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Botox (Generic OnabotulinumtoxinA Injection)

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WARNING

Onabotulinumtoxin A shot is administered as a series of microscopic injections that are solely meant to influence the targeted location. However, it’s possible that the medicine will impact muscles in other parts of the body after spreading from the injection site. You may experience severe breathing or swallowing difficulties that could last for several months and result in death if the muscles that govern these functions are compromised. To prevent food or drink from entering your lungs, you might need to be fed through a feeding tube if you have trouble swallowing.

Onabotulinumtoxin Although no one has yet had these symptoms after getting the medicine at the prescribed doses to treat wrinkles, eye issues, headaches, or extreme underarm perspiration, an injection may spread and cause symptoms in anyone of any age who are having treatment for any condition. Children receiving treatment for spasticity (muscle stiffness and tightness) and people who have or have ever had breathing or swallowing issues due to asthma or emphysema, or any condition that affects the muscles or nerves like amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) are likely to be at the highest risk of the medication spreading beyond the injection site. Motor neuropathy (condition where muscles deteriorate over time), Myasthenia gravis (condition where some muscles deteriorate, especially after activity), or Lambert-Eaton syndrome are all conditions where the nerves that regulate muscle action slowly die (condition that causes muscle weakness that may improve with activity). If you currently have or have ever had any of these conditions, let your doctor know.

Onabotulinumtoxin’s spread In addition to making it difficult to breathe or swallow, an injection into untreated areas can result in other symptoms. Hours after receiving an injection or even weeks later, symptoms may appear. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: the inability to control urine, loss of strength or muscle weakness throughout the body, double or blurred vision, drooping eyelids or brows, difficulty breathing, hoarseness or change in voice, or loss of voice.

Every time you receive an injection of onabotulinumtoxinA, your doctor will provide you a patient information leaflet (Medication Guide) from the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Why is this medication prescribed?

The injection of onabotulinumtoxinA (Botox, Botox Cosmetic) is used to treat a variety of ailments.

Using an injection of onabotulinumtoxinA (Botox), you can:

  • Alleviate adults 16 years of age and older from the symptoms of cervical dystonia (spasmodic torticollis; involuntary tightening of the neck muscles that may cause neck pain and aberrant head positions);
  • Reduce the signs of blepharospasm (uncontrollable tightening of the eyelid muscles that may result in abnormal eyelid movements, blinking, and squinting) and strabismus (an eye muscle disorder that causes the eye to turn inward or outward) in adults and adolescents 12 years of age and older;
  • Prevent headaches in adults over 18 who have chronic migraine, which causes intense, throbbing headaches that can occasionally be accompanied by nausea and sensitivity to light or sound, and who experience at least 15 days per month with headaches lasting four hours or more;
  • Treat overactive bladder (a condition where the bladder muscles spasm uncontrollably and result in frequent urine, a need to urinate immediately, and an inability to control urination) in adults 18 years of age and older when other drugs do not work well enough or cannot be administered;
  • When other drugs failed to work or were intolerable in children aged 5 and older with neurogenic detrusor overactivity (NDO; a bladder control disorder caused by a brain, spinal cord, or nerve problem);
  • Treating incontinence (urine leakage) in adults (18 years and older) with overactive bladder (condition in which the bladder muscles have uncontrollable spasms) brought on by nerve issues like spinal cord injury or multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, problems with vision, speech, and bladder control);
  • Treat adults and children 2 years of age and older with spasticity (muscle stiffness and tightness) of the arms and legs;
  • Relieve extreme underarm perspiration in adults (18 years of age and older) who are unable to be treated with topical treatments;

And

Using an injection of onabotulinumtoxinA (Botox Cosmetic),

  • In people 18 years of age and older, temporarily smooth frown lines (wrinkles between the eyebrows,
  • When used on people 18 years of age and older, crow’s foot wrinkles (wrinkles near the outer corner of the eye) are momentarily smoothed.
  • And in individuals 18 years of age and older to momentarily reduce forehead wrinkles.

The drug onabotulinumtoxinA injection belongs to a group of drugs known as neurotoxins. When onabotulinumtoxinA is injected into a muscle, it inhibits the nerve signals that result in the muscle’s irrational contraction and movement. Injecting onabotulinumtoxinA into a sweat gland causes the gland’s activity to decrease, which lessens sweating. Injecting onabotulinumtoxinA into the bladder reduces bladder contractions and obstructs signals that alert the nervous system to a full bladder.

How should this medicine be used?

Doctors can inject onabotulinumtoxin as an injection into a muscle, skin, or bladder wall by combining the powder form with a liquid. To treat your disease, your doctor will decide where to inject the medication best. You may need additional injections every 3 to 4 months, depending on your condition and how long the effects of the treatment last, if you are receiving onabotulinumtoxinA to treat frown lines, forehead lines, crow’s feet lines, cervical dystonia, blepharospasm, strabismus, spasticity, urinary incontinence, overactive bladder, or chronic migraines. If you are having onabotulinumtoxinA injections for neurogenic detrusor overactivity or intense underarm sweating, you might need to get more shots every six to seven months or as your doctor advises if your symptoms come back.

Your doctor will likely conduct a test to identify the areas that require treatment if you are receiving an injection of onabotulinumtoxinA to treat extreme underarm perspiration. How to get ready for this test will be given to you by your doctor. It is likely that you may be instructed to shave your underarms and refrain from using over-the-counter deodorants or antiperspirants for 24 hours before to the test.

Your doctor may recommend antibiotics for you to take for 1-3 days prior to your treatment, on the day of your treatment, and for 1 to 3 days following your treatment if you are receiving onabotulinumtoxinA injection to treat urine incontinence.

To determine the dosage that will work best for you, your doctor may adjust the onabotulinumtoxinA injection you are receiving.

Before injecting onabotulinumtoxinA, your doctor may numb your skin with an anaesthetic cream, a cold pack, or eye drops.

Botulinum toxin cannot be switched out for another brand or variety.

An injection of onabotulinumtoxinA may help you manage your disease, but it won’t make it go away. Before you get the full effects of the onabotulinumtoxinA injection, it could take a few days or even a few weeks. If your symptoms don’t go away within the anticipated time frame, call your doctor. Ask your doctor when you might expect to notice improvement.

Other uses for this medicine

An injection of onabotulinumtoxinA is also occasionally used to treat various disorders in which unnatural muscular tightening results in discomfort, unnatural motions, or other symptoms. Injections of onabotulinumtoxinA are also occasionally used to treat tremor (uncontrollable shaking of a region of the body), anal fissures, numerous types of facial wrinkles, and excessive hand sweating (a split or tear in the tissue near the rectal area). Additionally, the drug is occasionally used to help youngsters with cerebral palsy move more freely (condition that causes difficulty with movement and balance). The dangers of using this drug for your illness should be discussed with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving onabotulinumtoxinA injection,

  • If you have an allergy to onabotulinumtoxinA, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB, let your doctor and pharmacist know right away (Myobloc). Additionally, let your doctor know if you have any drug or onabotulinumtoxinA injectable ingredient allergies. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: anticoagulants (‘blood thinners’) such warfarin (Coumadin, Jantoven); antihistamines; some antibiotics like amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, kanamycin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin; heparin, medications for allergies, colds, or sleep, muscle relaxants, and platelet inhibitors like clopidogrel (Plavix), dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), and ticlopidine. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosy (Ticlid). Additionally, let your doctor know if you’ve recently had injections of any botulinum toxin, such as abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB (Myobloc). Your doctor might need to adjust the dosages or timing of your prescriptions, or he or she might need to keep a close eye out for any side effects. OnabotulinumtoxinA may also interact with a wide range of other drugs, so be sure to let your doctor know about every medicine you’re taking—even those that aren’t on this list.
  • Swelling, other infection-related symptoms, or indicators of weakening in the location where onabotulinumtoxinA will be administered should be reported to your doctor. A weak or contaminated spot won’t receive the pharmaceutical injection from your doctor.
  • If you will be receiving an injection of onabotulinumtoxinA to treat urinary incontinence, let your doctor know if you have urinary retention (inability to completely empty the bladder) and do not routinely empty your bladder with a catheter. Urinary retention can include symptoms like pain or burning when you urinate, frequent urination, or fever. Your doctor is unlikely to provide an injection of onabotulinumtoxinA to you.
  • Inform your doctor if you have or have ever had bleeding issues, seizures, hyperthyroidism (a condition in which the thyroid gland produces too much thyroid hormone), diabetes, lung or heart illness, or if you have had any negative effects from any botulinum toxin product, eye or facial surgery.
  • Your doctor will evaluate you if you will be receiving a onabotulinumtoxinA injection to treat wrinkles to determine whether the drug is likely to be effective for you. If you have drooping eyelids, difficulty raising your eyebrows, or any other alteration in how your face typically looks, onabotulinumtoxinA injection may not smooth your wrinkles or may create additional difficulties.
  • If you are 65 years of age or older and will be receiving an injection of onabotulinumtoxinA (Botox Cosmetic) to temporarily smooth out crow’s feet, forehead lines, or frown lines, you should be aware that this treatment has not been as effective for older adults as it has for people younger than 65 years of age.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you conceive while having an injection of onabotulinumtoxinA.
  • Inform the surgeon or dentist that you are receiving a onabotulinumtoxinA injection if you are undergoing surgery, including dental surgery.
  • You should be aware that onabotulinumtoxinA injection can impair vision or result in a loss of strength or muscular weakness throughout the body. Do not operate machinery, drive a car, or engage in any other risky activity if you have any of these symptoms.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

The injection of onabotulinumtoxinA may have unwanted effects. Since some adverse effects may be more common in the area of the body where you received the injection, ask your doctor the side effects you are most likely to suffer. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Injection site discomfort, sensitivity, pain, swelling, redness, bleeding, or bruising
  • Tiredness
  • Neck pain
  • Headache
  • Drowsiness
  • Discomfort, stiffness, tightness, weakness, or spasms in the muscles
  • Face or neck discomfort or stiffness
  • Mouth ache
  • Nausea
  • Constipation
  • Anxiety
  • Perspiration from locations other than the underarms on the body
  • Fever, nasal congestion, sneezing, cough, or sore throat

Some adverse effects can be very harmful. During the initial few weeks following your treatment, if you ever develop any of these symptoms or those in the IMPORTANT WARNING section, call your doctor right away or seek emergency medical attention:

  • Double, hazy, or reduced vision
  • Swollen eyelids
  • Changes in eyesight (such as light sensitivity or blurred vision)
  • Eyes that are itchy, dry, or hurt.
  • Face has trouble moving
  • Irregular heartbeat
  • Seizures
  • Experiencing discomfort in the chest
  • Arms, back, neck, or jaw ache
  • Breathing difficulty
  • Fainting
  • Dizziness
  • Rash
  • Hives
  • Itching
  • Edoema of the lower legs, ankles, feet, or hands
  • Mucus-producing cough, fever, or chills
  • An incapacity to urinate on your own
  • Frequent urination or discomfort or burning when urinating
  • Urinary blood
  • Fever

Other adverse effects from onabotulinumtoxinA injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs typically do not show up right away after the injection. Tell your doctor straight away if you received too much onabotulinumtoxinA or if you swallowed the drug. Also let them know if you have any of the following symptoms during the following few weeks:

  • Weakness
  • Having trouble moving any bodily portion
  • Having trouble breathing
  • Having trouble swallowing

What other information should I know?

Keep all of your doctor’s appointments.

Ask your pharmacist any inquiries you may have regarding the injection of onabotulinumtoxinA.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamiYou should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.ns and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Botox®
  • Botox® Cosmetic
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