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Product Name
:
FAMOX COMPLIETE
Chemical Name
:
Famotidine+Calcium Carbonate+magnesium Hydrxide
Therapeutic Category
:
Gastro-intestinal drugs
Pharmacologic Category
:
Antacid - Histamine H2 Antagonist
Pharmaceutical Form
:
Tablets
Composition
:
Famotidine 10mg +Calcium Carbonate 800mg +magnesium Hydrxide 165mg
Pregnancy
Lactation
Monitoring Parameters
Dosing
 
Dosing: Adult
Relief of heartburn due to acid indigestion: Oral: Famox® Complete: 1 tablet as needed; no more than 2 tablets in 24 hours; do not swallow whole, chew tablet completely before swallowing; do not use for longer than 14 days (see Additional Information or Pharmacotherapy Pearls for dosing ranges for individual ingredients)

Dosing: Pediatric

Children ≥12 years: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.
Use
 
Relief of heartburn due to acid indigestion
Adverse Reactions
 
Famotidine :
1% to 10%:
Central nervous system: Headache (5%), dizziness (1%)
Gastrointestinal: Diarrhea (2%), constipation (1%)
<1% (Limited to important or life-threatening): Abdominal discomfort, acne, agitation, agranulocytosis, allergic reaction, alopecia, anaphylaxis, angioedema, anorexia, anxiety, arrhythmia, arthralgia, AV block, bronchospasm, cholestatic jaundice, confusion, conjunctival injection, depression, dry skin, facial edema, fatigue, fever, flushing, hallucinations, hepatitis, injection site reactions, insomnia, interstitial pneumonia, leukopenia, libido decreased, liver function tests increased, muscle cramps, nausea, palpitation, pancytopenia, paresthesia, pruritus, QT-interval prolongation, rash, seizure, somnolence, Stevens-Johnson syndrome, taste disorder, tinnitus, thrombocytopenia, torsade de pointes, toxic epidermal necrolysis, urticaria, vomiting, weakness, xerostomia

Calcium carbonate

Well tolerated
1% to 10%:
Central nervous system: Headache
Endocrine & metabolic: Hypophosphatemia, hypercalcemia
Gastrointestinal: Constipation, laxative effect, acid rebound, nausea, vomiting, anorexia, abdominal pain, xerostomia, flatulence
Miscellaneous: Milk-alkali syndrome with very high, chronic dosing and/or renal failure (headache, nausea, irritability, and weakness or alkalosis, hypercalcemia, renal impairment)
Contraindications
 
Hypersensitivity to famotidine or other H2 antagonists, calcium carbonate, magnesium hydroxide, or any component of the formulation. See individual agents for additional information.
Warnings / Precautions Drug
 
