DALFAMPRIDINE tablet, film coated, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)

Pieejams no:

Hikma Pharmaceuticals USA Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)]. The use of Dalfampridine extended-release tablets is contraindicated in the following conditions: Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of deve

Produktu pārskats:

Dalfampridine Extended-release Tablets 10 mg tablets are supplied as white to off-white, film coated oval tablets with “54 052” debossed on one side and plain on the other side. NDC 0054-0479-21 Bottle of 60 Store at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.]

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

DALFAMPRIDINE- dalfampridine tablet, film coated, extended release
Hikma Pharmaceuticals USA Inc.
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Medication Guide
MEDICATION GUIDE
Dalfampridine Extended-release Tablets
(dal fam’ pri deen)
Rx only
Read this Medication Guide before you start taking Dalfampridine
Extended-release Tablets and each time
you get a refill. There may be new information. This information does
not take the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about
Dalfampridine?
Dalfampridine can cause seizures.
•
You could have a seizure even if you never had a seizure before.
•
Your chance of having a seizure is higher if you take too much
Dalfampridine or if your kidneys have a
mild decrease of function, which is common after age 50.
•
Your doctor may do a blood test to check how well your kidneys are
working, if that is not known
before you start taking Dalfampridine.
•
Do not take Dalfampridine if you have ever had a seizure.
•
Before taking Dalfampridine tell your doctor if you have kidney
problems.
•
Take Dalfampridine exactly as prescribed by your doctor. See "How
should I take Dalfampridine?"
Stop taking Dalfampridine and call your doctor right away if you have
a seizure while taking Dalfampridine.
What is Dalfampridine?
Dalfampridine is a prescription medicine used to help improve walking
in adults with multiple sclerosis
(MS). This was shown by an increase in walking speed.
It is not known if Dalfampridine is safe or effective in children less
than 18 years of age.
Who should not take Dalfampridine?
Do not take Dalfampridineif you:
•
have ever had a seizure
•
have certain types of kidney problems
•
are allergic to dalfampridine (4-aminopyridine), the active ingredient
in Dalfampridine
What should I tell my doctor before taking Dalfampridine?
Before you take Dalfampridine, tell your doctor if you:
•
have any other medical conditions
•
are taking compounded 4-aminopyridine (fampridine, 4-AP)
•
are taking any ot

Produkta apraksts

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DALFAMPRIDINE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DALFAMPRIDINE EXTENDED-RELEASE TABLETS.
DALFAMPRIDINE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
Dalfampridine extended-release tablets are a potassium channel blocker
indicated to improve walking in
adult patients with multiple sclerosis (MS). This was demonstrated by
an increase in walking speed (1, 14).
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
10 mg tablets (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most common adverse events (incidence ≥2% and at a rate greater
than the placebo rate) for
Dalfampridine were urinary tract infection, insomnia, dizziness,
headache, nausea, asthenia, back pain,
balance disorder, multiple sclerosis relapse, paresthesia,
nasopharyngitis, constipation, dyspepsia, and
pharyngolaryngeal pain (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
OCT2 Inhibitors: Concomitant use may cause an increased exposure and
potential risk of seizures (7.1)
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
The maximum recommended dosage is 10 mg twice daily (approximately 12
hours apart). There is no
evidence of additional benefit with doses greater than 10 mg twice
daily. Adverse reactions, including
seizures, were more frequent at higher doses. (2.1)
Take with or without food. Administer tablets whole; do not divide,
crush, chew, or dissolve (2.2)
Patients should not take double or extra doses if they miss a dose.
(2.2)
Estimated creatinine clearance (CrCl) should be known before
initiating treatment