DisperMox

Name: DisperMox

Dispermox Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • birth control pills
  • probenecid (Benemid)
  • warfarin (Coumadin, Jantoven)
  • other antibiotics such as chloramphenicol, erythromycin, clarithromycin, azithromycin, doxycylcine, minocycline, tetracycline, or "sulfa drugs"

This is not a complete list of amoxicillin drug interactions. Ask your doctor or pharmacist for more information.

Dispermox Dosage

Take Amoxicillin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Amoxicillin dose your doctor recommends will be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age
  • your gender

Neonates and Infants aged 12 weeks or younger (≤ 3 months): the recommended upper dose of amoxicillin is 30 mg/kg/day divided and given twice daily.

Adult Dosing (or children 40kg/88 lbs or greater):

  • Ear/Nose/Throat infection, mild or moderate: 500 mg twice daily or 250 mg three times daily
  • Ear/Nose/Throat, severe infection: 875 mg twice daily or 500 mg three times daily
  • Lower respiratory tract (airway) infection, mild or moderate or severe: 875 mg twice daily or 500 mg three times daily
  • Skin/Skin Structure infection, mild or moderate: 500 mg twice daily or 250 mg three times
  • Skin/Skin Structure infection, severe: 875 mg twice daily or 500 mg three times daily
  • Genitourinary tract infection, mild or moderate: 500 mg twice daily or 250 mg three times daily
  • Genitourinary tract infection, severe: 875 mg twice daily or 500 mg three times daily
  • Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females: 3 grams as single oral dose

Dosing in Children (greater than 3 months old or less than 40 kg/88 lbs):

  • Ear/Nose/Throat infection, mild or moderate: hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
  • Ear/Nose/Throat, severe infection: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
  • Lower respiratory tract (airway) infection, mild or moderate or severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
  • Skin/Skin Structure infection, mild or moderate: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
  • Skin/Skin Structure infection, severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
  • Genitourinary tract infection, mild or moderate: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours
  • Genitourinary tract infection, severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours
  • Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females:
    • Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, DO NOT USE THIS REGIMEN IN THESE CASES.

Other Requirements

  • Keep this and all medications out of the reach of children.
  • Store amoxicillin capsules, tablets, and chewable tablets in the original container, tightly closed, away from excess heat (at room temperature) and moisture.
  • The liquid suspension and pediatric drops are best kept in the refrigerator, but may be stored at room temperature. Do not freeze. Throw away any unused liquid amoxicillin after 14 days.

Before Using DisperMox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of this medicine.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving amoxicillin.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Chlortetracycline
  • Cholera Vaccine, Live
  • Demeclocycline
  • Doxycycline
  • Lymecycline
  • Meclocycline
  • Methacycline
  • Methotrexate
  • Minocycline
  • Oxytetracycline
  • Rolitetracycline
  • Tetracycline
  • Venlafaxine
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Khat
  • Probenecid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or
  • Mononucleosis (viral infection)—Should not be used in patients with these conditions.
  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

This section provides information on the proper use of a number of products that contain amoxicillin. It may not be specific to DisperMox. Please read with care.

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.

DisperMox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • feeling of discomfort
  • fever
  • general body swelling
  • headache
  • heavier menstrual periods
  • hives or welts
  • increased thirst
  • inflammation of the joints
  • 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 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 of blood
  • watery or bloody diarrhea
  • wheezing
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce 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 tooth (brown, yellow, or gray staining)
  • dizziness
  • sleeplessness
  • trouble with 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.

Indications and Usage for DisperMox

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DisperMox and other antibacterial drugs, DisperMox 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.

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY ß-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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

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. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Warnings

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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

How is DisperMox Supplied

Amoxicillin Tablets for Oral Suspension:

Each tablet for oral suspension contains 200 mg, 400 mg or 600 mg amoxicillin as the trihydrate.

200 mg Tablet for Oral Suspension

200 mg light pink colored, strawberry flavored, circular, biconvex, unscored, mottled tablets, debossed with “RX565” on one side and plain on the other.

NDC 10631-565-20 Bottles of 20

NDC 10631-565-60 Bottles of 60

NDC 10631-565-10 Bottles of 1000

NDC 10631-565-80 Strip unit-dose pack of 100s

400 mg Tablet for Oral Suspension

400 mg light pink colored, strawberry flavored, circular, biconvex, unscored, mottled tablets, debossed with “RX567” on one side and plain on the other.

