Lotrisone Lotion

Pronunciation: kloe-TRIM-a-zole/BAY-ta-METH-a-sone
Generic Name: Clotrimazole/Betamethasone
Brand Name: Lotrisone

Lotrisone Lotion is used for:

Treating certain fungal skin infections, including ringworm, athlete's foot, and jock itch. It also relieves redness, swelling, and itching associated with infection.

Lotrisone Lotion is an antifungal and corticosteroid combination. It works by weakening the cell membrane of certain fungi. It also acts as an anti-inflammatory and anti-itching agent.

Do NOT use Lotrisone Lotion if:

• you are allergic to any ingredient in Lotrisone Lotion


• you are taking pimozide or an ergot alkaloid (eg, ergotamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lotrisone Lotion:

Some medical conditions may interact with Lotrisone Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diaper rash, eczema, measles, tuberculosis (TB) or a positive TB skin test, chickenpox, shingles, or thinning of the skin


• if you have recently received a vaccination

Some MEDICINES MAY INTERACT with Lotrisone Lotion. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clarithromycin because the risk of certain side effects may be increased


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Lotrisone Lotion's effectiveness


• Ergot alkaloids (eg, ergotamine), imatinib, live vaccines, macrolide immunosuppressants (eg, tacrolimus), pimozide, or ritodrine because their actions and the risk of their side effects may be increased by Lotrisone Lotion


• Hydantoins (eg, phenytoin) or interleukin-2 because their effectiveness may be decreased by Lotrisone Lotion

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lotrisone Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lotrisone Lotion:

Use Lotrisone Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and after applying Lotrisone Lotion.


• Shake well before each use.


• Wash and completely dry the affected area.


• Gently rub the medicine into the affected and surrounding areas until it is evenly distributed.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you are using Lotrisone Lotion in the groin area, use only for 2 weeks and apply the lotion sparingly. Wear loose-fitting clothing. Notify your doctor if your condition persists after 2 weeks.


• Use Lotrisone Lotion on a regular schedule to get the most benefit from it.


• To clear up your infection completely, use Lotrisone Lotion for the full course of treatment. Keep using it even if you feel better in a few days.


• Notify your doctor if there is no improvement of your symptoms after 1 week of treatment on the groin or body or after 2 weeks of treatment on the feet.


• If you miss a dose of Lotrisone Lotion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Lotrisone Lotion.

Important safety information:

• Lotrisone Lotion is for external use only. Avoid getting Lotrisone Lotion in the eyes, vagina, mouth, or nose. If Lotrisone Lotion gets in the eyes, immediately wash out with cool tap water.


• Lotrisone Lotion has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Be sure to use Lotrisone Lotion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not apply Lotrisone Lotion over large areas of the body without first checking with your doctor.


• Do not use Lotrisone Lotion for other skin conditions at a later time.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not use Lotrisone Lotion for diaper rash.


• Serious side effects may occur if too much of Lotrisone Lotion is absorbed through the skin. This may be more likely to occur if you use Lotrisone Lotion over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Lotrisone Lotion. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• Use Lotrisone Lotion with caution in the ELDERLY; they may be more sensitive to its effects, especially thinning skin.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while using a corticosteroid.


• Lotrisone Lotion should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lotrisone Lotion while you are pregnant. It is not known if Lotrisone Lotion is found in breast milk. If you are or will be breast-feeding while you use Lotrisone Lotion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lotrisone Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; mild burning or stinging at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, itching, peeling, redness, blistering, swelling, oozing, or severe burning at the application site; spider veins; thinning, softening, or discoloration of the skin; unusual bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lotrisone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Lotrisone Lotion may be harmful if swallowed.

Proper storage of Lotrisone Lotion:

Store Lotrisone Lotion at 77 degrees F (25 degrees C) in the upright position only. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Store Lotrisone Lotion away from products used in the eyes or ears to avoid using Lotrisone Lotion incorrectly. Keep Lotrisone Lotion out of the reach of children and away from pets.

General information:

• If you have any questions about Lotrisone Lotion, please talk with your doctor, pharmacist, or other health care provider.


• Lotrisone Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Lotrisone Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lotrisone resources

• Lotrisone Side Effects (in more detail)
• Lotrisone Use in Pregnancy & Breastfeeding
• Lotrisone Drug Interactions
• Lotrisone Support Group
• 0 Reviews for Lotrisone - Add your own review/rating

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Allercet

Allercet may be available in the countries listed below.

Ingredient matches for Allercet

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Allercet in the following countries:

• Myanmar


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International Drug Name Search

Lignospan Injection

Dosage Form: injection, solution
LIGNOSPAN FORTE (Lidocaine HCl 2% and Epinephrine 1:50,000 Injection)

LIGNOSPAN STANDARD (Lidocaine HCl 2% and Epinephrine 1:100,000 Injection)

(Lidocaine hydrochloride and epinephrine injection, USP)

Rx only

Solutions for local anesthesia in Dentistry

Lignospan Injection Description

LIGNOSPAN FORTE and LIGNOSPAN STANDARD are sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula :

C14H22N20•HCl• H20     M.W. 288.8

Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula :

C9H13NO3•C4H606     M.W. 333.3

COMPOSITION OF AVAILABLE SOLUTIONS

PRODUCT IDENTIFICATION		FORMULA
		SINGLE DOSE CARTRIDGE
Lidocaine hydrochloride	Epinephrine (as the bitartrate)	Sodium Chloride	Potassium metabisulfite	Edetate Disodium
Concentration %	Dilution	(mg/mL)	(mg/mL)	(mg/mL)
The pH of the LIGNOSPAN FORTE and the LIGNOSPAN STANDARD solutions are adjusted to USP limits with sodium hydroxide.
2	1:50,000	6.5	1.2	0.25
2	1:100,000	6.5	1.2	0.25

Lignospan Injection - Clinical Pharmacology

Mechanism of action

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anesthetic action.

