Friday, November 11, 2016

Cimetidine



Class: Histamine H2-Antagonists
VA Class: GA301
CAS Number: 51481-61-9
Brands: Tagamet

Introduction

Histamine H2 receptor antagonist.b


Uses for Cimetidine


Duodenal Ulcer


Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).a b


Maintainence of healing and reduction in recurrence of duodenal ulcer.a b


Pathologic GI Hypersecretory Conditions


Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis.a b


Gastric Ulcer


Short-term treatment of active benign gastric ulcer.a b


Gastroesophageal Reflux (GERD)


Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.118


Treatment of symptomatic GERD.105 106 123 288


Self-medication as initial therapy to achieve acid suppression, control symptoms, and prevent complications of less severe symptomatic GERD.288


Upper GI Bleeding


Prevention of upper GI bleeding resulting from stress-related mucosal damage (erosive esophagitis, stress ulcers) in critically ill patients.118 142 143 144 145 146 147 152 153 154 155 156 157 161 162 163 164 165 166 170 171 172 173 174 175 176 177 179 188 191


Treatment of upper GI bleeding secondary to hepatic failure, esophagitis, duodenal or gastric ulcers when hemorrhage is not caused by major blood vessel erosion.b


Heartburn (pyrosis), Acid Indigestion (hyperchlorhydria), or Sour Stomach


Short-term self-medication for relief of heartburn symptoms in adults and adolescents≥12 years of age.c


Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion (hyperchlorhydria) and sour stomach brought on by ingestion of certain foods and beverages in adults and children ≥12 years of age.c


Allergic Conditions and Urticarias124 125 126 127 128 129 130 131 132 133 134 135 136 137


Cimetidine Dosage and Administration


Administration


Administer orally, IV, or IM.118


Administer by IM or slow IV injection, or by intermittent or continuous IV infusion in hospitalized patients with pathological GI hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible.118


Oral Administration


Administer with or without food; administration with food may delay and slightly decrease absorption, but achieves maximum antisecretory effect when stomach is no longer protected by food buffering effect. Administer oral tablets with water.b


Antacids may be given as necessary for pain relief, but not at the same time.a b


For duodenal ulcer treatment, administration once daily at bedtime is the regimen of choice because of a high healing rate, maximal pain relief, decreased drug interaction potential, and maximal compliance.117 118 119


For gastric ulcer treatment, administration once daily at bedtime is the regimen of choice because of convenience and decreased drug interaction potential.118


For gastroesophageal reflux, once-daily dosing is not considered appropriate.288


IM Administration


May be administered undiluted.a b


Intermittent Direct IV Injection


Dilution

Dilute 300 mg to 20 mL with 0.9% sodium chloride injection or other compatible IV solution before direct IV injection (see Compatibility under Stability).118


Rate of Administration

Inject over ≥5 minutes.118


Intermittent IV infusion


Reconstitution

Reconstitute ADD-Vantage vials according to manufacturer’s directions.118


Dilution

Dilute 300 mg in at least 50 mL of 0.9% sodium chloride injection or 5% dextrose injection or other compatible IV solution (see Compatibility under Stability).118


No additional dilution required for commercially available infusion solution (300 mg cimetidine in 50 mL of 0.9% sodium chloride injection).a


Rate of Administration

Over 15–20 minutes.118


Continuous IV Infusion


Dilution

Dilute 900 mg in 100–1000 mL of a compatible IV solution (see Compatibility under Stability).a b


Rate of Administration

Over 24 hours.a b


Adjust rate to individual patient requirements.a b


Volume <250 mL: use controlled-infusion device (e.g., pump).a b


Dosage


Dosage of cimetidine hydrochloride expressed in terms of cimetidine.118


Pediatric Patients


20–40 mg/kg daily in divided doses has been used in a limited number of children when potential benefits are thought to outweigh the possible risks.118


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn Relief (Self-medication)

Oral

Adolescents ≥12 years of age: 200 mg once or twice daily, or as directed by a clinician.268


Prevention of Heartburn (Self-medication)

Oral

Adolescents ≥12 years of age: 200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c


Adults


General Parenteral Dosage

Parenteral dosage regimens for GERD have not been established.a


General parenteral dosage (in hospitalized patients with pathologic hypersecretory conditions or intractable ulcer, or for short-term use when oral therapy is not feasible):a


IM

300 mg every 6–8 hours.118


Intermittent Direct IV Injection

300 mg every 6–8 hours.118


300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118


Intermittent IV Infusion

300 mg every 6–8 hours.118


300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118


Continuous IV infusion

900 mg over 24 hours (37.5 mg/hour).a b See Pathologic GI Hypersecretory Conditions under Dosage: Adults.


For more rapid increase in gastric pH, a loading dose of 150 mg may be given as an intermittent infusion before continuous infusion.a b


Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

Dosage of choice: 800 mg once daily at bedtime.117 118 119


Patients with ulcer >1 cm in diameter who are heavy smokers (i.e., ≥1 pack daily) when rapid healing (e.g., within 4 weeks) is considered important:118 1.6 g daily at bedtime.117 118 119


Administer for 4–6 weeks unless healing is confirmed earlier.117 118 If not healed or symptoms continue after 4 weeks, additional 2–4 weeks of full dosage therapy may be beneficial.118 More than 6–8 weeks at full dosage is rarely needed.118


Healing of active duodenal ulcers may occur in 2 weeks in some, and occurs within 4 weeks in most patients.117 118 119 120 121 122


Other regimens (no apparent rationale for these other than familiarity of use) that have been used:117 118 300 mg 4 times daily with meals and at bedtime; 200 mg 3 times daily and 400 mg at bedtime; 400 mg twice daily in the morning and at bedtime.b


Maintenance of Healing of Duodenal Ulcer

Oral

400 mg daily at bedtime.118 Efficacy not increased by higher dosages or more frequent administration.b


Pathologic GI Hypersecretory Conditions

Zollinger-Ellison Syndrome

Oral

300 mg 4 times daily with meals and at bedtime.118


Higher doses administered more frequently may be necessary;a b adjust dosage according to response and tolerance but in general, do not exceed 2400 mg daily.a


Continue as long as necessary.118


Continuous IV Infusion

Mean infused dose of 160 mg/hour (range: 40-600 mg/hour) in one study.a


Gastric Ulcer

Oral

Preferred regimen: 800 mg once daily at bedtime.118


Alternative regimen: 300 mg 4 times daily, with meals and at bedtime.118


Monitor to ensure rapid progress to complete healing.a b


Studies limited to 6 weeks, efficacy for >8 weeks not established.118


GERD

Once daily (at bedtime) not considered appropriate therapy.288


Treatment of Symptomatic GERD

Oral

300 mg 4 times daily has been used.105 106 123


Treatment of Erosive Esophagitis

Oral

800 mg twice daily or 400 mg 4 times daily (e.g., before meals and at bedtime) for up to 12 weeks.118


Upper GI Bleeding

Prevention of Upper GI Bleeding

Continuous IV Infusion

50 mg/hour; loading dose not required.118


Safety and efficacy of therapy beyond 7 days has not been established.118


Alternative dosage: Some clinicians recommend 300-mg IV loading dose over 5–20 minutes, then continuous IV infusion at 37.5–50 mg/hour; titrate with 25-mg/hour increments up to 100 mg/hour based on gastric pH (e.g., to maintain a pH of at least 3.5–4).118 143 144 173 174 176 188


Intermittent IV doses may be less effective in preventing upper GI bleeding than continuous IV infusion.155 172 173 174 175 176 177 178 188 189 191


Treatment of Upper GI Bleeding

Oral

1–2 g daily in 4 divided doses has been used.b


IV

1–2 g daily in 4 divided doses has been used.b


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn (Self-medication)

Oral

200 mg once or twice daily, or as directed by clinician.268


Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c


Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prescribing Limits


Pediatric Patients


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn (Self-Medication)

Oral

Adolescents ≥12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

Adolescents ≥12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Adults


General Parenteral Dosage

General parenteral dosage (hospitalized patients with pathologic hypersecretory conditions or intractable duodenal ulcer, or short-term use when oral therapy is not feasible):


Direct IV injection

Maximum 2.4 g daily.a


Maximum 300 mg per dose.a


Maximum concentration 300 mg/20 mL.a


Maximum injection rate: 20 mL over not less than 5 minutes (4 mL per minute).a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Maximum 300 mg per dose.a


Maximum concentration 300 mg/50 mL.a


Maximum infusion rate: 15–20 minutes.a


GERD

Short-term Treatment of Erosive Esophagitis

Oral

Safety and efficacy beyond 12 weeks of administration have not been established.a


Heartburn, Acid Indigestion, or Sour Stomach

Heartburn Relief (Self-medication)

Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Prevention of Heartburn (Self-medication)

Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c


Duodenal Ulcer

Intermittent Direct IV Injecton

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Gastric Ulcer

Short-term treatment of Active Benign Gastric Ulcer

Oral

Safety and efficacy beyond 8 weeks have not been established.118


Intermittent Direct IV Injection

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)

Oral

Maximum usually 2.4 g daily.118


Intermittent Direct IV Injection

Maximum 2.4 g daily.a


Intermittent IV Infusion

Maximum 2.4 g daily.a


Upper GI Bleeding

Prevention of Upper GI Bleeding

Continuous IV Infusion

Safety and efficacy beyond 7 days have not been established.a


Special Populations


Renal Impairment


Severe (Clcr< 30 mL/minute)

Oral

300 mg every 12 hours.118


Accumulation may occur; use lowest frequency of dosing compatible with adequate response.118


Increase frequency to every 8 hours or more frequently (with caution) if required.118


Presence of hepatic impairment may require further dosage reduction.118


Direct IV Injection

300 mg every 12 hours.118


Accumulation may occur; use lowest frequency compatible with adequate response.118


Increase frequency to every 8 hours or more frequently (with caution) if required118


Presence of hepatic impairment may require further dosage reduction.118


Continuous IV Infusion

Prevention of Upper GI Bleeding: One-half recommended dosage (i.e., 25 mg/hour).118


Hemodialysis

Decreases blood levels; administer at the end of hemodialysis and every 12 hours during interdialysis.b


Hepatic Impairment


May require further dosage reduction in the presence of severe renal impairment.118


Cautions for Cimetidine


Contraindications



  • Known hypersensitivity to cimetidine or any ingredient in the formulation.118



Warnings/Precautions


General Precautions


Cardiovascular Effects

Rapid IV administration associated rarely with hypotension, cardiac arrhythmias; avoid.a b


Gastric Malignancy

Response to cimetidine does not preclude presence of gastric malignancy.118


CNS Effects

Reversible confusional states reported, especially in geriatric (i.e., ≥50 years) and severely ill (e.g., hepatic or renal disease, organic brain syndrome) patients.118 b Usually occurs within 2–3 days after initiating cimetidine and resolves within 3–4 days after discontinuance.118 b


Respiratory Effects

Administration of H2-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).302 303


Specific Populations


Pregnancy

Category B.a


Pregnant women should consult a clinician before using for self-medication.268


Lactation

Distributed into milk.118 Generally, do not nurse during therapy with cimetidine.118


Nursing women should consult a clinician before using for self-medication.268


Pediatric Use

Safety and efficacy not established in children <16 years of age; do not use unless potential benefits outweigh risks.118


Safety and efficacy for self-medication not established in children <12 years of age; do not use unless directed by a clinician.c


Renal Impairment

Dosage adjustments necessary in patients with severe renal impairment.118 (See Renal Impairment under Dosage and Administration.)


Hepatic Impairment

Further dosage adjustments may be necessary in presence of severe renal impairment.118 (See Hepatic Impairment under Dosage and Administration.)


Immunocompromised Patients

Increased possibility of Strongyloides stercoralis hyperinfection with decreased gastric acidity.118 269 270


Common Adverse Effects


Headache,118 144 dizziness, somnolence, diarrhea.118


With ≥1 month of therapy: gynecomastia.118 b


With IM therapy: transient pain at injection site.118


Interactions for Cimetidine


Inhibits hepatic microsomal enzyme systems, decreases hepatic metabolism of some drugs.118 If necessary, adjust dosage of hepatically metabolized drugs when cimetidine therapy is initiated or discontinued.b


Specific Drugs
















































Drug



Interaction



Comments



Alcohol



Possible increased blood alcohol concentrations,256 257 258 259 260 261 263 264 265 psychomotor impairment256 257 258 259 260 261 267



Potential for psychomotor impairment controversial, 256 257 258 259 260 261 267 but use caution during performance of hazardous tasks requiring mental alertness, physical coordination257 258 261



Antacidsb



Decreased cimetidine absorptionb



Administer 1 hour before or after cimetidine in the fasting state, or 1 hour after cimetidine is taken with food.a b



Benzodiazepines118



Potential for delayed elimination, increased blood concentrations of certain benzodiazepines (e.g., diazepam, chlordiazepoxide, triazolam)118



Adjust dosage if needed b



Calcium-channel blockers (e.g., nifedipine)a



Potential for delayed elimination, increased blood concentrations of nifedipine118



Adjust dosage if needed b



Ketoconazole118



Absorption of ketoconazole may be affected by altered gastric pH118



Administer ≥2 hours before cimetidine118



Lidocaine118



Potential for delayed elimination, increased blood concentrations of lidocaine118



Adverse effects reported, adjust dosage if needed b



Metronidazole118



Potential for delayed elimination, increased blood concentrations of metronidazole118



Adjust dosage if neededb



Myelosuppressive drugs (e.g., alkylating agents [e.g., carmustine], antimetabolites) and/or therapies (radiation)b



May potentiate myelosuppressionb



 



Phenytoin118



Potential for delayed elimination, increased blood concentrations of phenytoin118



Adverse effects reported, adjust dosage if needed b



Propranolol118



Potential for delayed elimination, increased blood concentrations of propranolol118



Adjust dosage if needed b



Theophylline118



Potential for delayed elimination, increased blood concentrations of theophylline118



Adverse effects reported, adjust dosage if needed b



Triamterene108



Potential for delayed elimination, increased blood concentrations of triamterene118



Consider potential of clinically important interaction108



Tricyclic Antidepressants118



Potential for delayed elimination, increased blood concentrations of certain tricyclic antidepressants118



Adjust dosage if neededb



Warfarin118



Potential for delayed elimination, increased blood concentrations of warfarin118



Monitor PT, adjust dosage if neededb


Cimetidine Pharmacokinetics


Absorption


Bioavailability


Oral: 60–70%.b


Onset


≥70% decrease in basal acid secretion within 45 minutes after single 300- or 400-mg IV dose in healthy males.100


Duration
















































Dosage Regimen



Effect On Acid Secretion



Comments



Oral: 800 mg at bedtime in duodenal ulcer patients118



Mean hourly nocturnal secretion decreased by 85% over 8 hours.118



No effect on daytime acid secretion118



Oral: 1600 mg at bedtime in duodenal ulcer patients 118



Mean hourly nocturnal secretion decreased by 100% over 8 hours, 35% decrease for additional 5 hours.118



Moderate (<60%) 24-hour suppression118



Oral: 400 mg twice daily in duodenal ulcer pateints118



Nocturnal secretion decreased by 47–83% over 6–8 hours 118



Moderate (<60%) 24-hour suppression118



Oral: 300 mg 4 times daily in duodenal ulcer patients118



Nocturnal secretion decreased by 54% over 9 hours118



Moderate (<60%) 24-hour suppression118



Oral: Single 300-mg dose within 1 hour after meal in duodenal ulcer patientsa



Food-stimulated secretion decreased by 50% for 1 hour, then 75% for 2 hours.a



 



Oral: 300-mg dose at breakfast in duodenal ulcer patientsa



Continued suppression for 4 hours, with partial suppression after luncha



Effect enhanced and maintained by additional 300-mg dose with luncha



Oral: 300-mg dose with foodb



Mean gastric pH 3.5–4 at 1 hour, 5.5–6.1 at 4 hoursb



 



Oral: Single dose 300 mg with fooda



Mean gastric pH: 3.5, 3.1, 3.8, 6.1 at hour 1, 2, 3, 4, respectivelya



Placebo mean gastric pH: 2.6, 1.6, 1.9, 2.2 at hour 1, 2, 3, 4, respectivelya



Oral: 300–400 mg in fasting state in duodenal ulcer patientsb



Anacidity for up to 8 hoursb



 



Oral: 300 mg in duodenal ulcer patientsb



Basal gastric acid output decreased by 90% for 4 hoursb



Meal-stimulated acid secretion by 66% for 3 hoursb



IV continuous infusion: mean dosage of 160 mg/hour (range:40-600 mg/hour) in pathologic hypersecretory conditionsb



Maintained secretion at ≤10 mEq/hourb



 



IV continuous infusion (37.5 mg/hour or 900 mg daily) in patients with active or healed duodenal or gastric ulcerb



Maintained gastric pH at >4 for >50% of the time at steady-state.b



 



Intermittent injection: (300 mg every 6 hours or 1200 mg daily) in patients with active or healed duodenal or gastric ulcerb



Maintained gastric pH at >4 for >50% of the time at steady-state.b



 



IV: Single 300- or 400-mg dose in healthy males



≥70% decrease in basal acid secretion maintained for 4–4.5 hours100



 


Food


Delays, slightly decreases absorption.b However, administration with meals achieves maximum blood concentrations and antisecretory effect when stomach is no longer protected by food buffering effect.b


Distribution


Extent


Widely distributed throughout the body.b


Distributed into human milk.b


Crosses the placenta in animals.b


Plasma Protein Binding


15–20%.b


Elimination


Metabolism


Metabolized to sulfoxide (major metabolite) and 5-hydroxymethyl derivatives in liver.a b More extensively metabolized after oral than parenteral administration.a


Elimination Route


Excreted principally in urine.a b Single oral dose: 48% (unchanged) excreted in urine over 24 hours.a IV or IM: about 75% (unchanged) excreted in urine within 24 hours.a Single IV dose of radiolabeled cimetidine: 80–90% (50–73% unchanged, remainder as metabolites) excreted in urine over 24 hours.b About 10% excreted in feces.b


Half-life


2 hours.a


After IV administration in children 4.1–15 years of age: Apparent biphasic decline of plasma cimetidine and cimetidine sulfoxide concentrations with half-lives of 1.4 and 2.6 hours, respectively.102


Special Populations


2.9 hours in patients with Clcr 20–50 mL/minute.b 3.7 hours in patients with Clcr <20 mL/minute.b 5 hours in anephric patients.b


Stability


Storage


Oral


Liquid and Tablets

Tight, light-resistant containers at 15–30°C.b


Parenteral


Injection

15–30°C.b Protect from light.b Do not refrigerate.b Stable in most IV solutions for at least 3 days at room temperature in concentrations of 1.2–5 mg/mL,b but use within 48 hours when diluted as directed.118 b


Injection for IV infusion only

15–30°C.b Protect from excessive heat; brief exposure up to 40°C does not adversely affect stability.b Stable through the labeled expiration date when stored as recommended.118


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution CompatibilityHID


































Compatible



Amino acids 3.5, 5.5, or 8.5% with electrolytes



Amino acids 5.5 or 8.5%



Dextrose 5% with Ascor-B-Sol



Dextrose 5% and Electrolyte #48



Dextrose 5% and Electrolyte #75



Dextrose 5% in Ringer’s injection, lactated



Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%



Dextrose 10% in sodium chloride 0.9%



Dextrose 5% in water



Dextrose 10% in water



Dextrose 5% in water with vitamins



Fructose 5% and Electrolyte #48



Fructose 5% and Electrolyte #75



Invert sugar 5% in water



Invert sugar 10% in water



Ionosol B in dextrose 5% in water



Ionosol MB in dextrose 5% in water



Ionosol T in dextrose 5% in water



Mannitol 10% in water



Normosol M, 900 cal



Normosol M in dextrose 5% in water



Normosol M and Surbex T in dextrose 5% in water



Normosol R



Normosol R, pH 7.4



Normosol R in dextrose 5% in water



Plasma-Lyte 56 in dextrose 5% in water



Plasma-Lyte M in dextrose 5% in water



Ringer’s injection



Ringer’s injection, lactated



Sodium bicarbonate 5%



Sodium chloride 0.9%


Drug Compatibility















































Admixture CompatibilityHID

Compatible



Acetazolamide sodium



Amikacin sulfate



Aminophylline



Atracurium besylate



Cefoxitin sodium



Chlorothiazide sodium



Ciprofloxacin



Clindamycin phosphate



Colistimethate sodium



Dexamethasone sodium phosphate



Digoxin



Epinephrine HCl



Erythromycin lactobionate



Ethacrynate sodium



Flumazenil



Furosemide



Gentamicin sulfate



Insulin, regular



Isoproterenol HCl



Lidocaine HCl



Lincomycin HCl



Meropenem



Metaraminol bitartrate



Methylprednisolone sodium succinate



Midazolam HCl



Norepinephrine bitartrate



Penicillin G potassium



Phytonadione



Polymyxin B sulfate



Potassium chloride



Protamine sulfate



Quinidine gluconate



Sodium nitroprusside



Tacrolimus



Vancomycin HCl



Verapamil HCl



Vitamin B complex



Vitamin B complex with C



Incompatible



Amphotericin B



Variable



Ampicillin sodium



Cefazolin sodium



Metoclopramide HCl









































































Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Amifostine



Aminophylline



Anakinra



Anidulafungin



Atracurium besylate



Aztreonam



Bivalirudin



Cisplatin



Cladribine



Clarithromycin



Cyclophosphamide



Cytarabine



Dexmedetomidine HCl



Diltiazem HCl



Docetaxel



Doxorubicin HCl



Doxorubicin HCl liposome injection



Enalaprilat



Esmolol HCl



Etoposide phosphate



Fenoldopam mesylate



Filgrastim



Fluconazole



Fludarabine phosphate



Foscarnet sodium



Gallium nitrate



Gemcitabine HCl



Granisetron HCl



Haloperidol lactate



Heparin sodium



Hetastarch in lactated electrolyte injection (Hextend)



Hetastarch in sodium chloride 0.9%



Idarubicin HCl



Inamrinone lactate



Labetalol HCl



Levofloxacin



Linezolid



Melphalan HCl



Meropenem



Methotrexate sodium



Midazolam HCl



Milrinone lactate



Nicardipine HCl



Ondansetron HCl



Oxaliplatin



Paclitaxel



Pancuronium bromide



Pemetrexed disodium



Piperacillin sodium–tazobactam sodium



Propofol



Remifentanil HCl



Sargramostim



Tacrolimus



Teniposide



Theophylline



Thiotepa



Topotecan HCl



Vecuronium bromide



Vinorelbine tartrate



Zidovudine



Incompatible



Allopurinol sodium



Amphotericin B cholesteryl sulfate complex



Amsacrine



Cefepime HCl



Indomethacin sodium trihydrate



Lansoprazole



Warfarin sodium


ActionsActions



  • Inhibits basal and stimulated gastric acid secretion.b




  • Competitively inhibits histamine at parietal cell H2 receptors.b




  • Weak antiandrogenic effect.b



Advice to Patients



  • Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.289




  • Importance of taking antacids on an empty stomach 1 hour before or 1 hour after oral administration of cimetidine, or 1 hour after the drug is taken with food,b but not at same time as oral cimetidine.a b




  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.289




  • Before self-medication, importance of consulting clinician if taking warfarin, theophylline, or phenytoin.268




  • Importance of following dosage instructions when cimetidine is administered for self-medication, unless otherwise directed by a clinician.c




  • Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.268




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name











































Cimetidine

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



300 mg/mL*



Cimetidine Hydrochloride Oral Solution



Actavis, Duramed, Endo, Hi-Tech, Morton Grove, Pharmaceutical Associates, Teva



Tagamet (with parabens, povidone, and propylene glycol)



GlaxoSmithKline



Tablets, film-coated



200 mg*



Tagamet HB 200



GlaxoSmithKline



Tagamet HB (with povidone)



GlaxoSmithKline



300 mg*



Tagamet (with povidone and propylene glycol)



GlaxoSmithKline



400 mg*



Tagamet Tiltab (with povidone and propylene glycol)



GlaxoSmithKline



800 mg*



Tagamet Tiltab (with povidone and propylene glycol; scored)



GlaxoSmithKline


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name



















Cimetidine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



300 mg (of cimetidine) per 5 mL*



Tagamet HCl (with alcohol 2.8% parabens and propylene glycol)



GlaxoSmithKline



Parenteral



Injection



150 mg (of cimetidine) per mL



Cimetidine Hydrochloride Injection



Endo, Hospira, Sicor



Injecti


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