MOXIFLOXACIN - moxifloxacin tablet, film coated
Dr. Reddy's Laboratories Limited

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FDA-Approved Medication Guide

MEDICATION GUIDE

Moxifloxacin H ydrochloride Tablets

(mox'' i flox' a sin hye'' droe klor' ide)

Read the Medication Guide that comes with moxifloxacin hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about moxifloxacin h ydrochloride tablets?

Moxifloxacin hydrochloride tablet belongs to a class of antibiotics called fluoroquinolones. Moxifloxacin hydrochloride tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin hydrochloride tablets.

1. Tendon rupture or swelling of the tendon (tendinitis).

Tendon problems can happen in people who do not have the above risk factors when they take moxifloxacin hydrochloride tablets.

2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including moxifloxacin hydrochloride tablets. Stop taking moxifloxacin hydrochloride tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

• pain

• burning

• tingling

• numbness

• weakness

Moxifloxacin hydrochloride tablets may need to be stopped to prevent permanent nerve damage.

3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including moxifloxacin hydrochloride tablets. Tell your healthcare provider if you have a history of seizures before you start taking moxifloxacin hydrochloride tablets. CNS side effects may happen as soon as after taking the first dose of moxifloxacin hydrochloride tablets. Stop taking moxifloxacin hydrochloride tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

• seizures

• hear voices, see things, or sense things that are not there (hallucinations)

• feel restless

• tremors

• feel anxious or nervous

• confusion

• depression

• trouble sleeping

• nightmares

• feel lightheaded or dizzy

• feel more suspicious (paranoia)

• suicidal thoughts or acts

• headaches that will not go away, with or without blurred vision.

4. Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like moxifloxacin hydrochloride tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider right away if you have a history of myasthenia gravis before you start taking moxifloxacin hydrochloride tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section “ What are the possible side effects of moxifloxacin hydrochloride tablets? ” for more information about side effects.

What are moxifloxacin hydrochloride tablets?

Moxifloxacin hydrochloride tablets are a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. These bacterial infections include:

• Community Acquired Pneumonia

• Uncomplicated Skin and Skin Structure Infections

• Complicated Skin and Skin Structure Infections

• Complicated Intra-Abdominal Infections

• Plague

• Acute Bacterial Sinusitis

• Acute Bacterial Exacerbation of Chronic Bronchitis

Moxifloxacin hydrochloride tablets should not be used in patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.

Studies of moxifloxacin for use in the treatment of plague were done in animals only, because plague could not be studied in people.

It is not known if moxifloxacin hydrochloride tablets are safe and works in people under 18 years of age. Children have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibiotic medicines.

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including moxifloxacin hydrochloride tablets, do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking moxifloxacin hydrochloride tablets.

Who should not take moxifloxacin hydrochloride tablets?

Do not take moxifloxacin hydrochloride tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in moxifloxacin hydrochloride tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in moxifloxacin hydrochloride tablets at the end of this Medication Guide.

What should I tell my healthcare provider before taking moxifloxacin hydrochloride tablets?

See “What is the most important information I should know about moxifloxacin hydrochloride tablets?”

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Moxifloxacin hydrochloride tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if any of your medicines are listed above. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take moxifloxacin hydrochloride tablets?

What should I avoid while taking moxifloxacin hydrochloride tablets?

What are the possible side effects of moxifloxacin hydrochloride tablets?

Moxifloxacin hydrochloride tablets can cause side effects that may be serious or even cause death. See “ What is the most important information I should know about moxifloxacin hydrochloride tablets?

Other serious side effects of moxifloxacin hydrochloride tablets include:

Serious allergic reactions

Aortic aneurysm and dissection

Skin rash

Serious heart rhythm changes

Intestine infection (Pseudomembranous colitis)

Changes in blood sugar

Sensitivity to sunlight (photosensitivity)

These are not all the possible side effects of moxifloxacin hydrochloride tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store moxifloxacin hydrochloride tablets?

Moxifloxacin Hydrochloride Tablets

Keep moxifloxacin hydrochloride tablets and all medicines out of the reach of children.

General Information about moxifloxacin hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use moxifloxacin hydrochloride tablets for a condition for which it is not prescribed.  Do not give moxifloxacin hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about moxifloxacin hydrochloride tablets. If you would like more information about moxifloxacin hydrochloride tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about moxifloxacin hydrochloride tablets that is written for healthcare professionals. For more information call 1-888-375-3784 (toll free).

What are the ingredients in moxifloxacin hydrochloride tablets?

Moxifloxacin Hydrochloride Tablets :

Active ingredient: moxifloxacin hydrochloride

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, sodium stearyl fumarate, talc and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rx only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA

Revised: 0619

Dispense the Medication Guide available at:

www.drreddys.com/medguide/moxifloxacintabs.pdf

Revised: 6/2019
Dr. Reddy's Laboratories Limited