Details for: JAMP-AMOXICILLIN
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02433060 | JAMP-AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 250 MG | CAPSULE | ORAL |
| 02433079 | JAMP-AMOXICILLIN | AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 500 MG | CAPSULE | ORAL |
Summary Reports
Summary Safety Review - Amoxicillin-containing Products - Assessing the Potential Risk of Aseptic Meningitis
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
JAMP-AMOXICILLIN is used to treat bacterial infections, such as:
- infections of upper respiratory tract (ear, nose, tonsils and throat);
- infections of lower respiratory tract (bronchi and lungs)
- urinary tract infections
- infections of the skin
- Gonorrhea
Antibacterial drugs like JAMP-AMOXICILLIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, JAMP-AMOXICILLIN should be used exactly as directed. Misuse or overuse of JAMP-AMOXICILLIN could lead to the growth of bacteria that will not be killed by JAMP-AMOXICILLIN (resistance). This means that JAMP-AMOXICILLIN may not work for you in the future. Do not share your medicine.
What it does
Amoxicillin interferes with the synthesis of the bacterial cell wall, contributing to bacterial death.
When it should not be used
You should not take JAMP-AMOXICILLIN if:
- you have ever had an unusual hypersensitivity or allergic reaction to penicillin or to any other component of this product
- have infectious mononucleosis (suspected or confirmed)
What the medicinal ingredient is
JAMP-AMOXICILLIN contains the active ingredient called amoxicillin.
What the non-medicinal ingredients are
JAMP-AMOXICILLIN also contains the following nonmedicinal
ingredients:
250 mg and 500 mg capsules: Magnesium stearate, talc, gelatin
If you are on a special diet, or if you are allergic to any
substance, ask your doctor or pharmacist whether any of these
ingredients may cause a problem.
What dosage form it comes in
JAMP-AMOXICILLIN is available as capsules, 250 mg in # 1 capsules with red cap and white body, 500 mg in #0 capsules with red cap and white body
Warnings and precautions
Serious and occasionally fatal allergic (hypersensitivity)
reactions have been reported in patients on penicillin
therapy (see Side Effects and Serious Side Effects)
BEFORE you use JAMP-AMOXICILLIN talk to your doctor or
pharmacist if:
- you have previous hypersensitivity reactions to penicillins and other allergens
- you have any allergies to this drug or its ingredients or components of the container
- you are taking anticoagulants – please advise of any signs of bleeding including prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeds from gums brushing, unusual bleeding or bruising, red or brown urine or red or black stools
- you have kidney problems. Your doctor may monitor your kidney and liver functions during prolonged therapy with JAMP-AMOXICILLIN.
As the safety of JAMP-AMOXICILLIN in the treatment of infections in pregnancy is not established, your doctor will determine if JAMP-AMOXICILLIN treatment is suitable for you.
Interactions with this medication
As with other medicines, interactions with other drugs are
possible. Therefore, do not take any other medicines unless you
have discussed the matter with your physician or your pharmacist.
Talk to your doctor before taking the following drugs, as there
may be interactions:
- methotrexate (anti-cancer agent), probenecid (gout treatment), tetracyclines (antibiotics), oral contraceptives, anticoagulants (e.g. warfain).
Before taking JAMP-AMOXICILLIN make sure your doctor knows about all the medications you are taking, including those not prescribed by your doctor. It may be necessary to change the dose, take other precautions, or perhaps stop one of the medicines. This applies to both prescription and non-prescription medicines.
Proper use of this medication
Usual dose
It is very important that you take this medicine exactly as your
doctor tells you in order to get the best results and reduce the
chance of side effects.
Infections of upper respiratory tract (ear, nose, tonsils and
throat) and Infections of urinary tract
The usual dosage for the treatment of upper respiratory tract and
urinary infections is one 250 mg tablet every 8 hours for adults.
For children under 20 kg, the dose should be calculated by your
doctor considering 20 mg/kg/day in divided doses every 8 hours.
In severe infections the recommended dose for adults is 500 mg
every 8 hours and for children under 20 kg, 40 mg/kg/day in
divided doses every 8 hours. For children over 20 kg, the adult
dose should be used.
Infections of lower respiratory tract (bronchi and lungs)
The recommended dose for adults is 500 mg every 8 hours and for
children 40 mg/kg/day in divided doses every 8 hours.
The children's dosage should not exceed that recommended for
adults. Children weighing more than 20 kg should be dosed
according to the adult recommendations.
Overdose
Hemodialysis would be the proper treatment in case of severe
overdose.
Activated charcoal may be administered to aid in the removal
of unabsorbed drug. General supportive measures are
recommended.
Missed Dose
Try to take your dose as per your doctor’s recommendations. If you/your child miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.
Side effects and what to do about them
Like all medicines, JAMP-AMOXICILLIN may cause unwanted reactions, so called side effects. Most patients do not experience side effects from JAMP-AMOXICILLIN. Examples of occasional side effects include:
- Nausea
- Vomiting and diarrhea
- Skin rashes
If you suffer severe, persistent diarrhea (bloody or watery), with or without fever, abdominal pain and vomiting, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking JAMP-AMOXICILLIN and call your healthcare professional immediately.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Common | |||
| Allergic reactions Skin rash, skin eruption or other effect on the skin or eyes | ✔ | ||
| Uncommon | |||
| Gastrointestinal (nausea, vomiting, diarrhea, bloody stool) | ✔ | ||
| Serious Allergic Reactions anaphylaxis – (swollen nose, eyes, throat, difficulty breathing, and serious skin reactions such as blistering, peeling skin, rash) | ✔ | ||
| Kidney disorder (excretion of crystals in the urine – crystalluria) | ✔ | ||
| Liver disorder yellowing of the skin and eyes (Jaundice), abdominal pain, nausea, cytolytic hepatitis (destruction of liver cells), | ✔ | ||
| Oral (glossitis – black “hairy” tongue and stomatitis, tooth discoloration in children (brown, yellow or gray staining) | ✔ | ||
| Central Nervous System (dizziness, anxiety, insomnia, confusion, behavioral changes | ✔ | ||
| Blood problems such as leukopenia (low white blood cell count), neutropenia (low blood cell count ) | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Do not take JAMP-AMOXICILLIN past the expiry date shown on the
pack.
Store your JAMP-AMOXICILLIN as follows: Store in original
package at 25°C with excursions permitted to 15°C - 30°C.
Always remember
This medicine has been prescribed to you for your current medical
problem only. Do not give it to other people.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhpmps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph prepared for
health professionals can be found by contacting the sponsor Jamp
Pharma at:
1-866-399-9091
This leaflet was prepared by Jamp Pharma
Last revised: November 30, 2017