Presentation and Status in Health Basket
Film Coated Tablets
5 x 400 mg
The dose of Megaxin is 400 mg (orally or as an intravenous infusion) once every 24 hours.
The duration of therapy depends on the type of infection as described in the doctor’s leaflet.
Conversion of Intravenous to Oral Dosing in Adults: Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from
intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Megaxin IV may be switched to Megaxin Tablets when clinically indicated at the discretion of the physician.
Important Administration Instructions:
With Multivalent Cations: Administer MEGAXIN Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.
With Food: MEGAXIN Tablets can be taken with or without food, drink fluids liberally.
MEGAXIN IV Solution for Infusion:
Administer by Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer MEGAXIN IV if particulate matter and/or discoloration is observed.
Discard any unused portion because the glass bottles are for single-use only.
See prescribing information for full details.
For the treatment of the following bacterial infections in patients of 18 years and older
• Respiratory infections:
– Uncomplicated Acute bacterial sinusitis (ABS)
– Acute exacerbations of chronic bronchitis (AECB)
Megaxin tablets should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
– Community acquired pneumonia, except severe cases.
Megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
• Community-acquired spontaneous and wound infections of the skin and skin structure.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with Megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
MEGAXIN IV / MEGAXIN Tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials.
MEGAXIN IV / MEGAXIN Tablets are contraindicated in case of hypersensitivity to any of the inactive ingredients.
Disabling and Potentially Irreversible Serious Adverse Reactions Including
Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects: Fluoroquinolones, including MEGAXIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting MEGAXIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue MEGAXIN IV / Tablets immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including MEGAXIN IV / Tablets, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture: Fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the
Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting moxifloxacin or as long as several months after completion of therapy. Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors 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. Discontinue MEGAXIN 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 contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. Avoid fluoroquinolones, including MEGAXIN, in patients who have a history of tendon
disorders or who have experienced tendinitis or tendon rupture.
Peripheral Neuropathy: Fluoroquinolones, including MEGAXIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including MEGAXIN IV / MEGAXIN Tablets. Symptoms may occur soon after initiation of MEGAXIN IV / MEGAXIN Tablets and may be irreversible in some patients.
Discontinue MEGAXIN IV / MEGAXIN Tablets immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation. Avoid fluoroquinolones, including MEGAXIN, in patients who have previously experienced peripheral neuropathy.
Central Nervous System Effects
Psychiatric Adverse Reactions: Fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, or paranoia; depression or suicidal thoughts or acts; anxiety, agitation, or nervousness;
confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving MEGAXIN IV / MEGAXIN Tablets, discontinue MEGAXIN IV / MEGAXIN Tablets immediately and institute appropriate measures.
Central Nervous System Adverse Reactions: Fluoroquinolones, including MEGAXIN, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri),
dizziness, and tremors. As with all fluoroquinolones, use MEGAXIN IV / MEGAXIN Tablets with caution in patients with known or suspected CNS disorders (for example, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving MEGAXIN IV / MEGAXIN Tablets, discontinue MEGAXIN IV / MEGAXIN Tablets immediately and institute appropriate measures.
Exacerbation of Myasthenia Gravis: Fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid MEGAXIN IV / MEGAXIN Tablets in patients with known history of myasthenia gravis.
Hypersensitivity Reactions: Serious anaphylactic reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including MEGAXIN IV / MEGAXIN Tablets. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Discontinue MEGAXIN IV / MEGAXIN Tablets at the first appearance of a skin rash or any other sign of hypersensitivity.
Risk of Aortic Aneurysm and Dissection: Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve Megaxin IV/ Megaxin Tablets for use only when there are no alternative antibacterial treatments available.
Blood Glucose Disturbances: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with MEGAXIN IV / MEGAXIN Tablets. In MEGAXIN IV / MEGAXIN Tablets-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, sulfonylurea) or with insulin. Severe cases of hypoglycemia resulting in coma or death have been reported. In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, discontinue MEGAXIN IV / MEGAXIN Tablets and initiate appropriate therapy immediately.
Photosensitivity/Phototoxicity: Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets, after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. MEGAXIN IV / MEGAXIN Tablets should be discontinued if phototoxicity occurs.
See prescribing information for full details.
The most common adverse drug reactions (3%) are nausea, diarrhea, headache, and dizziness.
The most common adverse reactions (>0.3%) leading to discontinuation with the 400 mg oral doses were nausea, diarrhea, dizziness, and vomiting.
The most common adverse reaction leading to discontinuation with the 400 mg intravenous dose was rash. The most common adverse reactions leading to discontinuation with the 400 mg intravenous/oral sequential dose were diarrhea, pyrexia.
See prescribing information for full details.
Antacids, Sucralfate, Multivitamins and other products containing Multivalent Cations: Fluoroquinolones, including MEGAXIN form chelates with alkaline earth and transition metal cations. Oral administration of MEGAXIN with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of MEGAXIN, resulting in systemic concentrations considerably lower than desired. Therefore, MEGAXIN Tablets should be taken at least 4 hours before or 8 hours after these agents.
Warfarin: Fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely
monitored if MEGAXIN Tablets/MEGAXIN IV is administered concomitantly with warfarin or its derivatives.
Antidiabetic Agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones, including MEGAXIN IV / MEGAXIN Tablets and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered. If a hypoglycemic reaction occurs, MEGAXIN IV / MEGAXIN Tablets should be discontinued and appropriate therapy should be initiated immediately.
Nonsteroidal Anti-Inflammatory Drugs: The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolone, including MEGAXIN IV / MEGAXIN Tablets may increase the risks of CNS stimulation and convulsions.
Drugs that Prolong QT: There is limited information available on the potential for a pharmacodynamic interaction in humans between MEGAXIN IV / MEGAXIN Tablets and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous MEGAXIN in dogs.
Therefore, MEGAXIN IV / MEGAXIN Tablets should be avoided with Class IA and Class III antiarrhythmics.
Pregnancy and Lactation
Pregnancy: There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, MEGAXIN may cause fetal harm. Moxifloxacin was not teratogenic when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.25–2.5 times of those at the human clinical dose (400 mg/day MEGAXIN). However, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed. Advise pregnant women of the potential risk to the fetus.
Lactation: It is not known if moxifloxacin is present in human milk. Based on animal studies in rats, moxifloxacin may be excreted in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MEGAXIN and any potential adverse effects on the breastfed child from MEGAXIN or from the underlying maternal condition.
See prescribing information for full details.
Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation. Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.