Information for the Patient
Pepcid Complete
Pharmacology
Heartburn is a common symptom for which a variety of treatments exist. Single doses of antacid alone and histamine H2-receptor antagonists (acid reducers) alone have been shown to relieve heartburn more effectively than placebo. Although both agents are believed to act by reducing intraluminal acidity, their mechanisms of action and pharmacodynamic profiles differ substantially.
Antacids are believed to provide a fast onset of action by neutralizing intraluminal acid on contact but their duration of action is limited by physiologic clearing mechanisms. Histamine H2-receptor antagonists inhibit gastric juice secretion, reducing acid and pepsin content, as well as the volume, of basal, nocturnal and stimulated gastric secretion. These acid reducers are believed to require a longer time to onset of effect than antacids but these antagonists have an appreciably longer duration of action.
Pepcid Complete contains both antacids (calcium carbonate and magnesium hydroxide) and an acid reducer, famotidine (an H2-receptor antagonist).
In a clinical study to determine the pharmacodynamic profile of Pepcid Complete, esophageal and gastric pH were measured following administration of either Pepcid Complete, famotidine 10 mg, antacid (calcium carbonate/magnesium hydroxide 21 mEq) or placebo.
Figure 1 displays gastric pH by treatment from 2 hours prior to dosing to 12 hours postdose. During 5- to 9-hours postdose, the mean intragastric pH was significantly greater with Pepcid Complete and famotidine treatments than with the antacid (calcium carbonate/magnesium hydroxide 21 mEq) and placebo. The mean intragastric pH for the antacid and placebo treatments were similar during the 5 to 9 hour postdose period. These results demonstrate the longer duration of effect on gastric pH of the acid reducer and Pepcid Complete over the antacid.
Figure 1 - Pepcid CompleteGastric pH Means at 30-minute Time Intervals Relative to Dosing (n=23)
Legend
FACT=famotidine Antacid Combination Tablet (famotidine 10 mg, antacid 21 mEq).
Famotidine=famotidine 10 mg film-coated tablet.
Antacid=calcium carbonate/magnesium hydroxide 21 mEq.
Figure 2 displays mean esophageal pH by treatment from 15 minutes prior to dosing to 60 minutes postdose. Compared to famotidine and placebo, mean intraesophageal pH was significantly greater in the Pepcid Complete and antacid groups during the first hour. These results demonstrate that Pepcid Complete and the antacid have a faster onset of effect on esophageal pH than the acid reducer (famotidine 10 mg).
Figure 2 - Pepcid CompleteEsophageal pH Means at 1-minute Time Intervals Relative to Dose: 0 to 60 Minutes Postdose (n=23)
Legend
FACT=famotidine Antacid Combination Tablet (famotidine 10 mg, antacid 21 mEq).
Famotidine=famotidine 10 mg film-coated tablet.
Antacid=calcium carbonate/magnesium hydroxide 21 mEq.
This study shows that the pharmacodynamic profile of Pepcid Complete reflects the action of both the antacid and acid reducer components. The Pepcid Complete combination tablet has a faster onset of effect on esophageal pH than the acid reducer and a longer duration of effect on gastric pH than the antacid.
These results are consistent with clinical data, obtained from 3 studies, demonstrating the onset and duration benefits of Pepcid Complete in heartburn relief. According to the data, Pepcid Complete relieved heartburn significantly longer than the antacid and significantly faster than the acid reducer.
In a double-blind, randomized, parallel-group, multiple-dose study comparing Pepcid Complete to famotidine 10 mg, antacid (calcium carbonate/magnesium hydroxide 21 mEq) and placebo in patients with frequent heartburn, the adequacy of relief was assessed at 15-minute intervals for the first hour post-dose, then hourly for 8 hours postdose. Table 1 shows the number of heartburn episodes each patient recorded with adequate relief first occurring at each time point within 2 hours. Heartburn treated with Pepcid Complete was statistically more likely to achieve adequate relief at an earlier time point than episodes treated with the acid reducer, famotidine 10 mg (p=0.011). Heartburn episodes for Pepcid Complete patients were also more likely to achieve adequate relief at an earlier time point than episodes for the antacid (calcium carbonate/magnesium hydroxide 21 mEq) and placebo patients, respectively (p=0.042 and p<0.001).
Results presented in Table 2 show that, in this same study, Pepcid Complete produces a statistically longer duration of adequate relief than the antacid. The proportion of episodes relieved for at least 7 hours was greater with Pepcid Complete than antacid (p=0.001) and placebo (p<0.001).
Indications
The treatment of the following conditions where neutralization of gastric acid and a controlled reduction of gastric secretion is required, such as acid indigestion, heartburn, sour or upset stomach. Pepcid Complete is also indicated for the prevention of these symptoms when associated with the consumption of food and/or beverage. Pepcid Complete relieves and prevents daytime heartburn symptoms and relieves heartburn during the night.
Precautions
No dosage adjustment is required based on age.
Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man have included warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic blood flow and/or hepatic drug extraction has been tested and no significant effects have been found. Famotidine does not affect gastric alcohol dehydrogenase and, consequently, blood ethanol levels.