Onset and duration of anesthesia

When used for infiltration anesthesia in dental patients, the time of onset averages less than two minutes for each of the two forms of LIGNOSPAN. LIGNOSPAN FORTE (lidocaine HCI 2% solution with a 1:50,000 epinephrine concentration) or LIGNOSPAN STANDARD (lidocaine HCI 2% solution with a1:100,000 epinephrine concentration) provide an average pulp anesthesia of at least 60 minutes with an average duration of soft tissue anesthesia of approximately 2.5 hours.When used for nerve blocks in dental patients, the time of onset for both forms of LIGNOSPAN averages 2-4 minutes. LIGNOSPAN FORTE (lidocaine HCI 2% solution with a 1:50,000 epinephrine concentration) or LIGNOSPAN STANDARD (lidocaine HCI 2% solution with a 1:100,000 epinephrine concentration) provide pulp anesthesia averaging at least 90 minutes with an average duration of soft tissue anesthesia of 3 to 3.5 hours.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system and/or the beta-adrenergic receptor stimulating action of epinephrine when present.

Pharmacokinetics and metabolism

Information derived from diverse formulations, concentrations and usages reveals that lidocaine is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the lowest after subcutaneous administration.

The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentratlon. At concentration of 1 to 4 μg of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-l-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.

Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.

Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 μg free base per mL. In the rhesus monkey, arterial blood levels of 18-21 μg/mL have been shown to be the threshold for convulsive activity.

Indications and Usage for Lignospan Injection

LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.

Only accepted procedures for these techniques as described in standard textbooks are recommended.

Contraindications

LINGOSPAN is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any components of the injectable formulations.

Warnings

DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES WHICH MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.

To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided.

Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.

LIGNOSPAN solutions contain potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

LIGNOSPAN, along with other local anesthetics, is capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.

The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.)

Precautions

General

The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions and readiness for emergencies. Consult standard textbooks for specific techniques and precautions for various regional anesthetic procedures. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use (See WARNINGS AND ADVERSE REACTIONS).

The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical condition.

If sedatives are employed to reduce patient apprehension, reduced doses should be used since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent.

Lidocaine should be used with caution in patients with severe shock or heart block. Lidocaine should also be used with caution in patients with impaired cardiovascular function. Local anesthetic solutions containing a vasoconstrictor should be used with caution in areas of the body supplied by end arteries or having otherwise compromised blood supply. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury ( such as exfoliating or ulcerating lesions)or necrosis may result. Preparations containing a vasoconstrictor should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions.

Cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be monitored after each local anesthetic injection. Restlessness, anxiety tinnitus, dizziness, blurred vision, tremors, depression or drowsiness should alert the practitioner to the possibility of central nervous system toxicity. Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position : placing the patient in the recumbent position is recommended when an adverse response is noted after injection of a local anesthetic (See ADVERSE REACTIONS - Cardiovascular System.) Vasovagal reactions may elicit a range of clinical manifestations, from prodrome signs of pre-syncope (e.g., lightheadedness, pallor, nausea, sweating, visual disturbances, weakness) to brief loss of consciousness (i.e., syncope).

Lidocaine should be used with caution in patients with hepatic disease, since amide-type local anesthetics are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction, and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspected triggering agent (s) and prompt treatment, including oxygen therapy, dantrolene (consult dantrolene sodium intravenous package insert before using) and other supportive measures.

Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

Use in the Head and Neck Area

Small doses of local anesthetics injected into the head and neck area, including retrobulbar, dental and stellate ganglion blocks, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratony depression and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded (See DOSAGE AND ADMINISTRATION).

Information for Patients

The patient should be informed of the possibility of temporary loss of sensation and muscle function following infiltration or nerve block injections.

The patient should be advised to to exert caution to avoid inadvertent trauma to the lips, tongue, cheek mucosae or soft palate when these structures are anesthetized. The ingestion of food should therefore be postponed until normal function returns. The patient should be advised to consult the dentist if anesthesia persists or if a rash develops.

Clinically Significant Drug Interactions

The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension.

Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.

Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

As the LIGNOSPAN STANDARD and the LIGNOSPAN FORTE solutions both contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block.

Drug/Laboratory test interactions

The intramuscular injection of lidocaine may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of lidocaine.

Carcinogenesis, mutagenesis, impairment of fertility

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

PREGNANCY

Teratogenic Effects Pregnancy Category B

Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.

Pediatric use

Dosages in pediatric population should be reduced, commensurate with age, body weight and physical condition (See DOSAGE AND ADMINISTRATION).

Adverse Reactions

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide-type local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels (which may be caused by excessive dosage, rapid absorption, unintended intravascular injection or slow metabolic degradation), injection technique, volume of injection, hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported :

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular system

Cardiovascular manifestations in response to lidocaine are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.In addition, the beta-adrenergic receptor-stimulating action of epinephrine may lead to excitatory cardiovascular responses, such as tachycardia, palpitations, and hypertension.

Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the patient is in an upright position. Less commonly, they may result from a direct effect of the drug. Failure to recognize the premonitory signs such as sweating, a feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and ventilation with oxygen. Supportive treatment of circulatory depression may require the administration of intravenous fluids and, when appropriate, a vasopressor (e.g, ephedrine) as directed by the clinical situation.

Allergic reactions

Allergic reactions are characterized by cutaneous lesions, urticaria, edema, anaphylactoid reactions, or dyspnea due to bronchoconstriction. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Neurologic reactions

The incidences of adverse reactions (e.g., persistent neurologic deficit) associated with the use of local anesthetics may be related to the technique employed, the total dose of local anesthetic administered, the particular drug used, the route of administration, and the physical condition of the patient.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of lidocaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (See ADVERSE REACTIONS, WARNINGS AND PRECAUTIONS).

