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Xeomin

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Overview

What is Xeomin?

The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemagglutinins and non-hemagglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular injection after reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP (3). One vial of XEOMIN contains 50 Units, 100 Units, or 200 Units of incobotulinumtoxinA, human albumin (1 mg), and sucrose (4.7 mg).

The primary release procedure for XEOMIN uses a cell-based potency assay to determine the potency relative to a reference standard. One Unit corresponds to the median intraperitoneal lethal dose (LD) in mice. As the method for conducting the assay is specific to XEOMIN, Units of biological activity of XEOMIN cannot be converted into Units of any other botulinum toxin assessed with other specific assays.



What does Xeomin look like?



What are the available doses of Xeomin?

For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.

What should I talk to my health care provider before I take Xeomin?

How should I use Xeomin?

XEOMIN (incobotulinumtoxinA) is indicated for the treatment of upper limb spasticity in adult patients.

The potency Units of XEOMIN (incobotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method . Reconstituted Xeomin is intended for intramuscular injection only.

The recommended maximum cumulative dose for any indication should not exceed 400 Units in a treatment session.


What interacts with Xeomin?

Sorry No Records found


What are the warnings of Xeomin?

Sorry No Records found


What are the precautions of Xeomin?

Sorry No Records found


What are the side effects of Xeomin?

Sorry No records found


What should I look out for while using Xeomin?

Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients ()

Infection at the proposed injection sites ()

Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses .


What might happen if I take too much Xeomin?

Excessive doses of XEOMIN may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis Symptomatic treatment may be necessary.

Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.

There is no significant information regarding overdose from clinical studies of XEOMIN.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at .


How should I store and handle Xeomin?

XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.XEOMIN is reconstituted prior to use with sterile preservative-free 0.9% Sodium Chloride Injection, USP XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.Any reconstituted toxin solution for injection that has been stored for more than 24 hours, as well as any unused solution for injection, should be discarded.Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84 Amcinonide Lotion, 0.1% is supplied as follows: NDC 0168-0280-60 60 mL bottle Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT FREEZE. E. FOUGERA & CO.FougeraI2280CR07/12#84


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

XEOMIN blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine. Impulse transmission is re-established by the formation of new nerve endings.

Non-Clinical Toxicology
Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients ()

Infection at the proposed injection sites ()

Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses .

As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).

Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death related to the spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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