drug-information.ru

|Olmesartan Medoxomil/Hydrochlorothiazide

Olmesartan Medoxomil/Hydrochlorothiazide

Trade Names:
Benicar HCT
- Tablets olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg
- Tablets olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg
- Tablets olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg

Indications and Usage

Treatment of hypertension.

Contraindications

Anuria; hypersensitivity to sulfonamide-derivatives or any component of the product.

Dosage and Administration

PO Titrate the dose based on individual response to each component as monotherapy. The dosage range for olmesartan/hydrochlorothiazide is 10 mg/12.5 mg to 40 mg/25 mg once daily.

Olmesartan: The usual starting dosage of olmesartan is 20 mg once daily as monotherapy. If further reduction of BP is needed after 2 wk of therapy, the dose may be increased to 40 mg. If BP is not controlled by olmesartan alone, hydrochlorothiazide may be added, starting with 12.5 mg and then titrating to 25 mg once daily.

Hydrochlorothiazide: If a patient is taking hydrochlorothiazide, olmesartan may be added, starting with 20 mg once daily and titrating to 40 mg. Consider reducing larger doses of hydrochlorothiazide to 12.5 mg before adding olmesartan.

PO If Ccr is over 30 mL/min, the usual regimens of olmesartan/hydrochlorothiazide may be followed. In more severe renal function impairment, olmesartan/hydrochlorothiazide is not recommended.

General Advice

• May be given with other antihypertensive agents.
• May be given with or without food.
• Depending on the BP, the dose may be titrated at 2 to 4wk intervals.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Potentiation of orthostatic hypotension may occur.

Dosage adjustments of the antidiabetic agent may be needed.

Effects may be additive or potentiated.

Hydrochlorothiazide absorption may be reduced up to 85%.

Increased risk of electrolyte depletion (eg, hypokalemia).

Increased risk of lithium toxicity caused by reduced clearance. Do not coadminister.

Effect of muscle relaxant may be enhanced.

The antihypertensive effect of hydrochlorothiazide may be reduced.

Effect of pressor amine may be reduced.

Laboratory Test Interactions

Hydrochlorothiazide may decrease serum protein-bound iodine levels without signs of thyroid disturbance; may cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, serum bilirubin levels, and serum uric acid levels; may cause intermittent and slight elevations in serum calcium without known disorders of calcium metabolism.

Adverse Reactions

CNS

Dizziness (9%); vertigo (greater than 1%); asthenia (postmarketing).

Dermatologic

Rash (greater than 1%); alopecia, pruritus, urticaria (postmarketing).

GI

Nausea (3%); abdominal pain, diarrhea, dyspepsia, gastroenteritis (greater than 1%); vomiting (postmarketing).

Genitourinary

Hematuria (greater than 1%); acute renal failure, increased blood creatinine levels (postmarketing).

Hepatic

Increased AST, ALT, and glucose tolerance test (greater than 1%).

Lab Tests

Increased BUN and serum creatinine (1%).

Metabolic-Nutritional

Hyperuricemia (4%); increased creatine phosphokinase, hyperglycemia, hyperlipidemia (greater than 1%).

Musculoskeletal

Arthralgia, arthritis, back pain, myalgia (greater than 1%); rhabdomyolysis (postmarketing).

Respiratory

Upper respiratory tract infection (7%); coughing (greater than 1%).

Miscellaneous

Chest pain, peripheral edema (greater than 1%); angioedema (postmarketing).

Precautions

Pregnancy

Category C (first trimester); Category D (second and third trimesters).

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Hypersensitivity

May occur in patients with or without a history of allergy or bronchial asthma.

Renal Function

Not recommended in patients with severe renal function impairment; cumulative effects may develop in patients with impaired renal function.

Hepatic Function

Use with caution in patients with impaired hepatic function or progressive liver disease.

Hyperglycemia

Hyperglycemia may occur; latent diabetes mellitus may become manifest.

Hyperuricemia

Hyperuricemia or frank gout may be precipitated.

Lipid disorders

Increases in cholesterol and triglyceride levels may occur.

Systemic lupus erythematosus

Activation or exacerbation may occur.

Volume or salt depletion

Symptomatic hypotension may occur after initiation of treatment in patients with an activated renin-angiotensin system (eg, volume- or salt-depleted patients).

Overdosage

Symptoms

Bradycardia, dehydration, electrolyte depletion (ie, hypochloremia, hypokalemia, hyponatremia), hypotension, tachycardia.

Patient Information

• Advise patient to read the Patient Information material before using product for the first time and with each refill.
• Explain name, dose, action, possible drug interactions, and potential adverse reactions of drug.
• Obtain patient history, including drug history and any known allergies.
• Instruct patient regarding how to store, administer, and dispose of outdated medication.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
• Caution patients to inform health care provider if light-headedness occurs. If syncope occurs, the drug should be stopped until the health care provider is contacted.
• Caution patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
• Advise patient that follow-up visits may be necessary and to keep appointments.