ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Guardian Drug Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acid reducer - treats frequent heartburn (occurs 2 or more days a week) - not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect  - trouble or pain swallowing food, vomiting with blood, or bloody or black stools - heartburn with lightheadedness, sweating or dizziness - chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness - frequent chest pain These may be signs of a serious condition. See your doctor. - had heartburn over 3 months. This may be a sign of a more serious condition. - frequent wheezing, particularly with heartburn  - unexplained weight loss - nausea or vomiting - stomach pain - taking a prescription drug. Acid reducers may interact with certain prescription drugs.  - your heartburn continues or worsens - you need to take this product for more than 14 days - you need to take more than 1 course of treatment every 4 months - you get diarrhea - you develop a rash or joint pain

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM - ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
GUARDIAN DRUG COMPANY
----------
ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES
ACTIVE INGREDIENT(IN EACH CAPSULE)
*Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.3 mg esomeprazole
magnesium
trihydrate)
PURPOSE
Acid reducer
USE(S)
treats frequent heartburn (occurs 2 OR MORE days a week)
not intended for immediate relief of heartburn; this drug may take 1
to 4 days for full
effect
WARNINGS
ALLERGY ALERT:
· Do not use if you are allergic to esomeprazole.
· Esomeprazole may cause severe skin reactions. Symptoms may include:
· skin reddening
· blisters
· rash
If an allergic reaction occurs, stop use and seek medical help right
away.
DO NOT USE IF YOU HAVE
trouble or pain swallowing food, vomiting with blood, or bloody or
black stools
heartburn with LIGHTHEADEDNESS, SWEATING OR DIZZINESS
chest pain or shoulder pain with shortness of breath; sweating; pain
spreading to
arms, neck or shoulders; or lightheadedness
frequent CHEST PAIN
These may be signs of a serious condition. See your doctor.
ASK A DOCTOR BEFORE USE IF YOU HAVE
had heartburn over 3 months. This may be a sign of a more serious
condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug. Acid reducers may interact with certain
prescription
drugs.
STOP USE AND ASK DOCTOR IF
your heartburn continues or worsens
you need to take this product for more than 14 days
you need to take more than 1 course of treatment every 4 months
you get diarrhea
you develop a rash or joint pain
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for
14 days
may take 1 to 4 days for full effect
14-DAY COURSE OF TREATMEN