Afamox® ( amoxicillin ) Capsule 250 mg

Amoxicillin

Category

Antibacterial (systemic)

Dosage forms

Capsule:

250 mg Amoxicillin(as trihydrate)

500 mg Amoxicillin(as trihydrate)

Dry Powder for Suspension:

125 mg Amoxicillin(as trihydrate)/5ml

250 mg Amoxicillin(as trihydrate)/5ml

Before Using This Medicine

 

• Read all of this leaflet carefully before you start taking this medicine.
• This medicine is available only with your doctor’s prescription.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• Tell your doctor if you have ever had any unusual or allergic reaction to any of the penicillins or cephalosporins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, dyes or procaines.

 

• Inform your doctor if you are taking or have recently taken other medicines, including medicines without a prescription. Please tell your doctor if you are taking any of the following medicines:

Anticoagulants, Dipyridamole, Heparin, Pentoxifylline, Plicamycin , Sulfinpyrazone, Oral contraceptives, Probenecid.

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 medicine.

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

 

• Allergy to penicillins
• Congestive heart failure
• Kidney disease
• Phenylketonuria
• Gastrointestinal disease, history of, specially antibiotic- associated collitis

Precautions While Using This Medicine

• If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
• Penicillins may cause diarrhea in some patients. Check with your doctor if severe diarrhea occurs. Do not take anti-diarrheal medicine, without your doctor’s prescription.
• For patients with diabetes, Penicillin and beta-lactamase inhibitor combinations may cause false test results with some urine sugar tests.
• Penicillins have not been studied in pregnant women. However, penicillins have been widely used in pregnant women and have not been shown to cause birth defects or other problems in animal studies.

 

• Penicillins pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.
• Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

 

 

How to use Amoxicillin

 

• Amoxicillin, may be taken on full or empty stomach.
• Amoxicilin Capsule: Swallow the capsule whole with a full glass of water.
• Amoxicillin Suspension: Prepare the suspension by dispersing the dry powder in the specified volume of water, shake the bottle well and use a specially marked measuring spoon or other device to measure each dose accurately.
• Do not use, after the expiry date on the label.

Dosing

 

• To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days.
• This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night.
• The dose of these medicines will be different for different patients. Follow your doctor’s orders. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
• For bacterial infections:

For oral dosage forms (capsule & oral suspension):

Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds):

250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours, depending on the type and severity of the infection.

Neonates and infants up to 3 months of age:

Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight or less every twelve hours.

 

Infants 3 months of age and older and children weighing up to 40 kg (88 lbs.):

Dose is based on body weight and must be determined by your doctor. The usual dose is 6.7 to 13.3 mg per kg (3 to 6 mg per pound) of body weight every eight hours or 12.5 to 22.5 mg per kg (5.7 to 10.2 mg per pound) of body weight every twelve hours

• For duodenal ulcers (associated with Helicobacter pylori bacterial infection)

For oral dosage forms (capsule & oral suspension):

 

• For triple medicine therapy:

Adults: 1000 mg twice a day every twelve hours for fourteen days, along with the two other medicines, Clarithromycin and Lansoprazole, as directed by your doctor.

Teenagers and children: Use and dose must be determined by your doctor.

• For dual medicine therapy:

Adults: 1000 mg three times a day every eight hours for fourteen days, along with the other medicine, lansoprazole, as directed by your doctor.

Teenagers and 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. This will help to keep a constant amount of medicine in the blood or urine. 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 dose.

• In case of emergency/overdose: In case of overdose, call your local poison control center.

Side Effects of This Medicine

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. Stop taking this medicine and get emergency help immediately if any of the following side effects occur:

Incidence less frequent:

Allergic reactions specifically anaphylaxis (Fast or irregular breathing, puffiness or swelling around face, shortness of breath, sudden and severe decrease in blood pressure), red and scaly skin, serum sickness like reactions (skin rash, joint pain, fever).

Incidence rare:

Abdominal or stomach cramps and pain (severe), abdominal tenderness, convulsions (seizures), decreased amount of urine, diarrhea (watery and severe), which may also be bloody, mental depression, nausea and vomiting, sore throat and fever, unusual bleeding or bruising, yellow eyes or skin.

 

Note: Some of the above side effects (severe abdominal or stomach cramps and pain, and watery and severe diarrhea, which may also be bloody) may also occur up to several weeks after you stop taking any of these medicines.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Diarrhea (mild), headache, sore mouth or tongue, vaginal itching and discharge, white patches in the mouth and/or on the tongue.

Storage

• Keep out of the reach of children.
• Store away from heat, moisture and direct light.
• Store dry powder at temperature below 30ºC. Store in the original container. Keep the container tightly closed.
• Store suspension after reconstitution in the refrigerator. Shake well before each dose. Do not freeze. Discard any unused suspension after 14 days.
• Store capsules below 30°C .

Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Reference

 

USP DI 2007 ( Page No: 2304-2311)