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Amoxicillin warnings

October 12th, 2009 No comments

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 Amoxicillin, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, Amoxicillin 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) has been reported with use of 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.

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Amoxicillin contraindications

October 12th, 2009 No comments

A history of allergic reaction to any of the penicillins is a contraindication.

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Indications and Usage for Amoxicillin

October 12th, 2009 No comments

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below:

- Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
- Infections of the genitourinary tract – due to E. coli, P. mirabilis, or E. faecalis.
- Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.
- Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
- Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females).
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple Therapy
Amoxicillin/clarithromycin/lansoprazole

 
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual Therapy
Amoxicillin/lansoprazole

 
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
 
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
 
Indicated surgical procedures should be performed.

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Amoxicillin Description

October 11th, 2009 No comments

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Formulations of Amoxicillin capsules, USP contain Amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S,5R,6R) – 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.

The Amoxicillin molecular formula is C16H19N3O5S•3H2O, and the molecular weight is 419.45.

Capsules of Amoxicillin are intended for oral administration.

Each capsule of Amoxicillin with blue cap and pink body, contains 250 mg or 500 mg Amoxicillin as the trihydrate.  The body of the 250 mg capsule is imprinted with ‘A44’ in black ink.  The body of the 500 mg capsule is imprinted with ‘A45’ in black ink.  Inactive ingredients:  microcrystalline cellulose, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate.
 
Meets USP Dissolution Test 2.

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Amoxicillin general information

October 10th, 2009 No comments

- If you have any questions about Amoxicillin , please talk with your doctor, pharmacist, or other health care provider.
- Amoxicillin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Amoxicillin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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If Amoxicillin OVERDOSE is suspected

October 10th, 2009 No comments

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination.

Proper storage of Amoxicillin :
Store Amoxicillin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amoxicillin out of the reach of children and away from pets.

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Possible side effects of Amoxicillin

October 8th, 2009 No comments

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:

Diarrhea; nausea; vomiting.

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

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Amoxicillin important safety information

October 8th, 2009 No comments

- Amoxicillin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amoxicillin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

- Amoxicillin only works against bacteria; it does not treat viral infections (eg, the common cold).

- Be sure to use Amoxicillin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

- Long-term or repeated use of Amoxicillin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

- Hormonal birth control (eg, birth control pills) may not work as well while you are using Amoxicillin . To prevent pregnancy, use an extra form of birth control (eg, condoms).

- Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

- Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Amoxicillin . It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.

Diabetes patients – Amoxicillin may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

- Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Amoxicillin for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

- Use Amoxicillin with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.

- Use Amoxicillin with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.

- Caution is advised when using Amoxicillin in CHILDREN younger than 3 months old; they may be more sensitive to its effects.

- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amoxicillin while you are pregnant. Amoxicillin is found in breast milk. If you are or will be breast-feeding while you use Amoxicillin , check with your doctor. Discuss any possible risks to your baby.

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How to use Amoxicillin

October 8th, 2009 No comments

Use Amoxicillin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

- An extra patient leaflet is available with Amoxicillin . Talk to your pharmacist if you have questions about this information.
- Take Amoxicillin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do NOT chew or swallow Amoxicillin whole.
- Place Amoxicillin in a small amount of water (about 2 teaspoons/10 mL). Do NOT use any other liquid. Swirl or stir until the tablet is completely mixed in the water. Drink right after mixing. Be sure to drink the entire mixture. Rinse the container with an additional small amount of water and drink to be sure all the medicine is taken.
- To clear up your infection completely, take Amoxicillin for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Amoxicillin , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amoxicillin.

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Before using Amoxicillin

October 8th, 2009 No comments

Some medical conditions may interact with Amoxicillin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of allergies, asthma, hay fever, or hives
- if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)
- if you have kidney problems, phenylketonuria, or gonorrhea

Some MEDICINES MAY INTERACT with Amoxicillin . Tell your health care provider if you are taking any other medicines, especially any of the following:

- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Probenecid because it may increase the amount of Amoxicillin in your blood
- Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Amoxicillin ’s effectiveness
- Methotrexate because the risk of its side effects may be increased by Amoxicillin
- Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Amoxicillin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amoxicillin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

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