Approved Drug Label (PDF)
5
Warnings and Precautions
5.9 Serious Skin Reactions
Additions and/or
revisions underlined:
NSAIDs, including indomethacin, can cause serious
skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome
(SJS), and toxic epidermal necrolysis (TEN), which can be fatal. NSAIDs can
also cause fixed drug eruption (FDE). FDE may present as a more severe variant
known as generalized bullous fixed drug eruption (GBFDE), which can be
life-threatening. These serious events may occur without warning. Inform
patients about the signs and symptoms of serious skin reactions, and to
discontinue the use of indomethacin capsules at the first appearance of skin
rash or any other sign of hypersensitivity. Indomethacin capsules are
contraindicated in patients with previous serious skin reactions to NSAIDs [see
Contraindications (4)].
6
Adverse Reactions
6.2 Postmarketing Experience
Newly added subsection:
The following adverse reactions have been identified
during postapproval use of indomethacin. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.
Skin and Appendages: Exfoliative dermatitis,
Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed
drug eruption (FDE).
Approved Drug Label (PDF)
5
Warnings and Precautions
5.10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
New subsection
added
Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) has been reported in patients taking NSAIDs such as
indomethacin. Some of these events have been fatal or life- threatening. DRESS typically, although not exclusively, presents
with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical
manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis,
or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection.
Eosinophilia is often present. Because this disorder is variable in its presentation,
other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity,
such as fever or lymphadenopathy, may be present even though rash is not
evident. If such signs or symptoms are present, discontinue indomethacin capsules
and evaluate the patient immediately.
5.11 Fetal Toxicity
Additions underlined
Premature Closure of Fetal Ductus Arteriosus
Avoid use of NSAIDs, including indomethacin capsules,
in pregnant women at about 30 weeks gestation and later. NSAIDs,
including indomethacin capsules, increase the risk of premature closure of the fetal
ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment
Use of NSAIDs, including indomethacin capsules, at about
20 weeks gestation or later in pregnancy may cause fetal renal dysfunction
leading to oligohydramnios and, in some cases, neonatal renal impairment. These
adverse outcomes are seen, on average, after days to weeks of treatment, although
oligohydramnios has been infrequently reported as soon as 48 hours after NSAID
initiation. Oligohydramnios is often, but not always, reversible with treatment
discontinuation. Complicationsof prolonged
oligohydramnios may, for example, include limb contractures and delayed lung
maturation. In some postmarketing cases of impaired neonatal renal function,
invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20
weeks and 30 weeks gestation, limit indomethacin capsules use to the lowest effective
dose and shortest duration possible. Consider ultrasound monitoring of amniotic
fluid if indomethacin capsules treatment extends beyond 48 hours. Discontinue indomethacin
capsules if oligohydramnios occurs and follow up according to clinical practice [see Use in Specific Populations (8.1)].
8
Use in Specific Populations
8.1 Pregnancy
Extensive additions
and revisions, please refer to label for complete information.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions underlined
…
Before
taking NSAIDS, tell your healthcare provider about all of your medical
conditions, including if you:
have liver or kidney problems
have high blood pressure
have asthma
are pregnant or plan to become pregnant. Taking NSAIDs
at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to
take NSAIDs for more than 2 days when you are between 20 and 30 weeks of
pregnancy, your healthcare provider may need to monitor the amount of
fluid in your womb around your baby. You should not take NSAIDs after about
30 weeks of pregnancy.
are breastfeeding or plan to breast feed.
…
PATIENT COUNSELING INFORMATION
Additions underlined
…
Serious Skin Reactions, including DRESS
Advise patients to stop taking indomethacin capsules
immediately if they develop any type of rash or fever and to contact their healthcare
provider as soon as possible [see Warnings
and Precautions (5.9, 5.10)].
…
Fetal Toxicity
Inform pregnant women to avoid use of indomethacin capsules
and other NSAIDs starting at 30 weeks gestation because of the risk of the premature
closing of the fetal ductus arteriosus. If treatment with indomethacin capsules
is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her
that she may need to be monitored for oligohydramnios, if treatment continues
for longer than 48 hours [see Warnings
and Precautions (5.11) and Use in Specific Populations (8.1)].
…