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What is Moxifloxacin Holsten?
Moxifloxacin Holsten is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.
Moxifloxacin Holsten ophthalmic (for use in the eyes) is used to treat bacterial infections of the eyes.
Moxifloxacin Holsten will not treat a viral or fungal infection of the eye. This medicine is for use in treating only bacterial infections.
Moxifloxacin Holsten ophthalmic may also be used for purposes not listed in this medication guide.
Moxifloxacin Holsten indications
Community Acquired Pneumonia
Moxifloxacin Holsten is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumonia .
MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Uncomplicated Skin And Skin Structure Infections
Moxifloxacin Holsten is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
Complicated Skin And Skin Structure Infections
Moxifloxacin Holsten is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
Complicated Intra-Abdominal Infections
Moxifloxacin Holsten is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.
Moxifloxacin Holsten is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of Moxifloxacin Holsten could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.
Acute Bacterial Sinusitis
Moxifloxacin Holsten is indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Holsten, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacin Holsten for treatment of ABS in patients who have no alternative treatment options.
Acute Bacterial Exacerbation Of Chronic Bronchitis
Moxifloxacin Holsten is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.
Because fluoroquinolones, including Moxifloxacin Holsten, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacin Holsten for treatment of ABECB in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Holsten and other antibacterial drugs, Moxifloxacin Holsten 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 Holsten?
Use Moxifloxacin Holsten tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Moxifloxacin Holsten tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Moxifloxacin Holsten tablets refilled.
- Take Moxifloxacin Holsten tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Drink plenty of liquids while taking Moxifloxacin Holsten tablets.
- 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 Holsten tablets. 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 Holsten tablets from a certain food or product.
- Take Moxifloxacin Holsten tablets on a regular schedule to get the most benefit from it.
- To clear up your infection completely, take Moxifloxacin Holsten tablets 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 Holsten tablets, 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 Holsten tablets.
Uses of Moxifloxacin Holsten in details
Moxifloxacin Holsten is used to treat bacterial infections of the respiratory tract, infections of female upper genital tract, abdominal infections and infections of skin and eye.
Moxifloxacin Holsten description
Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacin Holsten 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 Holsten HCl 436.8 mg equivalent to Moxifloxacin Holsten 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.
Moxifloxacin Holsten dosage
Dosage In Adult Patients
The dose of Moxifloxacin Holsten 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 Table 1.
Table 1: Dosage and Duration of Therapy in Adult Patients
|Type of InfectionDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.|
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 Moxifloxacin Holsten Injection may be switched to Moxifloxacin Holsten Tablets when clinically indicated at the discretion of the physician.
Important Administration Instructions
Moxifloxacin Holsten Tablets
With Multivalent Cations
Administer Moxifloxacin Holsten 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.
Moxifloxacin Holsten Tablets can be taken with or without food, drink fluids liberally.
Moxifloxacin Holsten Injection
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.
Discard any unused portion because the premix flexible containers are for single-use only.
Drug and Diluent Compatibilities
Because only limited data are available on the compatibility of Moxifloxacin Holsten intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin Holsten Injection 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 Holsten Injection with an infusion solution compatible with Moxifloxacin Holsten Injection as well as with other drug(s) administered via this common line.
Intravenous Solutions:Moxifloxacin Holsten Injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:
0.9% Sodium Chloride Injection, USP
1 Molar Sodium Chloride Injection
5% Dextrose Injection, USP
Sterile Water for Injection, USP
10% Dextrose for Injection, USP
Moxifloxacin Holsten interactions
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin Holsten 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 Holsten with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin Holsten 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 Holsten dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin Holsten. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin Holsten 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 Holsten is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacin Holsten on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin Holsten 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 Holsten. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin Holsten 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 Holsten with oral contraceptives.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin Holsten.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin Holsten treatment. Pharmacokinetics of Moxifloxacin Holsten were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin Holsten and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin Holsten (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin Holsten increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Parenteral administration of morphine with Moxifloxacin Holsten did not reduce the oral bioavailability of Moxifloxacin Holsten and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin Holsten. 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 Holsten was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin Holsten 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 Holsten was not altered by food intake (including dairy products). Moxifloxacin Holsten can be taken independent from food intake.
Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.
Moxifloxacin Holsten side effects
Applies to Moxifloxacin Holsten ophthalmic: ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Moxifloxacin Holsten ophthalmic (the active ingredient contained in Moxifloxacin Holsten). 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 Holsten 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 Holsten 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)
Moxifloxacin Holsten contraindications
You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacin Holsten or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.
Before taking Moxifloxacin Holsten, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, a history of seizures, low levels of potassium in your blood (hypokalemia), muscle weakness or trouble breathing, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.
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 Moxifloxacin Holsten. These other medicines can make Moxifloxacin Holsten much less effective when taken at the same time.
Taking Moxifloxacin Holsten can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.
Moxifloxacin Holsten 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 steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Moxifloxacin Holsten 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.
Active ingredient matches for Moxifloxacin Holsten:
Moxifloxacin in Germany.
- PubChem. "moxifloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- 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).
ReviewsThe results of a survey conducted on ndrugs.com for Moxifloxacin Holsten 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 Holsten. 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.
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Information checked by Dr. Sachin Kumar, MD Pharmacology