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Introduction About NABOTA 100UNITS INJECTION

NABOTA 100UNITS INJECTION contains Botulinum Toxin Type A, which belongs to the group of medicines called Muscle relaxants. NABOTA 100UNITS INJECTION is used to manage persistent muscle spasms in the elbow, wrist, and hand, ankle, and foot in children aged two years or older with cerebral palsy. NABOTA 100UNITS INJECTION is used to support rehabilitation therapy. It is used to manage persistent muscle spasms in the hand, arm, shoulder, ankle or foot, eyelid and face, neck, and shoulders of adult patients.

NABOTA 100UNITS INJECTION is used to manage headaches in adult patients with chronic migraine, overactive bladder with leakage of urine (the sudden urge to empty your bladder and needing to go to the toilet more than usual), and leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis.

It is used to reduce excessive sweating of the armpits when other local treatments do not help. It is used for the temporary improvement in the appearance of vertical lines between the eyebrows seen at maximum frown and/or fan-shaped lines from the corner of the eyes seen at maximum smile and/or forehead lines seen at maximum raised eyebrows in adult patients.

NABOTA 100UNITS INJECTION should be used with caution if you suffer from cardiovascular disease (disease of the heart or blood vessels). NABOTA 100UNITS INJECTION is not recommended for use in pregnant and breastfeeding women.

The safety and effectiveness of NABOTA 100UNITS INJECTION have been established in children and adolescents over the age of two years for the management of persistent muscle spasms in the elbow, wrist, and hand or ankle and foot, associated with cerebral palsy.

NABOTA 100UNITS INJECTION should be used with caution in elderly patients aged 65 years and above with other serious illnesses. The most common side effects of using NABOTA 100UNITS INJECTION are drooping of the eyelid, difficulty in swallowing, pain, muscle weakness, urinary tract infection, painful urination after the injection, inability to empty the bladder (urinary retention), and pain at the site of injection. Consult your doctor if any of the side effects worsen.

Uses Of NABOTA 100UNITS INJECTION

To manage persistent muscle spasms in the elbow, wrist, and hand, ankle, and foot in children aged two years or older with cerebral palsy
To manage persistent muscle spasms in the hand, arm, shoulder, ankle or foot, eyelid and face, neck, and shoulders of adult patients
To manage headaches in adult patients with chronic migraine
To manage overactive bladder with leakage of urine
To reduce excessive sweating of the armpits
For the temporary improvement in the appearance of vertical lines between the eyebrows and/or fan-shaped lines from the corner of the eyes

How NABOTA 100UNITS INJECTION Works

NABOTA 100UNITS INJECTION works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. In the case of chronic migraine, it is thought that NABOTA 100UNITS INJECTION blocks pain signals, which indirectly blocks the development of a migraine.

When injected into the skin, NABOTA 100UNITS INJECTION works on sweat glands to reduce the amount of sweat produced. When injected into the bladder wall, NABOTA 100UNITS INJECTION works on the bladder muscle to stop leakage of urine (urinary incontinence) due to uncontrolled contractions of the bladder muscle.

How to use NABOTA 100UNITS INJECTION

NABOTA 100UNITS INJECTION will be administered only by a doctor or a nurse into your muscles (intramuscularly), into the bladder wall via a specific instrument (cystoscope) to inject into the bladder, or deep into the skin (intradermally). Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight, and disease condition.

Side Effects Of NABOTA 100UNITS INJECTION

Common

Upper respiratory tract infection
Nausea, dry mouth, constipation
Muscle weakness, tiredness
Pain at the site of injection or injection site haematoma or bruising
Problems with walking
Rash, irritation, itching, numbness
Pain or swelling in the hand and fingers
Fall
Joint pain or inflammation
Neck pain, muscle pain, stiff or sore muscles, increased muscle tension
Dizziness, sleepiness, headache
Feeling of weakness or generally unwell
Flu manifestations
Increase in headache or migraine
Weakness of the face muscles
Drooping of the eyelid
Urinary tract infection, painful urination after the injection
Inability to empty the bladder (urinary retention)
Incomplete emptying of the bladder, frequent daytime urination
Abdominal pain, lower abdominal pain
Face pain
Skin redness, hot flushes
Hair loss

Uncommon

Drooping of the muscles on one side of the face
Double vision, fever
Visual disturbance, blurred vision
Inflammation of the eyelid, eye pain
inflammation of the cornea (transparent surface covering the front of the eye), abnormal turning of the eyelids outwards or inwards
changes in voice
Skin pain, jaw pain
Anxiety
skin sensitivity to light, dry skin, itching
Muscle twitching
Mephisto sign (raising of the outer eyebrows)
Injection site tingling or numbness

Rare

Stop receiving NABOTA 100UNITS INJECTION and inform your doctor immediately if you experience any of the following side effects:

symptoms of severe allergic reaction such as hives, swelling of the face or throat causing wheezing, difficulty in breathing, swallowing, or speaking, feeling faint, and shortness of breath (possible)
difficulty in breathing, swallowing, or speaking after receiving BOTOX,

How To Manage Side Effects

Constipation

Try to eat more high-fiber foods such as fresh fruit, vegetables, and cereals, and drink plenty of water. If this does not help, consult your doctor about receiving alternate management for constipation.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol. Consult your doctor if your dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids, such as water or electrolytes. Applying pain-relieving balm to your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Nausea And Vomiting

Take NABOTA 100UNITS INJECTION with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Consult your doctor if your nausea worsens.

Skin rash Or Itching

Avoid hot baths because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your rashes worsen.

Stomach Pain

Try to rest and relax. Eat and drink slowly or try to eat smaller meals more frequently. Keep a heat pad on your stomach. Consult your doctor if the stomach pain does not improve.

Warning & Precautions

Pregnancy

Contraindicated

NABOTA 100UNITS INJECTION is not recommended for use during pregnancy, and women of childbearing potential are not using contraception.

Breastfeeding

Contraindicated

NABOTA 100UNITS INJECTION is not recommended for use in breastfeeding women.

Driving and Using Machines

Use with Caution

Do not drive or operate any machinery if you feel dizziness, sleepiness, tiredness, or problems with your vision.

Allergy

Contraindicated

NABOTA 100UNITS INJECTION is not recommended for use if you are allergic to botulinum toxin type A or any other ingredients in this medicine.

Heart Disease

Use with Caution

NABOTA 100UNITS INJECTION should be used with caution if you suffer from cardiovascular disease (disease of the heart or blood vessels).

Use In Pediatrics

Consult your doctor

Use In Geriatrics

Use with Caution

NABOTA 100UNITS INJECTION should be used with caution in elderly patients aged 65 years and above with other serious illnesses. There is limited experience of using NABOTA 100UNITS INJECTION in the management of vertical and/or fan-shaped and/or forehead lines in patients older than 65 years.

Others

NABOTA 100UNITS INJECTION is not recommended for use if:

you have an infection at the proposed site of injection
you are being treated for leakage of urine and have either a urinary tract infection or a sudden inability to empty your bladder (and are not regularly using a catheter)
you have bladder stones
you are being treated for leakage of urine and are not willing to begin using a catheter if required

Before receiving NABOTA 100UNITS INJECTION, inform your doctor if you:

ever had problems with swallowing or food or liquid accidentally going into your lungs, especially if you will be treated for persistent muscle spasms in the neck and shoulders
suffer from muscle problems or chronic diseases affecting your muscles (such as myasthenia gravis or Eaton Lambert Syndrome)
suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy)
have significant weakness or wasting of the muscles
have a history of any surgery that affects the muscle to be injected
have a previous history of fainting after receiving injection
have inflammation in the muscles or skin at the site of injection
have had problems in the past with previous botulinum toxin injections
have seizures
have closed-angle glaucoma (high pressure in the eye) or are at risk for developing this type of glaucoma
are scheduled for operation

Interactions

A. Drug-Drug Interactions:

Inform your physician if you are taking any of the following drugs before using NABOTA 100UNITS INJECTION:

Anticoagulants (blood thinners) (Ex. warfarin)
Antibiotics (Ex. gentamicin, tobramycin)
Anticholinesterase (Ex. neostigmine, pyridostigmine)
Muscle relaxants (Ex. diazepam, baclofen)
Antiplatelets (Ex. aspirin, clopidogrel)

B. Drug-food interactions:

Overdose:

NABOTA 100UNITS INJECTION will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to result in an overdose. If you have received too much of NABOTA 100UNITS INJECTION, you will experience muscle weakness, difficulty breathing, swallowing, or speaking due to muscle paralysis; food or liquid accidentally going into your lungs, which might cause pneumonia (infection of the lungs) due to muscle paralysis; drooping of the eyelids; double vision; and generalized weakness.

Synopsis

Drug	:	Botulinum Toxin Type A
Pharmacological Category	:	Muscle Relaxants
Therapeutic Indication	:	To manage persistent muscles, headaches, an overactive bladder, and excessive sweating of the armpits
Dosage Forms	:	Injection

More Information

Storage

Keep NABOTA 100UNITS INJECTION out of reach of children
Store NABOTA 100UNITS INJECTION in a refrigerator (2 °C–8 °C)

FAQs About NABOTA 100UNITS INJECTION

Q: What are the side effects of NABOTA 100UNITS INJECTION?

A: The most common side effects of using NABOTA 100UNITS INJECTION are drooping of the eyelid, difficulty in swallowing, pain, muscle weakness, urinary tract infection, painful urination after the injection, inability to empty the bladder (urinary retention), and pain at the site of injection. Consult your doctor if any of the side effects worsen.

Q: What is the use of NABOTA 100UNITS INJECTION?

A: NABOTA 100UNITS INJECTION is used to manage persistent muscle spasms in the elbow, wrist, and hand, ankle, and foot in children aged two years or older with cerebral palsy and persistent muscle spasms in the hand, arm, shoulder, ankle, or foot, eyelid and face, neck, and shoulders of adult patients.

NABOTA 100UNITS INJECTION is used to manage headaches in adult patients with chronic migraine, overactive bladder with leakage of urine, and leakage of urine due to bladder problems associated with spinal cord injury or multiple sclerosis.

It is used to reduce excessive sweating of the armpits when other local treatments do not help. It is used for the temporary improvement in the appearance of vertical lines between the eyebrows and/or fan-shaped lines from the corner of the eyes in adult patients.

Q: How NABOTA 100UNITS INJECTION is given?

A: NABOTA 100UNITS INJECTION will be administered only by a doctor or a nurse into your muscles (intramuscularly), into the bladder wall via a specific instrument (cystoscope) to inject into the bladder, or deep into the skin (intradermally). Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight, and disease condition.

Q: How does NABOTA 100UNITS INJECTION work?

A: NABOTA 100UNITS INJECTION works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. In the case of chronic migraine, it is thought that NABOTA 100UNITS INJECTION blocks pain signals, which indirectly blocks the development of a migraine.

Q: Is NABOTA 100UNITS INJECTION safe during pregnancy?

A: NABOTA 100UNITS INJECTION is not recommended for use during pregnancy, and women of childbearing potential are not using contraception.

Q: Can NABOTA 100UNITS INJECTION be used in children?

A: The safety and effectiveness of NABOTA 100UNITS INJECTION have been established in children and adolescents over the age of two years for the management of persistent muscle spasms in the elbow, wrist, and hand or ankle and foot, associated with cerebral palsy. Consult your child’s doctor for advice.

Q: Who should avoid using NABOTA 100UNITS INJECTION?

A: NABOTA 100UNITS INJECTION is not recommended for use if you have an infection at the proposed site of injection, are being treated for leakage of urine and have either a urinary tract infection or a sudden inability to empty your bladder (and are not regularly using a catheter), have bladder stones, are being treated for leakage of urine and are not willing to begin using a catheter if required, or are allergic to botulinum toxin type A.

Q: What precautions must be taken while using NABOTA 100UNITS INJECTION?

A: Before receiving NABOTA 100UNITS INJECTION, inform your doctor if you have cardiovascular disease, ever had problems with swallowing or food or liquid accidentally going into your lungs, especially if you will be treated for persistent muscle spasms in the neck and shoulders, suffer from muscle problems or chronic diseases affecting your muscles (such as myasthenia gravis or Eaton Lambert Syndrome), amyotrophic lateral sclerosis or motor neuropathy, weakness or wasting of the muscles, history of any surgery that affects the muscle to be injected, pervious history of fainting after receiving injection, or have inflammation in the muscles or skin at the site of injection, have had problems in the past with previous botulinum toxin injections, seizures, closed-angle glaucoma (high pressure in the eye) or are at risk for developing this type of glaucoma, or are scheduled for operation

Q: Does NABOTA 100UNITS INJECTION manage headaches?

A: NABOTA 100UNITS INJECTION is used to manage headaches in adult patients with chronic migraine. It has been shown to significantly reduce the frequency of days with headaches and to improve the quality of life of patients suffering from chronic migraine. After two treatment sessions, approximately 47% of patients had a 50% or greater reduction from baseline in the number of days with headaches they experienced.

Q: Can I drive after the procedure?

A: Do not drive or operate any machinery if you feel dizziness, sleepiness, tiredness, or problems with your vision.

References

1. Inderbir S. Padda; Prasanna Tadi. Botulinum Toxin. Stat Pearls. 2023. [Accessed on 12th September 2024] https://www.ncbi.nlm.nih.gov/books/NBK557387/

2. Allergan Pharmaceuticals Ireland. Electronic Medicines Compendium (EMC). [Revised in April 2024] [Accessed on 12th September 2024] https://www.medicines.org.uk/emc/files/pil.859.pdf

3. Allergan Pharmaceuticals Ireland. Botulinum Toxin Type A. [Accessed on 12th September 2024] https://media.allergan.com/actavis/actavis/media/general/Oman-PIL-BOTOX-100U.pdf

4. Drug bank. Botulinum Toxin Type A. [Accessed on 12th September 2024] https://go.drugbank.com/drugs/DB00083

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Author Details

Written By Dr. N. Sai Swaroop - Pharm.D

Reviewed For Accuracy By Dr. Sankara Babu Gorle - MBBS, MD (Pharmacology)

Last updated on 13 Sep 2024 | 05:32 PM(IST)