moxifloxacin

REMS

Treatment of the following infections:
- Acute sinusitis (should be used only when there are no other alternative treatment options),
- Acute bacterial exacerbations of chronic bronchitis (should be used only when there are no other alternative treatment options)
- Community-acquired pneumonia (CAP),
- Uncomplicated and complicated skin and skin structure infections,
- Complicated intra-abdominal infections,
Treatment and prophylaxis of plague.

Contraindicated in:

Hypersensitivity (cross-sensitivity within class may exist);
QTc interval prolongation;
Uncorrected hypokalemia or hypomagnesemia;
Concurrent use of Class IA antiarrhythmics (disopyramide, quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol) (↑risk of QTc interval prolongation and torsade de pointes);
History of myasthenia gravis (may worsen symptoms including muscle weakness and breathing problems).

Use Cautiously in:

Known or suspected CNS disorder;
Concurrent use of erythromycin, antipsychotics, and tricyclic antidepressants (↑risk of QTc interval prolongation and torsade de pointes);
Bradycardia;
Acute myocardial ischemia;
Concurrent use of corticosteroids (↑ risk of tendinitis/tendon rupture);
Hepatic dysfunction;
Kidney, heart, or lung transplant patients (↑ risk of tendinitis/tendon rupture);
Patients with or at risk for aortic aneurysms;
Diabetes;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk for tendon disorders/rupture, aortic aneurysm/dissection (within 2 mo following discontinuation), and QT interval prolongation in older adults.

CV: QT interval prolongation, AORTIC ANEURYSM/DISSECTION, TORSADE DE POINTES

Derm: photosensitivity, STEVENS-JOHNSON SYNDROME

Endo: hyperglycemia, hypoglycemia

GI: diarrhea, nausea, ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), abdominal pain, dyspepsia, vomiting

MS: arthralgia, myalgia, tendinitis, tendon rupture

Neuro: agitation, anxiety, confusion, depression, dizziness, ELEVATED INTRACRANIAL PRESSURE (INCLUDING PSEUDOTUMOR CEREBRI), hallucinations, headache, insomnia, nightmares, paranoia, peripheral neuropathy, SEIZURES, SUICIDAL THOUGHTS, toxic psychosis, tremor

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

Concurrent use ofamiodarone, disopyramide, erythromycin, procainamide, dofetilide, quinidine, some antipsychotics, sotalol, or tricyclic antidepressants↑ risk of torsade de pointes in susceptible individuals (avoid concurrent use).
May ↑ risk of bleeding with warfarin.
Iron supplements and aluminum-, calcium-, or magnesium-containing antacids, bismuth subsalicylate, sucralfate, multivitamins with zinc↓ absorption (take at least 2 hr before or 4 hr).
Serum levels of fluoroquinolones may be ↓ by antineoplastics.
Cimetidine may interfere with elimination of fluoroquinolones.
May ↑ risk of nephrotoxicity from cyclosporine.
Concurrent corticosteroid therapy may ↑ risk of tendon rupture.
May ↑ risk of hypoglycemia when used with antidiabetic agents.

(Generic available)

Tablets: 400 mg
Premixed infusion: 400 mg/250 mL 0.8% NaCl

PO IV (Adults ): Bacterial sinusitis: 400 mg once daily for 10 days; CAP: 400 mg once daily for 7–14 days. Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily for 5 days. Complicated intra-abdominal infection: 400 mg once daily for 5–14 days. Skin/skin structure infections: 400 mg once daily for 7–21 days. Treatment/prevention of plague: 400 mg once daily for 10–14 days.

Inhibits bacterial DNA synthesis by inhibiting DNA gyrase enzyme.

Therapeutic effects:

Death of susceptible bacteria.

Spectrum:

Active against gram-positive pathogens, including:
- Staphylococcus aureus ,
- Streptococcus pyogenes,
- Streptococcus pneumoniae (including multi-drug resistant strains).
- Streptococcus anginosus,
- Streptococcus constellatus,
- Enterococcus faecalis.
Gram-negative spectrum notable for activity against:
- Escherichia coli,
- Klebsiella pneumoniae,
- Haemophilus influenzae,
- Haemophilus parainfluenzae,
- Enterobacter cloacae,
- Moraxella catarrhalis,
- Proteus mirabilis,
- Yersinia pestis.
Additional spectrum includes:
- Chlamydophylia pneumoniae,
- Mycoplasma pneumoniae,
- Bacteroides fragilis,
- Bacteroides thetaiotaomicron ,
- Peptostreptococcus,
- Clostridium perfringens.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: Fluoroquinolones

Absorption: Well absorbed (90%) following oral administration.

Distribution: Widely distributed; tissue concentrations may exceed plasma concentrations.

Metabolism/Excretion: Mostly metabolized by the liver; 20% excreted unchanged in urine, 25% excreted unchanged in feces.

Half-Life: 12 hr.

