Drug Information

Calcium carbonate and simethicone

Drug ratings in pregnancy (US Food & Drug Administration) Category Interpretation A Controlled studies show no risk Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote. B No evidence of human risk in controlled studies Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters. C Risk cannot be ruled out Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus. D Positive evidence of risk There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). X Contraindicated in pregnancy Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Reproduced with permission from: Lacy CF, Armstrong LL, Goldman MP, Lance LL. Lexi-Comp Drug Information Handbook, 20th Edition. Hudson, OH: Lexi-Comp, 2011. Copyright © 2011.
Drug ratings in pregnancy (US Food & Drug Administration) Category Interpretation A Controlled studies show no risk Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote. B No evidence of human risk in controlled studies Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters. C Risk cannot be ruled out Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus. D Positive evidence of risk There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). X Contraindicated in pregnancy Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Reproduced with permission from: Lacy CF, Armstrong LL, Goldman MP, Lance LL. Lexi-Comp Drug Information Handbook, 20th Edition. Hudson, OH: Lexi-Comp, 2011. Copyright © 2011.

Brand Names: U.S.

  • Gas Ban™ [OTC];
  • Maalox® Advanced Maximum Strength [OTC];
  • Maalox® Junior Plus Antigas [OTC];
  • Titralac® Plus [OTC]

Pharmacologic Category

  • Antacid;
  • Antiflatulent

Dosing: AdultHyperacidity, gas: Oral (OTC labeling):

Maalox® Advanced Maximum Strength: 1-2 tablets as symptoms occur or as directed by healthcare provider (maximum: 8 tablets/24 hours)

Titralac® Plus: Two tablets every 2-3 hours as needed (maximum: 19 tablets/24 hours)

Dosing: PediatricHyperacidity, gas: Oral (OTC labeling):

Children 6-11 years: Maalox® Junior Plus Antigas: Two tablets as symptoms occur or as directed by healthcare provider (maximum: 6 tablets/24 hours)

Children ≥12 years: Maalox® Advanced Maximum Strength: Refer to adult dosing.

Dosing: GeriatricRefer to adult dosing.

Dosage Forms: U.S.Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, chewable:

Gas Ban™: Calcium carbonate 300 mg and simethicone 40 mg

Maalox® Advanced Maximum Strength: Calcium carbonate 1000 mg and simethicone 60 mg [equivalent to elemental calcium 400 mg; assorted fruit flavor, lemon flavor, wildberry flavor]

Maalox® Junior Plus Antigas: Calcium carbonate 400 mg and simethicone 24 mg [equivalent to elemental calcium 160 mg; wildberry flavor]

Titralac® Plus: Calcium carbonate 420 mg and simethicone 21 mg [equivalent to elemental calcium 168 mg; sugar free; spearmint flavor]

Generic Equivalent Available: U.S.No

AdministrationTablets may be chewed, swallowed whole, or allowed to melt in the mouth.

UseRelief of acid indigestion, heartburn, bloating, pressure, and discomfort of gas

Medication Safety Issues

International issues:

Remegel Wind Relief [Great Britain] may be confused with Renagel brand name for sevelamer [U.S., Canada, and multiple international markets]

Adverse Reactions SignificantFrequency not defined: Gastrointestinal: Constipation

Warnings/Precautions Other warnings/precautions:

• Self medication (OTC labeling): Prior to self medication patients should contact healthcare provider if they have kidney stones, are on a calcium-restricted diet, or are taking any prescription medications. Patients should discontinue use and contact healthcare provider if symptoms persist for >2 weeks. Patients should not use the maximum dose for >2 weeks unless directed by healthcare provider.

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

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

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

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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

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 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: 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: 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

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

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

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

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

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

HMG-CoA Reductase Inhibitors: Antacids may decrease the serum concentration of HMG-CoA Reductase Inhibitors. Risk C: Monitor therapy

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Iron Salts: Antacids may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification

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

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 (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

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

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

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

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

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

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

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

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

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Tetracycline Derivatives: Antacids may decrease the absorption of Tetracycline Derivatives. 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

Vitamin D Analogs: Calcium Salts may enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy

Pregnancy Risk FactorC (show table)

Drug ratings in pregnancy (US Food & Drug Administration)
Category Interpretation
A Controlled studies show no risk
Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote.
B No evidence of human risk in controlled studies
Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters.
C Risk cannot be ruled out
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus.
D Positive evidence of risk
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X Contraindicated in pregnancy
Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Reproduced with permission from: Lacy CF, Armstrong LL, Goldman MP, Lance LL. Lexi-Comp Drug Information Handbook, 20th Edition. Hudson, OH: Lexi-Comp, 2011. Copyright © 2011.

Pharmacodynamics/KineticsSee individual agents.

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