Management of local anesthetic emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of clrculatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardio-pulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

The intravenous LD50 of lidocaine HCI in female mice is 26 (21-31) mg/kg and the subcutaneous LD50 is 264 (203-304) mg /kg.

Lignospan Injection Dosage and Administration

The dosage of LIGNOSPAN (lidocaine HCL and epinephrine) depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks.

For most routine dental procedures, LIGNOSPAN STANDARD (lidocaine HCI 2% with a 1:100,000 epinephrine concentration) is preferred. However, when greater depth and a more pronounced hemostasis are required, LIGNOSPAN FORTE (lidocaine HCI 2 % with 1:50,000 epinephrine concentration) should be used.

Dosage requirements should be determined on an individual basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 - 5.0 mL (1/2 to 2.5 cartridges) of LIGNOSPAN (lidocaine HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually effective.

In children under 10 years of age, it is rarely necessary to administer more than one-half cartridge (0.9-1.0 mL or 18-20 mg of lidocaine) per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug, will allow treatment of the teeth of an entire quadrant. Aspiration is recommended since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failures to a minimum. Moreover, injection should always be made slowly.

Maximum recommended dosages for LIGNOSPAN (lidocaine HCI 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration).

Adult

For normal healthy adults, the amount of lidocaine HCI administered should be kept below 500 mg, and in any case, should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

Pediatric

Pediatric patients : It is difficult to recommend a maximum dose of any drug for pediatric patients since this varies as a function of age and weight. For pediatric patients of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in pediatric patients of five years weighing 50 Ibs, the dose of lidocaine hydrochloride should not exceed 75-100mg when calculated according to Clark's rule. In any case, the maximum dose of lidocaine hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

NOTE : Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and / or contain particulate matter should not be used and any unused portion of a cartridge of LINGOSPAN should be discarded.

How is Lignospan Injection Supplied

-

LINGOSPAN FORTE (Lidocaine Hydrochloride 2% and Epinephrine 1:50,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL cartridges. (NDC 51004-1096-7).

-

LINGOSPAN STANDARD (Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 injection) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL cartridges.(NDC 51004-1095-6)

Store at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze.

BOXES : For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap.

Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.

STERILIZATION : STORAGE AND TECHNICAL PROCEDURES

1. Cartridges should not be autoclaved, because the closures employed cannot withstand autoclaving temperatures and pressures.


2. If chemical disinfection of anesthetic cartridges is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of U.S.P grade, contain denaturants that are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished just prior to use by wiping the cartridge cap thoroughly with a pledge of cotton that has been moistened with recommended alcohol.


3. Certain metallic ions (mercury, zinc, copper, etc.) have been related to swelling and edema after local anesthesia in dentistry. Therefore, chemical disinfectants containing or releasing these ions are not recommended. Antirust tablets usually contain sodium nitrite or some similar agents that may be capable of releasing metal ions. Because of this, aluminium sealed cartridges should not be kept in such solutions.


4. Quaternary ammonium salts, such as benzalkonium chloride, are electrolytically incompatible with aluminium. Cartridges of Lidocaine and Epinephrine Injections are sealed with aluminium caps and therefore should not be immersed in any solution containing these salts.


5. To avoid leakage of solutions during injection, be sure to penetrate the center of the rubber diaphragm when loading the syringe. An off-center penetration produces an oval shaped puncture that allows leakage around the needle.
   
   Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.7 mL cartridges, and inadvertent freezing.


6. Cracking of glass cartridges is most often the result of an attempt to use a cartridge with an extruded plunger. An extruded plunger loses its lubrication and can be forced back into the cartridge only with difficulty. Cartridges with extruded plungers should be discarded.


7. Store at controlled room temperature, below 25°C (77°F).

Manufactured by :

Novocol Pharmaceutical of Canada, Inc.

25 Wolseley Court

Cambridge, Ontario

N1R 6X3

Made in Canada

PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton

NDC 51004-1095-6

LIGNOSPAN STANDARD

LIDOCAINE HCl 2% and EPINEPHRINE 1:100,000

(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION,USP

50 Cartridges • 1.7 mL each

FOR DENTAL BLOCK AND INFILTRATION ONLY

Rx Only

LIGNOSPAN STANDARD  lidocaine hydrochloride and epinephrine bitartrate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51004-1095 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 20 mg  in 1 mL Epinephrine Bitartrate (Epinephrine) Epinephrine 0.01 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Potassium Metabisulfite 1.2 mg  in 1 mL Sodium Chloride 6.5 mg  in 1 mL Edetate Disodium 0.25 mg  in 1 mL Sodium Hydroxide   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51004-1095-6 50 CARTRIDGE In 1 CARTON contains a CARTRIDGE 1 1.7 mL In 1 CARTRIDGE This package is contained within the CARTON (51004-1095-6)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088390	10/15/2011

Labeler - Novocol Pharmaceutical of Canada, Inc. (201719960)

Registrant - Novocol Pharmaceutical of Canada, Inc. (201719960)

Establishment
Name	Address	ID/FEI	Operations
Novocol Pharmaceutical of Canada, Inc.		201719960	MANUFACTURE

Revised: 11/2011Novocol Pharmaceutical of Canada, Inc.

Orazinc 110

Generic Name: zinc supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Galzin


• M2 Zinc 50


• Orazinc 110


• Orazinc 220


• Zinc-220


• Zinc Chelated


• Zn Plus Protein

In Canada

• Prostavan

Available Dosage Forms:

• Tablet


• Capsule


• Tablet, Extended Release

Uses For Orazinc 110

Zinc supplements are used to prevent or treat zinc deficiency.

The body needs zinc for normal growth and health. For patients who are unable to get enough zinc in their regular diet or who have a need for more zinc, zinc supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection.

Zinc supplements may be used for other conditions as determined by your health care professional.

Lack of zinc may lead to poor night vision and wound-healing, a decrease in sense of taste and smell, a reduced ability to fight infections, and poor development of reproductive organs.

