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PEPCID COMPLETE is a brand name for Famotidine, supplied as a tablet (chewable). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PEPCID® COMPLETE® (famotidine, calcium carbonate, magnesium hydroxide) is indicated for: • 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; • the prevention of these…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, patients should be advised to stop use and consult a physician. • Individuals with kidney disease should not take this product except on the advice of a physician.
48 m2). See 7 WARNINGS AND PRECAUTIONS.
Product Monograph Master Template Template Date:
September 2020 PEPCID® COMPLETE® Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets Page 5 of 31 Unclassified / Non classifié • This product should not be taken within two hours of another medicine because the effectiveness of the other medicine may be altered.
2 Recommended Dose and Dosage Adjustment For heartburn or acid indigestion (Adults and children 12 years and older): For fast, long lasting and effective relief of symptoms: one (1) tablet (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg).
If symptoms return, another tablet may be taken. For prevention of acid-related symptoms brought on by consuming food and/or beverage: one (1) tablet 1 hour before eating. A maximum of 2 tablets should be taken in 24 hours. Health Canada has not authorized an indication for pediatric use.
1 Pediatrics above. 4 Administration Do not swallow tablet whole: chew completely.
).
Calcium Carbonate and Magnesium Hydroxide:
Calcium carbonate and magnesium hydroxide has not been demonstrated to have effects on the ability to drive or use machines. Gastrointestinal Patients with a previous history of ulcer disease complications, 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®.
Renal Patients with severe kidney disease should consult a physician before commencing therapy with PEPCID® COMPLETE®. 48m2). Magnesium is principally eliminated from the kidney, and the risk of developing hypermagnesemia is increased with impaired renal function.
Oral calcium carbonate intake has occasionally been associated with milk alkali syndrome, and the risk of developing milk alkali syndrome is increased with impaired renal function. Patients with pre-existing hypercalcemia or hypermagnesemia should consult a physician before using famotidine / antacid combination.
Both magnesium and calcium are absorbed systemically following use of oral magnesium or calcium containing antacids, which could result in an increase in already raised blood calcium or magnesium levels. 3 Pharmacokinetics. 1 Pregnant Women Famotidine: 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.
Calcium:
The maximum daily dose in case of pregnancy is 5000 mg of calcium carbonate (2000 mg of elemental calcium). Overconsumption of calcium carbonate as antacids or supplements may put pregnant women at risk for the possible development of milk-alkali syndrome, characterized by hypercalcemia, metabolic alkalosis, and acute kidney injury.
Product Monograph Master Template Template Date:
September 2020 PEPCID® COMPLETE® Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets Page 5 of 31 Unclassified / Non classifié • This product should not be taken within two hours of another medicine because the effectiveness of the other medicine may be altered.
2 Recommended Dose and Dosage Adjustment For heartburn or acid indigestion (Adults and children 12 years and older): For fast, long lasting and effective relief of symptoms: one (1) tablet (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg).
If symptoms return, another tablet may be taken. For prevention of acid-related symptoms brought on by consuming food and/or beverage: one (1) tablet 1 hour before eating. A maximum of 2 tablets should be taken in 24 hours. Health Canada has not authorized an indication for pediatric use.
1 Pediatrics above. 4 Administration Do not swallow tablet whole: chew completely. 5 OVERDOSAGE There is no experience to date with deliberate overdosage. Doses of up to 800 mg/day famotidine have been employed in patients with pathological hypersecretory conditions with no serious adverse effects.
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.
Famotidine:
The oral LD50 of famotidine in male and female rats and mice was >5000 mg/kg.
Calcium Carbonate:
Overdosage may result in hypercalcemia which may be associated with nausea, vomiting, constipation, mental status changes, lethargy, and weakness. Chronic overdose of calcium carbonate alone or with other calcium salts combined with alkali may result in milk-alkali syndrome, which presents typically with hypercalcemia, alkalosis, and renal dysfunction.
• Famotidine/Calcium Carbonate/Magnesium Hydroxide is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Famotidine in Canada.
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Generally, it is considered that elemental calcium intake of 4000 mg/day can cause milk-alkali syndrome, but there have been some cases reporting its development in pregnant women who took >2000 mg/day of elemental calcium. There are no adequate, well-controlled clinical studies in pregnancy for the combination of calcium carbonate, famotidine, and magnesium hydroxide.
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. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus.
2 Breast-feeding Famotidine: Famotidine is detectable in human milk. Breast-feeding mothers should either stop PEPCID® COMPLETE® or should stop breast-feeding.
Calcium Carbonate:
Excessive use of calcium-containing antacids should be avoided. Calcium can cross the placenta and is secreted in breast milk in significant amounts. When taken as directed, calcium carbonate does not appear to adversely affect the mother or fetus.
Maternal ingestion of calcium carbonate in labeled doses does not present at risk to the breast-feeding infant.
Magnesium Hydroxide:
There are no adequate or well-controlled studies of magnesium hydroxide in breast-feeding women. Magnesium hydroxide is acceptable to use while breast-feeding. Magnesium- containing emulsions administered orally to mothers did not affect the stools of breast- feeding infants.
3 Pediatrics Safety and effectiveness in children have not been established. PEPCID® COMPLETE® should not be administered to children under 12 years of age. 3 Pharmacokinetics). 1 Adverse Reaction Overview PEPCID® COMPLETE® (famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) has been demonstrated to be generally well tolerated.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 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.
6% of patients receiving PEPCID® COMPLETE®. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings 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.
5 Post-Market Adverse Reactions During marketed use of prescription […]
Patients with renal insufficiency and renal failure may be predisposed to this condition.
Magnesium Hydroxide:
The oral ingestion of magnesium rarely results in toxicity in patients with normal renal function. 8 mg/dL). Symptoms generally correlate to magnesium blood levels; however, there is variability among literature reports in patients with similar blood levels.
8-12 mg/dL) include nausea, vomiting, flushing, somnolence, and hypotension. Symptoms that appear at or above plasma levels of 10 mEq/L (12 mg/dL) include ECG changes, loss of deep tendon reflex, Product Monograph Master Template Template Date: September 2020 PEPCID® COMPLETE® Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets Page 6 of 31 Unclassified / Non classifié paralysis of voluntary muscle, and respiratory depression.
Around 15 mEq/L (18 mg/dL) heart block and cardiac arrest may occur. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Each PEPCID® COMPLETE® chewable tablet contains 10 mg famotidine, 800 mg of calcium carbonate, and 165 mg of magnesium hydroxide.
Each tablet provides 320 mg of elemental calcium and 70 mg of elemental magnesium. PEPCID® COMPLETE® chewable tablets (mint flavour) also contain FD&C Blue #1 and Yellow Iron Oxide . These tablets are round, with a concave centre, green-coloured tablets embossed with "P".
Available in bottles of 25 and 50. PEPCID® COMPLETE® chewable tablets (berry flavour) also contain D&C Red #7, FD&C Red #40, FD&C Blue #1 and corn starch modified. These tablets are round, with a concave centre, purple-coloured tablets embossed with "P".
Available in bottles of 25. , 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 or pain on swallowing, severe vomiting, black stool, choking, chest pain, 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 coexisting illness should consult a physician before commencing therapy with PEPCID® COMPLETE®. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral chewable tablet / famotidine 10 mg, calcium carbonate 800 mg and magnesium hydroxide 165 mg cellulose acetate, corn starch, crospovidone, dextrose monohydrate, flavours, gum arabic hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, Prosweet® Powder, sucralose Product Monograph Master Template Template Date: September 2020 PEPCID® COMPLETE® Famotidine / Calcium Carbonate / Magnesium Hydroxide Chewable Tablets Page 7 of 31 Unclassified / Non classifié Patients consuming nonsteroidal anti-inflammatory drugs may have dyspepsia as a side effect of these medicines and should consult a physician or a pharmacist before taking PEPCID® COMPLETE®.
Patients over 40 who are experiencing heartburn for the first time, and patients who have noticed unintentional weight loss should consult a physician before using the product. Therapy should not exceed two weeks of continuous treatment without medical consultation.
Driving and Operating Machinery Famotidine:
In very rare cases, some patients have experienced adverse reactions such as dizziness and somnolence while taking famotidine. Patients should be informed that they should avoid driving vehicles, operating machinery or doing activities which require prompt vigilance if they experience these symptoms (see