A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Claritin D Indications, Dosage, Storage, Stability - Loratadine and Pseudoephedrine
Claritin D Indications, Dosage, Storage, Stability - Loratadine and Pseudoephedrine
INDICATIONS
Loratadine; pseudoephedrine sulfate
extended release tablets
are indicated for the relief
of symptoms of seasonal allergic
rhinitis. Loratadine; pseudoephedrine sulfate extended release
tablets should be administered when both the antihistaminic properties
of loratadine and
the nasal decongestant
activity of pseudoephedrine are desired (see CLINICAL
PHARMACOLOGY).
DOSAGE AND ADMINISTRATION
Adults and Children 12 Years of Age and Over: 12
Hour Tablet: One tablet
twice a day (every 12 hours); 24 Hour Tablet: One tablet
daily taken with a full glass
of water (see PRECAUTIONS
and ADVERSE REACTIONS). Because
the doses of this fixed combination product
cannot be individually titrated and hepatic
insufficiency results in a reduced clearance
of loratadine to a much greater extent than pseudoephedrine, loratadine;
pseudoephedrine sulfate extended release
tablets should generally be avoided in patients with hepatic
insufficiency. Patients with renal
insufficiency (GFR <30 ml/min) should be given a lower initial
dose (one 12 hour tablet
per day, or one 24 hour
tablet every other day)
because they have reduced clearance of loratadine
and pseudoephedrine. Patients who have a history of difficulty in
swallowing tablets
or who have known upper gastrointestinal
narrowing or abnormal
esophageal peristalsis
should not use the 24 hour tablet (see PRECAUTIONS,
Information for the Patient; and ADVERSE
REACTIONS).
HOW SUPPLIED
Claritin-D 12 Hour Extended Release Tablets
Claritin-D 12 hour extended release
tablets contain 5 mg loratadine
and 120 mg pseudoephedrine
sulfate. Claritin-D 12 hour extended release tablets are white
tablets branded in green
with "CLARITIN-D".
Storage: Keep Unit-of-Use packaging and Unit Dose-Hospital
Pack in a dry place. Store between 2-25°C (36-77°F).
Claritin-D 24 Hour Extended Release Tablets
Claritin-D 24 hour extended release
tablets contain 10 mg loratadine
in the tablet coating
for immediate release
and 240 mg pseudoephedrine
sulfate in an extended-release core. Claritin-D 24 hour extended
release tablets are white
to off-white oval, biconvex, coated tablets branded in black with
"CLARITIN-D 24 HOUR".
Storage: Protect Unit Dose-Hospital Pack from
light and store in a dry place. Store between 15-25°C (59-77°F).
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