Moxatag
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Moxatag
Moxatag Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Moxatag in Detail - Patient Information: Side Effects
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 a serious side effect such as:
- white patches or sores inside your mouth or on your lips;
- fever, swollen glands, rash or itching, joint pain, or general ill feeling;
- severe blistering, peeling, and red skin rash;
- pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;
- severe tingling, numbness, pain, muscle weakness; or
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.
Less serious side effects may include:
- stomach pain, nausea, vomiting;
- 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.
Read the entire detailed patient monograph for Moxatag (Amoxicillin Extended-Release Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Moxatag Overview - Patient Information: Side Effects
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.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.
Tell your doctor immediately if any of these rare but serious side effects occur: dark urine, persistent nausea or vomiting, stomach/abdominal pain, yellowing eyes or skin, easy bruising or bleeding, new/worsening sore throat, new/worsening fever.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.
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.
Read the entire patient information overview for Moxatag (Amoxicillin Extended-Release Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Moxatag FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Study Experience
Tonsillitis and/or Pharyngitis
In a controlled Phase 3 trial, 302 adult and pediatric patients ( ≥ 12 years) were treated with MOXATAG (amoxicillin extended-release tablets) 775 mg once-daily for 10 days and 306 adult and pediatric patients ( ≥ 12 years) were treated with penicillin VK 250 mg QID for 10 days.
In this clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature with similar frequency reported in both treatment groups. Discontinuation due to drug-related treatment- emergent adverse reactions occurred in 1.3 % of the MOXATAG (amoxicillin extended-release tablets) -treated patients and 3.3 % of the penicillin VK-treated patients.
The most frequently reported adverse reactions ( ≥ 1%) which were suspected or probably drug-related are shown in Table 1.
Table 1: Drug-Related Treatment-Emergent Adverse Reactions
by System Organ Class Experienced by ≥ 1% of Patients in Either Treatment
Group - ITT/Safety Population
| Number (%) of patients | ||
| System Organ Class/Preferred Term* | MOXATAG (N =302) |
Pen VK (N = 306 ) |
| Patients with at least one drug-related treatment-emergent adverse event Infections and infestations | 32 (10.6) | 45 (14.7) |
| Vulvovaginal mycotic infection | 6 (2.0) | 8 (2.6) |
| Gastrointestinal disorders | ||
| Diarrhea | 5 (1.7) | 6 (2.0) |
| Nausea | 4 (1.3) | 2 (0.7) |
| Vomiting | 2 (0.7) | 5 (1.6) |
| Abdominal pain | 1 (0.3) | 3 (1.0) |
| Nervous system disorders | ||
| Headache | 3 (1.0) | 3 (1.0) |
| *Presented in decreasing order of frequency in the MOXATAG column within each system organ class. | ||
Adverse Reactions for Other Amoxicillin Products
The following adverse reactions have been reported for other products containing amoxicillin:
Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Nausea, vomiting, diarrhea, and hemorrhagic/ pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions: Anaphylaxis (See WARNINGS and PRECAUTIONS)
Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported. (NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.)
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.
Renal: Crystalluria has also been reported
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Read the entire FDA prescribing information for Moxatag (Amoxicillin Extended-Release Tablets) »
Additional Moxatag Information
Moxatag - User Reviews
Moxatag User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Moxatag sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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