Lisinopril and Hydrochlorothiazide (Page 8 of 8)

Lisinopril

Following a single oral dose of 20 g/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.

Lisinopril can be removed by hemodialysis (see WARNINGS , Anaphylactoid Reactions During Membrane Exposure).

Hydrochlorothiazide

Oral administration of a single oral dose of 10 g/kg to mice and rats was not lethal. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

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/hydrochlorothiazide 10/12.5 tablets USP or lisinopril/hydrochlorothiazide 20/12.5 tablets USP, 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/hydrochlorothiazide 10/12.5 tablets USP.

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 tablets USP 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/hydrochlorothiazide tablets USP 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 USP is not recommended (see WARNINGS , Anaphylactoid Reactions During Membrane Exposure).

HOW SUPPLIED

Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5 mg are available as blue, round, biconvex, unscored tablets debossed

company logo

and “5033” on one side and “10/12.5” on the other side containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets.

Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5 mg are available as yellow, round, flat-faced, beveled edge, unscored tablets debossed

company logo

and “5034” on one side and “20/12.5” on the other side containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets.

Lisinopril and Hydrochlorothiazide Tablets USP, 20/25 mg are available as peach, round, flat-faced, beveled edge, unscored tablets debossed

company logo

and “5032” on one side and “20/25” on the other side containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets.

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

PROTECT FROM EXCESSIVE LIGHT AND HUMIDITY

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All trademarks are the property of their respective owners.

Manufactured In India By:

EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. I 11/2012

PRINCIPAL DISPLAY PANEL

lisinopril/hydrochlorothiazide 10mg/12.5mg tablet #30
(click image for full-size original)
LISINOPRIL AND HYDROCHLOROTHIAZIDE
lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-300(NDC:0172-5033)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
TALC
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 5033;10;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-300-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075776 07/01/2002
Labeler — MedVantx, Inc. (806427725)
Registrant — IVAX Pharmaceuticals, Inc. (884075235)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-300)

Revised: 12/2012 MedVantx, Inc.

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