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Details for: AMPICILLIN SODIUM FOR INJECTION, USP

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
01933345AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)1 G / VIALPOWDER FOR SOLUTIONINTRAVENOUS
01933345AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)1 G / VIALPOWDER FOR SOLUTIONINTRAMUSCULAR
01933353AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)2 G / VIALPOWDER FOR SOLUTIONINTRAVENOUS
01933353AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)2 G / VIALPOWDER FOR SOLUTIONINTRAMUSCULAR
00872644AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)250 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
00872644AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)250 MG / VIALPOWDER FOR SOLUTIONINTRAMUSCULAR
00872652AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)500 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
00872652AMPICILLIN SODIUM FOR INJECTION, USPAMPICILLIN (AMPICILLIN SODIUM)500 MG / VIALPOWDER FOR SOLUTIONINTRAMUSCULAR
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Summary Reports

Summary Safety Review - Beta-lactam antibiotics - Assessing the potential risk of severe skin side effects

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

AMPICILLIN SODIUM FOR INJECTION is used to treat certain infections of the:

  • Ear
  • Nose
  • Throat
  • Lower Respiratory tract
  • Antibacterial drugs like AMPICILLIN SODIUM FOR INJECTION treat onlv bacterial infections. They do not treat viral infections.
What it does

AMPICILLIN SODIUM FOR INJECTION is an antibiotic that works by:

  • Stopping the growth of bacteria.
  • Killing bacteria.

When it should not be used

Do not use AMPICILLIN SODIUM FOR INJECTION if:

  • You have had an allergic reaction to AMPICILLIN SODIUM FOR INJECTION or other medicines such as cephalosporins or penicillins.
What the medicinal ingredient is

Ampicillin Sodium
Each gram of ampicillin sodium for injection contains approximately 60 mg, or approximately 6-8% sodium.

What dosage form it comes in

AMPICILLIN SODIUM FOR INJECTION is supplied as a dry powder in vials containing: 250 mg, 500 mg, 1,000 mg or 2,000 mg of ampicillin base as the sodium salt.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMPICILLIN SODIUM FOR INJECTION. Talk about any health conditions or problems you may have, including if you:

  • Have severe kidney disease with or without significant liver disease
  • Are pregnant or planning to become pregnant
  • Are breast feeding or planning to breastfeed.
Other warnings that you should know:

AMPICILLIN SODIUM FOR INJECTION may affect certain urine test results. Remind your healthcare professional that you are taking AMPICILLIN SODIUM FOR INJECTION if a urine test is ordered.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with AMPICILLIN SODIUM FOR INJECTION:

  • Allopurinol, used to treat gout or kidney stones

Proper use of this medication

How to take AMPICILLIN SODIUM FOR INJECTION:

  • Although you may feel better early in treatment, AMPICILLIN SODIUM FOR INJECTION should be used exactly as directed.
  • Misuse or overuse of AMPICILLIN SODIUM FOR INJECTION could lead to the growth of bacteria that will not be killed by AMPICILLIN SODIUM FOR INJECTION (resistance). This means that AMPICILLIN SODIUM FOR INJECTION may not work for you in the future.
  • Do not share your medicine.

Usual Dose

Adults: Your doctor will decide your dose based on your infection. The usual dose is 250 mg – 500 mg every 6 hours.

Children: Your doctor will decide your child’s dose based on your child’s weight and their infection.

Overdose

If you think you have taken too much AMPICILLIN SODIUM FOR INJECTION, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Side effects and what to do about them

What are possible side effects from using AMPICILLIN SODIUM FOR INJECTION?
These are not all the possible side effects you may feel when taking AMPICILLIN SODIUM FOR INJECTION. If you experience any side effects not listed here, contact your healthcare professional.

  • Upper stomach pain
  • Flatulence
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 for any side effect that seems unusual or that is especially bothersome.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Rare
an allergic reaction (difficulty in breathing, closing of the throat, swelling of the lips, face or tongue; hives or a rash)     ✔
redness, or itching     ✔
severe nausea, vomiting, or diarrhea     ✔
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
  • Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish)
  • Swelling and redness of eyes or face
  • Flu-like feeling, fever, chills, body aches, swollen glands, cough
  • Shortness of breath, chest pain or discomfort
    ✔

This is not a complete list of side effects. For any unexpected effects while taking AMPICILLIN SODIUM FOR INJECTION, contact your doctor or pharmacist.

How to store

Dry Powder: Store the dry powder at controlled room temperature not exceeding 25°C.

Reconstituted Solutions: Use sterile water for injection as the only diluent. Reconstituted solutions should be used within 1 hour when kept at controlled room temperature not exceeding 25°C. Protect reconstituted solutions from freezing. Keep out of reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at MedEffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about AMPICILLIN SODIUM FOR INJECTION:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com

Date of Revision: February 14, 2020

Date modified: