safety and efficacy in pediatric patients have not been established. Hydrochlorothiazide: Avoid in severe renal disease (ineffective). Electrolyte disturbances (hypokalemia, hypochloremic alkalosis, hyponatremia) can occur. Use with caution in severe hepatic dysfunction; hepatic encephalopathy can be caused by electrolyte disturbances. Gout can be precipitate in certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure. Cautious use in diabetics; may see a change in glucose control. Hypersensitivity reactions can occur. Can cause SLE exacerbation or activation. Use with caution in patients with hypercholesterolemia. Photosensitization may occur. Correct hypokalemia before initiating therapy. Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.
Adverse Reactions: Frequencies reported with combination product. See individual monographs for additional adverse effects reported with each agent. Cardiovascular: Chest pain, peripheral edema Central nervous system: Dizziness (9%), vertigo Dermatologic: Rash Endocrine & metabolic: Hyperuricemia (4%), hyperglycemia Gastrointestinal: Nausea (3%), abdominal pain, dyspepsia, gastroenteritis, diarrhea Genitourinary: Hematuria Hepatic: Transaminases increased Neuromuscular & skeletal: Back pain, arthritis, arthralgia, myalgia Respiratory: Upper respiratory infection (7%), cough Miscellaneous: CPK increased Angioedema and rhabdomyolysis have been reported with angiotensin-receptor blockers. Severe dermatologic reactions, hypokalemia, and pancreatitis have been reported with hydrochlorothiazide.
Drug Interactions: See individual agents.
Stability: Store at 20°C to 25°C (68°F to 77°F).
Mechanism of Action: Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide inhibits sodium reabsorption in the distal tubules causing increased excretion of sodium and water as well as potassium and hydrogen ions.
Pharmacodynamics/Kinetics: See individual agents.
Dosage: Oral: Adults: One tablet daily; dosage must be individualized (see below). May be titrated at 2- to 4-week intervals. Replacement therapy: May be substituted for previously titrated dosages of the individual components. Patients not controlled with single-agent therapy: Initiate by adding the lowest available dose of the alternative component (hydrochlorothiazide 12.5 mg or olmesartan 20 mg). Titrate to effect (maximum daily hydrochlorothiazide dose: 25 mg; maximum daily olmesartan dose: 40 mg). Dosage adjustment in renal impairment: Not recommended in patients with Clcr<30 mL/minute
Monitoring Parameters: Blood pressure; serum potassium
Patient Education: See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.
Dental Health: Effects on Dental Treatment: No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions: No information available to require special precautions
Mental Health: Effects on Mental Status: May cause dizziness
Mental Health: Effects on Psychiatric Treatment: May cause hyperglycemia and hypertriglyceridemia; combined use with psychotropics (atypical antipsychotics and mirtazapine) may produce additive effects. May cause diarrhea, these effects may be additive with concurrent use of SSRIs, lithium, or valproate. May cause flu-like symptoms, take this into consideration if also concerned about SSRI discontinuation syndrome. Combined use with lithium may produce lithium toxicity; monitor lithium levels.
Dosage Forms: Tablet: 20/12.5: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg 40/12.5: Olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg 40/25: Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg
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