The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Heartburn associated with acid indigestion and sour stomach
Pepcid Complete combines an acid reducer (famotidine) with
antacids (calcium carbonate and magnesium hydroxide) to relieve
heartburn in two different ways: acid reducers decrease the
production of new stomach acid, while antacids neutralize acid
already present in the stomach. Heartburn is caused by acid moving
from the stomach into the esophagus through a valve-like muscle
called the lower esophageal sphincter (LES). This occurs when the
LES is relaxed and in an open position, and can result in burning
pain and discomfort that interferes with everyday activities.
Pepcid Complete is available in a chewable tablet form, and is
approved for adults and children twelve years of age and older.
In clinical trials, Pepcid Complete was shown to be
significantly more effective than placebo in relieving heartburn.
Forty-five percent of heartburn episodes were relieved within 30
minutes with Pepcid Complete, and 70% of heartburn episodes were
relieved for at least seven hours.
The following adverse reactions have been reported to occur in
more than 1% of patients on therapy with Pepcid (famotidine) in
controlled clinical trials, and may be causally related to the
- Headache (4.7%)
- Dizziness (1.3%)
- Constipation (1.2%)
- Diarrhea (1.7%)
The following list includes (but does not contain all) other
adverse reactions that have been reported infrequently in clinical
trials or since Pepcid (famotidine) was marketed. The relationship
to therapy with Pepcid has been unclear in many cases. Within each
category the adverse reactions are listed in order of decreasing
- Body as a Whole: fever, fatigue
- Cardiovascular: arrhythmia, heart palpitation
- Gastrointestinal: vomiting, nausea, abdominal discomfort,
anorexia, dry mouth
- Musculoskeletal: musculoskeletal pain including muscle
- Nervous System/Psychiatric: psychic disturbances, which were
reversible in cases for which follow-up was obtained, including
hallucinations, confusion, agitation, depression, anxiety,
decreased libido; insomnia; somnolence
Pepcid Complete should not be used by patients allergic to
famotidine or other acid reducers, or by individuals who have
trouble swallowing. Use should be discontinued if stomach pain
continues or the product needs to be taken for more than 14 days.
Additionally, pregnant or breast-feeding women should check with
their physician before use.
Mechanism of Action
Famotidine is an H2 (histamine)-receptor antagonist, also known
as an H2-blocker. Histamine is a chemical in some cells of the body
that causes production of acid in the stomach. H2-blockers inhibit
histamine action, and therefore reduce gastric secretion or the
amount of acid produced. Magnesium hydroxide and calcium carbonate
are both antacids that function by neutralizing excess gastric
According to Pepcid Complete labeling, the following tips can
assist with managing heartburn:
- Do not lie flat or bend over soon after eating.
- Do not eat late at night, or just before bedtime.
- Certain foods or drinks are more likely to cause heartburn,
such as rich, spicy, fatty, and fried foods, chocolate, caffeine,
alcohol, and even some fruits and vegetables.
- Eat slowly and do not eat big meals.
- Maintain healthy body weight.
- Do not smoke.
- Raise the head of your bed.
- Wear loose fitting clothing around your stomach.
For additional information on Pepcid products, please visit the
web site of Merck
& Co., Inc.