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 |
|
|
|
|
|
|
|
MEROPENEM meropenem injection |
|
|
|
|
|
|
|
Revised: 06/2019 Gland Pharma Limited
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/meropenem-12/page/8/