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DisperMox Side Effects

Generic Name: amoxicillin,amoxicillin and clavulanate potassium

Please note - some side effects for DisperMox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of DisperMox - for the Consumer

DisperMox

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using DisperMox:

Diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using DisperMox:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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DisperMox Side Effects - for the Professional

DisperMox

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Gastrointestinal:

Nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Hypersensitivity Reactions:

Serum sickness-like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthemataus 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.

Renal:

Crystalluria has also 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.

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.

Combination Therapy with Clarithromycin and Lansoprazole:

In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole.

Triple Therapy:

Amoxicillin/Clarithromycin/Lansoprazole:

The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual therapy:

Amoxicillin/Lansoprazole:

The most frequently reported adverse events for patients who received amoxicillin three times daily plus lansoprazole three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin three times daily plus lansoprazole three times daily dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity reactions are more likely in patients with a history of allergy, asthma, hay fever, or urticaria.

Hypersensitivity reactions have been reported in up to 10% of patients and have included anaphylaxis, urticarial rash, erythematous maculopapular rash, serum sickness-like reactions, erythema multiforme, urticaria, edema, hypotension, fever, eosinophilia, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, angioedema, Stevens-Johnson syndrome, and dyspnea.

Dermatologic

Dermatologic side effects have included rash, fixed drug eruption, and bullous pemphigoid. Erythematous maculopapular rashes occur frequently in patients with infectious mononucleosis who take amoxicillin; these may be due to hypersensitivity.

Three out of four patients with infectious mononucleosis and an amoxicillin-associated rash displayed hypersensitivity to amoxicillin and ampicillin by skin tests and lymphocyte transformation tests. Two of these patients had side-chain-specific sensitization.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, generalized abdominal cramps, colitis, hemorrhagic colitis, pseudomembranous colitis (Clostridium difficile associated diarrhea), and black hairy tongue. Abdominal pain has also been reported.

Amoxicillin has been associated with hemorrhagic, sometimes inflammatory colitis, which typically affects the ascending colon. Clostridium difficile pseudomembranous colitis has been reported.

Renal

Renal side effects have included crystalluria and acute interstitial nephritis, often associated with fever, rash and eosinophilia.

Hematologic

A patient undergoing dental extraction and receiving warfarin anticoagulation therapy had prolonged bleeding times (PT and INR), and decreased hemoglobin and hematocrit. The bleeding was felt due to vitamin K deficiency as a result of depletion of intrinsic vitamin K-producing gut flora from use of amoxicillin for prophylaxis of subacute bacterial endocarditis.

Hematologic side effects associated with penicillins have included thrombocytopenia, anemia, leukopenia, thrombocytopenic purpura, agranulocytosis, hemolytic anemia, eosinophilia, and granulocytopenia. These effects are usually reversible and are believed to be due to hypersensitivity reactions.

Immunologic

Immunologic side effects have included mucocutaneous candidiasis and vulvovaginal mycotic infection.

Nervous system

Nervous system side effects have rarely included headache, somnolence, dizziness, reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and aseptic meningitis. Rare cases of psychosis associated with amoxicillin therapy have been reported but may have been due to underlying infection or concomitant medication.

Hepatic

Hepatic side effects have included moderate elevations of AST (SGOT) and/or ALT (SGPT) levels, cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis.

Other

Other side effects have rarely included brown, yellow, or gray tooth discoloration, primarily in pediatric patients. Brushing or dental cleaning reduced or eliminated the discoloration in most cases.

Respiratory

Respiratory side effects have included cough and rhinorrhea.

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