Botox (OnabotulinumtoxinA) - Intramuscular, Intradetrusor, or Intradermal

What Is Botox?

Botox (onabotulinumtoxinA) is a prescription injection with various medical uses. It is injected into certain areas of the body by a healthcare provider to treat the following conditions:

• Certain types of eye muscle problems (strabismus) or abnormal eyelid spasms (blepharospasm) in people 12 years and older.
• Abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
• Prevent headaches in adults with chronic migraines who have 15 or more days each month with a headache lasting four or more hours each day.
• Symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.
• Overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
• Leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
• Increased muscle stiffness in people 2 years and older with spasticity.

Botox helps to treat most of these conditions because it can block the nerve signals when it is injected into specific muscles of the body (neuromuscular blocking agent). It also inhibits the release of acetylcholine, a type of chemical messenger or neurotransmitter. This prevents muscle contraction which leads to muscle paralysis.

What Is Botox Used For?

Botox is used to treat the following conditions:

• Certain types of eye muscle problems (strabismus) or abnormal eyelid spasms (blepharospasm) in people 12 years and older.
• Abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
• Prevent headaches in adults with chronic migraines who have 15 or more days each month with a headache lasting four or more hours each day.
• Symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.
• Overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
• Leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
• Increased muscle stiffness in people 2 years and older with spasticity.
  

How to Take Botox

Your healthcare provider will prescribe your exact dose of Botox and tell you how often it should be given. A few things to keep in mind while taking Botox:

• A healthcare provider gives this medicine as a shot under your skin or into a muscle.
• You may be given medicine to numb the injection site.
• If you receive Botox around your eyes, you may be given eye drops or ointment to numb the area. After your injection, you may need to wear a protective contact lens or an eye patch.
• If you are being treated for bladder problems, you may also receive medicine to help prevent urinary tract infections before, during, or after treatment with Botox.
• If you are being treated for excessive sweating, shave your underarms but do not use deodorant for 24 hours before your injection. Avoid exercise, hot foods or liquids, or anything else that could make you sweat for 30 minutes before your injection.
• The recommended treatment schedule for chronic migraine is every 12 weeks.
• Botox starts working slowly. Once your condition has improved, the medicine will last about three months. Then, the effects will slowly go away. You might need more injections to treat your condition.
  

Storage

Botox is normally stored, handled, and usually administered by your healthcare provider. Unopened vials of Botox are stored in a refrigerator for up to 36 months. Once Botox is reconstituted for injection, it should be stored in a refrigerator and used within 24 hours. Reconstituted Botox should be clear, colorless, and free of particulate matter.

Off-Label Uses

Healthcare providers may prescribe Botox for off-label uses, meaning for conditions not specifically indicated by the Food and Drug Administration (FDA). 

Off-label uses of Botox include:

• Achalasia (movement disorder of the esophagus that causes difficulty swallowing and other problems)
• Chronic anal fissure
• Auriculotemporal syndrome
• Back pain
• Benign prostatic hyperplasia (BPH)
• Cervicogenic headache (headache that seems to come from the neck)
• Detrusor sphincter dyssynergia (other bladder dysfunction issues)
• Difficulty talking after removal of part or all of the larynx (voice box) (total laryngectomy)
• Disorder of esophagus
• Disorder of the nervous system (excessive drooling)
• Epicondylitis/tennis elbow
• Essential tremor
• Excessive drooling due to advanced Parkinson's disease
• Excessive tear production
• Gilles de la Tourette syndrome
• Granuloma (inflammation) of the vocal cords that do not respond to standard surgical and medical therapies
• Hemifacial spasm (nervous system disorder in which the muscles on one side of your face twitch involuntarily)
• Pain after a hemorrhoidectomy (surgery to remove internal or external hemorrhoids that are extensive or severe)
• Trigeminal neuralgia of unknown cause that has not responded to treatment
• Infantile esotropia
• Injury to the oculomotor nerve (acute)
• Isolated oromandibular dystonia (involuntary movement or spasm of the lips and tongue, involuntary jaw opening or closing, and lip pursing)
• Larynx closure in a surgical procedure
• Prevention of migraine episodes
• Organic voice tremor
• Constipation due to abnormal movement of the pelvic floor muscles
• Spasms of a pharyngoesophageal segment (upper esophagus) after removal of part or all of the larynx (voice box) (total laryngectomy)
• Spastic dysphonia (voice disorder)
• Stuttering
• Tardive dyskinesia
• Temporomandibular joint disorder (TMJ)
• Tension-type headache
• Thoracic outlet syndrome
• Whiplash injury to the neck
  

