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Pronunciation |
|
(gla
TIR a mer AS e
tate) |
|
|
U.S. Brand
Names |
|
Copaxone® |
|
|
Generic
Available |
|
No |
|
|
Synonyms |
|
Copolymer-1 |
|
|
Pharmacological Index |
|
Biological, Miscellaneous |
|
|
Use |
|
Relapsing-remitting type multiple sclerosis; studies indicate that it reduces
the frequency of attacks and the severity of disability; appears to be most
effective for patients with minimal disability |
|
|
Pregnancy Risk
Factor |
|
B |
|
|
Contraindications |
|
Previous hypersensitivity to any component of the copolymer
formulation |
|
|
Adverse
Reactions |
|
>10%:
Cardiovascular: Chest pain (26%)
Local: Pain
1% to 10%:
Cardiovascular: Chest tightness, flushing, tachycardia, vasodilitation
Central nervous system: Anxiety, depression, dizziness
Dermatologic: Erythema (4%), urticaria
Hematologic: Transient eosinophilia
Local: Injection site reactions (6.5%)
Neuromuscular & skeletal: Tremor
Respiratory: Dyspnea
Miscellaneous: Diaphoresis, unintended pregnancy |
|
|
Overdosage/Toxicology |
|
Well tolerated; no serious toxicities can be anticipated |
|
|
Stability |
|
Reconstituted product contains no preservative, use immediately; store
unreconstituted product in refrigerator at 2°C to
8°C (36°F to
46°F); diluent may be stored at room
temperature |
|
|
Mechanism of
Action |
|
Glatiramer is a mixture of random polymers of four amino acids; L-alanine,
L-glutamic acid, L-lysine and L-tyrosine, the resulting mixture is antigenically
similar to myelin basic protein, which is an important component of the myelin
sheath of nerves; glatiramer is thought to suppress T-lymphocytes specific for a
myelin antigen, it is also proposed that glatiramer interferes with the
antigen-presenting function of certain immune cells opposing pathogenic T-cell
function |
|
|
Usual Dosage |
|
Adults: S.C.: 20 mg daily |
|
|
Mental Health: Effects
on Mental Status |
|
May cause anxiety or depression |
|
|
Mental Health:
Effects on Psychiatric
Treatment |
|
None reported |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
No effects or complications reported |
|
|
Patient
Information |
|
It is essential to provide the patient with proper handling and
reconstitution instruction, since they will most likely have to self-administer
the drug for an extended period |
|
|
Dosage Forms |
|
Injection: Single-use vials containing 20 mg of glatiramer and 40 mg
mannitol; packaged in 2 mL vials along with 1 mL vial of diluent (sterile water
for injection) |
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