くすりのしおり

Injection
Revised: 8/2021

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
BOTOX for Injection 100 units
 Active ingredient:
Botulinum toxin type A
 Dosage form:
injection
 Print on wrapping:

Effects of this medicine

This medicine inhibits neurotransmission at the nerve terminal, thereby relaxing muscles and suppressing sweating.
It is usually used to treat blepharospasm, hemifacial spasm, cervical dystonia, upper or lower limb spasticity, equinus foot deformity due to spasticity in juvenile cerebral palsy aged 2 years or over, severe primary axillary hyperhidrosis, strabismus and spasmodic dysphonia. It is also usually used to treat urinary urgency, frequent urination and urge incontinence due to overactive bladder and to treat urinary incontinence due to neurogenic bladder, in patients who have an inadequate response to or are intolerant of existing medication.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: systemic neuromuscular junction dysfunction, respiratory dysfunction, urinary tract infection, urinary retention which does not require routine urethral catheterization.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, this medicine is directly injected to affected areas intramuscularly or intradermally.
  • Effects of this medicine usually appear in 2 to 3 days and continue for 3 to 4 months (4 to 9 months for severe primary axillary hyperhidrosis, 4 to 8 months for overactive bladder and 8 to 11 months for neurogenic bladder). Therefore, repeated injections are needed.

Precautions while taking this medicine

  • This medicine may cause adverse reactions, such as lassitude, muscle weakness, dizziness and reduced visual acuity. Pay attention when operating dangerous machinery, such as driving a car.
  • If you have any restrictions on your daily activities before treatment, avoid performing physical exertion with excessive muscular contraction and resume activities gradually after starting injection of this medicine.
  • If you have a possibility of pregnancy, prevent pregnancy during treatment with this medicine and until the second menstrual period is over after the final injection.
  • Male patients should make sure to use adequate contraception during treatment with this medicine and for at least 3 months after the final injection.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include lagophthalmos, incomplete eyelid closure, localized muscle weakness (neck muscle weakness, drooping of a corner of the mouth, etc.), blepharoptosis, facial paralysis, lacrimation and dysphagia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • dyspnea, generalized hot flashes, rash [shock, anaphylaxis, serum sickness]
  • incomplete eyelid closure, dry eyes sensation, eye bloodshot [eye disorders (severe corneal exposure, persistent corneal epithelial defect, corneal ulcer, corneal perforation)]
  • difficulty in swallowing, change in voice quality, dyspnea [dysphagia, respiratory disorder]
  • convulsion, spasm, loss of consciousness [convulsive attack]
  • unable to empty your bladder on your own [urinary retention]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.