Moxatag

DRUG DESCRIPTION

MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with "MB-111" on one side in black edible ink.

Amoxicillin is a semi-synthetic antibiotic, an analog of ampicillin, with bactericidal activity against gram-positive and gram-negative microorganisms.

Chemically, amoxicillin is (2 S,5 R,6 R)-6-[(R)-(-)-2-amino-2-(p- hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. Its chemical name is amoxicillin. It may be represented structurally as:

MOXATAG (amoxicillin) structural formula illustration

The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45.

MOXATAG (amoxicillin extended-release tablets) is an extended release tablet formulation consisting of three components, one immediate-release and two delayed-release, each containing amoxicillin. The three components are combined in a specific ratio to prolong the release of amoxicillin from MOXATAG compared to immediate-release amoxicillin.

Each tablet contains amoxicillin, crospovidone, FD&C Blue #2 lake, hypromellose, hypromellose acetate succinate, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 400, polyoxyl 35 castor oil, shellac, colloidal silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate.

What are the precautions when taking amoxicillin extended-release tablets (Moxatag)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to quinolone antibiotics (such as ciprofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use of this medication for prolonged or repeated periods may result in a secondary infection.

This drug should be used...

Read All Potential Precautions of Moxatag


Moxatag Consumer (continued)

SIDE EFFECTS: Blurred vision, watery eyes, eye pain/dryness/redness/itchiness may occur. If any of these effects persist or worsen, inform your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the eye.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to quinolone antibiotics (such as ciprofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use of this medication for prolonged or repeated periods may result in a secondary infection.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.



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