ACE Inhibitors: Antacids may decrease the serum concentration of ACE Inhibitors. Management: Separate fosinopril administration from antacids by at least 2 hours. US and Canadian recommendations for use of other ACE- inhibitors with antacids may vary. Consult appropriate labeling. Monitor for decreased therapeutic effects of ACE-inhibitors. Exceptions: Ramipril. Risk D: Consider therapy modification
Alfacalcidol: May increase the serum concentration of Magnesium Salts. Risk D: Consider therapy modification
Allopurinol: Antacids may decrease the absorption of Allopurinol. Risk D: Consider therapy modification
Alpha-/Beta-Agonists: Antacids may decrease the excretion of Alpha-/Beta-Agonists. Exceptions: Dipivefrin. Risk C: Monitor therapy
Amphetamines: Antacids may decrease the excretion of Amphetamines. Risk C: Monitor therapy
Anticonvulsants (Hydantoin): Antacids may decrease the serum concentration of Anticonvulsants (Hydantoin). Risk C: Monitor therapy
Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Atazanavir: Antacids may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Atazanavir: H2-Antagonists may decrease the absorption of Atazanavir. Management: Specific dose limitations and administration guidelines exist; consult full interaction monograph or atazanavir prescribing information. Risk D: Consider therapy modification
Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Calcium Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral calcium supplements within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Antacids may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of antacids containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Magnesium Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral magnesium salts within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Calcitriol: May increase the serum concentration of Magnesium Salts. Risk D: Consider therapy modification
Calcium Acetate: Calcium Salts may enhance the adverse/toxic effect of Calcium Acetate. Risk X: Avoid combination
Calcium Channel Blockers: Calcium Salts may diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy
Calcium Channel Blockers: May enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy
Calcium Polystyrene Sulfonate: Laxatives may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of calcium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of calcium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives or sorbitol. Risk X: Avoid combination
Calcium Polystyrene Sulfonate: Antacids may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. The combined use of these two agents may result in metabolic alkalosis and/or loss of efficacy of the cation exchange resin. Management: To minimize this interaction, consider: a)separating doses by 2 or more hours; b)rectal administration of the exchange resin; or c)alternatives to antacids. Monitor for metabolic alkalosis and attenuation of CPS effects. Avoid magnesium hydroxide. Risk D: Consider therapy modification
Cefditoren: H2-Antagonists may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with H2-antagonists and antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of H2-antagonists can not be avoided. Risk D: Consider therapy modification
Cefditoren: Antacids may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy. If antacid therapy can not be avoided, separate dosing by several hours. Risk D: Consider therapy modification
Cefpodoxime: H2-Antagonists may decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy
Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Management: Consider administering antacids and cefuroxime at least 2 hours apart. Risk D: Consider therapy modification
Cefuroxime: H2-Antagonists may decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Risk C: Monitor therapy
Chloroquine: Antacids may decrease the serum concentration of Chloroquine. Management: Separate administration of antacids and chloroquine by at least 4 hours to minimize any potential negative impact of antacids on chloroquine bioavailability. Risk D: Consider therapy modification
Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification
Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Antacids may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Dasatinib: H2-Antagonists may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
Delavirdine: H2-Antagonists may decrease the serum concentration of Delavirdine. Management: Chronic therapy with H2-antagonists should be avoided in patients who are being treated with delavirdine. The clinical significance of short-term H2-antagonist therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination
Delavirdine: Antacids may decrease the serum concentration of Delavirdine. Management: Separate doses of delavirdine and antacids by at least 1 hour. Monitor for decreased delavirdine therapeutic effects with this combination. Risk D: Consider therapy modification
Dexmethylphenidate: Antacids may increase the absorption of Dexmethylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy
Dexmethylphenidate: H2-Antagonists may increase the absorption of Dexmethylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy
DOBUTamine: Calcium Salts may diminish the therapeutic effect of DOBUTamine. Risk C: Monitor therapy
Eltrombopag: Calcium Salts may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., calcium-containing products) by at least 4 hours. Risk D: Consider therapy modification
Eltrombopag: Magnesium Salts may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., magnesium-containing products) by at least 4 hours. Risk D: Consider therapy modification
Erlotinib: H2-Antagonists may decrease the serum concentration of Erlotinib. Management: Avoid H2-antagonists in patients receiving erlotinib when possible. If concomitant treatment cannot be avoided, erlotinib should be dosed once daily, 10 hours after and at least 2 hours before H2-antagonist dosing. Risk D: Consider therapy modification
Erlotinib: Antacids may decrease the serum concentration of Erlotinib. Management: Separate the administration of erlotinib and any antacid by several hours in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification
Estramustine: Calcium Salts may decrease the absorption of Estramustine. Risk D: Consider therapy modification
Fexofenadine: Antacids may decrease the serum concentration of Fexofenadine. Management: No specific recommendations concerning the time required between their administration are provided. Separate administration of each agent by as much time as possible to decrease the risk of an interaction. Risk D: Consider therapy modification
Fosamprenavir: H2-Antagonists may decrease the serum concentration of Fosamprenavir. Cimetidine may also inhibit the metabolism of the active metabolite amprenavir, making its effects on fosamprenavir/amprenavir concentrations difficult to predict. Risk C: Monitor therapy
Gabapentin: Antacids may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after antacid administration. Monitor patients closely for evidence of reduced response to gabapentin therapy when both of these drugs are being used. Risk D: Consider therapy modification
Gefitinib: H2-Antagonists may decrease the serum concentration of Gefitinib. Risk C: Monitor therapy
HMG-CoA Reductase Inhibitors: Antacids may decrease the serum concentration of HMG-CoA Reductase Inhibitors. Risk C: Monitor therapy
Indinavir: H2-Antagonists may decrease the serum concentration of Indinavir. Risk C: Monitor therapy
Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Iron Salts: H2-Antagonists may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk C: Monitor therapy
Isoniazid: Antacids may decrease the absorption of Isoniazid. Risk D: Consider therapy modification
Itraconazole: Antacids may decrease the serum concentration of Itraconazole. Management: Administer itraconazole at least 1 hour after and 2 hours before administration of any antacids. Itraconazole oral suspension may be less sensitive to the effects of decreased gastric acidity. Risk D: Consider therapy modification
Itraconazole: H2-Antagonists may decrease the serum concentration of Itraconazole. Management: When this combination is used, the itraconazole should be administered with a cola beverage (8 ounces). Itraconazole oral suspension may be less sensitive to this interaction. Monitor patient response to itraconazole closely. Risk D: Consider therapy modification
Ketoconazole: Antacids may decrease the serum concentration of Ketoconazole. Management: Administer oral ketoconazole at least 2 hours prior to use of any antacid product. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification
Ketoconazole: H2-Antagonists may decrease the serum concentration of Ketoconazole. Management: Administer oral ketoconazole at least 2 hours prior to use of any H2-receptor antagonist. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification
Ketoconazole (Systemic): Antacids may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any antacid product. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification
Ketoconazole (Systemic): H2-Antagonists may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any H2-receptor antagonist. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification
Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Risk D: Consider therapy modification
Mesalamine: H2-Antagonists may diminish the therapeutic effect of Mesalamine. Histamine H2-Antagonist-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose histamine H2-receptor antagonists with sustained-release mesalamine products. Risk D: Consider therapy modification
Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Risk D: Consider therapy modification
Methylphenidate: Antacids may increase the absorption of Methylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy
Methylphenidate: H2-Antagonists may increase the absorption of Methylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy
Misoprostol: Antacids may enhance the adverse/toxic effect of Misoprostol. More specifically, concomitant use with magnesium-containing antacids may increase the risk of diarrhea. Management: Avoid concomitant use of misoprostol and magnesium-containing antacids. In patients requiring antacid therapy, employ magnesium-free preparations. Monitor for increased adverse effects (e.g., diarrhea, dehydration). Risk D: Consider therapy modification
Mycophenolate: Antacids may decrease the absorption of Mycophenolate. Management: Separate doses of mycophenolate and antacids by at least 2 hours. Monitor for reduced effects of mycophenolate if taken concomitant with antacids. Risk D: Consider therapy modification
Mycophenolate: Magnesium Salts may decrease the serum concentration of Mycophenolate. Management: Separate doses of mycophenolate and oral magnesium salts. Monitor for reduced effects of mycophenolate if taken concomitant with oral magnesium salts. Risk D: Consider therapy modification
Nelfinavir: H2-Antagonists may decrease the serum concentration of Nelfinavir. Concentrations of the active M8 metabolite may also be reduced. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Penicillamine: Antacids may decrease the serum concentration of Penicillamine. Risk D: Consider therapy modification
Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Exceptions: Potassium Phosphate. Risk D: Consider therapy modification
Phosphate Supplements: Calcium Salts may decrease the absorption of Phosphate Supplements. Exceptions: Potassium Phosphate. Risk D: Consider therapy modification
Phosphate Supplements: Magnesium Salts may decrease the serum concentration of Phosphate Supplements. Management: Administer oral phosphate supplements at least 1 hour before, or 2 hours after, oral magnesium salt administration. Exceptions: Potassium Phosphate. Risk D: Consider therapy modification
Posaconazole: H2-Antagonists may decrease the serum concentration of Posaconazole. Management: Avoid concurrent use whenever possible. Monitor patients closely for decreased antifungal effects if this combination is used. Consider using a noninteracting antifungal as appropriate. Risk D: Consider therapy modification
Protease Inhibitors: Antacids may decrease the absorption of Protease Inhibitors. Exceptions: Darunavir. Risk C: Monitor therapy
QuiNIDine: Antacids may decrease the excretion of QuiNIDine. Risk C: Monitor therapy
QuiNINE: Antacids may decrease the serum concentration of QuiNINE. Risk X: Avoid combination
Quinolone Antibiotics: Antacids may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Quinolone Antibiotics: Calcium Salts may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Moxifloxacin; Moxifloxacin (Systemic). Risk D: Consider therapy modification
Quinolone Antibiotics: Magnesium Salts may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
Rilpivirine: Antacids may decrease the serum concentration of Rilpivirine. Management: Administer antacids at least 2 hours before or 4 hours after rilpivirine. Risk D: Consider therapy modification
Rilpivirine: H2-Antagonists may decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. Risk D: Consider therapy modification
Saquinavir: H2-Antagonists may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Sodium Polystyrene Sulfonate: Laxatives may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of sodium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of sodium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives or sorbitol. Risk X: Avoid combination
Sodium Polystyrene Sulfonate: Antacids may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. The combined use of these two agents may result in metabolic alkalosis and/or loss of efficacy of the exchange resin. Management: To minimize this interaction, consider: a)separating doses by 2 or more hours; b)rectal administration of the exchange resin; or c)alternatives to antacids. Monitor for metabolic alkalosis and attenuation of SPS effects. Avoid magnesium hydroxide. Risk D: Consider therapy modification
Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. Risk D: Consider therapy modification
Tetracycline Derivatives: Magnesium Salts may decrease the absorption of Tetracycline Derivatives. Only applicable to oral preparations of each agent. Risk D: Consider therapy modification
Tetracycline Derivatives: Calcium Salts may decrease the serum concentration of Tetracycline Derivatives. Management: If coadministration of oral calcium with oral tetracyclines can not be avoided, consider separating administration of each agent by several hours. Risk D: Consider therapy modification
Thiazide Diuretics: May decrease the excretion of Calcium Salts. Continued concomitant use can also result in metabolic alkalosis. Risk C: Monitor therapy
Thyroid Products: Calcium Salts may diminish the therapeutic effect of Thyroid Products. Management: Separate the doses of the thyroid product and the oral calcium supplement by at least 4 hours. Risk D: Consider therapy modification
Trientine: Antacids may decrease the absorption of Trientine. Management: Separate trientine dosing from other oral drugs (eg, antacids) by at least 1 hour. Monitor for decreased therapeutic effects of trientine if an antacid is initiated/dose increased, or increased effects if an antacid is discontinued/dose decreased. Risk D: Consider therapy modification
Trientine: May decrease the serum concentration of Calcium Salts. Calcium Salts may decrease the serum concentration of Trientine. Risk D: Consider therapy modification
Trientine: May decrease the serum concentration of Magnesium Salts. Magnesium Salts may decrease the serum concentration of Trientine. Risk D: Consider therapy modification
Varenicline: H2-Antagonists may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of cimetidine or other H2-antagonists, particulary in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Risk C: Monitor therapy
Vitamin D Analogs: Calcium Salts may enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy
Mechanism of Action
 
Famotidine: H2 antagonist
Calcium carbonate: Antacid
Magnesium hydroxide: Antacid
Pharmacodynamics / Kinetics
 
Famotidine :
Onset of action: Antisecretory effect: Oral: Within 1 hour
Peak effect: Antisecretory effect: Oral: Within 1-3 hours (dose-dependent)
Duration: Antisecretory effec. Oral: 10-12 hours
Absorption: Oral: Incompletely absorbed
Distribution: Vd:
Infants: 0-3 months: ~1.4-1.8 L/kg; >3-12 months: ~2.3 L/kg
Children: ~2 L/kg
Adults: ~1 L/kg
Protein binding: 15% to 20%
Metabolism: Minimal first-pass metabolism; forms one metabolite (S-oxide)
Bioavailability: Oral: 40% to 45%
Half-life elimination:
Infants: 0-3 months: ~8-10.5 hours; >3-12 months: ~4.5 hours
Children: 3.4 hours
Adults: 2.5-3.5 hours; prolonged with renal impairment; Oliguria: >20 hours
Time to peak, serum: Oral: ~1-3 hours
Excretion: Urine (25% to 30% [oral], 65% to 70% [I.V.] as unchanged drug)
 
   
 
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