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Details for: BOTOX COSMETIC

Company: ALLERGAN INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02243721BOTOX COSMETICONABOTULINUMTOXINA100 UNIT / VIALPOWDER FOR SOLUTIONINTRAMUSCULAR
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Summary Reports

Regulatory Decision Summary

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

BOTOX COSMETIC® is used to treat upper facial lines, including forehead, crow’s feet, and frown lines.

What it does

BOTOX COSMETIC® is a muscle relaxant that is injected into the muscles. It works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. The muscle relaxation is reversible with a time limited duration of effect.

When it should not be used

  • you are allergic or sensitive to any of the ingredients;
  • you have an infection in the muscles where it would normally be injected;
  • you have any muscle disorders in other parts of your body, including myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis.
What the medicinal ingredient is

OnabotulinumtoxinA

What the non-medicinal ingredients are

Albumin (human) and sodium chloride.

What dosage form it comes in

Sterile vacuum-dried concentrate; powder for solution for injection; 50, 100 and 200 Allergan units per vial.

Warnings and precautions

Serious Warnings and Precautions

  • BOTOX COSMETIC® should only be given by a physician or authorized prescriber with the appropriate qualifications and experience in the treatment and the use of required equipment.
  • DISTANT SPREAD OF TOXIN EFFECT: The effects of BOTOX COSMETIC® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
  • Seek immediate medical attention if swallowing, speech or respiratory problems arise.
  • Tell your doctor if you experience any difficulties in swallowing food while on BOTOX COSMETIC® , as it could be related to the dosage. Difficulty in swallowing food, ranging from very mild to severe, can persist for 2-3 weeks after injection, or longer.
  • Tell your doctor if you are taking other medicines, including any you have bought at your pharmacy, supermarket or health food shop.

To help avoid side effects and ensure proper use, talk to your doctor or healthcare professional before you take BOTOX COSMETIC® . Talk about any health conditions or problems you may have, including if you:

  • you have myasthenia gravis or Eaton Lambert Syndrome, amyotrophic lateral sclerosis or another muscle disorder;
  • you are allergic or sensitive to BOTOX COSMETIC® ;
  • you have an infection at a proposed injection site;
  • you are scheduled to have surgery using a general anaesthetic;
  • you are taking or are likely to take antibiotics, especially aminoglycoside antibiotics;
  • you are pregnant or become pregnant while taking this drug. Repeated doses of BOTOX COSMETIC® given to rabbits during pregnancy have caused abortion or fetal malformations;
  • you are nursing. It is not known whether this drug is excreted in human milk, but many drugs are excreted in human milk.

BOTOX COSMETIC® is for intramuscular use only.

Other warnings you should know about

Seek immediate medical care if swallowing, speech or respiratory problems arise

Tell your healthcare professional if you experience any difficulties in swallowing food while on BOTOX COSMETIC® , as it could be related to the dosage. Difficulty in swallowing food, ranging from very mild to severe, can persist for 2-3 weeks after injection, or longer.

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 effect of BOTOX COSMETIC® may be increased by aminoglycoside antibiotics (e.g. streptomycin, tobramycin, neomycin, gentamicin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin or any other drugs that interfere with neuromuscular transmission.

Proper use of this medication

Overdose

In case of drug overdose, contact a 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

These are not all the possible side effects you may feel when receiving BOTOX COSMETIC® . If you experience any side effects not listed here, contact your healthcare professional.

General

Pain, tenderness and/or bruising at the site of injection. Malaise (generally feeling unwell), lasting up to six weeks after injection with BOTOX COSMETIC® . Weakness and rarely, changes in the way the heart beats, chest pain, skin rash and allergic reaction (symptoms: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin).

The following side effects were reported in clinical trials: headache, drooping eyelid, eyelid swelling, eyelid change, bruising under the skin, aching or itching forehead, double vision, asymmetric smile, skin tightness, face pain, injection site pain/burning/stinging, swelling of the injection site, nausea, local muscle weakness, redness of the skin and abnormal sensation.

The following events have been reported rarely ( <0.1%) since BOTOX COSMETIC® has been marketed: skin rash, itching, allergic reaction (including anaphylaxis), dysphagia, respiratory compromise, seizures, facial paralysis, dry mouth, abdominal pain, anorexia, diarrhea, vomiting, eye problems including glaucoma, double vision, blurred vision decreased eye sight, dry eye, ear problems including not hearing well, tinnitus, numbness in your face, localised muscle twitches, tiredness. There have also been rare reports after botulinum toxin treatment of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including cardiovascular disease.

Eyelid swelling has been reported following injections into area around eyes.

This is not a complete list of side effects. For any unexpected effects while taking BOTOX COSMETIC® , contact your healthcare professional.

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

Store the vacuum-dried product either in a refrigerator at 2° - 8°C, or in a freezer at or below -5°C.

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:

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

  • 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; the manufacturer’s website www.allergan.ca or by calling 1-800-668-6424.

This leaflet was prepared by Allergan Inc.
Last Revised: June-29-2020

Date modified: