Moxifloxacin

Brands of Moxifloxacin in Kenya

Avelon, Bayer Pharma AG
Avelox, Bayer Pharma AG
Floxsafe, MSN Laboratories Private Limited.
M-Flox , Hetero Labs Limited
Mahaflox , Mankind Pharma Ltd
Maxim , Jamjoom Pharmaceuticals Company Limited
Micromox, Micro Labs Limited India
Milflox, Sun Pharmaceutical Industries Limited
Molox , CCL Pharma (pvt) Ltd
Moxaf , Guilin Pharmaceutical (Shanghai) Co. Ltd.
Moxi-Bio , Sava Healthcare Ltd
Moxidoc, Medisel Kenya Ltd.
Moxiget, Getz Pharma (Pvt) Limited
Moxima , Stallion Laboratories Pvt Ltd
Moximac, Macleods Pharmaceuticals Limited
Moxicip, Cipla
Moxeque , Questa Care Inc
Plenmoxi , Unosource Pharma Ltd
Zeebact , Zest Pharma


Moxifloxacin in Kenya : Price, Brand names, Cost in Kenya
Moxifloxacin Chemical Structure

INDICATIONS:

Acute bacterial sinusitis

– Acute exacerbation of chronic obstructive pulmonary disease including bronchitis

In the following indications, Moxifloxacin should be used 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:

– Community acquired pneumonia, except severe cases

– Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.

Moxifloxacin are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae  unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. 

 Moxifloxacin may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications:

– Community-acquired pneumonia

– Complicated skin and skin structure infections

 Moxifloxacin should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

CONTRAINDICATIONS:

Known hypersensitivity to moxifloxacin or other quinolones.

Pregnancy and lactation.

– Patients below 18 years of age.

– Patients with a history of tendon disease/disorder related to quinolone treatment.

Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with:

– Congenital or documented acquired QT prolongation

– Electrolyte disturbances, particularly in uncorrected hypokalaemia

– Clinically relevant bradycardia

– Clinically relevant heart failure with reduced left-ventricular ejection fraction left-ventricular ejection fraction

– Previous history of symptomatic arrhythmias

Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval .

Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.

DRUG INTERACTIONS

An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore, co-administration of moxifloxacin with any of the following medicinal products is contraindicated :

– anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)

– anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)

– antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)

– tricyclic antidepressive agents

– certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)

– certain antihistaminics (terfenadine, astemizole, mizolastine)

– others (cisapride, vincamine IV, bepridil, diphemanil).

Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels (e.g. loop and thiazide-type diuretics, laxatives and enemas [high doses], corticosteroids, amphotericin B) or medication that is associated with clinically significant bradycardia.

An interval of about 6 hours should be left between administration of agents containing bivalent or trivalent cations (e.g. antacids containing magnesium or aluminium, didanosine tablets, sucralfate and agents containing iron or zinc) and administration of moxifloxacin.

Concomitant administration of charcoal with an oral dose of 400 mg moxifloxacin led to a pronounced prevention of drug absorption and a reduced systemic availability of the drug by more than 80%. Therefore, the concomitant use of these two drugs is not recommended (except for overdose cases) 

After repeated dosing in healthy volunteers, moxifloxacin increased Cmax of digoxin by approximately 30% without affecting AUC or trough levels. No precaution is required for use with digoxin.

After repeated dosing in healthy volunteers, moxifloxacin increased Cmax of digoxin by approximately 30% without affecting AUC or trough levels. No precaution is required for use with digoxin.

In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide. The combination of glibenclamide and moxifloxacin could theoretically result in a mild and transient hyperglycaemia. However, the observed pharmacokinetic changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin). Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.

Changes in INR

A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins. The infectious and inflammatory conditions, age and general status of the patient appear to be risk factors. Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio) disorder. A precautionary measure would be to more frequently monitor the INR. If necessary, the oral anticoagulant dosage should be adjusted as appropriate.

Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline, cyclosporine or itraconazole.

In vitro studies with human cytochrome P450 enzymes supported these findings. Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.

Interaction with food

Moxifloxacin has no clinically relevant interaction with food including dairy products.

