ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Commercializzato da:

Solco Healthcare US LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsu

Dettagli prodotto:

Esomeprazole magnesium delayed-release capsules, USP, 20 mg esomeprazole, are opaque, hard gelatin capsule, with pink cap and white body. Capsule printed with “S001” in black on the cap and “20 mg” in black on the body. Containing white to light yellow pellets. They are supplied as follows: NDC 43547-001-03 bottles of 30 NDC 43547-001-09 bottles of 90 Esomeprazole magnesium delayed-release capsules, USP, 40 mg esomeprazole, are opaque, hard gelatin, pink capsule printed with “S002” in black on the cap and “40 mg” in black on the body. Containing white to light yellow pellets. They are supplied as follows: NDC 43547-002-03 bottles of 30 NDC 43547-002-09 bottles of 90 NDC 43547-002-11 bottles of 1,000 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules product package is subdivided.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Solco Healthcare US LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/esomeprazole-dr-capsules.pdf.
Esomeprazole (es oh ME pray zol) Magnesium (mag NEE zee uhm)
Delayed-Release Capsules, for oral
use
What is the most important information I should know about
esomeprazole magnesium delayed-release
capsules?
Esomeprazole magnesium delayed-release capsules may help your
acid-related symptoms, but you could
still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules can cause serious side
effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, may
develop a kidney problem called acute tubulointerstitial nephritis
that can happen at any time during
treatment with esomeprazole magnesium delayed-release capsules. Call
your doctor right away if
you have a decrease in the amount that you urinate or if you have
blood in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right
away if you have watery stools or stomach pain that does not go away.
You 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 doctor if you have 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 esomeprazole magnesium delayed-release capsules, may develop
certain types of lupus
erythematosus or have worsening of the lupus they already have. Call
your doctor right away if you
h

Scheda tecnica

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
SOLCO HEALTHCARE US LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.9) 03/2022
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are a proton pump
inhibitor (PPI).
Esomeprazole magnesium delayed-release capsules are indicated for the:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1)
AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE
Adults
20 mg or 40 mg1 once daily for
4 to 8 weeks; some patients
may require an additional 4 to 8
weeks
12 years to 17
years
20 mg or 40 mg once daily for
4 to 8 weeks
MAINTENANCE OF HEALING OF EE
Adults
20 mg once daily. Controlled
studies do not extend
beyond 6 months
TREATMENT OF SYMPTOMATIC GERD
Adults
20 mg once daily for 4 weeks
some patients may require an
additional 4 weeks
12 years to 17
years
20 mg once daily for 4 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC
ULCER
Adults
20 mg or 40 mg once daily for
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 12
years to 17 years of age. (1.1)
Maintenance of healing of EE in adults. (1.2)
Short-term treatment of heartburn and other symptoms associated GERD
in adults and pediatric
patients 12 years to 17 years of age. (1.3)
Risk reduction of nonsteroidal anti-inflammatory drugs
(NSAID)-associated gastric ulcer in adults at
risk for developing gastric ulcers due to age (60 years and older)
and/or documented history of gastric
ulcers. (1.4)
_Helicobacter pylori _eradication in adult patients to reduce the risk