Moxatag

Moxatag is part of the drug class:

• Penicillins with extended spectrum

You should not use this medicine if you are allergic to any penicillin antibiotic, such as ampicillin, dicloxacillin, oxacillin, penicillin, or ticarcillin.

To make sure amoxicillin is safe for you, tell your doctor if you have:

• asthma;

• liver or kidney disease;

• mononucleosis (also called "mono");

• a history of diarrhea caused by taking antibiotics; or

• food or drug allergies (especially to a cephalosporin antibiotic such as Omnicef, Cefzil, Ceftin, Keflex, and others).

If you are being treated for gonorrhea, your doctor may also have you tested for syphilis, another sexually transmitted disease.

Amoxicillin is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Amoxicillin can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking amoxicillin.

Amoxicillin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The amoxicillin chewable tablet may contain phenylalanine. Talk to your doctor before using this form of amoxicillin if you have phenylketonuria (PKU).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• diarrhea that is watery or bloody;

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• swollen glands, rash or itching, joint pain, or general ill feeling;

• pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;

• severe tingling, numbness, pain, muscle weakness;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea;

• vaginal itching or discharge;

• headache; or

• swollen, black, or "hairy" tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to amoxicillin, any penicillin, or any other part of Moxatag (amoxicillin extended-release tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have mono.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Moxatag with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Moxatag (amoxicillin extended-release tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Moxatag. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Anaphylaxis and Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with Moxatag, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Moxatag should be discontinued and appropriate therapy instituted.

Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Clostridium difficile Associated Diarrhea (CDAD)

Clostridium difficile Associated Diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Superinfections

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

Mononucleosis Rash

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

Development of Drug-Resistant Bacteria

Prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

False-Positive Urinary Glucose Tests

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest®, Benedict's Solution or Fehling's Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.

Instructions for Administration of Moxatag

Patients should be informed that the recommended dose of Moxatag is 775 mg once daily taken with food for 10 days. Moxatag should be taken within 1 hour of finishing a meal and at approximately the same time every day. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes. Patients should be instructed not to chew or crush the tablet. No other forms of immediate-release amoxicillin can be substituted for Moxatag.

Hypersensitivity Reactions

Patients should be informed that serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported while on penicillin therapy. Patients should be questioned regarding any hypersensitivity reactions to penicillins, cephalosporins or other allergens. Whenever such reactions occur, the patient should be instructed to contact their physician immediately. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Clostridium difficile Associated Diarrhea

Patients should be informed that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

AUGMENTIN is a registered trademark of GlaxoSmithKline.
CLINITEST is a registered trademark of Siemens Healthcare Diagnostic Inc.
CLINISTIX is a registered trademark of Bayer Corporation.
Moxatag is a registered trademark of Vernalis (R&D) Ltd. all rights reserved.

Manufactured in Ireland for:
Vernalis (R&D) Ltd.

Distributed by:
Vernalis Therapeutics, Inc., Berwyn, PA 19312

U.S. Patents 6,544,555; 6,669,948; 6,723,341

Rev 06/16

You should not use Moxatag if you are allergic to any penicillin antibiotic, such as ampicillin, dicloxacillin, oxacillin, penicillin, or ticarcillin.

Before using Moxatag, tell your doctor if you are allergic to cephalosporins such as Omnicef, Cefzil, Ceftin, Keflex, and others. Also tell your doctor if you have asthma, liver or kidney disease, a bleeding or blood clotting disorder, mononucleosis (also called "mono"), or any type of allergy.

Moxatag can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking Moxatag. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Amoxicillin will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Moxatag and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Applies to amoxicillin: oral capsule, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet dispersible, oral tablet extended release

General

The most frequently reported side effects were diarrhea, nausea, and skin rash.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Hemorrhagic/pseudomembranous colitis, tooth discolored, black hairy tongue, glossitis, stomatitis
Postmarketing reports: Sore mouth/tongue[Ref]

Dermatologic

Common (1% to 10%): Erythema, exanthema, rash
Uncommon (0.1% to 1%): Urticaria, pruritus
Very rare (less than 0.01%): Angioedema, hypersensitivity vasculitis
Frequency not reported: Erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, bullous dermatitis, exfoliative dermatitis, toxic epidermal necrolysis/Lyell's syndrome, acute generalized exanthematous pustulosis, maculopapular rash, erythema nodosum, pemphigoid reactions[Ref]

Genitourinary

Common (1% to 10%): Vulvovaginal mycotic infection[Ref]

Nervous system

Common (1% to 10%): Headache, taste perversion
Very rare (less than 0.01%): Convulsion, dizziness, hyperkinesia
Frequency not reported: Reversible hyperactivity, central nervous system toxicity, encephalopathy[Ref]

Immunologic

Very rare (less than 0.01%): Anaphylaxis, serum sickness-like reaction
Frequency not reported: Jarisch-Herxheimer reaction[Ref]

Renal

Very rare (less than 0.01%): Crystalluria, interstitial nephritis
Frequency not reported: Nephropathy[Ref]

Hematologic

Very rare (less than 0.01%): Leucopenia, severe neutropenia, agranulocytosis, hemolytic anemia, thrombocytopenia, bleeding time prolonged, prothrombin time prolonged
Frequency not reported: Anemia, thrombocytopenic purpura, eosinophilia, platelet function defective, lymphadenopathy[Ref]

Other

Common (1% to 10%): Candidiasis, fungal/mycotic infection
Very rare (less than 0.01%): Mucocutaneous candidiasis
Frequency not reported: Intestinal candidiasis, oral moniliasis, vaginal moniliasis, fever, chills[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, cholestatic jaundice, AST increased, ALT increased
Frequency not reported: Hepatic dysfunction, hepatic cholestasis, acute cytolytic hepatitis[Ref]

Respiratory

Frequency not reported: Bronchospasm, acute severe dyspnea, pneumonitis allergic[Ref]

Local

Frequency not reported: Phlebitis, injection site pain[Ref]

Metabolic

Frequency not reported: Electrolyte disturbance, hypokalemia[Ref]

Musculoskeletal

Frequency not reported: Joint pain, arthralgia[Ref]

Psychiatric

Frequency not reported: Agitation, anxiety, insomnia, confusion, behavior changed, hallucination[Ref]

Some side effects of Moxatag may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.