• Acrodermatitis enteropathica (a lack of absorption of zinc from the intestine)


• Alcoholism


• Burns


• Type 2 diabetes mellitus


• Down's syndrome


• Eating disorders


• Intestine diseases


• Infections (continuing or chronic)


• Kidney disease


• Liver disease


• Pancreas disease


• Sickle cell disease


• Skin disorders


• Stomach removal


• Stress (continuing)


• Thalassemia


• Trauma (prolonged)

In addition, premature infants may need additional zinc.

Increased need for zinc should be determined by your health care professional.

Claims that zinc is effective in preventing vision loss in the elderly have not been proven. Zinc has not been proven effective in the treatment of porphyria.

Injectable zinc is given by or under the supervision of a health care professional. Other forms of zinc are available without a prescription.

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, zinc supplements are used in certain patients with the following medical condition:

• Wilson's disease (a disease of too much copper in the body)

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Zinc is found in various foods, including lean red meats, seafood (especially herring and oysters), peas, and beans. Zinc is also found in whole grains; however, large amounts of whole-grains have been found to decrease the amount of zinc that is absorbed. Additional zinc may be added to the diet through treated (galvanized) cookware. Foods stored in uncoated tin cans may cause less zinc to be available for absorption from food.

The daily amount of zinc needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for zinc are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants and children birth to 3 years of age	5–10	2–4
Children 4 to 6 years of age	10	5
Children 7 to 10 years of age	10	7–9
Adolescent and adult males	15	9–12
Adolescent and adult females	12	9
Pregnant females	15	15
Breast-feeding females	16–19	15

Before Using Orazinc 110

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. There is some evidence that the elderly may be at risk of becoming deficient in zinc due to poor food selection, decreased absorption of zinc by the body, or medicines that decrease absorption of zinc or increase loss of zinc from the body.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. There is evidence that low blood levels of zinc may lead to problems in pregnancy or defects in the baby. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amygdalin


• Deferoxamine


• Eltrombopag

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Copper deficiency—Zinc supplements may make this condition worse.

Proper Use of zinc supplement

This section provides information on the proper use of a number of products that contain zinc supplement. It may not be specific to Orazinc 110. Please read with care.

Zinc supplements are most effective if they are taken at least 1 hour before or 2 hours after meals. However, if zinc supplements cause stomach upset, they may be taken with a meal. You should tell your health care professional if you are taking your zinc supplement with meals.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, lozenges, tablets, extended-release tablets):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes (Note that the normal daily recommended intakes are expressed as an actual amount of zinc. The dosage form [e.g., zinc gluconate, zinc sulfate] has a different strength):
    
    • For the U.S
    
    
    • Adult and teenage males—15 milligrams (mg) per day.
    
    
    • Adult and teenage females—12 mg per day.
    
    
    • Pregnant females—15 mg per day.
    
    
    • Breast-feeding females—16 to 19 mg per day.
    
    
    • Children 4 to 10 years of age—10 mg per day.
    
    
    • Children birth to 3 years of age—5 to 10 mg per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—9 to 12 mg per day.
    
    
    • Adult and teenage females—9 mg per day.
    
    
    • Pregnant females—15 mg per day.
    
    
    • Breast-feeding females—15 mg per day.
    
    
    • Children 7 to 10 years of age—7 to 9 mg per day.
    
    
    • Children 4 to 6 years of age—5 mg per day.
    
    
    • Children birth to 3 years of age—2 to 4 mg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking zinc supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in zinc. However, if your health care professional has recommended that you take zinc, try to remember to take it as directed every day.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Orazinc 110

When zinc combines with certain foods it may not be absorbed into your body and it will do you no good. If you are taking zinc, the following foods should be avoided or taken 2 hours after you take zinc:

• Bran


• Fiber-containing foods


• Phosphorus-containing foods such as milk or poultry


• Whole-grain breads and cereals

Do not take zinc supplements and copper, iron, or phosphorus supplements at the same time. It is best to space doses of these products 2 hours apart, to get the full benefit from each dietary supplement.

Orazinc 110 Side Effects

Along with its needed effects, a dietary supplement may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare - With large doses

• Chills


• continuing ulcers or sores in mouth or throat


• fever


• heartburn


• indigestion


• nausea


• sore throat


• unusual tiredness or weakness

Symptoms of overdose

• Chest pain


• dizziness


• fainting


• shortness of breath


• vomiting


• yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Levofloxacin

Class: Quinolones
VA Class: AM900
Chemical Name: (S) - 9 - Fluoro - 2,3 - dihydro - 3 - methyl - 10 - (4 - methyl - 1 - piperazinyl) - 7 - oxo - 7H - pyrido[1,2,3 - de] - 1,4 - benzoxazine - 6 - carboxylic acid hydrate (2:1)
Molecular Formula: C₁₈H₂₀FN₃O₄•½H₂O
CAS Number: 138199-71-0
Brands: Levaquin

• 
  

  Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.^{1 128 129} This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.^{1 128 129} (See Tendinopathy and Tendon Rupture under Cautions.)

