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ZERBAXA

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Overview

What is ZERBAXA?

ZERBAXA (ceftolozane and tazobactam) is an antibacterial combination product consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium for intravenous administration.

Ceftolozane sulfate is a semi-synthetic antibacterial drug of the beta-lactam class for parenteral administration. The chemical name of ceftolozane sulfate is 1-Pyrazolium, 5-amino-4-[[[(2-aminoethyl)amino]carbonyl]amino]-2-[[(6,7)-7-[[(2)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methyl-,sulfate (1:1). The molecular formula is CHNOS ∙HSO and the molecular weight is 764.77.

Figure 1: Chemical structure of ceftolozane sulfate

Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is CHNNaOS and the molecular weight is 322.3.

Figure 2: Chemical structure of tazobactam sodium

ZERBAXA 1.5 g (ceftolozane and tazobactam) for injection is a white to yellow sterile powder for reconstitution consisting of ceftolozane 1 g (equivalent to 1.147 g of ceftolozane sulfate) and tazobactam 0.5 g (equivalent to 0.537 g of tazobactam sodium) per vial, packaged in single-dose glass vials. The product contains sodium chloride (487 mg/vial) as a stabilizing agent, citric acid (21 mg/vial), and L-arginine (approximately 600 mg/vial) as excipients.



What does ZERBAXA look like?



What are the available doses of ZERBAXA?

ZERBAXA 1.5 g (ceftolozane and tazobactam) for injection is supplied as a white to yellow sterile powder for reconstitution in single-dose vials; each vial contains ceftolozane 1 g (equivalent to 1.147 g of ceftolozane sulfate) and tazobactam 0.5 g (equivalent to 0.537 g of tazobactam sodium).

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

How should I use ZERBAXA?

ZERBAXA (ceftolozane and tazobactam) for injection is indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms.

The recommended dosage regimen is ZERBAXA 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for injection administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and with normal renal function or mild renal impairment. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress (Table 1).


What interacts with ZERBAXA?

Sorry No Records found


What are the warnings of ZERBAXA?

Sorry No Records found


What are the precautions of ZERBAXA?

Sorry No Records found


What are the side effects of ZERBAXA?

Sorry No records found


What should I look out for while using ZERBAXA?

ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class.


What might happen if I take too much ZERBAXA?

In the event of overdose, discontinue ZERBAXA and provide general supportive treatment. ZERBAXA can be removed by hemodialysis. Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the tazobactam metabolite M1 were removed by dialysis. No information is available on the use of hemodialysis to treat overdosage.


How should I store and handle ZERBAXA?

ZERBAXA vials should be stored refrigerated at 2 to 8°C (36 to 46°F) and protected from light.The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2 to 8° C (36 to 46°F).ZERBAXA vials should be stored refrigerated at 2 to 8°C (36 to 46°F) and protected from light.The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2 to 8° C (36 to 46°F).Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of amitriptyline hydrochloride, USP.The 10 mg tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2610-01bottles of 100 tabletsNDC 0378-2610-10bottles of 1000 tabletsThe 25 mg tablets are light green, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2625-01bottles of 100 tabletsNDC 0378-2625-10bottles of 1000 tabletsThe 50 mg tablets are brown, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2650-01bottles of 100 tabletsNDC 0378-2650-10bottles of 1000 tabletsThe 75 mg tablets are blue, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2675-93bottles of 30 tabletsNDC 0378-2675-01bottles of 100 tabletsThe 100 mg tablets are orange, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2685-93bottles of 30 tabletsNDC 0378-2685-01bottles of 100 tabletsThe 150 mg tablets are flesh, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-2695-93bottles of 30 tabletsNDC 0378-2695-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

ZERBAXA is an antibacterial drug .

Non-Clinical Toxicology
ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class.

In a subgroup analysis of a Phase 3 cIAI trial, clinical cure rates were lower in patients with baseline creatinine clearance (CrCl) of 30 to ≤50 mL/min compared to those with CrCl >50 mL/min (Table 4). The reduction in clinical cure rates was more marked in the ZERBAXA plus metronidazole arm compared to the meropenem arm. A similar trend was also seen in the cUTI trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dosage of ZERBAXA accordingly .

The following serious reactions 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).