DisperMox (Oral)

Amoxicillin is used to treat bacterial infections in various parts of the body. It is also used with other medicines (like clarithromycin and lansoprazole) to treat H. pylori infection and duodenal ulcers.

Amoxicillin is part of a group of medicines called penicillin antibiotics. It works by killing bacteria and stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

If you or your child do not see any improvement in symptoms within a few days, or if symptoms get worse, contact your doctor.

This medicine can cause a serious allergic reaction known as anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you notice a skin rash; itching; shortness of breath; difficulty breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat after you or your child take this medicine.

Amoxicillin can cause diarrhea, which can sometimes be severe. This may happen 2 months or more after stopping the medicine. Do not take any medicine or give medicine to your child for diarrhea without first checking with your doctor. Diarrhea medicines might make the diarrhea worse or last longer. If you have questions about this or if mild diarrhea continues or worsens, consult your doctor.

Before you have any medical tests, inform the doctor that you or your child are taking this medicine. Some test results may be affected by this medicine.

In some young patients, this medicine may cause tooth discoloration. The teeth may develop brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Birth control pills may not be effective while you are using this medicine. To prevent pregnancy, use another form of birth control in addition to your birth control pills. Other options include a condom, a diaphragm, or contraceptive foam or jelly.

Do not take other medicines without discussing them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. Here are important factors to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of amoxicillin. However, newborns and infants 3 months old or younger may have underdeveloped kidney functions, which might require a lower dose of this medicine.

Geriatric

Studies have not indicated any specific problems in the elderly that would limit the usefulness of amoxicillin. However, older patients may be more likely to have age-related kidney issues, which may require careful monitoring and a dose adjustment for those taking amoxicillin.

Breast Feeding

There are no adequate studies on women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

While some medicines should not be used together, others may be used together with caution. If you are taking this medicine, it is very important for your healthcare professional to know if you are also taking any of the following medicines. The following interactions are based on their potential importance and are not a complete list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in certain cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Chlortetracycline
• Cholera Vaccine, Live
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Eravacycline
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Lymecycline
• Meclocycline
• Mestranol
• Methacycline
• Methotrexate
• Minocycline
• Mycophenolate Mofetil
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxytetracycline
• Rolitetracycline
• Sarecycline
• Sulfasalazine
• Tetracycline
• Tigecycline
• Venlafaxine
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Acenocoumarol
• Khat
• Probenecid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other health issues, especially:

• Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or
• Mononucleosis (viral infection)—This medicine should not be used in patients with these conditions.

• Severe kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can worsen this condition.

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

Incidence not known

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine
• bloody nose
• chest pain
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• severe, watery diarrhea, which may also be bloody
• difficulty breathing
• difficulty swallowing
• dizziness
• fast heartbeat
• feeling of discomfort
• fever
• general body swelling
• headache
• heavier menstrual periods
• hives or welts
• increased thirst
• joint inflammation
• itching
• joint or muscle pain
• loss of appetite
• muscle aches
• nausea or vomiting
• nosebleeds
• pain
• pain in the lower back
• pain or burning while urinating
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red, irritated eyes
• redness, soreness, or itching of the skin
• shortness of breath
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welting, or blisters
• sudden decrease in the amount of urine
• swollen lymph glands
• tenderness
• tightness in the chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting blood
• watery or bloody diarrhea
• wheezing
• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

Less common

• Bad, unusual, or unpleasant (after) taste
• change in taste

Incidence not known

• Agitation
• black, hairy tongue
• changes in behavior
• confusion
• convulsions
• discoloration of the teeth (brown, yellow, or gray staining)
• dizziness
• sleeplessness
• trouble sleeping
• unable to sleep
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Amoxicot
• Amoxil
• DisperMox
• Moxatag
• Moxilin
• Trimox

In Canada

• Amoxil Pediatric
• Apo-Amoxi
• Apo-Amoxi Sugar-Free
• Gen-Amoxicillin
• Med Amoxicillin
• Novamoxin
• Novamoxin Reduced Sugar
• Nu-Amoxi
• Riva-Amoxicillin
• Scheinpharm Amoxicillin
• Zimamox

Available Dosage Forms:

• Tablet
• Powder for Suspension
• Chewable Tablet
• Extended Release Tablet
• Capsule

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

For patients using the oral liquid:

• Shake the bottle well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, powder for suspension, and tablets): For bacterial infections: Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours. Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours. Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours. For treatment of gonorrhea: Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose. Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose. Children younger than 2 years of age—Use is not recommended. For treatment of H. pylori infection: Adults— Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days. Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 14 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.

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