What Are the Side Effects of Botox?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The common side effects of Botox may vary depending on which condition your healthcare provider is treating and where they inject the medication. The common side effects of Botox include:

• Injection site pain
• Sweating
• Backache
• Neck pain
• Pain in limb
• Headache
• Dry eyes
• Drooping eyelid(s)
• Inability to empty all the urine from your bladder (urinary retention)
• Urinary tract infections
• Cough
• Rhinitis (nose membrane inflammation due to a virus)
• Upper respiratory infection
• Fever 
• Flu-like symptoms
  

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency. Serious side effects and their symptoms can include the following:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness or trouble breathing
• Blurred or double vision, droopy eyelids, increased pressure behind the eyes
• Change in how much or how often you urinate, trouble urinating, painful urination, bloody or cloudy urine, lower back or side pain
• Changes in speech
• Chest pain, slow or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Headache, increased sweating, warmth or redness in your face, neck, or arm
• Muscle weakness
• Seizures
• Trouble swallowing, talking, or breathing
• Death
  

Long-Term Side Effects

Long-term effects of Botox are lacking.

Dosage: How Much Botox Should I Take?

Your healthcare provider will determine and administer the proper dosage of Botox for you.

Modifications

The following modifications (changes) should be kept in mind when using Botox:

Pregnancy or breastfeeding: There's not enough scientific evidence available to tell whether there would be a risk to your fetus when used during pregnancy or to your child during breastfeeding. If you're pregnant or breastfeeding, please talk with your healthcare provider before starting Botox.

Adults over 65: Based on the clinical studies of Botox, no overall differences in safety or effectiveness were found between adults over 65 and adults less than 65. However, some adults over 65 may be more sensitive to Botox than others.

Children: It is not known whether Botox is safe and effective in people younger than:

• 18 years for the treatment of urinary incontinence
  
• 18 years for the treatment of chronic migraine
  
• 18 years for the treatment of cervical dystonia
  
• 18 years for the treatment of hyperhidrosis
  
• 12 years for the treatment of strabismus or blepharospasm
  
• 2 years for the treatment of spasticity

Missed Dose

If you miss your appointment to receive your Botox injection please call your healthcare provider for further instructions.

Overdose: What Happens If I Take Too Much Botox?

The symptoms of a suspected overdose of Botox include progressive weakness and paralysis that may lead to trouble breathing (respiratory failure). Symptoms of overdose are likely not to be present immediately following injection. Signs of systemic weakness and muscle paralysis may occur within a day of a large exposure or up to several weeks after a smaller exposure.

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Botox?

You should not take Botox if you have one of the following:

• If you're allergic to any botulinum toxin product or any of the components in the formulation. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.
• Present infection at the proposed injection site(s).
• For intradetrusor (bladder) injection: Current urinary tract infection or urinary retention or post-void residual (PVR) urine volume >200 milliliters (mL) and not routinely performing clean intermittent self-catheterization (CIC), a method of draining urine via a catheter inserted into the urethra, past the sphincter into the bladder.

Please let your healthcare provider know if you have breathing or lung problems, bleeding problems, heart or blood vessel disease, or nerve or muscle problems (including Lou Gehrig disease, Lambert-Eaton syndrome, or myasthenia gravis) because taking Botox may worsen your condition. Also, tell your healthcare provider if you have ever had face surgery or have a urinary tract infection, trouble urinating, diabetes, or multiple sclerosis.

What Other Medications Interact With Botox?

Use caution when taking Botox with the following medications:

• Aminoglycosides such as amikacin, Gentak (gentamicin), streptomycin, Tobrex (tobramycin), and other drugs that interfere with neuromuscular transmission
• Anticholinergic drugs
• Muscle relaxers
• Other botulinum neurotoxin products

This is not a complete list of medicines that interact with Botox.

For more detailed information about medication interactions with Botox, speak with your pharmacist or other healthcare provider. 

Be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Botox is a Botulinum toxin Type A. Dysport and Xeomin are Type A Botulinum toxin injections like Botox.

How Can I Stay Healthy While Taking Botox?

Below are some general tips to support your health while taking Botox:

• Botox may cause loss of strength, muscle weakness, blurred vision, dizziness, or drooping eyelids. Do not drive or do anything else that could be dangerous until you know how Botox affects you.
• Your healthcare provider will schedule follow-up appointments to check on the effects of Botox.
• Keep all appointments and follow up with your healthcare provider to ensure successful treatment.