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	within 1 hr	1–3 hr	24 hr
IV	rapid	end of infusion	24 hr

Instruct patient to take medication as directed at evenly spaced times and to finish drug completely, even if feeling better. Take missed doses as soon as possible, unless within 8 hr of next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous.
Encourage patient to maintain a fluid intake of at least 1500–2000 mL/day to prevent crystalluria.
Advise patient that antacids or medications containing calcium, magnesium, aluminum, iron, or zinc will decrease absorption and should not be taken within 4 hr before or 8 hr after taking this medication.
May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, or recent myocardial ischemia or if fainting spells or palpitations occur. Patients with this history should not receive moxifloxacin.
Caution patient to use sunscreen and protective clothing to prevent phototoxicity reactions during and for 5 days after therapy. Notify health care professional if a sunburn-like reaction or skin eruption occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
Instruct patient to notify health care professional if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
Instruct patient to notify health care professional immediately if rash, jaundice, sign of hypersensitivity, or tendon (shoulder, hand, Achilles, and other) pain, swelling, or inflammation occurs. If tendon symptoms occur, avoid exercise and use of the affected area. Increased risk in >65 yr old, kidney, heart and lung transplant recipients, and patients taking corticosteroids concurrently. Therapy should be discontinued.
Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

NDC Code

0065- Alcon Laboratories, Inc.
- 0065-0006- MOXEZA
  - 0065-0006-03- 3 mL in 1 BOTTLE (0065-0006-03)

0065- Alcon Laboratories, Inc.
- 0065-4013- VIGAMOX
  - 0065-4013-01- 1 BOTTLE in 1 CARTON (0065-4013-01) > 1 mL in 1 BOTTLE

0065- Alcon Laboratories, Inc.
- 0065-4013- VIGAMOX
  - 0065-4013-03- 1 BOTTLE, PLASTIC in 1 CARTON (0065-4013-03) > 3 mL in 1 BOTTLE, PLASTIC

0093- Teva Pharmaceuticals USA, Inc.
- 0093-7387- Moxifloxacin Hydrochloride
  - 0093-7387-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-7387-56)

0781- Sandoz Inc
- 0781-7135- Moxifloxacin Ophthalmic Solution
  - 0781-7135-93- 1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) > 3 mL in 1 BOTTLE, PLASTIC

0904- Major Pharmaceuticals
- 0904-6406- Moxifloxacin
  - 0904-6406-04- 30 BLISTER PACK in 1 CARTON (0904-6406-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6406- Moxifloxacin
  - 0904-6406-06- 50 BLISTER PACK in 1 CARTON (0904-6406-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK

13668- Torrent Pharmaceuticals Limited
- 13668-201- moxifloxacin hydrochloride
  - 13668-201-01- 100 TABLET in 1 BOTTLE (13668-201-01)

13668- Torrent Pharmaceuticals Limited
- 13668-201- moxifloxacin hydrochloride
  - 13668-201-05- 500 TABLET in 1 BOTTLE (13668-201-05)

13668- Torrent Pharmaceuticals Limited
- 13668-201- moxifloxacin hydrochloride
  - 13668-201-30- 30 TABLET in 1 BOTTLE (13668-201-30)

13668- Torrent Pharmaceuticals Limited
- 13668-201- moxifloxacin hydrochloride
  - 13668-201-74- 100 TABLET in 1 CARTON (13668-201-74)

17478- Akorn, Inc.
- 17478-519- Moxifloxacin
  - 17478-519-19- 1 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER

40032- Novel Laboratories, Inc.
- 40032-034- Moxifloxacin Hydrochloride
  - 40032-034-03- 30 TABLET in 1 BOTTLE, PLASTIC (40032-034-03)

40032- Novel Laboratories, Inc.
- 40032-034- Moxifloxacin Hydrochloride
  - 40032-034-05- 500 TABLET in 1 BOTTLE, PLASTIC (40032-034-05)

40032- Novel Laboratories, Inc.
- 40032-034- Moxifloxacin Hydrochloride
  - 40032-034-31- 5 BLISTER PACK in 1 CARTON (40032-034-31) > 10 TABLET in 1 BLISTER PACK

47781- Alvogen, Inc.
- 47781-268- Moxifloxacin Hydrochloride
  - 47781-268-30- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47781-268-30)

48792- Sunshine Lake Pharma Co., Ltd.
- 48792-7823- Moxifloxacin
  - 48792-7823-1- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7823-1)

50090- A-S Medication Solutions
- 50090-0859- VIGAMOX
  - 50090-0859-0- 1 BOTTLE, PLASTIC in 1 CARTON (50090-0859-0) > 3 mL in 1 BOTTLE, PLASTIC

50090- A-S Medication Solutions
- 50090-3091- Moxifloxacin
  - 50090-3091-0- 1 BOTTLE, DROPPER in 1 CARTON (50090-3091-0) > 3 mL in 1 BOTTLE, DROPPER

50090- A-S Medication Solutions
- 50090-3147- Moxifloxacin
  - 50090-3147-0- 10 TABLET, FILM COATED in 1 BOTTLE (50090-3147-0)

50090- A-S Medication Solutions
- 50090-4058- Moxifloxacin Hydrochloride
  - 50090-4058-1- 30 TABLET in 1 BOTTLE (50090-4058-1)

