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Levid

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Last Updated: 30 October 2020

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Levid

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01 May 2021summer dmn levid

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Levid indications

Levid Tablets, USP indicate for inhalational anthrax to reduce incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Effectiveness of Levid Tablets, USP is based on plasma concentrations achieved in humans, surrogate endpoint reasonably likely to predict clinical benefit. Levid has not been tested in humans for post-exposure prevention of inhalation anthrax. The Safety of Levid in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been study. Prolong Levid therapy should only be used when benefit outweighs risk.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

How should I use Levid?

No significant effect of Levid on peak plasma concentrations, AUC, and other disposition parameters for R-and S-warfarin was detected in clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on Levid absorption and disposition was observe. However, there have been reports during postmarketing experience in patients that Levid enhances the effects of warfarin. Elevations of prothrombin time in the setting of concurrent warfarin and Levid use have been associated with episodes of bleeding. Prothrombin time, International normalize Ratio, or other suitable anticoagulation tests should be closely monitored if Levid is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levid dosage

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Because only limited data is available on compatibility of Levid Injection with other intravenous substances, additives or other medications should not be added to Levid Injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, line should be flush before and after infusion of Levid Injection with infusion solution compatible with Levid Injection and with any other drug administered via this common line. Levid Injection is supplied in single-use vials containing concentrate Levid solution with equivalent of 500 mg and 750 mg of Levid in Water for Injection, USP. 20 mL and 30 mL vials each contain 25 mg of Levid / mL. These Levid Injection single-use vials must be further diluted with appropriate solution prior to intravenous administration. Concentration of the resulting diluted solution should be 5 mg / mL prior to administration. Intravenous Solutions: Any of the following intravenous Solutions may be used to prepare a 5 mg / mL Levid solution with approximate pH values: since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since vials are for single-use only, any unused portion remaining in the vial should be discard. When used to prepare two 250 mg doses from 20 mL vial containing 500 mg of Levid, full content of vial should be withdrawn at once using single-entry procedure, and the second dose should be prepared and stored for subsequent use. Prepare desired dosage of Levid according to Table 5: for example, to prepare a 500 mg dose using a 20 mL vial, withdraw 20 mL and dilute with compatible intravenous solution to a total volume of 100 mL. This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discard. Stability of Levid Injection Following Dilution: Levid Injection, when diluted in compatible intravenous fluid to a concentration of 5 mg / mL, is stable for 72 hours when stored at or below 25C and for 14 days when stored under refrigeration at 5C in plastic intravenous containers. Solutions that are diluted in compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at-20C. Thaw frozen solutions at room temperature 25C or in a refrigerator 8C. Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.


Interactions

No significant effect of Levid on plasma concentrations, AUC, and other disposition parameters for theophylline was detected in clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on Levid absorption and disposition was observe. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and subsequent increase in risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when Levid is co-administer. Adverse reactions, including seizures, may occur with or without elevation in serum theophylline levels.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levid interactions

The usual dose of Levid Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance 50 mL / min. For patients with creatinine clearance < 50 mL / min, adjustments to dosing regimen are require. Table 1: Dosage in Adult Patients with Normal Renal Function Dosage in Pediatric Patients 6 months of age is described below in Table 2. Table 2: Dosage in Pediatric Patients 6 months of age sequential therapy may be instituted at the discretion of the physician. Drug administration should begin as soon as possible after suspect or confirm exposure to aerosolize B. Anthracis. This indication is based on surrogate endpoint. Levid plasma concentrations achieved in humans are reasonably likely to predict clinical benefit safety of Levid in Pediatric Patients for durations of therapy beyond 14 days has not been study. An increased incidence of musculoskeletal adverse events compared to controls has been observed in Pediatric Patients. Prolong Levid therapy should only be used when benefit outweighs risk. Drug administration should begin as soon as possible after suspect or confirmed exposure to Yersinia pestis. Administer Levid Injection with caution in presence of Renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of Levid may be reduce. No adjustment is necessary for patients with creatinine clearance 50 mL / min. In patients with impaired Renal Function, adjustment of the Dosage regimen is necessary to avoid accumulation of Levid due to decreased clearance. Table 3 shows how to adjust dose based on creatinine clearance. Levid Injection should not be coadministered with any solution containing multivalent cations, eg, magnesium, through the same intravenous line. Adequate hydration of patients receiving intravenous Levid Injection should be maintained to prevent formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Because only limited data is available on compatibility of Levid Injection with other intravenous substances, additives or other medications should not be added to Levid Injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, line should be flush before and after infusion of Levid Injection with infusion solution compatible with Levid Injection and with any other drug administered via this common line. Levid Injection is supplied in single-use vials containing concentrate Levid solution with equivalent of 500 mg and 750 mg of Levid in Water for Injection, USP. 20 mL and 30 mL vials each contain 25 mg of Levid / mL. These Levid Injection single-use vials must be further diluted with appropriate solution prior to intravenous administration.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Levid contraindications

Following Serious and otherwise important adverse Drug Reactions are discussed in greater detail in other sections of labeling: tendon Effects Exacerbation of Myasthenia Gravis Hypersensitivity Reactions Other Serious and Sometimes Fatal Reactions Hepatotoxicity Central Nervous System Effects Clostridium difficile-associate Diarrhea Peripheral Neuropathy that may be irreversible Prolongation of QT Interval Musculoskeletal Disorders in Pediatric Patients Blood Glucose Disturbances Photosensitivity / Phototoxicity [See Development of Drug Resistant Bacteria hypotension has been associate with rapid or bolus intravenous infusion of Levid. Levid should be infused slowly over 60 to 90 minutes, depending on dosage. Crystalluria and cylindruria have been reported with quinolones, including Levid. Therefore, adequate hydration of patients receiving Levid should be maintained to prevent formation of highly concentrated urine. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared to rates in clinical trials of another drug and may not reflect rates observed in practice. Data described below reflect exposure to Levid in 7537 patients in 29 pooled Phase 3 clinical trials. Population study had a mean age of 50 years, 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Levid for a wide variety of infectious diseases. Patients receive Levid doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days. Overall incidence, type and distribution of adverse reactions was similar in patients receiving Levid doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levid due to adverse Drug Reactions occurs in 4. 3% of Patients overall, 3. 8% of patients were treated with 250 mg and 500 mg doses and 5. 4% of patients were treated with a 750 mg dose. The most common adverse drug reactions leading to discontinuation with 250 and 500 mg doses were gastrointestinal, primarily nausea; vomiting; dizziness; and headache. The most common adverse drug reactions leading to discontinuation with 750 mg dose were gastrointestinal, primarily nausea, vomiting; dizziness; and headache. Adverse Reactions occurred in 1% of Levid-treated Patients and less common adverse reactions, occurring in 0. 1 to < 1% of Levid-treated Patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions are nausea, headache, Diarrhea, insomnia, constipation, and dizziness. In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including Levid. The relationship of drugs to these events is not presently establish. Table 8 lists adverse reactions that have been identified during post-approval use of Levid. Because these reactions are reported voluntarily from population of uncertain size, reliably estimating their frequency or establishing causal relationship to drug exposure is not always possible.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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