Lisinopril and Hydrochlorothiazide (Page 5 of 5)

DOSAGE AND ADMINISTRATION

Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.

The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide may be associated with either or both dose-independent or dose-dependent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.

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

Dose Titration Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, depending on current monotherapy dose. Further increases of either or both components should depend on clinical response with blood pressure measured at the interdosing interval to ensure that there is an adequate antihypertensive effect at that time. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. After addition of the diuretic it may be possible to reduce the dose of lisinopril. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen may achieve similar or greater blood-pressure control without electrolyte disturbance if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). If the patient’s blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued, an initial dose of 5 mg of lisinopril should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).

Concomitant administration of lisinopril and hydrochlorothiazide with potassium supplements, potassium salt substitutes or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).

Replacement Therapy

The combination may be substituted for the titrated individual components.

Use in Renal Impairment

Regimens of therapy with lisinopril and hydrochlorothiazide tablets need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.7m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (SEE WARNINGS, ANAPHYLACTOID REACTIONS DURING MEMBRANE EXPOSURE).

HOW SUPPLIED

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with “LL” debossed on one side and “B01” on other side.

They are supplied as follows:

NDC 68180-518-01 – 100’s bottle

NDC 68180-518-02 – 500’s bottle

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with “LL” debossed on one side and “B02” on other side.

They are supplied as follows:

NDC 68180-519-01 – 100’s bottle

NDC 68180-519-02 – 500’s bottle

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with “LL” debossed on one side and “B03” on other side.

They are supplied as follows:

NDC 68180-520-01 – 100’s bottle

NDC 68180-520-02 – 500’s bottle

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity.

*AN69 is a registered trademark of Hospal Ltd.

SPL UNCLASSIFIED SECTION

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA

Revised: December, 2015 ID#: 242993

PRINCIPAL DISPLAY PANEL

LISINOPRIL AND HYDROCHLOROTHIAZIDE lisinopril and hydrochlorothiazide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0920(NDC:68180-518) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE MANNITOL MAGNESIUM STEARATE ALUMINUM OXIDE FD&C BLUE NO. 2 STARCH, CORN

Product Characteristics Color blue Score no score Shape HEXAGON (6 sided) Size 7mm Flavor Imprint Code LL;B01 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67296-0920-1 90 TABLET in 1 BOTTLE None 2 NDC:67296-0920-3 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077912 10/04/2006

Labeler — RedPharm Drug, Inc. (828374897)

Establishment
Name	Address	ID/FEI	Operations
RedPharm Drug, Inc.		828374897	repack (67296-0920)

Revised: 01/2022 RedPharm Drug, Inc.