Neuronox

Neuronox Dosage/Direction for Use

Manufacturer:

Medytox

Distributor:

Medyceles
Full Prescribing Info
Dosage/Direction for Use
Blepharospasm: For blepharospasm, reconstituted NEURONOX (see Table 2) is injected using a sterile, 27 - 30 gauge needle without electromyographic guidance. The initial recommended dose is 1.25 - 2.5 U (0.05 ml, to 0.1 ml. volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient-usually defined as an effect that does not last longer than two months. However there appears to be little benefit obtainable from injecting more than 5.0 U per site. Some tolerance may be found when the drug is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.
The cumulative dose of NEURONOX treatment in a 30-day period should not exceed 200 U.
Pediatric cerebral palsy: For the pediatric cerebral palsy, reconstituted NEURONOX (see Table 2) is injected using a sterile, 26-30 gauge needle. It is recommended to inject to each of the medial and lateral heads of the gastrocnemius muscles. A total dose of 4U/kg bodyweight is recommended for the affected gastrocnemius muscle in patients with hemiplegia. And in patients with diplegia, the recommended dose is 6U/kg bodyweight divided between both legs. The maximum dose administered must not exceed 200U/patient at a time. After injection, patient should be monitored for at least 30 minutes for any presence of acute adverse event.
Glabellar wrinkles: NEURONOX is reconstituted to make 100U/2.5mL (4U/0.1 mL) with 0.9% non-preserved sterile saline. Using a 30 gauge needle, 20U of NEURONOX is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites with 0.1 mL per site. To reduce complications of drooping (ptosis) eyelids, injection is avoided in the levator palpebrae superioris vicinity, especially for patients with large corrugators muscles. When administering injection in the medial end of corrugators muscle and in the midpoint between each eyebrow, it must be done in a place at least 1 cm apart from supraorbital ridge. NEURONOX is injected with caution so that it does not enter the blood vessel, and to prevent effusion from the area below the orbital ridge, firmly place a thumb or an index finger on the area below the orbital ridge prior to injection. During injection, the needle should point upward toward the center and injection dose must be measured accurately. The corrugators muscle and orbicularis oculi muscle move the center of the forehead and generate the glabellar facial wrinkles. The protean muscle and depressor supercilii muscle pull the forehead down. Frowning or glabellar wrinkles are produced by these muscles. Because the position, size, and use of these muscles are different for individuals, an effective dose is determined based on general observations on the patient's ability to move the injected superficial muscles. The treatment effect of NEURONOX for glabellar wrinkles lasts approximately 3-4 months. Frequent injection of NEURONOX has not been clinically evaluated for safety and effectiveness, and it is not recommended. In general, the first NEURONOX injection induces chemical denervation in the injected muscles 1 to 2 days after injection and its intensity increases during the first week.
Muscle Spasticity: The exact dosage and the number of injection should be tailored to the individual based on the size, the number and location of the muscles involved, the severity of spasticity, presence of local muscle weakness, and the patients response to previous treatment. Clinical improvement in muscle tone is seen four to six weeks following treatment.
In controlled clinical trials, the following doses are administered: See Table 1.

Click on icon to see table/diagram/image

In the clinical trial, doses are not over 360U, injected into individual muscles.
Reconstituted NEURONOX is injected using a sterile 24-30 gauge needle for superficial muscles, and a longer needle may be used for deeper musculature. Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques is recommended.
Hemifacial spasm: Dosage: In the first treatment session, the doctor may give multiple injections in the affected muscles with 1.25 to 2.5 Units of NEURONOX into each injection site. The maximum dose for the first treatment session is 25 Units per affected area (for example per eye). For the following treatment sessions, the total maximum dose can be increased up to 100 Units, if needed.
Duration of treatment effect: Patient will usually see an improvement within 3 days after the injection. The maximum effect is usually seen 1 to 2 weeks after treatment. When the effect starts to wear off, patient can have the treatment again if needed, but not more often than every 3 months.
Strabismus: Dosage: In the first treatment session, the doctor may give multiple injections in the affected muscles with 1.25 to 2.5 Units of NEURONOX into each injection site. The maximum dose for the first treatment session is 25 Units per affected area (for example per eye). For the following treatment sessions, the total maximum dose can be increased up to 100 Units, if needed.
Duration of treatment effect: Patient will usually see an improvement within 3 days after the injection. The maximum effect is usually seen 1 to 2 weeks after treatment. When the effect starts to wear off, patient can have the treatment again if needed, but not more often than every 3 months.
Cervical dystonia: Dosage: The doctor may give multiple injections in the affected muscles. The dose and number of injections will vary depending on a number of factors, including patient's needs, the muscles to be injected, the size of the muscles, severity of spasms, etc.
Duration of treatment effect: Patient will usually see an improvement within the first 2 weeks after the injection. The maximum effect is usually seen about 4 to 6 weeks after treatment. When the effect starts to wear off, patient can have the treatment again if needed, but not more often than every 12 weeks.
Spasmodic torticollis: Dosage: The doctor may give multiple injections in the affected muscles with up to 50 Units of NEURONOX into each injection site. The maximum dose for the first treatment session is 200 Units. For the following treatment sessions, the maximum dose can be increased up to 300 Units.
Duration of treatment effect: Patient will usually see an improvement within 2 weeks after the injection. The maximum effect is usually seen about 6 weeks after treatment. When the effect starts to wear off, patient can have the treatment again if needed, but not more often than every 10 weeks.
Dilution technique: Prior to injection, reconstitute freeze-dried NEURONOX with sterile normal saline without a preservative. 0.9% Sodium chloride Injection is the recommended diluent. Draw up the proper amount of diluent in the appropriate size syringe. The diluent should be injected gently into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix NEURONOX with the saline by rotating the vial. NEURONOX should be administered within 24 hours after reconstitution. During this time period, reconstituted NEURONOX should be stored in a refrigerator (2 – 8 °C). Reconstituted NEURONOX should be clear, colorless and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Because the drug and diluent do not contain any preservative, one vial of NEURONOX should be used for a single patient. (See Table 2.)

Click on icon to see table/diagram/image

Note: These dilutions are calculated for an injection volume of 0.1 ml. A decrease or increase in dose is also possible by administering a smaller or larger injection volume - from 0.05 mL (50% decrease in dose) to 0.15 ml. (50% increase in dose).
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