Concomitant administration of antacids can reduce the absorption of a variety of drugs, such as tetracyclines, phenothiazines, benzodiazepines, and iron. Given the known drug-interaction profiles of the Pepcid Complete components, no studies were conducted with Pepcid Complete to directly characterize any potential interactions. Patients taking a prescription drug should check with their pharmacist or physician before taking Pepcid Complete. Most interactions can be avoided by taking Pepcid Complete 2 hours before or after ingestion of other drugs.
Famotidine is detectable in human milk. Nursing mothers should either stop Pepcid Complete or should stop nursing.
Safety and effectiveness in children have not been established. Pepcid Complete should not be administered to children under 12 years of age.
In clinical trials with famotidine (Pepcid AC), patients with other underlying acid gastrointestinal diseases (e.g., duodenal ulcer, gastric ulcer) did not experience complications; in general, they did not exhibit a clinically significant deterioration in their condition. However, if patients have difficulty swallowing or if abdominal discomfort persists, the underlying cause should be determined. Symptomatic response to therapy with Pepcid Complete does not preclude the presence of gastric malignancy.
Patients with severe kidney disease, previous history of ulcer disease complications, severe coexisting illness, those who are experiencing unintended weight loss in association with dyspeptic symptoms, and those who are middle-aged or older with new or recently changed dyspeptic symptoms should consult a physician before commencing therapy with Pepcid Complete.
Patients consuming NSAIDs may have dyspepsia as a side effect of these medicines and should consult a physician or a pharmacist before taking Pepcid Complete.
Therapy should not exceed 2 weeks of continuous treatment without medical consultation.
Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively (approximately 2500 and 625 times the maximum recommended human prescription dose [80 mg] of famotidine, respectively), and have revealed no evidence of impaired fertility or harm to the fetus due to famotidine. There are, however, no adequate or well-controlled studies in pregnant women with famotidine.
Since the safe use of Pepcid Complete in pregnant women has not been established, pregnant women should not use Pepcid Complete unless directed otherwise by a physician.
Supplied
Each chewable, berry flavoured, round, flat, purple coloured tablet, embossed with “P”, contains: famotidine 10 mg, calcium carbonate 800 mg and magnesium hydroxide 165 mg. Nonmedicinal ingredients: cellulose acetate, D&C Red No. 7, dextrates, FD&C Blue No. 1, FD&C Red No. 40, flavours, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate and sugar. Bottles of 25 and 50. Cartons of 5. Store at 15 to 25°C. Protect from moisture.
Each chewable, mint flavoured, round, flat, rose (pink) coloured tablet, embossed with “P”, contains: famotidine 10 mg, calcium carbonate 800 mg and magnesium hydroxide 165 mg. Nonmedicinal ingredients: cellulose acetate, dextrates, flavours, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, pregelatinized starch, red ferric oxide, sodium lauryl sulfate and sugar. Blisters of 5, 25 and 50. Bottles of 25 and 50. Cartons of 5. Store at 15 to 25°C. Protect from moisture.
Each chewable tablet, mint and berry flavoured, provides 320 mg of elemental calcium and 69 mg of elemental magnesium. Low sodium.
Contraindications
In individuals with a hypersensitivity to any component of this medication. Cross-sensitivity has been observed between H2-receptor antagonists. Therefore, Pepcid Complete should not be taken by individuals with a history of hypersensitivity to other drugs in this class of compounds.
Warnings
No data supplied by the manufacturer.
Adverse Effects
Pepcid Complete has been demonstrated to be generally well tolerated. In primary studies (comparing Pepcid Complete, antacid 21.5 mEq, famotidine 10 mg and placebo), Pepcid Complete and the antacid groups (calcium carbonate/magnesium hydroxide 21 mEq) had similar proportions of patients with adverse experiences. The most common adverse experience was headache, occurring in 2.6% of patients receiving Pepcid Complete.
Changes in laboratory parameters have been observed with famotidine 10 mg.
Among the laboratory changes that were reported during clinical trials with Pepcid AC were increases in AST, ALT, and WBC count, and decreases in hemoglobin and hematocrit. These changes were rarely of clinical significance. No famotidine-treated patients/subjects had to be discontinued from therapy because of laboratory adverse experiences.
During marketed use of prescription doses of famotidine, which are higher than those recommended for nonprescription use, the following adverse reactions have been reported; urticaria, liver enzymes abnormalities, cholestatic jaundice, anaphylaxis, angioedema. Toxic epidermal necrolysis has been reported very rarely with H2-receptor antagonists.
The following adverse reactions have been reported; however, a causal relationship to therapy with Pepcid has not been established: agitation, confusion, hallucinations, grand mal seizures, rare cases of impotence, thrombocytopenia, pancytopenia, leukopenia and agranulocytosis.
Gynecomastia has been reported rarely. In most cases that were followed up, it was reversible after discontinuing treatment.
Overdose
In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
The oral LD50 of famotidine in male and female rats and mice was >5000 mg/kg.
Dosage
Heartburn or Acid Indigestion Adults and children 12 years and older: For fast, long-lasting and effective relief of symptoms: 1 tablet. If symptoms return, another tablet may be taken. For prevention of acid-related symptoms brought on by consuming food and/or beverage: 1 tablet 1 hour before eating. Maximum 2 tablets in 24 hours.
If symptoms persist for more than 2 consecutive weeks, a physician should be consulted. Individuals with kidney disease should not take this product except on the advice of a physician. This product should not be taken within 2 hours of another medicine because the effectiveness of the other medicine may be altered.
