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BAXDELA is a brand name for Delafloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ). Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Aerobic bacteria Gram-positive bacteria Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates) Staphylococcus haemolyticus Staphylococcus lugdunensis Streptococcus pyogenes Streptococcus agalactiae Streptococcus…
Verbatim from this product's HC label. Tap a section to expand.
3 Reconstitution). 9% Sodium Chloride Injection has not been established. 9% Sodium Chloride Injection or D5W. 5 Missed Dose BAXDELA Tablets If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose.
If less than 8 hours remain before the next dose, wait until their next scheduled dose. BAXDELA / Delafloxacin Product Monograph Page 10 of 60 5. OVERDOSAGE Treatment of overdose with BAXDELA should consist of observation and general supportive measures.
Hemodialysis removed about 19% of delafloxacin and 56% of SBECD (Sulfobutylether-β-cyclodextrin) after intravenous administration of BAXDELA (see 10 CLINICAL PHARMACOLOGY). For management of a suspected drug overdose, contact your regional poison control centre.
6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 5 – Dosage Forms, Strengths, Composition and Packaging Formulation Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients BAXDELA, Powder for solution Intravenous infusion Powder for solution, 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine) in a single-dose vial Edetate disodium (EDTA); meglumine; sulfobutylether-β- cyclodextrin.
Sodium hydroxide and/or hydrochloric acid may have been used to adjust the pH. BAXDELA, Tablet Oral Tablet, 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine). Citric acid anhydrous; crospovidone; magnesium stearate; microcrystalline cellulose; povidone; sodium bicarbonate; sodium phosphate monobasic monohydrate.
BAXDELA for Injection A sterile, lyophilized powder containing 300 mg delafloxacin (equivalent to 433 mg delafloxacin meglumine) in a single-dose vial, which must be reconstituted and further diluted prior to intravenous infusion. The lyophilized powder is a light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and colour.
BAXDELA for Injection is supplied with 10 single dose vials per carton. The vials are clear colorless tubular type I injection glass (20R), closed with a rubber stopper colour gray and sealed with a 20 mm aluminum with polypropylene dark gray flip cap.
BAXDELA / Delafloxacin Product Monograph Page 11 of 60 BAXDELA Tablets Modified capsule shaped tablets in beige to mottled beige color with RX3341 debossed on one side containing 450 mg delafloxacin (equivalent to 649 mg delafloxacin meglumine).
). Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including BAXDELA. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated since surgical intervention may be required in certain severe cases (see 8 ADVERSE REACTIONS).
Hematologic Patients with Glucose-6-phosphate Dehydrogenase Deficiency Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to hemolytic reactions when treated with quinolone antibacterial agents.
Therefore, if BAXDELA has to be used in these patients, potential occurrence of hemolysis should be monitored. Immune Hypersensitivity Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving systemic therapy with quinolones, including delafloxacin.
4 Geriatrics). BAXDELA / Delafloxacin Product Monograph Page 5 of 60 2. CONTRAINDICATIONS BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin, to any of the fluoroquinolone class of antibacterial drugs, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 7 WARNINGS AND PRECAUTIONS. 3. SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including tendonitis, tendon rupture, peripheral neuropathy and Central Nervous System (CNS) effects.
Discontinue BAXDELA immediately at the first signs of any serious adverse reaction or avoid using it if you experienced any of these reactions with other fluoroquinolones. • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see 7 WARNINGS AND PRECAUTIONS).
• Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid using BAXDELA in patients with a known history of myasthenia gravis (see 7 WARNINGS AND PRECAUTIONS). • Fluoroquinolones, including BAXDELA, have been associated with an increased risk of psychiatric adverse reactions.
These adverse reactions may occur following the first dose (see 7 WARNINGS AND PRECAUTIONS). • Serious hypersensitivity and/or anaphylactic reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy including BAXDELA (see 7 WARNINGS AND PRECAUTIONS).
• Clostridium difficile-associated disease (CDAD) has been reported with the use of many antibacterial agents, including BAXDELA. CDAD may range in severity from mild diarrhea to fatal colitis (see 7 WARNINGS AND PRECAUTIONS). • Fluoroquinolones have been associated with an increased risk of convulsions, increased intracranial pressure, dizziness, and tremors.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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BAXDELA Tablets is supplied in a white high-density polyethylene (HDPE) bottle. The bottle is heat- induction sealed and closed with a child resistant HDPE screw cap. Each bottle contains 20 tablets. 7. WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
Cardiovascular Aortic Aneurysm and Aortic Dissection Epidemiologic studies report an increased risk of aortic aneurysm and aortic dissection after intake of fluoroquinolones, particularly in the older population. , Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, atherosclerosis).