50090- A-S Medication Solutions
- 50090-4100- Moxifloxacin Hydrochloride
  - 50090-4100-0- 10 TABLET in 1 BOTTLE (50090-4100-0)

50268- AvPAK
- 50268-576- Moxifloxacin Hydrochloride
  - 50268-576-13- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-576-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-576-11)

50419- Bayer HealthCare Pharmaceuticals Inc.
- 50419-537- Avelox
  - 50419-537-01- 250 mL in 1 BAG (50419-537-01)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-943- Moxifloxacin Hydrochloride
  - 51991-943-33- 30 TABLET in 1 BOTTLE (51991-943-33)

53217- Aidarex Pharmaceuticals LLC
- 53217-347- Moxifloxacin
  - 53217-347-01- 3 mL in 1 BOTTLE, DROPPER (53217-347-01)

55111- Dr. Reddy's Laboratories Limited
- 55111-112- Moxifloxacin
  - 55111-112-01- 100 TABLET, FILM COATED in 1 BOTTLE (55111-112-01)

55111- Dr. Reddy's Laboratories Limited
- 55111-112- Moxifloxacin
  - 55111-112-05- 500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05)

55111- Dr. Reddy's Laboratories Limited
- 55111-112- Moxifloxacin
  - 55111-112-30- 30 TABLET, FILM COATED in 1 BOTTLE (55111-112-30)

55111- Dr. Reddy's Laboratories Limited
- 55111-112- Moxifloxacin
  - 55111-112-66- 5 BLISTER PACK in 1 CARTON (55111-112-66) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-112-79)

57237- Rising Health, LLC
- 57237-156- Moxifloxacin Hydrochloride
  - 57237-156-30- 30 TABLET, FILM COATED in 1 BOTTLE (57237-156-30)

60429- Golden State Medical Supply, Inc.
- 60429-893- Moxifloxacin Hydrochloride
  - 60429-893-30- 30 TABLET in 1 BOTTLE (60429-893-30)

60505- Apotex Corp.
- 60505-0582- Moxifloxacin
  - 60505-0582-4- 1 BOTTLE, DROPPER in 1 CARTON (60505-0582-4) > 3 mL in 1 BOTTLE, DROPPER

61919- DIRECT RX
- 61919-553- MOXIFLOXACIN
  - 61919-553-05- 3 mL in 1 BOTTLE, DROPPER (61919-553-05)

63323- Fresenius Kabi USA, LLC
- 63323-850- Moxifloxacin
  - 63323-850-74- 250 mL in 1 BAG (63323-850-74)

65862- Aurobindo Pharma Limited
- 65862-603- MOXIFLOXACIN HYDROCHLORIDE
  - 65862-603-30- 30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30)

65862- Aurobindo Pharma Limited
- 65862-603- MOXIFLOXACIN HYDROCHLORIDE
  - 65862-603-55- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55) > 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10)

65862- Aurobindo Pharma Limited
- 65862-603- MOXIFLOXACIN HYDROCHLORIDE
  - 65862-603-99- 1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99)

65862- Aurobindo Pharma Limited
- 65862-840- MOXIFLOXACIN
  - 65862-840-03- 1 BOTTLE in 1 CARTON (65862-840-03) > 3 mL in 1 BOTTLE

66298- Fresenius Kabi Norge AS
- 66298-8507- Moxifloxacin
  - 66298-8507-4- 250 mL in 1 BAG (66298-8507-4)

67296- RedPharm Drug, Inc.
- 67296-1616- Moxifloxacin Hydrochloride
  - 67296-1616-5- 5 TABLET, FILM COATED in 1 BOTTLE (67296-1616-5)

67296- RedPharm Drug, Inc.
- 67296-1679- Moxifloxacin
  - 67296-1679-5- 5 TABLET, FILM COATED in 1 BOTTLE (67296-1679-5)

67457- Mylan Institutional LLC
- 67457-323- MOXIFLOXACIN HYDROCHLORIDE
  - 67457-323-25- 1 BAG in 1 CARTON (67457-323-25) > 250 mL in 1 BAG

68084- American Health Packaging
- 68084-722- Moxifloxacin Hydrochloride
  - 68084-722-65- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-722-65) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-722-11)

68180- Lupin Pharmaceuticals, Inc.
- 68180-422- Moxifloxacin
  - 68180-422-01- 1 BOTTLE in 1 CARTON (68180-422-01) > 3 mL in 1 BOTTLE

68788- Preferred Pharmaceuticals Inc.
- 68788-7404- Moxifloxacin
  - 68788-7404-3- 1 BOTTLE, DROPPER in 1 CARTON (68788-7404-3) > 3 mL in 1 BOTTLE, DROPPER

70518- REMEDYREPACK INC.
- 70518-2043- VIGAMOX
  - 70518-2043-0- 1 BOTTLE, PLASTIC in 1 CARTON (70518-2043-0) > 3 mL in 1 BOTTLE, PLASTIC

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-038- MOXIFLOXACIN HYDROCHLORIDE
  - 72789-038-10- 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-038-10)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