How do you administer this medicine?
What happens if I overdose Moxifloxacino Actavis?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Moxifloxacino Actavis tablets:
Store Moxifloxacino Actavis tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Do not store in the bathroom. Keep Moxifloxacino Actavis tablets out of the reach of children and away from pets.
Overdose of Moxifloxacino Actavis in details
Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. ECG monitoring is recommended due to the possibility of QT interval prolongation. The patient should be carefully observed and given supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic Moxifloxacino Actavis exposure. About 3% and 9% of the dose of Moxifloxacino Actavis, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.
Single oral Moxifloxacino Actavis doses of 2000, 500, and 1500 mg/kg were lethal to rats, mice, and cynomolgus monkeys, respectively. The minimum lethal intravenous dose in mice and rats was 100 mg/kg. Toxic signs after administration of a single high dose of Moxifloxacino Actavis to these animals included CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting and diarrhea.
DOSAGE AND ADMINISTRATION
The dose of Moxifloxacino Actavis 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 below.
For Complicated Intra-Abdominal Infections, therapy should usually be initiated with the intravenous formulation.
When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacino Actavis I.V. may be switched to Moxifloxacino Actavis Tablets when clinically indicated at the discretion of the physician.
Oral doses of Moxifloxacino Actavis should be administered at least 4 hours before or 8 hours after antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution.
Impaired Renal Function
No dosage adjustment is required in renally impaired patients, including those on either hemodialysis or continuous ambulatory peritoneal dialysis.
Impaired Hepatic Function
No dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).
Moxifloxacino Actavis I.V. should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Moxifloxacino Actavis I.V. should be administered 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. CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION MUST BE AVOIDED.
Since only limited data are available on the compatibility of Moxifloxacino Actavis intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacino Actavis I.V. or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of Moxifloxacino Actavis I.V. with an infusion solution compatible with Moxifloxacino Actavis I.V. as well as with other drug(s) administered via this common line.
Preparation for administration of Moxifloxacino Actavis I.V. injection premix in flexible containers:
- Close flow control clamp of administration set.
- Remove cover from port at bottom of container.
- Insert piercing pin from an appropriate transfer set (e.g. one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.
NOTE: Refer to complete directions that have been provided with the administration set.
What should I avoid while taking Moxifloxacino Actavis?
Do not take Moxifloxacino Actavis with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking Moxifloxacino Actavis. They could make the medication less effective.
You may be taking certain other medicines that should not be taken at the same time as Moxifloxacino Actavis. Avoid taking the following medicines within 8 hours before or 4 hours after you take Moxifloxacino Actavis. These other medicines can make Moxifloxacino Actavis much less effective when taken at the same time:
antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);
didanosine (Videx) powder or chewable tablets; or
vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.
Moxifloxacino Actavis may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Avoid exposure to sunlight or tanning beds. Moxifloxacino Actavis can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Moxifloxacino Actavis warnings
You should not use this medication if you are allergic to Moxifloxacino Actavis or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.
Before taking Moxifloxacino Actavis, tell your doctor if you have kidney or liver disease, myasthenia gravis, joint problems, diabetes, a history of seizures, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."
Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take Moxifloxacino Actavis. These other medicines can make Moxifloxacino Actavis much less effective when taken at the same time.
Taking Moxifloxacino Actavis can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.
Moxifloxacino Actavis may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles’ tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Moxifloxacino Actavis and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you do.
FDA pregnancy category C: It is not known whether Moxifloxacino Actavis is harmful to an unborn baby. Do not use Moxifloxacino Actavis without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Moxifloxacino Actavis passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
Moxifloxacino Actavis can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What should I discuss with my healthcare provider before taking Moxifloxacino Actavis?
Some medical conditions may interact with Moxifloxacino Actavis tablets. 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 a stomach infection, liver problems, brain or nervous system problems, increased pressure in the brain, Alzheimer disease, or brain blood vessel problems
- if you have a history of severe or persistent diarrhea, diabetes or high blood sugar, low blood sugar, seizures, skin sensitivity to the sun, low blood potassium levels, irregular heartbeat (eg, QT prolongation) or other heart problems (eg, fast or slow heartbeat, angina, heart failure), or heart attack, or if you have a family member with a history of irregular heartbeat (QT prolongation)
- if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant
- if you participate in strenuous physical work or exercise
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Some MEDICINES MAY INTERACT with Moxifloxacino Actavis tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased
- Antiarrhythmics (eg, amiodarone, dofetilide, dronedarone, procainamide, quinidine, sotalol), cisapride, diuretics (eg, furosemide, hydrochlorothiazide), erythromycin, medicines to help mental or mood problems, or tricyclic antidepressants (eg, amitriptyline) because the risk of severe and possibly fatal irregular heartbeat may be increased
- Insulin or oral diabetes medicines (eg, glyburide) because the risk of high or low blood sugar may be increased
- Warfarin because the risk of bleeding may be increased by Moxifloxacino Actavis tablets
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, ketorolac) because they may increase the risk of Moxifloxacino Actavis tablets's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Moxifloxacino Actavis tablets 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.
Moxifloxacino Actavis precautions
In some instances, the hypersensitivity and allergic reactions already occurred after the 1st administration and the doctor should be informed immediately.
Anaphylactic reactions in very rare instances can progress to a life-threatening shock, in some instances after the 1st administration. In these cases Moxifloxacino Actavis has to be discontinued, medical treatment (eg, treatment for shock) is required.
Moxifloxacino Actavis has been shown to prolong the QT interval of the ECG in some patients. It should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalaemia and patients receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.
An additive effect of Moxifloxacino Actavis and drugs that prolong the QT interval eg, cisapride, erythromycin, antipsychotics and tricyclic antidepressants cannot be excluded. Therefore, Moxifloxacino Actavis should be used with caution when given concurrently with these drugs.
Moxifloxacino Actavis should be used with caution in patients with ongoing pro-arrhythmic conditions eg, clinically significant bradycardia, acute myocardial ischemia.
As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose should not be exceeded. However, in patients suffering from pneumonia, no correlation between plasma concentrations of Moxifloxacino Actavis and QTc prolongation was observed. QT prolongation may lead to an increased risk for ventricular arrhythmias including Torsade de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Moxifloxacino Actavis treatment in clinical studies with >9000 patients, however certain predisposing conditions may increase the risk for ventricular arrhythmias.
Seizures may occur with quinolone therapy. Moxifloxacino Actavis should be used with caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold.
Due to limited clinical data, the use of Moxifloxacino Actavis is not recommended in patients with severe hepatic impairment (Child-Pugh C).
Antibiotic-associated colitis has been reported with the use of broad-spectrum antibiotics including Moxifloxacino Actavis, therefore, it is important to consider this diagnosis in patients who develop serious diarrhoea in association with the use of Moxifloxacino Actavis. In this clinical situation, adequate therapeutic measures should be initiated immediately.
Tendon inflammation and rupture may occur with quinolone therapy including Moxifloxacino Actavis, particularly in elderly patients and in those treated concurrently with corticosteroids. At the 1st sign of pain or inflammation, patients should discontinue treatment and rest the affected limbs.
Quinolones have been shown to cause photosensitivity reactions in patients. However, in specially designed preclinical and clinical studies, photosensitivity has not been observed with Moxifloxacino Actavis. In addition, since first marketed, there has been no clinical evidence that Moxifloxacino Actavis causes photosensitivity reactions. Nevertheless, patients should be advised to avoid extensive exposure to either ultraviolet irradiation or sunlight.
For patients with complicated pelvic inflammatory disease (eg, associated with a tubo-ovarian or pelvic abscess), for whom an IV treatment is considered necessary, treatment with Moxifloxacino Actavis 400 mg tablets is not recommended.
Effect on the Ability to Drive or Operate Machinery: In clinical trials, a low incidence of CNS reactions was observed. However, patients should be cautioned to see how they react before driving or operating machinery.
What happens if I miss a dose of Moxifloxacino Actavis?
Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of Moxifloxacino Actavis.
- DrugBank. "moxifloxacin". http://www.drugbank.ca/drugs/DB00218 (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- FDA Medication Guides. "Avelox: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.accessdata.fda.gov/drugs... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology