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quinapril/hydrochlorothiazide (Accuretic)

 

Classes: ACEI/Diuretic Combos; ACEI/HCTZ Combos

Dosing and uses of Accuretic (quinapril/hydrochlorothiazide)

 

Adult dosage forms and strengths

quinapril/hydrochlorothiazide

tablet

  • 10mg/12.5mg
  • 20mg/12.5mg
  • 20mg/25mg

 

Hypertension

Initial: 10 mg/12.5 mg or 20 mg/12.5 mg PO qDay

Increase either or both components based on clinical response

Do not increase hydrochlorothiazide component more often than q 2-3 weeks

To minimize dose-independent side effects, it is usually appropriate to initiate combination therapy only after inadequate response to quinapril monotherapy or significant potassium loss resulting from hydrochlorothiazide monotherapy

 

Renal Impairment

CrCl ≥30 mL/min: No dosage adjustment

CrCl <30 mL/min/1.73 m² or serum creatinine ≥3 mg/dL: Not recommended

 

Pediatric dosage forms and strengths

<18 years: Safety and efficacy not established

 

Accuretic (quinapril/hydrochlorothiazide) adverse (side) effects

No adverse effects specific to the combination have been observed; adverse effects limited to those previously reported with quinapril and hydrochlorothiazide

 

Quinapril

1-10%

  • Dizziness (4-8%)
  • Headache (2-6%)
  • Cough (2-4%)
  • Hyoptension (3%)
  • Fatigue (3%)
  • Hyperkalemia (2%)
  • Chest pain (2%)
  • Nausea/vomiting (1-2%)
  • Rash (1%)
  • Hyperkalemia (2%)
  • Myalagia (2-5%)
  • Back pain (1%)

Frequency not defined

  • Angioedema
  • Acute renal failure
  • Alopecia
  • Angina
  • Pancreatitis
  • Hyperkalemia

 

Hydrochlorothiazide

Frequency not defined

  • Anorexia
  • Epigastric distress
  • Hypotension
  • Orthostatic hypotension
  • Photosensitivity
  • Anaphylaxis
  • Anemia
  • Confusion
  • Erythema multiforme
  • Stevens-Johnson syndrome
  • Exfoliative dermatitis including toxic epidermal necrolysis
  • Hypomagnesemia
  • Dizziness
  • Headache
  • Hyperuricemia

 

Warnings

Black box warnings

Quinapril: Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

 

Contraindications

Hypersensitivity to either component or sulfonamides

History of hereditary or angioedema associated with previous ACE inhibitor treatment

Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)

Pregnancy (2nd and 3rd trimesters): significant risk of fetal/neonatal morbidity and mortality

 

Cautions

Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy

May aggravate digitalis toxicity

Sensitivity reactions may occur with or without history of allergy or asthma

Risk of male sexual dysfunction

Renal impairment may occur

Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors

If laryngeal stridor or angioedema of the face, tongue, or glottis occurs discontinue therapy and institute appropriate therapy immediately

Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (eg, temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema

Intestinal angioedema has been reported in patients treated with ACE inhibitors

Cholestatic jaundice may occur, which may progress to fulminant hepatic necrosis; discontinue

Dry hacking nonproductive cough may occur within few months of treatment; consider other causes of cough prior to discontinuation

Hyperkalemia may occur with ACE inhibitors; risk factors include renal dysfunction, diabetes mellitus, and concomitant use of potassium sparing diuretics and potassium supplements; use cautiously if at all with these agents

Thiazide diuretics may cause hypokalemia, hypochloremic alkalosis, hypomagnesemia, and hyponatremia

Hydrochlorothiazide may precipitate gout in patients with familial predisposition to gout or chronic renal failure

Symptomatic hypotension with or without syncope can occur with ACE inhibitors; mostly observed in volume depleted patients, correct volume depletion prior to initiation; monitor closely when initiating and increasing dosing

Agranulocytosis, neutropenia, or leukopenia with myeloid hypoplasia reported with other ACE inhibitor; patients with renal impairment are at high risk; monitor CBC with differential in these patients

Photosensitization may occur

Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma that may occur within hours of initiating therapy; discontinue therapy immediately in patients with acute decreases in visual acuity or ocular pain; additional treatment may be needed if uncontrolled intraocular pressure persists

Use caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in ischemia

Use hydrochlorothiazide with caution in patients with diabetes or at risk of diabetes; may see increase in glucose

Use caution in patients collagen vascular disease, especially in patients with concomitant renal impairment

Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia

 

Pregnancy and lactation

Pregnancy category: C (1st trimester); D (2nd & 3rd trimester)

Lactation: Excreted in breast milk, use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Accuretic (quinapril/hydrochlorothiazide)

Mechanism of action

Accuretic is a fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide

Quinapril competitively inhibits angiotensin-converting enzymes resulting in decreased plasma angiotensin II concentrations and consequently, blood pressure may be reduced in part through decreased vasoconstriction, increase renin activity, and decrease aldosterone secretion

Hydrochlorothiazide is a thiazide diuretic that inhibits Na reabsorption in distal renal tubules resulting in increased excretion of Na+ and water, also K+ and H+ ions

 

Pharmacokinetics

QuinapriL

  • Half-Life: 0.8 hr (quinapril); 3 hr (quinaprilat)
  • Onset: 1 hr
  • Duration: 24 hr
  • Peak Plasma Time: 1 hr (quinapril); 2 hr (quinaprilat)
  • Bioavailability: ≥60%
  • Protein Bound: 97%
  • Metabolite: Quinaprilat (active)
  • Metabolism: Liver
  • Excretion: Urine (50-60% primarily as quinaprilat)
  • Dialyzable: Minimally

Hydrochlorothiazide

  • Half-Life: 6-15 hr
  • Bioavailability: 70%
  • Onset: 2 hr (diuresis); 4-6 hr (peak effect)
  • Duration: 6-12 hr (diuresis); 1 wk (HTN)
  • Vd: 3.6-7.8 L/kg
  • Peak Plasma:1.5-2.5 hr
  • Protein Bound: 68%
  • Metabolism: Minimally metabolized
  • Clearance: 335 mL/min
  • Excretion: Urine 50-70%
  • Dialyzable: No