In case of sudden severe abdominal, chest or back pain, patients should be advised to immediately consult a health professional in an emergency department. , fatigue, asthenia, visual disturbances, dizziness, convulsions) may impair a patient’s ability to concentrate and react.
Therefore, patients should know how they react to BAXDELA before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Patients who experience such symptoms should be advised not to drive or use machines.
Patients need to notify their physician if a persistent headache with or without blurred vision occurs. , glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of BAXDELA / Delafloxacin Product Monograph Page 12 of 60 hypoglycemia resulting in coma or death have been reported with other fluoroquinolones.
If a hypoglycemic reaction occurs in a patient being treated with BAXDELA, discontinue BAXDELA immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS). Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including BAXDELA.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to […]
These reactions often occurred following the first dose. Some reactions have be en accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute re spiratory distress), dyspnea, BAXDELA / Delafloxacin Product Monograph Page 13 of 60 urticaria, itching, and other serious skin reactions.
Delafloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor, amines and airway management, as clinically indicated (see 8 ADVERSE REACTIONS).
Serious and sometimes fatal events, some due to hypersensitivity and some due to uncertain etiology, have rarely been reported in patients receiving systemic therapy with quinolones. These events may be severe, and generally occur following the administration of multiple doses.
, toxic epidermal necrolysis, Stevens-Johnson syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis, including acute hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The administration of BAXDELA should be discontinued immediately, at the first appearance of a skin rash or any other sign of hypersensitivity, and supportive measures instituted. Musculoskeletal Tendinitis and Tendon Rupture Rupture of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones.
BAXDELA should be discontinued if the patient experiences pain, inflammation or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over age 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplants.
Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Tendon rupture can occur during (within hours to weeks) or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. BAXDELA should be discontinued immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to promptly contact their health professional regarding changing to a non-quinolone antimicrobial drug. BAXDELA should not be used in patients with a history of tendon disease/disorder related to previously quinolone treatment.
Myasthenia Gravis Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness BAXDELA / Delafloxacin Product Monograph Page 14 of 60 in persons with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with […]
Use BAXDELA when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (see 7 WARNINGS AND PRECAUTIONS). BAXDELA / Delafloxacin Product Monograph Page 6 of 60 4. 4 Drug-Drug Interactions). 3 Pharmacokinetics).
4 Drug-Drug Interactions). Do NOT co-infuse BAXDELA for Injection with other medications. 2 Recommended Dose and Dosage Adjustment For treatment of adults with ABSSSI or CABP, the recommended dosage regimen of BAXDELA is described in Table 1 below.
Table 1 – Dosage of BAXDELA in Adult ABSSSI or CABP Patients Infection Dosage and Route of Administration Total Duration (days) ABSSSI 300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion Or 300 mg of BAXDELA for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg BAXDELA tablet orally every 12 hours at the discretion of the physician Or 450 mg BAXDELA tablet orally every 12 hours.
5 to 14 CABP 5 to 10 Health Canada has not authorized an indication for pediatric use. BAXDELA / Delafloxacin Product Monograph Page 7 of 60 Dosage in Patients with Renal Impairment Table 2 below describes the dosage modification based on the estimated glomerular filtration rate (eGFR) that is recommended in patients with renal impairment.
73 m2). BAXDELA is not recommended for patients with end stage renal disease (ESRD). 73 m2) renal impairment, accumulation of the intravenous vehicle sulfobutylether-β-cyclodextrin (SBECD) occurs; therefore, serum creatinine levels should be closely monitored in these patients receiving intravenous BAXDELA.
If serum creatinine level increases occur, consideration should be given to changing to oral BAXDELA. 73 m2, BAXDELA should be discontinued. 73 m2) are limited. Adult patients with severe renal impairment demonstrated elevated serum level of delafloxacin; therefore, these patients should be closely monitored during treatment with oral BAXDELA.
73 m2)a Recommended Dosage Regimenc BAXDELA Tablets BAXDELA for Injectionb 30-89 No dosage adjustment No dosage adjustment 15-29 No dosage adjustment 200 mg intravenously every 12 hours Or 200 mg intravenously every 12 hours, then switch to a 450 mg BAXDELA tablet orally every 12 hours at the discretion of the physician End stage renal disease (ESRD) (<15), including patients on hemodialysis (HD) Not Recommendedd a.
212 if African American). b. All doses of BAXDELA are administered by intravenous infusion over 60 minutes. c. For a total treatment duration of 5 to 14 […]