Approved Drug Label (PDF)
4
Contraindications
Additions and/or revisions underlined:
ZELAPAR is contraindicated in patients with:
Concomitant use of opioid drugs (e.g., meperidine,
tramadol, or methadone). Serotonin syndrome, a potentially serious condition,
which can result in death, has been reported with concomitant use of meperidine
(e.g., Demerol and other trade names). At least 14 days should elapse between
discontinuation of ZELAPAR and initiation of treatment with these medications [see Warnings and
Precautions (5.2)].
Concomitant use of other drugs in the monoamine
oxidase inhibitor (MAOI) class or other drugs that are potent
inhibitors of monoamine oxidase, including linezolid), because of an
increased risk for hypertensive crisis [see
Warnings and Precautions (5.1)]. At least 14 days should elapse
between discontinuation of ZELAPAR and initiation of treatment with any MAO inhibitor.
Concomitant
use of St. John’s wort or cyclobenzaprine (a tricyclic muscle relaxant).
Concomitant use of dextromethorphan, because of
reported episodes of psychosis or bizarre behavior.
5
Warnings and Precautions
5.10 Risk for Patients with Phenylketonuria
Additions and/or
revisions underlined:
Phenylalanine can
be harmful
to patients with phenylketonuria (PKU). ZELAPAR contains
phenylalanine, a component of aspartame. Each ZELAPAR 1.25 mg tablet
contains 1.25 mg phenylalanine. Patients taking the 2.5 mg dose of ZELAPAR will
receive 2.5 mg phenylalanine. Before prescribing ZELAPAR to a patient with
PKU, consider the combined daily amount of phenylalanine from all sources,
including ZELAPAR.
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
Table 1: Adverse Reactions*
in Double-Blind, Placebo-Controlled Trials with an Incidence greater
than or equal to 2% of Patients Treated with ZELAPAR and More Frequent than the
Placebo Group
7
Drug Interactions
Additions and/or
revisions underlined:
7.1 Opioid
Drugs
Because serious,
sometimes fatal reactions have been precipitated with concomitant use
of opioid drugs (e.g., meperidine and its derivatives, methadone,
or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant
use of these drugs with ZELAPAR is contraindicated [see Contraindications (4) and Warnings and Precautions (5.2)].
At least 14 days should elapse between discontinuation of ZELAPAR and
initiation of treatment with these drugs.
Additions and/or
revisions underlined:
7.3 MAO Inhibitors
ZELAPAR is
contraindicated for concomitant use with other drugs in the MAOI class
or other drugs that are potent inhibitors of monoamine oxidase (including
linezolid, an oxazolidinone antibacterial, which also has reversible
nonselective MAO inhibition activity) because of the increased risk for
hypertensive crisis [see Contraindications (4) and Warnings and Precautions (5.1)].
At least 14 days should elapse between discontinuation of ZELAPAR and
initiation of treatment with other MAOIs.
8
Use in Specific Populations
8.1 Pregnancy
PLLR conversion;
additions and/or revisions underlined:
Risk Summary
There are no
adequate data on the developmental
risk associated with the use of ZELAPAR in pregnant women. In animal
studies, administration of selegiline during pregnancy was associated with
developmental toxicity (decreased embryofetal and postnatal offspring growth
and survival) at doses greater than those used clinically.
In the U.S.
general population, the estimated background risk of major birth defects and of
miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%,
respectively. The background risk of major birth defects and miscarriage in the
indicated population is unknown.
Data
Animal
Data
In rats
administered selegiline orally …
8.2 Lactation
PLLR conversion;
additions and/or revisions underlined:
Risk Summary
There are no data
on the presence of selegiline or its metabolites in human milk, the effects on
the breastfed infant, or the effects on milk production. Selegiline and
metabolites were detected in rat milk at levels higher than those in maternal
plasma.
Because of the
potential for serious adverse reactions in breastfed infants from
ZELAPAR, including the potential for hypertensive reactions, advise a woman
that breastfeeding is not recommended during treatment with ZELAPAR and for
7 days after the final dose.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Instructions for
Use
Instruct patients not to remove the
blister from the sachet pouch until just prior to dosing. The blister
pack should then be peeled open with dry hands and the orally disintegrating
tablet placed on the tongue, where the tablet will disintegrate.
Patients should also avoid
drinking liquids or eating food 5 minutes before and after taking ZELAPAR. Use
ZELAPAR within 3 months of opening sachet pouch and immediately upon
opening individual blister. Store blister tablets in sachet pouch at
all times. Keep sachet pouch inside clear child-resistant pouch provided. Potency cannot be guaranteed after 3 months
of opening the pouch.
How should I store
ZELAPAR?
Store ZELAPAR at controlled room temperature 25°C (77°F).
Store blister tablets in sachet pouch at all times.
Keep sachet pouch sealed or closed inside of clear child-resistant
pouch provided.
Potency cannot be
guaranteed after 3 months of opening the sachet pouch.
Keep ZELAPAR and
all medicines out of the reach of children.
BLISTER
PACKS AND SACHET POUCHES ARE NOT CHILD-RESISTANT. THE CLEAR OUTER POUCH IS
CHILD-RESISTANT.
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