NDC 10631-567-20 Bottles of 20

NDC 10631-567-60 Bottles of 60

NDC 10631-567-05 Bottles of 500

NDC 10631-567-80 Strip unit-dose pack of 100s

600 mg Tablet for Oral Suspension

600 mg light pink colored, circular, biconvex mottled tablet debossed with ‘RX176’ on one side and plain on the other side with a characteristic strawberry flavor.

NDC 10631-176-20 Bottles of 20

NDC 10631-176-60 Bottle of 60

NDC 10631-176-01 Bottles of 100

NDC 10631-176-80 Strip unit-dose pack of 100s

The product is also available as:

Amoxicillin Capsules

Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate.

250 mg Capsule

250 mg yellow opaque cap and yellow opaque body, size 2, printed “RX654” on both cap and body.

NDC 63304-654-20 Bottles of 20

NDC 63304-654-30 Bottles of 30

NDC 63304-654-01 Bottles of 100

NDC 63304-654-05 Bottles of 500

NDC 63304-654-77 Strip unit-dose pack of 100s

500 mg Capsule

500 mg maroon opaque cap and yellow opaque body, size 0-el, printed “RX655” on both cap and body.

NDC 63304-655-20 Bottles of 20

NDC 63304-655-30 Bottles of 30

NDC 63304-655-40 Bottles of 40

NDC 63304-655-50 Bottles of 50

NDC 63304-655-01 Bottles of 100

NDC 63304-655-05 Bottles of 500

NDC 63304-655-77 Strip unit-dose pack of 100s

Amoxicillin Tablets:

Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

500 mg Tablet

500 mg pink colored, film coated, capsule shaped tablets; debossed with “RX762” on one side and plain on the other.

NDC 63304-762-82 Bottles of 12

NDC 63304-762-20 Bottles of 20

NDC 63304-762-01 Bottles of 100

NDC 63304-762-13 Bottles of 120

NDC 63304-762-05 Bottles of 500

875 mg Tablet

875 mg pink colored, film coated, capsule shaped tablets; debossed with “RX763” on one side and scored on reverse side.

NDC 63304-763-82 Bottles of 12

NDC 63304-763-20 Bottles of 20

NDC 63304-763-01 Bottles of 100

NDC 63304-763-13 Bottles of 120

NDC 63304-763-05 Bottles of 500

Amoxicillin Chewable Tablets:

Each chewable tablet contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

125 mg Tablet

125 mg pink colored, strawberry flavored, oval biconvex tablets, with mottled appearance; debossed with “RX514” on one side.

NDC 63304-514-01 Bottles of 100

NDC 63304-514-05 Bottles of 500

200 mg Tablet

200 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX760” on one side.

NDC 63304-760-20 Bottles of 20

NDC 63304-760-01 Bottles of 100

NDC 63304-760-05 Bottles of 500

250 mg Tablet

250 mg pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX515” on one side.

NDC 63304-515-30 Bottles of 30

NDC 63304-515-01 Bottles of 100

NDC 63304-515-04 Bottles of 250

400 mg Tablet

400 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX761” on one side.

NDC 63304-761-20 Bottles of 20

NDC 63304-761-01 Bottles of 100

NDC 63304-761-05 Bottles of 500

Amoxicillin For Oral Suspension:

200 mg /5mL

The 200 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:

NDC 63304-969-03 50 mL Bottles

NDC 63304-969-01 75 mL Bottles

NDC 63304-969-04 100 mL Bottles

400 mg /5mL

The 400 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:

NDC 63304-970-03 50 mL Bottles

NDC 63304-970-01 75 mL Bottles

NDC 63304-970-04 100 mL Bottles

*SHAKE ORAL SUSPENSION WELL BEFORE USING.

Store at 20 – 25°C (68 – 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.

References

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Fourth Edition;

Approved Standard. NCCLS Document M7-A4, Vol. 17, No.2. NCCLS, Wayne, PA, January 1997.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition; Approved Standard. NCCLS

Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997.

3. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol 1988;30:66-67.

CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation.

CLOtest is a registered trademark of Kimberly-Clark Corporation.

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