  
  

REMS:

FDA approved a REMS for levofloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of levofloxacin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; fluoroquinolone; the levorotatory isomer of ofloxacin.^{1 4 5 12}

Uses for Levofloxacin

Respiratory Tract Infections

Treatment of acute bacterial sinusitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.^{1 18 90}

Treatment of acute exacerbations of chronic bronchitis caused by susceptible Staphylococcus aureus, S. pneumoniae, H. influenzae, H. parainfluenzae, or M. catarrhalis.^{1 19 20}

Treatment of community-acquired pneumonia (CAP) caused by susceptible S. aureus, S. pneumoniae (including penicillin-resistant strains with penicillin MICs ≥2 mcg/mL), H. influenzae, H. parainfluenzae, Klebsiella pneumoniae, Legionella pneumoniae, M. catarrhalis, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Mycoplasma pneumoniae.^{1 21 31 95}

Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).³¹ Do not use a fluoroquinolone alone for empiric treatment of CAP in patients requiring treatment in an intensive care unit (ICU).³¹

For empiric outpatient treatment of CAP in previously healthy adults without risk factors for drug-resistant S. pneumoniae (DRSP), IDSA and ATS recommend monotherapy with a macrolide (azithromycin, clarithromycin, erythromycin) or, alternatively, doxycycline.³¹ If risk factors for DRSP are present (e.g., chronic heart, lung, liver, or renal disease, diabetes mellitus, alcoholism, malignancy, asplenia, immunosuppression, history of anti-infective treatment during previous 3 months), IDSA and ATS recommend empiric outpatient treatment with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) or, alternatively, a combination regimen that includes a β-lactam effective against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide or doxycycline.³¹

For empiric inpatient treatment of CAP in non-ICU patients, IDSA and ATS recommend adults receive monotherapy with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) or, alternatively, a regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.³¹ For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) Staphylococcus aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (gemifloxacin, levofloxacin, moxifloxacin).³¹

For empiric treatment of CAP in adults with risk factors for Ps. aeruginosa, IDSA and ATS recommend a combination regimen that includes an antipneumococcal, antipseudomonal β-lactam (cefepime, imipenem, meropenem, fixed combination of piperacillin and tazobactam) and ciprofloxacin or levofloxacin; one of these β-lactams, an aminoglycoside, and azithromycin; or one of these β-lactams, an aminoglycoside, and an antipneumococcal fluoroquinolone.³¹ If Ps. aeruginosa has been identified by appropriate microbiologic testing, these experts recommend treatment with a combination regimen that includes an antipseudomonal β-lactam (cefepime, ceftazidime, aztreonam, imipenem, meropenem, piperacillin, ticarcillin) and ciprofloxacin, levofloxacin, or an aminoglycoside or, alternatively, a combination regimen that includes an aminoglycoside and ciprofloxacin or levofloxacin.³¹

Treatment of nosocomial pneumonia caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only), S. pneumoniae, H. influenzae, Escherichia coli, K. pneumoniae, Pseudomonas aeruginosa, or Serratia marcescens.¹ Adjunctive therapy should be used as clinically indicated.¹ If Ps. aeruginosa are known or suspected to be involved in the infection, concomitant use of an antipseudomonal β-lactam is recommended.¹

Skin and Skin Structure Infections

Treatment of mild to moderate uncomplicated skin and skin structure infections (including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections) caused by susceptible S. aureus or S. pyogenes (group A β-hemolytic streptococci.^{1 26}

Treatment of complicated skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only), Enterococcus faecalis, S. pyogenes, or Proteus mirabilis.¹

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of mild to moderate uncomplicated UTIs caused by susceptible E. coli, K. pneumoniae, or S. saprophyticus.¹

Treatment of mild to moderate complicated UTIs caused by susceptible E. faecalis, Enterobacter cloacae, E. coli, K. pneumoniae, P. mirabilis, or P. aeruginosa.¹

Treatment of acute pyelonephritis caused by susceptible E. coli, including cases with concurrent bacteremia.¹

Treatment of chronic prostatitis caused by susceptible E. coli, E. faecalis, or S. epidermidis.¹

Anthrax

Postexposure prophylaxis to prevent development of inhalational anthrax following suspected or confirmed exposure to aerosolized Bacillus anthracis spores.¹ Approval for this indication based on a surrogate end point derived from a primate model of inhalational anthrax that predicts clinical benefit based on plasma levofloxacin concentrations achievable in humans with recommended oral or IV dosages.^{1 93} CDC and others recommend ciprofloxacin or doxycycline as initial drug of choice for such prophylaxis.^{33 47} Other fluoroquinolones (e.g., gatifloxacin, levofloxacin, moxifloxacin, ofloxacin) considered alternatives to ciprofloxacin when needed.³³

Alternative for treatment of inhalational anthrax† when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass-casualty setting).^{33 47} A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for initial treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.^{33 35 47}

Chlamydial Infections

Alternative for treatment of urogenital infections caused by C. trachomatis†, including presumptive treatment of chlamydial infections in patients with gonorrhea.¹¹ CDC and others recommend azithromycin or doxycycline as drugs of choice; erythromycin, ofloxacin, or levofloxacin are alternatives.^{11 52}

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).⁵⁵ AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,⁵⁵ but a fluoroquinolone (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used.⁵⁵ Consultation with an infectious disease specialist is recommended.⁵⁵

Gonorrhea and Associated Infections

Has been used for treatment of uncomplicated urethral, endocervical, or rectal gonorrhea† caused by susceptible Neisseria gonorrhoeae.¹¹

Has been used for treatment of disseminated gonococcal infections† caused by susceptible N. gonorrhoeae.¹¹

Treatment of epididymitis† most likely caused by sexually transmitted enteric bacteria (e.g., E. coli) or when culture or nucleic acid amplification tests are negative for N. gonorrhoeae.^{11 52 115}

Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea,^{11 114} CDC currently states that fluoroquinolones should not be used for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).^{52 114 115 116}

Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US.^{11 52 53 109 110 114 115 116} (See Resistance in Neisseria gonorrhoeae under Cautions.)