ADVERSE EFFECTS 

 

System Organ Class (MedDRA)

Common

Uncommon

Rare

Very Rare

Not known

Infections and infestationsSuperinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
Blood and lymphatic system disordersAnaemia

Leucopenia(s)

Neutropenia

Thrombocytopenia

Thrombocythemia

Blood eosinophilia

Prothrombin time prolonged/INR increased

Prothrombin level increased/INR decreased

Agranulocytosis

Pancytopenia

Immune system disordersAllergic reactionAnaphylaxis incl. very rarely life-threatening shock

Allergic oedema / angiooedema (incl. laryngeal oedema, potentially life-threatening

Endocrine disordersSyndrome of inappropriate antidiuretic hormone secretion (SIADH)
Metabolism and nutrition disordersHyperlipidemiaHyperglycemia

Hyperuricemia

Hypoglycemia

Hypoglycaemic coma

Psychiatric disorders*Anxiety reactions

Psychomotor hyperactivity/ agitation

Emotional lability

Depression (in very rare cases potentially culminating in self-injurious behaviour, such as suicidal ideations/ thoughts, or suicide attempts

Hallucination

Delirium

Depersonalization

Psychotic reactions (potentially culminating in self- injurious behaviour, such as suicidal ideations/ thoughts, or suicide attempts,

Nervous system disorders*Headache

Dizziness

Par- and Dysaesthesia

Taste disorders (incl. ageusia in very rare cases)

Confusion and disorientation

Sleep disorders (predominantly insomnia)

Tremor

Vertigo

Somnolence

Hypoaesthesia

Smell disorders (incl. anosmia)

Abnormal dreams

Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo)

Seizures incl. grand mal convulsions

Disturbed attention

Speech disorders

Amnesia

Peripheral neuropathy and polyneuropathy

Hyperaesthesia
Eye disorders*Visual disturbances incl. diplopia and blurred vision (especially in the course of CNS reactions,PhotophobiaTransient loss of vision (especially in the course of CNS reactions,

Uveitis and bilateral acute iris transillumination

Ear and labyrinth disorders*Tinnitus

Hearing impairment incl. deafness (usually reversible)

Cardiac disordersQT prolongation in patients with hypokalaemiaQT prolongation (see section 4.4)

Palpitations

Tachycardia

Atrial fibrillation

Angina pectoris

Ventricular tachyarrhythmias

Syncope (i.e., acute and short lasting loss of consciousness)

Unspecified arrhythmias

Torsade de Pointes (see

Vascular disordersVasodilatationHypertension

Hypotension

Vasculitis
Respiratory, thoracic and mediastinal disordersDyspnea (including asthmatic conditions)
Gastrointestinal disordersNausea

Vomiting

Gastrointestinal and abdominal pains

Diarrhoea

Decreased appetite and food intake

Constipation

Dyspepsia

Flatulence

Gastritis

Increased amylase

Dysphagia

Stomatitis

Antibiotic associated colitis (incl. pseudo-membranous colitis, in very rare cases associated with life-threatening complications,

Hepatobiliary disordersIncrease in transaminasesHepatic impairment (incl. LDH increase)

Increased bilirubin

Increased gamma-glutamyl-transferase

Increase in blood alkaline phosphatase

Jaundice

Hepatitis (predominantly cholestatic)

Fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases,
Skin and subcutaneous tissue disordersPruritus

Rash

Urticaria

Dry skin

Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening, seeAcute Generalised Exanthematous Pustulosis (AGEP)
Musculoskeletal and connective tissue disorders*Arthralgia

Myalgia

Tendonitis

Muscle cramp

Muscle twitching

Muscle weakness

Tendon rupture

Arthritis

Muscle rigidity

Exacerbation of symptoms of myasthenia gravis

Rhabdomyolysis
Renal and urinary disordersDehydrationRenal impairment (incl. increase in BUN and creatinine)

Renal failure

General disorders and administration site conditions*Feeling unwell (predominantly asthenia or fatigue)

Painful conditions (incl. pain in back, chest, pelvic and extremities)

Sweating

Oedema

 

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:


Moxifloxacin in Kenya
Moxifloxacin in Kenya
Moxifloxacin in Kenya
Moxifloxacin in Kenya
Moxifloxacin in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: C (Risk not ruled out)
Routes of Administration: By mouth, IV
Bioavailability: 86%
Protein Binding: 47%
Metabolosim: Glucuronide and sulfate conjugation; CYP450 system not involved
Onset of Action: N/A
Elimination Half life: 12.1 hours
Excretion: Urine, feces

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
Tablets, Injectable

Drug Indentifiers:

CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
NIAID ChemDB
CompTox Dashboard (EPA)
ECHA InfoCard


Drug Images

References/ Citation:




What was the patient being treated for
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