Qbrelis (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

QBRELIS (lisinopril), 1 mg/mL, is supplied as 150 mL of a clear to slightly opalescent, colorless aqueous oral solution with a sweet taste in a 150-mL high-density polyethylene (HDPE) bottle with a child-resistant cap (NDC 52652-3001-1).

Store at controlled room temperature 20°C-25°C (68°F-77°F) [see USP] in a tightly closed container. Protect from freezing and excessive heat.

17 PATIENT COUNSELING INFORMATION

Pregnancy: Tell female patients of childbearing age about the consequences of exposure to QBRELIS during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including QBRELIS. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.

Hyperkalemia: Tell patients to consult their physician prior to using salt substitutes containing potassium.

Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use [see Drug Interactions (7.2)].

Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

QBRELIS is a registered trademark of Silvergate Pharmaceuticals, Inc.

Manufactured for:
Silvergate Pharmaceuticals, Inc.
6251 Greenwood Plaza Blvd., Suite 101Greenwood Village, CO 80111

U.S. Patents: 9,463,183; 9,616,096; 9,814,751; 10,039,800

LI-1812

12/2018

PRINCIPAL DISPLAY PANEL — BOTTLE LABEL

Principal Display Panel -- Bottle Label
(click image for full-size original)

Bottle Label

NDC 52652-3001-1

Qbrelis®
(lisinopril)

Oral Solution
1 mg/mL

READY TO USE

150 mL
Silvergate
Pharmaceuticals Inc.
Rx Only

70036823

Each 1 mL contains
1 mg of lisinopril

Usual Dose:
See prescribing information.

Store at room temperature
20° — 25°C (68° — 77°F)
Avoid freezing and excessive heat.
Keep container tightly closed.

KEEP THIS AND ALL
MEDICATIONS OUT OF THE
REACH OF CHILDREN

Manufactured for:
Silvergate Pharmaceuticals, Inc.
6251 Greenwood Plaza Blvd.Greenwood Village, CO 80111

© Silvergate 2018

QBRELIS lisinopril solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52652-3001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
XYLITOL
SODIUM CITRATE, UNSPECIFIED FORM
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52652-3001-1 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208401 08/29/2016
Labeler — Silvergate Pharmaceuticals, Inc. (011248265)

Revised: 12/2018 Silvergate Pharmaceuticals, Inc.

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