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Ciprofloxacin

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Overview

What is CETRAXAL?

CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.

Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is CHFNO•HCl•HO, and molecular weight is 385.82.

The chemical structure of ciprofloxacin hydrochloride is:



What does CETRAXAL look like?



What are the available doses of CETRAXAL?

CETRAXAL is a sterile, preservative-free otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container. 

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

How should I use CETRAXAL?

CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates ofor

The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.

Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.


What interacts with CETRAXAL?

Sorry No Records found


What are the warnings of CETRAXAL?

Sorry No Records found


What are the precautions of CETRAXAL?

Sorry No Records found


What are the side effects of CETRAXAL?

Sorry No records found


What should I look out for while using CETRAXAL?

CETRAXAL is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.


What might happen if I take too much CETRAXAL?

Sorry No Records found


How should I store and handle CETRAXAL?

Store at room temperature between 20C to 25C (68F to 77F), with excursions permitted between 15C to 30C (59F to 86F). Do not store in the refrigerator or freezer.  Use nosepiece immediately after removing from foil pouch.CETRAXAL is a clear, colorless, sterile, preservative-free solution. CETRAXAL is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single use container. Each single use container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged in a foil overwrap pouch in a carton (NDC 66992-450-14).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ciprofloxacin is a fluoroquinolone antimicrobial (see 12.4 Clinical Pharmacology, Microbiology).

Non-Clinical Toxicology
CETRAXAL is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.

Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (eg, amiodarone) have not been performed, but caution is advised (see ).

Ropivacaine hydrochloride should be used with caution in patients receiving other local anesthetics or agents structurally related to amide‑type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3‑hydroxy ropivacaine, the major metabolite. , the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYPIA2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as tluvoxamine, given concomitantly during administration of ropivacaine hydrochloride, can interact with ropivacaine hydrochloride leading to increased ropivacaine plasma levels. Caution should be exercised when CYPlA2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYPlA2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in plasma clearance of ropivacaine.

CETRAXAL is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.

Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with CETRAXAL. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients.

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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

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