For treatment of uncomplicated cervical, urethral, or rectal gonorrhea, CDC and others recommend IM ceftriaxone or oral cefixime; IM ceftriaxone is drug of choice for pharyngeal infections.^{11 52 114 115}

For initial treatment of disseminated gonococcal infections, CDC recommends IM or IV ceftriaxone as drug of choice and IV cefotaxime, IV ceftizoxime (no longer commercially available in the US), or IM spectinomycin (not currently commercially available in the US) as alternatives.^{11 115} Initial parenteral regimen should be continued for 24–48 hours after improvement begins; therapy can be switched to oral cefixime or oral cefpodoxime and continued to complete ≥1 week of treatment.^{11 115} CDC states that fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin) may be an alternative treatment option for disseminated infections only if in vitro susceptibility can be documented by culture.¹¹⁵

For empiric treatment of epididymitis, especially when gonococcal or chlamydial infection is likely (e.g., in those <35 years of age), CDC recommends an initial regimen of IM ceftriaxone and oral doxycycline.^{11 115} Levofloxacin or ofloxacin should be used only if epididymitis is not caused by gonorrhea (i.e., results of culture or nucleic acid amplification testing are negative for N. gonorrhoeae) or is most likely caused by sexually transmitted enteric bacteria.^{11 52 115}

Meningitis and CNS Infections

Suggested as a possible alternative for use in conjunction with other anti-infectives for the treatment of meningitis† caused by susceptible bacteria.^{64 65} Safety and efficacy not established;⁶³ only very limited clinical experience.⁴⁷

Mycobacterial Infections

Alternative for use in multiple-drug regimens for treatment of active tuberculosis†.⁴⁰

CDC, ATS, and IDSA state that use of fluoroquinolones can be considered in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.⁴⁰ There have been recent reports of extensively drug-resistant tuberculosis (XDR tuberculosis).^{71 72} XDR tuberculosis is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).^{71 72}

Although there is clinical experience with several fluoroquinolones in the treatment of tuberculosis (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin),^{40 73 76 77 78 79} levofloxacin and moxifloxacin are the fluoroquinolones recommended by CDC, ATS, and IDSA and levofloxacin may be preferred on the basis of cumulative experience.⁴⁰

The most recent CDC, ATS, and IDSA recommendations for treatment of tuberculosis should be consulted for more specific information.⁴⁰

Nongonococcal Urethritis

Alternative for treatment of nongonococcal urethritis† (NGU).¹¹ CDC recommends azithromycin or doxycycline as drugs of choice;¹¹ erythromycin, ofloxacin, and levofloxacin are alternatives.¹¹

Pelvic Inflammatory Disease

Treatment of acute pelvic inflammatory disease† (PID).^{11 52 115} Do not use if QRNG may be involved or if in vitro susceptibility cannot be tested.^{11 52 115} (See Resistance in Neisseria gonorrhoeae under Cautions.)

When a parenteral regimen is indicated for PID, CDC recommends a regimen of IV cefoxitin and IV or oral doxycycline or IV clindamycin and IV or IM gentamicin or, alternatively, IV ampicillin-sulbactam and IV or oral doxycycline.^{11 115}

When an oral regimen is indicated for PID, CDC recommends a regimen that consists of a single dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime given with oral doxycycline (with or without oral metronidazole).^{11 115} If a parenteral cephalosporin is not feasible, a regimen of oral levofloxacin or oral ofloxacin given with or without oral metronidazole may be considered only if the community prevalence and individual risk of gonorrhea is low.¹¹⁵

Prior to use of a fluoroquinolone for treatment of PID, tests for gonorrhea must be performed.¹¹⁵ If the nucleic acid amplification test is positive for N. gonorrhoeae, a parenteral cephalosporin is recommended.¹¹⁵ If the culture for gonorrhea is positive, treatment should be based on results of in vitro susceptibility testing.¹¹⁵ If the isolate is QRNG or in vitro susceptibility cannot be assessed, a parenteral cephalosporin is recommended.¹¹⁵

Although levofloxacin may be effective used alone against susceptible organisms, metronidazole usually is included in the PID regimen to provide coverage against anaerobes.¹¹

Plague

Alternative for treatment of plague† caused by Yersinia pestis, including naturally occurring plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.^{47 48} Regimen of choice is streptomycin (or gentamicin) with or without doxycycline;^{8 30 47 48} alternatives are doxycycline, chloramphenicol (drug of choice for plague meningitis), fluoroquinolones (e.g., ciprofloxacin, levofloxacin), or co-trimoxazole (may be less effective than other alternatives).^{8 30 47 48}

Postexposure prophylaxis† following high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism).^{47 48} Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (e.g., ciprofloxacin, levofloxacin, ofloxacin); co-trimoxazole and chloramphenicol are alternatives.^{47 48}

Travelers’ Diarrhea

Treatment of travelers’ diarrhea†^{2 27 28 29 130} caused by susceptible bacteria (e.g., enterotoxigenic E. coli, Shigella, Salmonella, Campylobacter, Vibrio parahaemolyticus).^{27 28 29} Generally self-limited and may resolve within 3–4 days without anti-infective treatment;^{8 27 29 108} if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated.^{8 27 29 108 130} Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when anti-infective treatment, including self-treatment, is indicated.^{2 27 28 29 108 130} Azithromycin is an alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment.^{8 27 29 130} Rifaximin is another alternative for treatment of travelers’ diarrhea caused by noninvasive E. coli.^{27 29 130}

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.^{2 28 29} CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;^{8 27 29 108 130} the principal preventive measures are prudent dietary practices.^{29 108 130} If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults,^{27 29 130} although the increasing incidence of quinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter) should be considered.^{27 29}

Levofloxacin Dosage and Administration

Administration

Administer orally or by slow IV infusion.¹ Do not give IM, sub-Q, intrathecally, or intraperitoneally.¹

IV route generally reserved for patients who do not tolerate or are unable to take the drug orally and for other patients in whom the IV route offers a clinical advantage.¹ If IV route used initially, switch to oral route when clinically indicated.¹

Patients receiving oral or IV levofloxacin should be well hydrated and should be instructed to drink fluids liberally to prevent formation of highly concentrated urine.¹

Oral Administration

Manufacturer states tablets may be given without regard to meals.^{1 3 5} Administer oral solution 1 hour before or 2 hours after meals.¹ (See Pharmacokinetics.)

