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INVANZ

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Overview

What is INVANZ?

INVANZ (Ertapenem for Injection) is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics.

Chemically, INVANZ is described as [4-[3(3*,5*),4α,5β,6β(*)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is CHNOSNa, and its structural formula is:

Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran.

INVANZ is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem. The sodium content is approximately 137 mg (approximately 6.0 mEq).

Each vial of INVANZ contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5.



What does INVANZ look like?



What are the available doses of INVANZ?

Vials

INVANZ is a sterile lyophilized powder in a vial containing 1.046 g ertapenem sodium equivalent to 1 g ertapenem for intravenous infusion or for intramuscular injection.

ADD-Vantage Vials

INVANZ is a lyophilized powder in an ADD-Vantage vial containing 1.046 g ertapenem sodium equivalent to 1 g ertapenem for intravenous infusion.

What should I talk to my health care provider before I take INVANZ?

How should I use INVANZ?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment

INVANZ is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms

For Intravenous or Intramuscular Use

DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

INVANZ may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, INVANZ should be infused over a period of 30 minutes. Intramuscular administration of INVANZ may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.


What interacts with INVANZ?

Sorry No Records found


What are the warnings of INVANZ?

Sorry No Records found


What are the precautions of INVANZ?

Sorry No Records found


What are the side effects of INVANZ?

Sorry No records found


What should I look out for while using INVANZ?

Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ()

Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. ()


What might happen if I take too much INVANZ?

No specific information is available on the treatment of overdosage with INVANZ. Intentional overdosing of INVANZ is unlikely. Intravenous administration of INVANZ at a dose of 2 g over 30 min or 3 g over 1-2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 g doses of INVANZ in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.

In the event of an overdose, INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.

INVANZ can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.


How should I store and handle INVANZ?

Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Before reconstitutionDo not store lyophilized powder above 25°C (77°F).Reconstituted and infusion solutionsThe reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208Labetalol Hydrochloride Tablets USP, for oral administration, are available as:100 mgE” over “NDC 0185-0010-01 bottles of 100NDC 0185-0010-05 bottles of 500NDC 0185-0010-10 bottles of 1000200 mgE” over “NDC 0185-0117-01 bottles of 100NDC 0185-0117-05 bottles of 500NDC 0185-0117-10 bottles of 1000300 mgE” over “NDC 0185-0118-01 bottles of 100NDC 0185-0118-05 bottles of 500NDC 0185-0118-10 bottles of 1000Labetalol Hydrochloride Tablets USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Sandoz Inc.Princeton, NJ 08540OS7001Rev. 08/14MF0010REV08/14MG #13208


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Ertapenem sodium is a carbapenem antibiotic

Non-Clinical Toxicology
Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ()

Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. ()

In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol hydrochloride alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded.

Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses greater than the normal anti-asthmatic dose of beta-agonist bronchodilator drugs may be required.

Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.

Synergism has been shown between halothane anesthesia and intravenously administered labetalol hydrochloride. During controlled hypotensive anesthesia using labetalol hydrochloride in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. The anesthesiologist should be informed when a patient is receiving labetalol hydrochloride.

Labetalol hydrochloride blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effect. If labetalol hydrochloride is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.

Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam. Before initiating therapy with INVANZ, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to INVANZ occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.

The following are described in greater detail in the Warnings and Precautions section.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).