BOTOX 100U  (1 VIAL)

Generic Name: botulinum toxin type A
Brand Name: Botox
Drug class: Skeletal muscle relaxants

WHAT IS THE DOSAGE OF THIS MEDICATION?

Botox is available in sterile vials containing 50, 100, or 200 Allergan units of Clostridium botulinum toxin type A.

WHAT IS THIS MEDICATION USED FOR?

Botulinum toxin is a neuromuscular paralytic agent. It blocks the nerves that are responsible for muscle activity and helps to relax muscles that are in constant contraction (spasm). It is used to treat conditions that are caused by certain muscles going into spasm. These include:

• blepharospasm, a condition where the eyelid will not stay open because of a spasm of a muscle in the eye

• cervical dystonia, also known as spasmodic torticollis, a condition in which the muscles of the neck stay in a state of contraction

• focal spasticity such as arm spasms after a stroke

• chronic drooling (sialorrhea) caused by nerve disorders

Botulinum toxin is injected into a muscle (or under the skin when used for excessive underarm sweating) by a qualified health professional. When given for conditions of the eye, the medication is injected into the surrounding muscle or tissue of the eye.

The dose of medication required depends on the condition being treated and individual circumstances. More than one dose may be required, depending on the condition being treated. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive botulinum toxin, contact your doctor as soon as possible to reschedule your appointment. It is very important to keep your appointments for treatment and follow-up.

The dried product should be stored in a refrigerator at 2°C to 8°C, or in a freezer at or below -5°C. The dried product should be diluted with the supplied solution after it is removed from the freezer and kept in the refrigerator until use or up to 24 hours. This medication should be kept out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not take this medication if you:

• are sensitive or allergic to botulinum toxin or to any of the ingredients of this medication

• have an infection at the site the injection is to be given

• have myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome

POTENTIAL INTERACTION WITH OTHER MEDICATION

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

The following medications could potentially interact with this medication:

• aclidinium

• aminoglycoside antibiotics (e.g., gentamicin, neomycin, tobramycin, streptomycin)

• amoxapine

• antihistamines (e.g., brompheniramine, diphenhydramine)

• antipsychotics (e.g. clozapine, olanzapine, risperidone)

• atropine

• azelastine

• belladonna

• benztropine

• clidinium

• darifenacin

• disopyramide

• flavoxate

• glycopyrrolate

• ipratropium

• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)

• muscle relaxants (e.g., cyclobenzaprine, orphenadrine)

• oxybutynin

• quinidine

• scopolamine

• solifenacin

• tiotropium

• tolterodine

• tricyclic antidepressants (e.g., amitriptyline, clomipramine, imipramine)

• trospium

• umeclidinium

WHAT ARE THE SIDE EFFECTS OF THIS MEDICATION?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

This is not a complete list of possible side effects. If you notice other effects not listed, please contact your doctor or pharmacist.

Possible side effects include:

• General side effects:

  • pain, tenderness, or bruising at the place of injection

• When used for blepharospasm:

  • difficulty swallowing

  • drooping of the upper eyelid

  • double or blurred vision

  • dry eye

  • dry mouth

  • eye pain

  • headache

  • irritation or watering of the eye

  • nausea

  • not able to close the eye completely

  • sensitivity of the eye to light

  • speech problems

  • swelling of the eyelid

  • tiredness

  • vision impairment

• When used for cervical dystonia:

  • difficulty swallowing

  • dizziness

  • dry mouth

  • flu symptoms

  • headache

  • local or general weakness

  • muscle spasms, stiffness, or weakness

  • nausea

  • neck weakness

• When used for focal spasticity:

  • decreased coordination

  • difficulty swallowing

  • feeling of "pins and needles"

  • fever

  • flu symptoms

  • headache

  • increased sensitivity to touch

  • itching

  • joint pain

  • muscle tightness or weakness

  • nausea

  • pain in the affected limb (arm or leg)

• When used for chronic drooling (sialorrhea)

  • changed sense of taste

  • difficulty swallowing

  • dry mouth

  • feeling of pins and needles

  • speech problems

  • thickened saliva

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