fosinopril/hydrochlorothiazide (Rx)

Brand and Other Names:
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Dosing & Uses

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Dosage Forms & Strengths

fosinopril/hydrochlorothiazide

tablet

  • 10mg/12.5mg
  • 20mg/12.5mg
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Hypertension

10 mg/12.5 mg PO qDay initially

Dosage range: 10-80 mg/12.5-50 mg per day PO

Combination therapy indicated for patients whose blood pressure is not adequately controlled with fosinopril or hydrochlorothiazide monotherapy

Dosage Modifications

Renal impairment

  • CrCl <30 mL/min or serum creatinine ≥ 3 mg/dL: Use not recommended
  • CrCl ≥ 30 mL/min: Dose adjustment not necessary

Hepatic impairment

  • Metabolism of active metabolite fosinoprilat will be reduced in progressive liver disease; use caution

Safety and efficacy not established

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Interactions

Interaction Checker

and fosinopril/hydrochlorothiazide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Fosinopril

            >10%

            • Dizziness (1.6-11.9%)

            1-10%

            • Cough (2.2-9.7%)
            • Headache (3.2%)
            • Hyperkalemia (2.6%)
            • Diarrhea (2.2%)
            • Orthostatic hypotension (1.4-1.9%)
            • Fatigue (1-2%)

            Frequency Not Defined

            • Angioedema
            • ARF if renal artery stenosis
            • Aplastic anemia
            • Neutropenia
            • Arthralgia
            • Interstitial nephritis
            • Vasculitis
            • Rash

            Hydrochlorothiazide

            <1%

            • Anaphylaxis, anemia, confusion, erythema multiforme skin reactions including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, hypomagnesemia, hyponatremia, hypochloremia, dizziness, fatigue, headache, hypercalcemia, hyperuricemia, hyperglycemia, hyperlipidemia, hypercholesterolemia, muscle weakness or cramps, nausea, purpura, rash, vertigo, vomiting

            Frequency Not Defined

            • Anorexia
            • Epigastric distress
            • Hypotension
            • Orthostatic hypotension
            • Photosensitivity
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            Warnings

            Black Box Warnings

            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 ACE inhibitors, thiazides or sulfonamides

            History of hereditary or angioedema associated with previous ACE inhibitor treatment

            Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

            Anuria or renal artery stenosis

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

            Cautions

            Begin combination therapy only after failed monotherapy

            Severe renal impairment, hepatic impairment

            Risk of hypotension, especially with CHF

            Coadministration with mTOR inhibitors (eg, temsirolimus) may increased risk for angioedema

            Renal impairment may occur

            Neutropenia/agranulocytosis reported

            Cough may occur within the first few months

            Cholestatic jaundice may occur

            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

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            Pregnancy & Lactation

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

            Lactation: enters breast milk; contraindicated

            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.

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            Pharmacology

            Mechanism of Action

            Competitively inhibits angiotensin-converting enzymes, resulting in decreased plasma angiotensin II concentrations; BP may be reduced in part through decreased vasoconstriction, increased renin activity, and decreased aldosterone secretion; increases renal blood flow

            Absorption

            Bioavailability: 36%

            Distribution

            Protein bound: 99.4%

            Vd: Small

            Metabolism

            75% present as active fosinoprilat, 20-30% as a glucuronide conjugate of fosinoprilat, and 1-5% as a p-hydroxy metabolite of fosinoprilat

            Elimination

            Half-life: 12 hr (fosinoprilat); 14 hr (heart failure)

            Total body clearance: 26-39 mL/min

            Excretion: 50% urine; 50% feces

            Hemodialysis: 2%

            Peritoneal dialysis: 7%

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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