Meropenem (Page 8 of 8)

17 PATIENT COUNSELING INFORMATION

• Counsel patients that antibacterial drugs including Meropenem for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Meropenem for Injection, USP is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, take the medication exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Meropenem for Injection, USP or other antibacterial drugs in the future.
• Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.5)].
• Counsel patients to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with Meropenem for Injection, USP. If treatment with Meropenem for Injection, USP is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed [see Warnings and Precautions (5.4)].
• Patients receiving Meropenem for Injection, USP on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that Meropenem for Injection, USP is well tolerated, patients should not operate machinery or motorized vehicles [see Warnings and Precautions (5.9)].

Manufactured by:

Gland Pharma Limited
Pashamylaram, Patancheru,
Hyderabad — 502 307, India

Revised: May 2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68083-146-01
For Intravenous Use Only
Meropenem for Injection, USP (I.V.)
Equivalent to 500 mg/vial meropenem
Contents are Sterile Rx Only

NDC 68083-146-10
For Intravenous Use Only
Meropenem for Injection, USP (I.V.)
Equivalent to 500 mg/vial meropenem 10 × 500 mg

Sterile Vials

NDC 68083-147-01
For Intravenous Use Only
Meropenem for Injection, USP (I.V.)
Equivalent to 1 g/vial meropenem
Contents are Sterile Rx Only

NDC 68083-147-10
For Intravenous Use Only
Meropenem for Injection, USP (I.V.)
Equivalent to 1 g/vial meropenem 10 × 1 g

Sterile Vials

MEROPENEM meropenem injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-146 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEROPENEM (MEROPENEM ANHYDROUS) MEROPENEM 500 mg in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CARBONATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-146-10 10 VIAL in 1 CARTON contains a VIAL 1 20 mL in 1 VIAL This package is contained within the CARTON (68083-146-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206141 04/28/2017

MEROPENEM meropenem injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-147 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEROPENEM (MEROPENEM ANHYDROUS) MEROPENEM 1 g in 30 mL

Inactive Ingredients Ingredient Name Strength SODIUM CARBONATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-147-10 10 VIAL in 1 CARTON contains a VIAL 1 30 mL in 1 VIAL This package is contained within the CARTON (68083-147-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206141 04/28/2017

Labeler — Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		858971074	ANALYSIS (68083-146), ANALYSIS (68083-147), MANUFACTURE (68083-146), MANUFACTURE (68083-147)

Revised: 06/2019 Gland Pharma Limited