NYMALIZE- nimodipine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

nimodipine (UNII: 57WA9QZ5WH) (nimodipine - UNII:57WA9QZ5WH)

Available from:

Arbor Pharmaceuticals

INN (International Name):

nimodipine

Composition:

nimodipine 60 mg in 20 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NYMALIZE is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). None. Risk Summary There are no adequate data on the developmental risk associated with the use of NYMALIZE in pregnant women. In animal studies, oral administration of nimodipine during pregnancy resulted in adverse effects on development (increased embryofetal mortality, increased incidences of fetal structural abnormalities, decreased fetal growth) at doses equivalent to (rat) or less than (rabbit) those used clinically [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 2-4% and 15-20% respectively. The background risk of major birth defects and miscarriage for the indicated population is unknow

Product summary:

NYMALIZE (nimodipine) Oral Solution 3 mg/mL is a pale yellow solution and is supplied as follows: Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Do not refrigerate.

Authorization status:

New Drug Application

Summary of Product characteristics

NYMALIZE- NIMODIPINE SOLUTION
ARBOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NYMALIZE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NYMALIZE.
NYMALIZE (NIMODIPINE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
NYMALIZE is a dihydropyridine calcium channel blocker indicated for
the improvement of neurological outcome by
reducing the incidence and severity of ischemic deficits in adult
patients with subarachnoid hemorrhage (SAH) from
ruptured intracranial berry aneurysms regardless of their post-ictus
neurological condition (i.e., Hunt and Hess Grades I-V).
(1)
DOSAGE AND ADMINISTRATION
Administer only enterally (e.g., oral, nasogastric tube, or gastric
tube route). Do not administer intravenously or by
other parenteral routes. (2.1)
Give one hour before a meal OR two hours after a meal. (2.1)
Start dosing within 96 hours of the SAH. (2.1)
Recommended dose is 20 mL (60 mg) every 4 hours for 21 consecutive
days. (2.2)
_Nasogastric or Gastric Tube Administration:_ Administer 20 mL (60 mg)
every 4 hours with supplied oral syringe. Refill
syringe with 20 mL of 0.9% saline water solution; flush remaining
contents from nasogastric or gastric tube into
stomach. (2.3)
_Patients with Cirrhosis:_ Reduce dosage to 10 mL (30 mg) every 4
hours. (2.4)
DOSAGE FORMS AND STRENGTHS
Oral solution (3 mg per mL):
60 mg per 20 mL (3)
30 mg per 10 mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
_Hypotension:_ Monitor blood pressure. (5.1)
_Patients with Cirrhosis:_ Higher risk of adverse reactions. Monitor
blood pressure and pulse. (5.2)
_CYP3A4 Strong Inhibitors:_ May significantly increase risk of
hypotension. Concomitant use with NYMALIZE should
generally be avoided. (5.3)
_CYP3A4 Strong Inducers:_ May significantly reduce efficacy of
nimodipine. Concomitant use with NYMALIZE should
generally be avoided. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥1% and ≥1% placebo) were
hypot