methyldopa/hydrochlorothiazide (Rx)

Brand and Other Names:
  • Print

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

methyldopa/hydrochlorothiazide

tablet

  • 250mg/15mg
  • 250mg/25mg
more...

Hypertension

Not for initial therapy

Usual starting dose: 250 mg methyldopa/15-25 mg hydrochlorothiazide PO q12hr; alternatively 500 mgmethyldopa/30-50 mg hydrochlorothiazide PO qDay

Avoid hydrochlorothiazide doses >50 mg qDay

Dosage strength determined by individual titration

Renal Impairment

Use caution in dosing/titrating patients with renal dysfunction

Cumulative effects of thiazides may develop with impaired renal function; dose adjustment may be necessary; if CrCl < 30 mL/min avoid use; azotemia may be precipitated

Administration

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy

Since both components have a relatively short duration of action, withdrawal is followed by return of hypertension usually within 48 hours, not complicated by overshoot of blood pressure

<18 years: Safety/efficacy not established

Dose reduction may be necessary depending on patient's renal function

Next:

Interactions

Interaction Checker

and methyldopa/hydrochlorothiazide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            Frequency Not Defined

            Methyldopa

            • Angina
            • Arthralgia
            • Bradycardia
            • Orthostatic hypotension
            • Depression
            • Dizziness
            • Lethargy
            • Sedation
            • Rash, liver toxicity
            • Gynecomastia
            • Impotence
            • Dry mouth
            • Nausea/vomiting
            • Hemolytic anemia
            • Thrombocytopenia, lupus-like syndrome

            Hydrochlorothiazide

            • 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
            Previous
            Next:

            Warnings

            Black Box Warning

            Not indicated for initial therapy of hypertension; before initiating therapy requires therapy titrated to the individual patient; if fixed combination represents determined dosage for each individual agent; use may be more convenient in patient management; treatment of hypertension must be reevaluated as conditions in each patient warrant

            Contraindications

            Anuria

            Renal decompensation

            Hypersensitivity to either component or sulfonamides

            Mitral valve rheumatic heart disease

            Active liver disease, such as acute hepatitis and active cirrhosis

            Liver disorders previously associated with methyldopa therapy

            Concomitant therapy with monoamine oxidase (MAO) inhibitors

            Cautions

            This fixed-combination drug is not indicated for initial therapy of hypertension; requires therapy titrated to the individual patient before fixed-combination drug therapy initiated

            DM, fluid or electrolyte imbalance, hyperuricemia or gout, liver disease, renal disease, SLE, hypotension

            May aggravate digitalis toxicity

            Sensitivity reactions may occur with or w/o history of allergy or asthma

            Risk of male sexual dysfunction

            CHF, dialysis pts (increased risk of hypertension following procedure), edema, hemolytic anemia, severe bilateral CVD

            Avoid abrupt withdrawal

            Risk of decreased libido and impotence in men

            May impair ability to perform hazardous tasks

            Tolerance develops on prolonged therapy, especially if no concurrent diuretic (methyldopa causes Na and water retention)

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

            Interferes with some lab tests

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: both components appear 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.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Hydrochlorothiazide; methyldopa combines 2 antihypertensive agents with different mechanisms to lower blood pressure; effects of hydrochlorothiazide and methyldopa on blood pressure are additive

            Thiazide diuretics lower blood pressure by increasing the excretion of sodium, whereas methyldopa may lower blood pressure by stimulating central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity.

            Pharmacokinetics

            Methyldopa

            • Onset: 4-6 hr (PO, IV) hypotensive effect
            • Vd: 0.23 L/kg
            • Protein binding: 10-15%
            • Bioavailability: 42%
            • Half-life: 1.5-2 hr; prolonged in end stage renal disease
            • Peak plasma time: 2-4 hr
            • Excretion: Urine (70%)
            • Metabolism: Intestinal and hepatic
            • Duration: 12-24 hr (single dose); 24-48 hr (multiple dose)

            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
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous