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BOTOX® (onabotulinumtoxinA) & BOTOX®Cosmetic (onabotulinumtoxinA)

Chronic Migraine
BOTOX® (onabotulinumtoxinA) for injection is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).

Important limitations
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies

Upper Limb Spasticity

BOTOX® is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).

Important Limitations
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of BOTOX® have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX® has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX® is not intended to substitute for usual standard of care rehabilitation regimens.

Cervical Dystonia
BOTOX® is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Blepharospasm and Strabismus
BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

Primary Axillary Hyperhidrosis

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

Important Limitations
The safety and effectiveness of BOTOX® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX® for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX® have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.

Glabellar Lines
BOTOX®Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of BOTOX® or BOTOX® Cosmetic 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 adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

CONTRAINDICATIONS

BOTOX® and BOTOX® Cosmetic are contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS

Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX® and BOTOX® Cosmetic 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 BOTOX® and BOTOX® Cosmetic cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
See Boxed Warning.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX®/ BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported.

No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm at the recommended dose (30 Units and below), strabismus, or for chronic migraine at the labeled doses have been reported.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® or BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal cause of anaphylaxis has been reported in which lidocaine was used as the diluents, and consequently the causal agent cannot be reliably determined.

Dysphagia and Breathing Difficulties in Treatment of Cervical Dystonia
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved (see Boxed Warning).

Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX.®

Pulmonary Effects of BOTOX® in Patients With Compromised Respiratory Status Treated for Spasticity
Patients with compromised respiratory status treated with BOTOX® for upper limb spasticity should be monitored closely.

Corneal Exposure and Ulceration in Patients Treated With BOTOX® for Blepharospasm
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.

Retrobulbar Hemorrhages in Patients Treated With BOTOX® for Strabismus
During the administration of BOTOX® for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.

Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with BOTOX® (3% at 251-360 Units total dose) compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%).

Information for Patients
Patients should be counseled that if loss of strength, muscle weakness, or impaired vision occur, they should avoid driving a car or engaging in other potentially hazardous activities.

Pregnancy
Administration of BOTOX® or BOTOX® Cosmetic is not recommended during pregnancy. There are no adequate and well-controlled studies of BOTOX® or BOTOX® Cosmetic in pregnant women.

Nursing Mothers
It is not known whether BOTOX® or BOTOX® Cosmetic is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX® or BOTOX® Cosmetic is administered to a nursing woman.

Human Albumin and Transmission of Viral Diseases

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.

ADVERSE REACTIONS

The following adverse reactions to BOTOX® or BOTOX® Cosmetic for injection are discussed in greater detail in the following sections: Spread of Toxin Effect (see Boxed Warning); Hypersensitivity Reactions (see Contraindications and Warnings and Precautions); Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity (see Warnings and Precautions).

Chronic Migraine
The most frequently reported adverse reactions following injection of BOTOX® for chronic migraine include neck pain (9%), headache (5%), eyelid ptosis (4%), migraine (4%), muscular weakness (4%), musculoskeletal stiffness (4%), bronchitis (3%), injection-site pain (3%), musculoskeletal pain (3%), myalgia (3%), facial paresis (2%), hypertension (2%), and muscle spasms (2%).

Upper Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX® for upper limb spasticity include pain in extremity, muscle weakness, fatigue, nausea, and bronchitis.

Cervical Dystonia
The most frequently reported adverse reactions following injection of BOTOX® for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

Blepharospasm
The most frequently reported adverse reactions following injection of BOTOX® for blepharospasm include ptosis (21%), superficial punctate keratitis (6%), and eye dryness (6%).

Strabismus
The most frequently reported adverse events following injection of BOTOX® for strabismus include ptosis (15.7%) and vertical deviation (16.9%).

Primary Axillary Hyperhidrosis
The most frequently reported adverse events (3%-10% of adult patients) following injection of BOTOX® for severe primary axillary hyperhidrosis include injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

Glabellar Lines
The most frequently reported adverse events following injection of BOTOX® Cosmetic include blepharoptosis and nausea.

Post Marketing Experience

There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.

DRUG INTERACTIONS

No formal drug interaction studies have been conducted with BOTOX® or BOTOX® Cosmetic for injection. Co-administration of BOTOX® or BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (e.g. curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® or BOTOX® Cosmetic may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® or BOTOX® Cosmetic.