СИМОФЛОКС

СИМОФЛОКС Uses, Dosage, Side Effects, Food Interaction and all others data.

СИМОФЛОКС is a synthetic broad spectrum, flouroquinolone derivative antibacterial agent. СИМОФЛОКС has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. The bactericidal action of СИМОФЛОКС results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.

СИМОФЛОКС is a quinolone/fluoroquinolone antibiotic. СИМОФЛОКС can be used to treat infections caused by the following bacteria: Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, and Streptococcus viridans group. Aerobic Gram-negative microorganisms: Acinetobacter lwoffii, Haemophilus influenzae, and Haemophilus parainfluenzae. Other microorganisms: Chlamydia trachomatis.СИМОФЛОКС is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. СИМОФЛОКС is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.

Trade Name СИМОФЛОКС
Availability Prescription only
Generic Moxifloxacin
Moxifloxacin Other Names Moxifloxacin, Moxifloxacino
Related Drugs amoxicillin, prednisone, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin
Type
Formula C21H24FN3O4
Weight Average: 401.4314
Monoisotopic: 401.175084476
Protein binding

50% bound to serum proteins, independent of drug concentration.

Groups Approved, Investigational
Therapeutic Class 4-Quinolone preparations
Manufacturer
Available Country Russia
Last Updated: September 19, 2023 at 7:00 am
СИМОФЛОКС
СИМОФЛОКС

Uses

СИМОФЛОКС is used 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 infuenzae or Moraxella catarrhalis.
  • Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus infuenzae, Haemophilus parainfuenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis
  • Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus infuenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydophilia pneumoniae.
  • Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogen.
  • Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.
  • 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.

СИМОФЛОКС is also used to associated treatment for these conditions: Acute Exacerbation of Chronic Bronchitis (AECB), Bacterial Conjunctivitis, Community Acquired Pneumonia (CAP), Plague, Postoperative Inflammatory Response, Sinusitis, Skin Infections, Ocular bacterial infections, Post-operative infection

How СИМОФЛОКС works

The bactericidal action of moxifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Dosage

СИМОФЛОКС dosage

The dose of СИМОФЛОКС is 400 mg once every 24 hours. The duration of therapy depends on the type of infection as described bellow-

  • In Acute Bacterial Sinusitis: СИМОФЛОКС 400 mg is given once daily for 10 days.
  • In Acute Bacterial Exacerbation of Chronic Bronchitis: СИМОФЛОКС 400 mg is given once daily for 5 days.
  • In Community Acquired Pneumonia: СИМОФЛОКС 400 mg is given once daily for 7-14 days.
  • In Uncomplicated Skin & Skin Structure infections: СИМОФЛОКС 400 mg is given once daily for 7 days.
  • In Complicated Skin & Skin Structure infections: СИМОФЛОКС 400 mg is given once daily for 7-21 days.
  • In Complicated Intra-Abdominal infections: СИМОФЛОКС 400 mg is given once daily for 5-14 days.

СИМОФЛОКС 400 mg IV infusion can be administered intravenously for the entire treatment duration. Alternatively, therapy may be initial intravenous administration, followed by oral administration when clinically indicated. The recommended duration of treatment for the indication being treated should not be exceeded. The solution for infusion should be infused intravenously over 60 minutes.

Side Effects

The following one or more side effects may be observed: tendinopathy and tendon rupture, QT prolongation, hypersensitivity reactions, Clostridium difficile-associated diarrhea, peripheral neuropathy, photosensitivity, phototoxicity etc.

Toxicity

Symptoms of overdose include CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting, and diarrhea. The minimal lethal intravenous dose in mice and rats is 100 mg/kg.

Precaution

СИМОФЛОКС should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. СИМОФЛОКС should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Interaction

No quinolone should be co-administered with any solution containing multivalent cations (e.g. magnesium) through the same intravenous line. Antacids, iron and adsorbents reduce absorption of СИМОФЛОКС. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Food Interaction

  • Drink plenty of fluids.
  • Take with or without food.

СИМОФЛОКС multivitamins interaction

[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.

Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.

The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.

The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.

When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.

When coadministered with Suprep Bowel Prep (magnesium

Please consult individual product labeling for specific recommendations.

Volume of Distribution

  • 1.7 to 2.7 L/kg

Elimination Route

Well absorbed from the gastrointestinal tract. Absolute oral bioavailability is approximately 90%. Food has little effect on absorption.

Half Life

11.5-15.6 hours (single dose, oral)

Clearance

  • 12 +/- 2 L/hr

Elimination Route

Approximately 45% of an oral or intravenous dose of moxifloxacin is excreted as unchanged drug (~20% in urine and ~25% in feces).

Pregnancy & Breastfeeding use

Pregnancy Category C. СИМОФЛОКС is not recommended during pregnancy & lactation.

