Dosing & Uses
Dosage Forms & Strengths
Amyotrophic Lateral Sclerosis (ALS)
50 mg PO q12hr on empty stomach
Huntington Disease (Orphan)
Orphan indication sponsor
- Rhone-Poulenc Rorer Pharmaceuticals, Inc; 500 Arcola Road, PO Box 5096; Collegeville, PA 19426-0800
Orphan designation for treatment of spinocelebellar ataxia
- Biohaven Pharmaceutical Holding Company, Ltd; 234 Church Street, Suite 304; New Haven, Connecticut 06511
Amyotrophic Lateral Sclerosis (Orphan)
Oral suspension (Teglutik [brand name]) and orally dissolving tablet: Orphan designation for amyotrophic lateral sclerosis (ALS)
- Italfarmaco SpA; 54 Via dei Lavoratori; Cinisello Balsamo, Italy
Serious - Use Alternative
Significant - Monitor Closely
Skeletal weakness (19%)
Decreased lung function (11-15%)
Abdominal pain (6-10%)
Back pain (1-5%)
Circumoral paresthesia (1-5%)
Interstitial lung disease and hypersensitivity pneumonitis
Hypersensitivity to drug or any component of the formulation
Caution in hepatic impairment; not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue therapy if there is evidence of liver dysfunction
Case reports of clincial hepatitis reported
Interstitial lung disease reported (upon further investigation, many of these cases were hypersensitivity pneumonitis); discontinue immediately if dry cough or dyspnea develops
Neutropenia reported; advise patients to report any febrile illness
Caution in renal impairment
May cause drowsiness; use caution when performing hazardous tasks requiring alertness
Sedative effects may be potentiated when used concomitantly with other sedative drugs or ethanol
Use with caution in the elderly and in females as clearance may be reduced
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown; avoid during breastfeeding
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Benzathiazole; inhibits glutamate release, inactivates voltage-dependent Na+ channels, inhibits effects of excitatory neurotransmitters
Half-Life: 12 hr
Protein Bound: 96%
Metabolites: 6 major metabolites, some active
Excretion: Feces (5%); urine (90%)
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.