HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

RABEPRAZOLE SODIUM (UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)

Fáanlegur frá:

Aytu Therapeutics, LLC

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

ACIPHEX Sprinkle is indicated for treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age for up to 12 weeks. - ACIPHEX Sprinkle is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.3), Adverse Reactions (6)] . - PPIs, including ACIPHEX Sprinkle, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)] . Risk Summary There are no available human data on ACIPHEX use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnanc

Vörulýsing:

ACIPHEX Sprinkle delayed-release capsules (5 mg) are supplied as transparent blue and opaque white capsules containing enteric coated granules. Identification and strength (ACX 5mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule. Bottles of 30 (NDC 23594-205-01) ACIPHEX Sprinkle delayed-release capsules (10 mg) are supplied as transparent yellow and opaque white capsules containing enteric coated granules. Identification and strength (ACX 10mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule. Bottles of 30 (NDC 23594-210-01) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] . Protect from moisture.

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

ACIPHEX SPRINKLE- rabeprazole sodium capsule, delayed release
Aytu Therapeutics, LLC
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MEDICATION GUIDE
ACIPHEX® Sprinkle™ (a-se-feks spr-en-kle)
(rabeprazole sodium delayed-release capsules)
What is the most important information I should know about ACIPHEX
Sprinkle?
Your child should take ACIPHEX Sprinkle exactly as prescribed, at the
lowest dose possible and for the
shortest time needed.
ACIPHEX Sprinkle may help your child’s acid-related symptoms, but
your child could still have serious
stomach problems. Talk with your child’s doctor.
ACIPHEX Sprinkle can cause serious side effects, including:
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump inhibitor
(PPI) medicines, including ACIPHEX Sprinkle, may develop a kidney
problem called acute tubulointerstitial
nephritis that can happen at any time during treatment with ACIPHEX
Sprinkle. Call your child’s doctor
right away if your child has a decrease in the amount that they
urinate or if they have blood in their urine.
Diarrhea caused by an infection (Clostridium difficile) in your
child’s intestines. Call your child’s doctor
right away if your child has watery stools or stomach pain that does
not go away. Your child may or may not
have a fever.
Bone fractures (hip, wrist or spine). Bone fractures in the hip, wrist
or spine may happen in people who take
multiple daily doses of PPI medicines and for a long period of time (a
year or longer). Tell your child’s
doctor if your child has a bone fracture, especially in the hip, wrist
or spine.
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body’s immune
cells attack other cells or organs in the body). Some people who take
PPI medicines, including ACIPHEX
Sprinkle, may develop certain types of lupus erythematosus or have
worsening of the lupus they already
have. Call your child’s doctor right away if they have new or
worsening joint pain or a rash on their cheeks
or arms that gets worse in the sun.
Talk to

Vara einkenni

ACIPHEX SPRINKLE- RABEPRAZOLE SODIUM CAPSULE, DELAYED RELEASE
AYTU THERAPEUTICS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACIPHEX SPRINKLE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACIPHEX
SPRINKLE.
ACIPHEX SPRINKLE™ (RABEPRAZOLE SODIUM DELAYED-RELEASE CAPSULES), FOR ORAL
USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions
- Acute Tubulointerstitial Nephritis (5.3) 11/2020
INDICATIONS AND USAGE
ACIPHEX Sprinkle is a proton-pump inhibitor (PPI) indicated for the
treatment of Gastroesophageal Reflux
Disease (GERD) in pediatric patients 1 to 11 years of age ( 1).
DOSAGE AND ADMINISTRATION
Dosage Regimen ( 2.1) :
The recommended dosage in pediatric patients 1 to 11 years of age for
up to 12 weeks is:
_Less than 15 kg_: 5 mg once daily with the option to increase to 10
mg once daily, if inadequate
response
_15 kg or more_: 10 mg once daily
Administration Recommendations ( 2.2) :
Take dose 30 minutes before a meal
Do not swallow the capsule whole
Open an ACIPHEX Sprinkle capsule and sprinkle granule contents on a
spoonful of soft food or liquid
(e.g., applesauce). Food or liquid should be at or below room
temperature.
Do not chew or crush the granules
Take entire dose within 15 minutes of preparation
DOSAGE FORMS AND STRENGTHS
Delayed-Release Capsules: 5 mg and 10 mg ( 3).
CONTRAINDICATIONS
Patients with a history of hypersensitivity to rabeprazole ( 4).
PPIs, including ACIPHEX Sprinkle, are contraindicated in patients
receiving rilpivirine-containing products
( 4, 7).
ADVERSE REACTIONS
Most common adverse reactions (>5%) are vomiting, abdominal pain,
diarrhea, headache, and nausea
(6.1). (5)
(5)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AYTU THERAPEUTICS, LLC.
AT 855 298-
8246 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_ (5)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response to therapy with
rabeprazole does not preclude the
presence of gastric malignancy. Con