Torrent-Moxifloxacin: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Quinolone antibiotics, like Torrent-Moxifloxacin, are related to disabling and possibly long lasting effects such as:

  • inflamed tendon (tendonitis), tendon rupture.
  • nerve damage (peripheral neuropathy).

  • problems in the brain such as:

    • convulsions
    • nervous breakdown
    • confusion
    • and other symptoms

• Quinolone antibiotics, like Torrent-Moxifloxacin:

  • have lengthened the heartbeat (QT prolongation)
  • have led to serious allergic reactions, including death
  • may be related to increased tendonitis (inflamed tendon)
  • may worsen myasthenia gravis (a muscle disease)
  • may lead to seizures and nervous breakdowns. Tell your doctor if you have brain or spinal cord problems (such as epilepsy)
  • may cause liver injury which may lead to death

• For further information and symptoms see:

  • the “To help avoid side effects and ensure proper use,…” section
  • the “What are possible side effects from using Torrent-Moxifloxacin” section

Talk to your doctor to see if Torrent-Moxifloxacin is right for you.

What is Torrent-Moxifloxacin used for?

Your doctor has prescribed Torrent-Moxifloxacin because you have a certain type of bacterial infection.

Antibacterial drugs like Torrent-Moxifloxacin treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Torrent-Moxifloxacin should be used exactly as directed. Misuse or overuse of Torrent-Moxifloxacin could lead to the growth of bacteria that will not be killed by Torrent-Moxifloxacin (resistance). This means that Torrent-Moxifloxacin may not work for you in the future. Do not share your medicine.

How does Torrent-Moxifloxacin work?

Torrent-Moxifloxacin is an antibiotic. It kills many of the types of bacteria that can infect the lungs, sinuses, abdomen, and skin.

What are the ingredients in Torrent-Moxifloxacin Tablets?

Medicinal ingredients: 400 mg of moxifloxacin as moxifloxacin hydrochloride

Non-medicinal ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinised Starch, Colloidal Silicon Dioxide, Polyvinyl Pyrrolidone, Magnesium Stearate, Hypromellose, Polyethylene Glycol 400, Titanium Dioxide, Ferric Oxide Red.

Torrent-Moxifloxacin Tablets come in the following dosage forms:

Tablets: Light pink colored, capsule shaped, biconvex film-coated tablets containing 400 mg moxifloxacin (as hydrochloride). They are debossed with “1201” on one side and “400” on other side.

Do not use Torrent-Moxifloxacin if:

• you are allergic to Torrent-Moxifloxacin (moxifloxacin hydrochloride) or other quinolone antibiotics.
• you are allergic to any other ingredient in the formulation (see “What are the ingredients in Torrent-Moxifloxacin Tablets?”).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Torrent-Moxifloxacin. Talk about any health conditions or problems you may have, including if you:

• have or have a family history of irregular heart rhythm (such as QT prolongation).
• have or have had heart problems such as heart failure, an irregular heartbeat, or a slow heartbeat.
• have low potassium blood levels (see “The following may interact with Torrent-Moxifloxacin:”).
• have a history of seizures.

• are pregnant, planning to become pregnant, or if you are breast feeding.

• are less than 18 years of age.
• have a history of tendon problems (such as pain, swelling or rupture of a tendon) related to the use of quinolone antibiotics.
• have myasthenia gravis (a muscle disease).
• have diabetes as Torrent-Moxifloxacin may affect blood sugar levels. Torrent-Moxifloxacin may also affect blood sugar levels in those without diabetes.

Other warnings you should know about:

Blood Sugar Changes

Medicines like Torrent-Moxifloxacin can cause blood sugar levels to rise and drop in patients with diabetes. Serious cases of hypoglycemia (low blood sugar levels) that caused coma or death have been seen with medicines like Torrent-Moxifloxacin. If you have diabetes, check your blood sugar levels often while taking Torrent-Moxifloxacin.

While taking Torrent-Moxifloxacin:

• Avoid too much sunlight or artificial ultraviolet light (such as sunlamps).

  • Contact your doctor if a sunburn or rash occurs.

• Do not drive or use machinery if you feel dizzy or lightheaded.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Torrent-Moxifloxacin:

• Antacids or vitamin/mineral supplements
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Antidiabetic medicines (such as, insulin, glyburide, glibenclamide)
• Quinidine, procainamide, amiodarone, sotalol, cisapride^b, erythromycin, antipsychotics, tricyclic antidepressants, diuretics (furosemide, hydrochlorothiazide).

^b no longer marketed in Canada

How to take Torrent-Moxifloxacin:

• You must take Torrent-Moxifloxacin exactly as prescribed by your doctor. YOU SHOULD NOT INCREASE THE PRESCRIBED DOSE.

• You can take Torrent-Moxifloxacin with or without food.

• You should drink lots of fluids while taking Torrent-Moxifloxacin.
• If your doctor decides to stop the treatment, dispose of all unused Torrent-Moxifloxacin tablets.

Usual dose:

• Take one 400 mg Torrent-Moxifloxacin tablet once a day.
• Swallow each Torrent-Moxifloxacin tablet whole with a drink of water. Do not crush or chew Torrent-Moxifloxacin tablets.
• If you are taking antacids or vitamin/mineral supplements which contain magnesium or aluminium, take Torrent-Moxifloxacin at least 4 hours before or 8 hours after taking the supplement or antacid.
• Your doctor has decided on the best dose for you and for how long based on your needs.
• The usual length of treatment with Torrent-Moxifloxacin is 5-10 days. IT IS IMPORTANT TO COMPLETE THE FULL LENGTH OF TREATMENT, EVEN IF YOU BEGIN TO FEEL BETTER.

Overdose:

Missed Dose:

If you forget to take a dose, take another as soon as you remember. Take the next dose 24 hours later. Do not take two doses in any 24 hour period.

What are possible side effects from using Torrent-Moxifloxacin?

All medicines, including Torrent-Moxifloxacin, can cause side effects, although not everyone gets them.

These are not all the possible side effects you may feel when taking Torrent-Moxifloxacin. If you have any side effects not listed here or if conditions worsen or do not improve then:

• contact your healthcare professional.
• see the “To help avoid side effects and ensure proper use, …” section.

If you think you have taken too much Torrent-Moxifloxacin, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Stop taking Torrent-Moxifloxacin and contact your doctor if:

1. a)

   you have symptoms of an allergic reaction such as:

   • rash, hives, blistering or other skin reaction
   • swelling of the mouth, throat, limbs
   • difficulty breathing
   • irregular or rapid heartbeat, or fainting spells
2. b)

   you have pain, swelling or rupture of a tendon. You should:

   • rest
   • avoid physical exercise
3. c)

   you have neuropathy (damage to the nerves) with symptoms such as:

   • pain, burning, tingling, numbness or weakness
4. d)

   you have severe diarrhea (bloody or watery) with or without:

   • fever
   • stomach pain or tenderness

You may have Clostridium difficile colitis (bowel inflammation). See your doctor right away.

Other side effects include:

• your eyesight worsens or changes. See your doctor or eye specialist right away.
• nausea, dizziness

• worsening of myasthenia gravis (a muscle disease) with symptoms such as:

  • weakness
  • difficulty walking, swallowing, drooping eyelids

Do not use Torrent-Moxifloxacin if you have this condition.

• mental problems such as:

  • confusion, headache, shaking
  • hallucinations, depression, agitation
  • difficulty sleeping, anxiety, nervousness, suicidal thoughts

Contact your doctor if you have suicidal thoughts.

Self-Limiting Side Effects:

• feeling lightheaded
• insomnia (difficulty sleeping)
• nightmares

If any of these affect you severely, tell your doctor or pharmacist.

Serious Side Effects and What to do About Them

Serious Side Effects and What to do About Them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Storage:

Torrent-Moxifloxacin tablets should be stored:

• at room temperature (15°C –30°C)
• in a tightly closed container away from heat and direct light. Do not freeze the tablets.

Keep out of reach and sight of children.

If you want more information about Torrent-Moxifloxacin:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.healthcanada.gc.ca); the manufacturer’s website http://www.torrentpharma.com or by contacting Torrent Medical Information at 1-800-912-9561 or Medinfo.Torrent@apcerls.com.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (www.healthcanada.gc.ca/medeffect);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Last Revised: July 19, 2019

Manufacturing Address:

Torrent Pharmaceuticals Limited

Ahmedabad-Mehsana Highway

Taluka-Kadi, Dist. Mehsana

Indrad-382 721,

Gujarat, India

http://www.torrentpharma.com