Contraindication

СИМОФЛОКС is contraindicated in persons with a history of hypersensitivity to СИМОФЛОКС or any member of the quinolone class of antimicrobial agents and any component of this formulation.

Special Warning

Elderly: No adjustment of dosage is required in the elderly.

Children: Efficacy and safety of СИМОФЛОКС IV infusion in children and adolescent have not been established.

Acute Overdose

In the events of an acute overdose, the stomach should be emptied. The patient should be kept under observation and appropriate hydration should be maintained.

Storage Condition

Store between 15 to 30° C. Protect from light and moisture. Keep away from reach of children.

Innovators Monograph

You find simplified version here СИМОФЛОКС

СИМОФЛОКС contains Moxifloxacin see full prescribing information from innovator СИМОФЛОКС Monograph, СИМОФЛОКС MSDS, СИМОФЛОКС FDA label

FAQ

What is СИМОФЛОКС used for?

СИМОФЛОКС is used to treat certain infections caused by bacteria such as pneumonia, and skin, and abdominal (stomach area) infections.СИМОФЛОКС is also used to prevent and treat plague a serious infection that may be spread on purpose as part of a bioterror attack.

How safe is СИМОФЛОКС?

СИМОФЛОКС may cause problems with bones, joints, and tissues around joints in children.СИМОФЛОКС should not be given to children younger than 18 years old.СИМОФЛОКС may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

How does СИМОФЛОКС work?

СИМОФЛОКС works by killing the bacteria that cause infections. Antibiotics such as СИМОФЛОКС will not work for colds, flu, or other viral infections.

What are the common side effects of СИМОФЛОКС?

The common side effects of СИМОФЛОКС are include:

  • nausea.
  • vomiting.
  • stomach pain.
  • diarrhea.
  • constipation.
  • heartburn

Is СИМОФЛОКС safe during pregnancy?

Use is considered acceptable; according to some experts,this drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

Is СИМОФЛОКС safe during breastfeeding?

Use of СИМОФЛОКС is acceptable in nursing mothers with monitoring of the infant for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis..СИМОФЛОКС is preferable to use an alternate drug for which safety information is available.

Can I drink alcohol with СИМОФЛОКС?

Do not drink alcohol. Drinking alcohol can increase the chance of liver problems while you are taking СИМОФЛОКС. Avoid hard physical activity. Although not common, СИМОФЛОКС can make it easier to get tendon injuries.

Can I drive after taking СИМОФЛОКС?

Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

What is the best time to take СИМОФЛОКС?

СИМОФЛОКС is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take СИМОФЛОКС. Take СИМОФЛОКС at around the same time every day.

Can I take СИМОФЛОКС at night?

Take СИМОФЛОКС exactly as your doctor tells you to. You will be prescribed a dose of one tablet a day. Try to take the tablets at the same time of day each day, as this will help you to remember to take СИМОФЛОКС regularly.

Is СИМОФЛОКС a good antibiotic?

Normally, СИМОФЛОКСis not a dangerous antibiotic for most people, but in rare cases, it can cause serious side effects such as heart rhythm problems, liver damage, and tendon rupture.

Does СИМОФЛОКС make me sleepy?

СИМОФЛОКС may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally.

Can СИМОФЛОКС cause blurry vision?

СИМОФЛОКС ophthalmic may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Can СИМОФЛОКС increase heart rate?

СИМОФЛОКС causes increase heart rate greater than 10 bpm.

How often can I use СИМОФЛОКС?

СИМОФЛОКС is usually used three times a day for 7 days. Try to use at around the same times every day.

Can I overdose on СИМОФЛОКС?

An overdose of СИМОФЛОКС ophthalmic is not expected to be dangerous. Seek emergency medical attention  if anyone has accidentally swallowed the medication. Do not use other eye medications unless your doctor tells you to.

Can СИМОФЛОКС cause permanent damage?

СИМОФЛОКС can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.

How long does btrand stay in my body?

The elimination half-life of СИМОФЛОКС is 11.5 to 15.6 hours .About 45% of an oral or intravenous dose of СИМОФЛОКС is excreted as unchanged drug.

Can I take СИМОФЛОКС for a long time?

СИМОФЛОКС oral tablet is used for short-term treatment.

How long can I take СИМОФЛОКС?

СИМОФЛОКС comes as tablet to take by mouth.СИМОФЛОКС is usually taken with or without food once a day for 5 to 21 days. The length of treatment depends on the type of infection being treated.

Who should СИМОФЛОКС take СИМОФЛОКС?

Stop using СИМОФЛОКС and call your doctor at once if you have symptoms such as:headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

*** Taking medicines without doctor's advice can cause long-term problems.
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