Adult Dosing

Heartburn associated with acid indigestion and sour stomach

• Chew 1 tablet (800 mg/10 mg/165 mg) PO qd
• Max: 2 tablets/day (1600 mg/20 mg/330 mg)

Note:

• Chew tablet completely; do not swallow whole

Pediatric Dosing

Heartburn associated with acid indigestion and sour stomach

Children >12 yrs

• Chew 1 tablet (800 mg/10 mg/165 mg) PO qd
• Max: 2 tablets/day (1600 mg/20 mg/330 mg)

Note:

• Chew tablet completely; do not swallow whole

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of heartburn associated with acid indigestion and sour stomach

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with other acid reducers

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Therapy should not be used in patients having difficulty or pain swallowing food, vomiting with blood, or in those with bloody or black stools
• Consult a physician before using therapy in patients with heartburn over 3 months, frequent wheezing with heartburn; lightheadedness, sweating, or dizziness with heartburn; and in those with chest pain or shoulder pain associated with shortness of breath, sweating, pain spreading to arms/neck/shoulders, or lightheadedness
• Discontinue therapy and consult a clinician if heartburn persists or worsens and if the product has to be used for more than 14 days
• Keep this drug out of reach of children

Cautions: Use cautiously in

• Frequent chest pain
• Unexplained weight loss
• Stomach pain
• Nausea or vomiting

Pregnancy Category:NR

Breastfeeding: Famotidine has been used in newborn infants in higher dosages than are transmitted in breastmilk. Hence, it would not be expected to cause any adverse effects in breastfed infants. Magnesium hydroxide is acceptable to use during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 14 July 2011).

• CNS: Dizziness, seizure, slow reflexes
• PSYCHIATRIC: Mental/mood changes
• CV: Heartburn, irregular heartbeat
• GI: Diarrhea, constipation, stomach cramps, nausea, vomiting
• GU: Dark urine
• DERM: Easy bruising/bleeding, yellowing skin/eyes
• METABOLIC: Loss of appetite
• HYPERSENSITIVITY: Severe allergic reactions
• MISC: Signs of infection

Calcium carbonate

• Antacid; acts by neutralizing hydrochloric acid in gastric secretions and also inhibits the action of pepsin by increasing the pH and via adsorption
• Absorbed from the GI tract in the presence of vitamin D
• Metabolism: Unknown
• Excretion: Primarily in feces (80%), minimally in urine (20%)
• Half-life: Unknown

Famotidine

• Anti-ulcer agent; competitively blocks histamine at H2 receptors, particularly those in gastric parietal cells, causing inhibition of gastric acid secretion
• Bioavailability of oral doses is 40-45%
• Partially metabolized by liver
• Renally excreted (25-30% unchanged)
• Half-life: 2.5-3.5 hrs (increased in renal impairment)

Magnesium hydroxide

• Antacid/laxative; neutralizes gastric acid; causes water retention in stool, producing laxative effect
• Absorption: 15-30%
• Metabolism: Unknown
• Excretion: Urine, feces
• Half-life: Unknown

US Trade Name(s)

• Pepcid Complete

US Availability

calcium carbonate/famotidine/magnesium hydroxide (generic)

• OTC CHEW TABS: 800 mg/10 mg/165 mg

Pepcid Complete (calcium carbonate/famotidine/magnesium hydroxide)

• OTC CHEW TABS: 800 mg/10 mg/165 mg

Canadian Trade Name(s)

• Pepcid Complete

Canadian Availability

Pepcid Complete (calcium carbonate/famotidine/magnesium hydroxide)

• OTC CHEW TABS: 800 mg/10 mg/165 mg

UK Trade Name(s)

• Pepcidtwo

UK Availability

Pepcidtwo (calcium carbonate/famotidine/magnesium hydroxide)

• CHEW TABS: 800 mg/10 mg/165 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Antacids/Histamine H2 Antagonists; Combinations

• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (American Sales Company)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (BJWC)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Dolgencorp Inc)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Kroger Company)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Rite Aid Corporation)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Target Corporation)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Topco Associates LLC)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Wal-Mart Stores Inc)
• Calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet (Walgreen Company)