IV Infusion

Concentrate for injection (single-use vials containing 25 mg/mL) must be diluted prior to IV infusion.¹

Premixed injection for IV infusion in 5% dextrose (containing 5 mg/mL) may be used without further dilution.¹

Concentrate for injection and premixed injection for IV infusion contain no preservatives; discard any unused portions.¹

Additives or other drugs should not be infused simultaneously through the same IV line.¹

For solution and drug compatibility information, see Compatibility under Stability.

Dilution

Dilute concentrate for injection (single-use vials containing 25 mg/mL) with a compatible IV solution prior to IV infusion to provide a solution containing 5 mg/mL.^{1 6}

Rate of Administration

Administer by IV infusion over ≥60–90 minutes depending on dosage.¹ Because of the risk of hypotension, avoid rapid IV injection or infusion.¹

Administer 250- or 500-mg doses by IV infusion over 60 minutes and 750-mg doses over 90 minutes.¹

Dosage

Dosage of oral and IV levofloxacin is identical.¹ No dosage adjustment needed when switching from IV to oral administration, or vice versa.¹

Pediatric Patients

Anthrax

Postexposure Prophylaxis Following Inhalational Exposure

Oral or IV

Children ≥6 months of age weighing >50 kg: 500 mg once daily for 60 days.¹

Children ≥6 months of age weighing <50 kg: 8 mg/kg (up to 250 mg) every 12 hours for 60 days.¹

Initiate as soon as possible following suspected or confirmed exposure to aerosolized B. anthracis.¹ Switch from IV or oral therapy may be instituted at discretion of clinician.¹

Safety of levofloxacin given for >14 days in children younger than 18 years of age has not been evaluated.¹ Manufacturer states prolonged therapy should be used only when potential benefits outweigh risks.¹ (See Pediatric Use under Cautions.)

Adults

Respiratory Tract Infections

Acute Bacterial Sinusitis

Oral or IV

500 mg once every 24 hours for 10–14 days.¹

Alternatively, 750 mg once every 24 hours for 5 days.¹

Acute Exacerbations of Chronic Bronchitis

Oral or IV

500 mg once every 24 hours for 7 days.¹

Community-acquired Pneumonia (CAP)

Oral or IV

500 mg once every 24 hours for 7–14 days.¹

Alternatively, 750 mg once every 24 hours for 5 days can be used for treatment of CAP caused by S. pneumoniae (penicillin-susceptible strains), H. influenzae, H. parainfluenzae, C. pneumoniae, or M. pneumoniae.¹

When used for empiric treatment of CAP or treatment of CAP caused by Ps. aeruginosa, IDSA and ATS recommend 750 mg once daily.³¹ IDSA and ATS state that CAP should be treated for a minimum of 5 days and patients should be afebrile for 48–72 hours before discontinuing anti-infective therapy.³¹

Nosocomial Pneumonia

Oral or IV

750 mg once every 24 hours for 7–14 days.¹

Skin and Skin Structure Infections

Uncomplicated Infections

Oral or IV

500 mg once every 24 hours for 7–10 days.¹

Complicated Infections

Oral or IV

750 mg once every 24 hours for 7–14 days.¹

Urinary Tract Infections (UTIs) and Prostatitis

Uncomplicated UTIs

Oral or IV

250 mg once every 24 hours for 3 days.¹

Complicated UTIs

Oral or IV

250 mg once every 24 hours for 10 days.¹

Alternatively, 750 mg once every 24 hours for 5 days can be used for treatment of complicated UTIs caused by E. coli, K. pneumoniae, or P. mirabilis.¹

Acute Pyelonephritis

Oral or IV

250 mg once every 24 hours for 10 days.¹

Alternatively, 750 mg once every 24 hours for 5 days can be used for treatment of acute pyelonephritis caused by E. coli, including cases with concurrent bacteremia.¹

Chronic Prostatitis

Oral or IV

500 mg once every 24 hours for 28 days.¹

Anthrax

Postexposure Prophylaxis Following Inhalational Exposure

Oral or IV

500 mg once daily.^{1 33 34} Initiate as soon as possible following suspected or confirmed exposure to aerosolized B. anthracis.¹

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,^{47 56} but prolonged postexposure prophylaxis usually required.^{33 47} A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.⁵⁶ CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend that postexposure prophylaxis in unvaccinated individuals be continued for ≥60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures).^{33 34 47 59} The US Public Health Service Advisory Committee on Immunization Practices (ACIP) and USAMRIID recommend that individuals who are partially or fully vaccinated against anthrax receive postexposure prophylaxis for ≥30 days;^{47 60} if given in conjunction with anthrax vaccine, continue prophylaxis for at least 7–14 days after the third vaccine dose.^{47 60}

Safety of levofloxacin given for >28 days has not been evaluated.¹ Manufacturer states prolonged therapy should be used only when potential benefits outweigh risks.¹

Treatment of Inhalational Anthrax†

Oral or IV

500 mg once daily³³ for ≥60 days.^{33 35 47}

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).^{33 35} Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.^{33 35 47}

Chlamydial Infections†

Urogenital Infections†

Oral

500 mg once daily for 7 days recommended by CDC and others.^{11 52}

Gonorrhea and Associated Infections†

Uncomplicated Urethral, Endocervical, or Rectal Gonorrhea†

Oral

250 mg as a single dose has been used for infections caused by susceptible Neisseria gonorrhoeae.¹¹

Because of increased prevalence of quinolone-resistant N. gonorrhoeae (QRNG), CDC no longer recommends fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis).^{52 114 115 116} (See Gonorrhea and Associated Infections under Uses.)

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea should also receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).¹¹

Disseminated Gonococcal Infections†

IV, then Oral

250 mg IV once daily has been used for initial treatment.¹¹ IV regimen is continued for 24–48 hours after improvement begins, then switched to 500 mg orally once daily to complete ≥1 week of treatment.¹¹

Because of increased prevalence of QRNG, CDC no longer recommends fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis).^{114 115 116} Use as an alternative treatment option for disseminated infections only if in vitro susceptibility can be documented by culture.¹¹⁵ (See Gonorrhea and Associated Infections under Uses.)

Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea should also receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).¹¹

Epididymitis†

Oral

500 mg once daily for 10 days recommended by CDC and others.^{11 52 115}

Should be used only when epididymitis† most likely caused by sexually transmitted enteric bacteria (e.g., Escherichia coli) or when culture or nucleic acid amplification tests are negative for N. gonorrhoeae.^{11 115}

Mycobacterial Infections†

Active Tuberculosis†

Oral or IV

0.5–1 g once daily.⁴⁰ Must be used in conjunction with other antituberculosis agents.⁴⁰

Multiple-drug regimen usually given for 12–18 months when rifampin-resistant M. tuberculosis are involved; for 18–24 months when isoniazid- and rifampin-resistant strains are involved; or for 24 months when the strain is resistant to isoniazid, rifampin, ethambutol, and/or pyrazinamide.⁴⁰

Nongonococcal Urethritis†

Oral

500 mg once daily for 7 days recommended by CDC.¹¹

Pelvic Inflammatory Disease†

Oral

500 mg once daily given for 14 days; used with or without oral metronidazole (500 mg twice daily for 14 days).^{11 52 115}

Should be used for treatment of PID only when cephalosporins are not feasible, community prevalence and individual risk of gonorrhea is low, and in vitro susceptibility has been confirmed.¹¹⁵ (See Pelvic Inflammatory Disease under Uses.)

IV

500 mg once daily; used with or without IV metronidazole (500 mg every 8 hours).^{11 52}

Should be used for treatment of PID only when cephalosporins are not feasible, community prevalence and individual risk of gonorrhea is low, and in vitro susceptibility has been confirmed.¹¹⁵ (See Pelvic Inflammatory Disease under Uses.)

Travelers’ Diarrhea†

Treatment of Travelers’ Diarrhea†

Oral

500 mg once daily for 1–3 days.^{2 27 29 130}

Prevention of Travelers’ Diarrhea†

Oral

500 mg once daily during the period of risk.^{27 28 130}

Although anti-infective prophylaxis generally is discouraged,^{27 28 29 130} some clinicians state that it can be given during the period of risk (for ≤3 weeks) beginning the day of travel and continuing for 1 or 2 days after leaving the area of risk.^{28 130}

Special Populations

Hepatic Impairment

Dosage adjustments not required.¹

Renal Impairment

Dosage adjustments required in adults with Cl_cr <50 mL/minute.¹ (See Table 1.)No dosage recommendations provided by manufacturer for pediatric patients with renal impairment.¹

Table 1. Dosage for Adults with Renal Impairment1

Usual Dosage (Clcr ≥ 50 mL/min)	Clcr (mL/min)	Dosage for Renal Impairment
250 mg	20–49	Dosage adjustment not required
250 mg	Hemodialysis or CAPD Patients	Information not available
250 mg	10–19	Uncomplicated UTIs: Dosage adjustment not required Other infections: 250 mg every 48 hours
500 mg	20–49	Initial 500-mg dose, then 250 mg once every 24 hours
500 mg	10–19	Initial 500-mg dose, then 250 mg once every 48 hours
500 mg	Hemodialysis or CAPD Patients	Initial 500-mg dose, then 250 mg once every 48 hours; supplemental doses not required after dialysis
750 mg	20–49	Initial 750-mg dose, then 750 mg once every 48 hours
750 mg	10–19	Initial 750-mg dose, then 500 mg once every 48 hours
750 mg	Hemodialysis or CAPD Patients	Initial 750-mg dose, then 500 mg once every 48 hours; supplemental doses not required after dialysis

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Levofloxacin

Contraindications

• 
  

  Known hypersensitivity to levofloxacin or other quinolones.¹

  
  

Warnings/Precautions

Warnings

Tendinopathy and Tendon Rupture

Fluoroquinolones, including levofloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups.^{1 128 129} This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.^{1 128 129} (See Geriatric Use under Cautions.)

Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.^{1 128 129} Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.¹

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair.¹ Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.¹

Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.¹

Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs.^{1 128 129} Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon; weakness or inability to use a joint).^{1 128 129} (See Advice to Patients.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones, including levofloxacin.¹ These reactions may occur with first dose.¹

Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions.¹

In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses.¹ These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.¹

Discontinue levofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.¹ Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported with fluoroquinolones, including levofloxacin¹

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually the face, neck, extensor surfaces of forearms, dorsa of hands).¹

Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear.¹³¹ Factors that contribute to susceptibility to this adverse effect during fluoroquinolone therapy include patient's skin pigmentation, frequency and duration of exposure to sun and UV light, use of protective clothing and sunscreen, concomitant use of other drugs, and dosage and duration of fluoroquinolone therapy.¹³¹

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving levofloxacin.¹ If patient needs to be outdoors, they should wear loose-fitting clothing that protects skin from sun exposure and use other sun protection measures (sunscreen).¹

Discontinue levofloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.¹

Other Warnings/Precautions

Hepatotoxicity

Severe hepatotoxicity, including acute hepatitis, has occurred and sometimes resulted in death.¹ Most cases occurred within 6–14 days of initiation of levofloxacin therapy and were not associated with hypersensitivity reactions.¹ The majority of fatal cases of hepatotoxicity were in geriatric patients ≥65 years of age.¹ (See Geriatric Use under Cautions.)

Levofloxacin should be discontinued in any patient who experiences loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin or eyes, light colored bowel movements, or dark colored urine.¹

CNS Effects

Seizures and toxic psychoses reported with fluoroquinolones, including levofloxacin.¹ Increased intracranial pressure and CNS stimulation, which may lead to tremor, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia,