What is Moxifloxacin-Actavis?
Moxifloxacin-Actavis injection is used to treat bacterial infections in many different parts of the body.
Moxifloxacin-Actavis belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Moxifloxacin-Actavis will not work for colds, flu, or other virus infections.
Moxifloxacin-Actavis is to be given only by or under the direct supervision of your doctor.
Moxifloxacin-Actavis and I.V. are indicated for the treatment of adults ( ≥ 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.
* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S. pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.
Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
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-Actavis. Therapy with Moxifloxacin-Actavis may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin-Actavis and other antibacterial drugs, Moxifloxacin-Actavis should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How should I use Moxifloxacin-Actavis?
Use Moxifloxacin-Actavis as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Moxifloxacin-Actavis comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Moxifloxacin-Actavis refilled.
- Take Moxifloxacin-Actavis by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Drink plenty of liquids while taking Moxifloxacin-Actavis.
- Do not take a product that has magnesium, aluminum, calcium, zinc, iron, or sucralfate in it within 8 hours before or 4 hours after you take Moxifloxacin-Actavis. Examples of these products include antacids, multivitamins, chewable/buffered didanosine, didanosine suspension, and quinapril. Check with your doctor or pharmacist if you have a question about whether you should separate Moxifloxacin-Actavis from a certain food or product.
- Take Moxifloxacin-Actavis on a regular schedule to get the most benefit from it.
- To clear up your infection completely, take Moxifloxacin-Actavis for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Moxifloxacin-Actavis, take 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. Do not take more than 1 dose in the same day.
Ask your health care provider any questions you may have about how to use Moxifloxacin-Actavis.
Uses of Moxifloxacin-Actavis in details
Moxifloxacin-Actavis is used to treat bacterial infections of the respiratory tract, infections of female upper genital tract, abdominal infections and infections of skin and eye.
Each tablet contains Moxifloxacin-Actavis HCl 436.8 mg equivalent to Moxifloxacin-Actavis 400 mg. It also contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 4000, titanium dioxide (E171) and ferric oxide (E172) as inactive constituents.
Each 250 mL solution for infusion contain Moxifloxacin-Actavis HCl 436.8 mg equivalent to Moxifloxacin-Actavis 400 mg. It also contains sodium chloride, 1N hydrochloric acid, 2N sodium hydroxide and water for injection. The solution for infusion (250 mL) contains sodium 34 mmol.
DOSAGE AND ADMINISTRATION
The dose of Moxifloxacin-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 Moxifloxacin-Actavis I.V. may be switched to Moxifloxacin-Actavis Tablets when clinically indicated at the discretion of the physician.
Oral doses of Moxifloxacin-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).
Moxifloxacin-Actavis I.V. should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Moxifloxacin-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 Moxifloxacin-Actavis intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin-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 Moxifloxacin-Actavis I.V. with an infusion solution compatible with Moxifloxacin-Actavis I.V. as well as with other drug(s) administered via this common line.
Preparation for administration of Moxifloxacin-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.
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin-Actavis was proven: Atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.
Antacids, Minerals and Multivitamins: Concomitant ingestion of Moxifloxacin-Actavis with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin-Actavis after oral administration due to formation of chelate complexes with the multivalent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, antiretroviral drugs (eg, didanosine) and other preparations containing magnesium or aluminium, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral Moxifloxacin-Actavis dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin-Actavis. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin-Actavis uptake from the gastrointestinal tract.
Calcium Supplements: When given with high dose calcium supplements, only a slightly reduced rate of absorption was observed, while extent of absorption remained unaffected. The effect of high-dose calcium supplements on the absorption of Moxifloxacin-Actavis is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacin-Actavis on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin-Actavis does not interfere with the 1A2 subtypes of the CYP450 enzymes.
Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.
Changes in International Normalized Ratio (INR): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacin-Actavis. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin-Actavis and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Oral Contraceptives:No interaction has occured following concomitant oral administration of Moxifloxacin-Actavis with oral contraceptives.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin-Actavis.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin-Actavis treatment. Pharmacokinetics of Moxifloxacin-Actavis were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin-Actavis and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin-Actavis (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin-Actavis increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Parenteral administration of morphine with Moxifloxacin-Actavis did not reduce the oral bioavailability of Moxifloxacin-Actavis and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin-Actavis. Following single dose administration in healthy subjects, AUC was marginally increased (by approximately 4%) and peak concentrations were decreased by 10%.
Probenecid: No significant effect on apparent total body clearance and renal clearance of Moxifloxacin-Actavis was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin-Actavis 400 mg reduced the systemic availability of the drug by >80% by preventing absorption in vivo. The application of activated charcoal in the early absorption phase prevents further increase of systemic exposure in cases of overdose.
After IV drug administration, carbo medicinalis only slightly reduces systemic exposure (approximately 20%).
Food and Dairy Products: Absorption of Moxifloxacin-Actavis was not altered by food intake (including dairy products). Moxifloxacin-Actavis can be taken independent from food intake.
Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.
Moxifloxacin-Actavis side effects
Applies to Moxifloxacin-Actavis ophthalmic: ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Moxifloxacin-Actavis ophthalmic (the active ingredient contained in Moxifloxacin-Actavis). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Moxifloxacin-Actavis ophthalmic:
Incidence not known:
- Fainting or loss of consciousness
- fast or irregular breathing
- skin rash
- swelling of the eyes or eyelids
- tightness in the chest or wheezing
- trouble with breathing
Minor Side Effects
Some of the side effects that can occur with Moxifloxacin-Actavis ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
- Burning, dry, or itching eyes
- change in vision
- decreased vision
- dry eye
- excessive tearing
- eye discharge
- itching of the eye
- pain in the eye
- red, sore eyes
- redness of the eye
- swelling of the eye, eyelid, or inner lining of the eyelid
- Body aches or pain
- cough or hoarseness
- decreased hearing
- dryness or soreness of the throat
- fever or chills
- general body discomfort
- lower back or side pain
- painful or difficult urination
- rubbing or pulling of the ears (in children)
- runny nose
- sore throat
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- vomiting and diarrhea (in infants)
Hypersensitivity to other quinolones, Moxifloxacin-Actavis or any of the excipients of Moxifloxacin-Actavis.
Use in pregnancy: The safe use of Moxifloxacin-Actavis in human pregnancy has not been established. Reversible joint injuries are described in children receiving some quinolones. However, this effect has not been reported as occurring on exposed foetuses. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.
Consequently, the use of Moxifloxacin-Actavis during pregnancy is contraindicated.
Use in lactation: As with other quinolones, Moxifloxacin-Actavis has been shown to cause lesions in the cartilage of the weight bearing joints of immature animals. Preclinical evidence indicates that small amounts of Moxifloxacin-Actavis may be secreted in human milk. There is no data available in lactating or nursing women. Therefore, the use of Moxifloxacin-Actavis in nursing mothers is contraindicated.
Use in children: Safety and efficacy of Moxifloxacin-Actavis in children and adolescents have not been established.
Active ingredient matches for Moxifloxacin-Actavis:
Moxifloxacin in Denmark, Germany, Switzerland.
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ReviewsThe results of a survey conducted on ndrugs.com for Moxifloxacin-Actavis are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Moxifloxacin-Actavis. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Information checked by Dr. Sachin Kumar, MD Pharmacology