Cimetidine 800 mg Tablet, Film Coated, 100-count — NDC 0093-8305-01 (Billing 00093-8305-01)
This is a package of 100 tablets of Cimetidine 800 mg Tablet, Film Coated from Teva Pharmaceuticals USA, Inc., marketed since Dec 2003 and currently FDA-listed; retail pharmacies pay about $0.7208 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0093-8305-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0093 labeler · 8305 product · 01 package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 0093830501 8
- Medicaid fills, this package
- 1,571 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 011668
- GCN: 46753
- HICL (First Databank): 004518
- AHFS class code: 04:92.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter cimetidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Cimetidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.
Read the full MedlinePlus article ↗- It lowers stomach acid. The over-the-counter tablets relieve and prevent heartburn. Prescription forms treat duodenal and gastric ulcers, erosive GERD and conditions with too much...
- Swallow it by mouth. For over-the-counter tablets, take one with water to relieve heartburn, or up to 30 minutes before a meal that triggers it. Don't take more than 2 tablets in 2...
- Mild diarrhea, headache, dizziness or sleepiness are possible. Call your doctor if you feel confused, develop a severe rash, or notice signs of allergic reaction.
- Check with me first. Cimetidine can raise levels of several drugs, including warfarin, phenytoin, theophylline and lidocaine. Ketoconazole should be taken at least 2 hours before i...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cimetidine — tap one for details:
Cimetidine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.721 | $72.08 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.05 | $104.95 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.4545 | $45.45 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00093-8305-01 You're viewing this Main listing | 100 TABLET, FILM COATED in 1 BOTTLE | $0.7208 / ea | $72.08 | 2003-12-23 | — | Active |
| 00093-8305-99 0093-8305-99 | 16484 TABLET, FILM COATED in 1 PAIL | — | — | — | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00093-8305-99?
What NDC number is used to bill for this package of Cimetidine 800 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cimetidine 800 mgthis 00093-8305-01 | Teva | 100 tablets | $0.721 | AB | Availability likely | — |
| Cimetidine 800 mg 00378-0541-01 | Mylan | 100 tablets | $0.721 | AB | Availability likely | — |
| Cimetidine 800 mg 62135-0633-90 | Chartwell | 90 tablets | $0.721 | AB | Availability likely | — |
| Cimetidine 800 mg 69452-0326-20 | Bionpharma | 100 tablets | $0.721 | AB | Availability likely | — |
| Cimetidine 800 mg 59651-0826-55 | Aurobindo | 15000 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Cimetidine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII K0KQV10C35
Povidone K25 is a synthetic polymer made from vinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach for better absorption.
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UNII H7AGY1OJO8
Povidone K27 is a synthetic polymer made from polyvinylpyrrolidone. It works as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Teva Pharmaceuticals USA, Inc. labeler code 00093
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- Eletriptan Hydrobromide 20 mg Tablet, Film Coated NDC 0093-8310-18
- Eletriptan Hydrobromide 40 mg Tablet, Film Coated NDC 0093-8311-18
- Glyburide 1.25 mg Tablet NDC 0093-8342-01
- Glyburide 2.5 mg Tablet NDC 0093-8343-01
- Glyburide 5 mg Tablet NDC 0093-8344-01
- Amoxicillin and Clavulanate Potassium 600 mg/5mL; 42.9 mg/5mL Powder, For Suspension NDC 0093-8675-74
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cimetidine tablets USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION , Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain.
However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg at bedtime for periods of up to five years.
Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. Erosive gastroesophageal reflux disease (GERD).
Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established [see DOSAGE AND ADMINISTRATION , Erosive Gastroesophageal Reflux ( GERD )].
The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Duodenal Ulcer Active Duodenal Ulcer Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY , Acid Secretion ). This is supported by recent clinical trials (see Clinical Trials , Active duodenal ulcer). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime oral dosage regimen.
In a U.S. oral dose-ranging study of 400 mg at bedtime, 800 mg at bedtime and 1600 mg at bedtime, a continuous dose response relationship for ulcer healing was demonstrated. However, 800 mg at bedtime is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg at bedtime and 1600 mg at bedtime being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS , Drug Interactions ) and maximal patient convenience. Patients unhealed at four weeks, or those with persistent symptoms, have been shown to benefit from two to four weeks of continued therapy.
It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e., smoke one pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with cimetidine 1600 mg at bedtime. While early pain relief with either 800 mg at bedtime or 1600 mg at bedtime is equivalent in all patients, 1600 mg at bedtime provides an appropriate alternative when it is important to ensure healing within four weeks for this subpopulation.
Alternatively, approximately 94% of all patients will also heal in eight weeks with cimetidine 800 mg at bedtime. Other cimetidine oral regimens in the U.S. which have been shown to be effective are: 300 mg four times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see Clinical Trials , Active duodenal ulcer). Concomitant antacids should be given as needed for relief of pain.
However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. While healing with cimetidine often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination. Maintenance Therapy for Duodenal Ulcer In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.
Active Benign Gastric Ulcer The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg at bedtime, or 300 mg four times a day with meals and at bedtime. Controlled clinical studies were limited to six weeks of treatment (see Clinical Trials ). 800 mg at bedtime is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions.
Symptomatic response to cimetidine does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing. Erosive Gastroesophageal Reflux Disease (GERD) The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1600 mg daily in divided doses (800 mg twice daily or 400 mg four times daily) for 12 weeks.
The use of cimetidine beyond 12 weeks has not been established. Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome) Recommended adult oral dosage: 300 mg four times a day with meals at bedtime. In some patients it may be necessary to administer higher doses more frequently.
Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically needed. Dos… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Cimetidine is contraindicated for patients known to have hypersensitivity to the product.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse effects reported in patients taking cimetidine are described below by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies. Gastrointestinal Diarrhea (usually mild) has been reported in approximately 1 in 100 patients.
CNS Headaches, ranging from mild to severe, have been reported in 3.5% of 924 patients taking 1600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo. Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1600 mg/day or 800 mg/day. Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients.
They have usually developed within 2 to 3 days of initiation of cimetidine therapy and have cleared within 3 to 4 days of discontinuation of the drug. Endocrine Gynecomastia has been reported in patients treated for one month or longer. In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies.
No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing cimetidine treatment. Reversible impotence has been reported in patients with pathological hypersecretory disorders, e.g., Zollinger-Ellison Syndrome, receiving cimetidine, particularly in high doses for at least 12 months (range 12 to 79 months, mean 38 months). However, in large-scale surveillance studies at regular dosage, the incidence has not exceeded that commonly reported in the general population.
Hematologic Decreased white blood cell counts in cimetidine-treated patients (approximately 1 per 100,000 patients), including agranulocytosis (approximately 3 per million patients, have been reported, including a few reports of recurrence on rechallenge. Most of these reports were in patients who had serious concomitant illnesses and received drugs and/or treatment known to produce neutropenia. Thrombocytopenia (approximately 3 per million patients) and, very rarely, cases of pancytopenia or aplastic anemia have also been reported.
As with some other H 2 -receptor antagonists, there have been extremely rare reports of immune hemolytic anemia. Hepatobiliary Dose-related increases in serum transaminase have been reported. In most cases they did not progress with continued therapy and returned to normal at the end of therapy.
There have been rare reports of cholestatic or mixed cholestatic-hepatocellular effects. These were usually reversible. Because of the predominance of cholestatic features, severe parenchymal injury is considered highly unlikely.
However, as in the occasional liver injury with other H 2 -receptor antagonists, in exceedingly rare circumstances fatal outcomes have been reported. There has been reported a single case of biopsy-proven periportal hepatic fibrosis in a patient receiving cimetidine. Rare cases of pancreatitis, which cleared on withdrawal of the drug, have been reported.
Hypersensitivity Rare cases of fever and allergic reactions including anaphylaxis and hypersensitivity vasculitis, which cleared on withdrawal of the drug, have been reported. Renal Small, possibly dose-related increases in plasma creatinine, presumably due to competition for renal tubular secretion, are not uncommon and do not signify deteriorating renal function. Rare cases of interstitial nephritis and urinary retention, which cleared on withdrawal of the drug, have been reported.
Cardiovascular Rare cases of bradycardia, tachycardia and A-V heart block have been reported with H 2 -receptor antagonists. Musculoskeletal There have been rare reports of reversible arthralgia and myalgia; exacerbation of joint symptoms in patients with preexisting arthritis has also been reported.… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
Drug Interactions Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs. Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly.
Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects. However, a crossover study in healthy subjects receiving either cimetidine 300 mg four times daily or 800 mg at bedtime concomitantly with a 300 mg twice daily dosage of theophylline extended-release tablets (Theo-Dur ® *) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available.
(Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.) Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping concomitantly administered cimetidine to maintain optimum therapeutic blood levels. Alteration of pH may affect absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.
Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Reproduction studies have been performed in rats, rabbits and mice at doses up to 40 times the normal human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cimetidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Clinical experience in pediatric patients is limited. Therefore, cimetidine therapy cannot be recommended for pediatric patients under 16, unless, in the judgment of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 to 40 mg/kg/day have been used.
🆘 Overdosage ▾
OVERDOSAGE Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia that may be controlled by assisted respiration and the administration of a beta-blocker. Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and cimetidine 4800 mg intravenously over a 24 hour period experienced mental deterioration with reversal on cimetidine discontinuation.
There have been two deaths in adults who have been reported to ingest over 40 grams orally on a single occasion.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Cimetidine competitively inhibits the action of histamine at the histamine H 2 receptors of the parietal cells and thus is a histamine H 2 -receptor antagonist. Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine inhibits both daytime and nocturnal basal gastric acid secretion.
Cimetidine also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin. Antisecretory Activity 1) Acid Secretion Nocturnal Cimetidine 800 mg orally at bedtime reduces mean hourly H + activity by greater than 85% over an eight-hour period in duodenal ulcer patients, with no effect on daytime acid secretion. Cimetidine 1600 mg orally at bedtime produces 100% inhibition of mean hourly H + activity over an eight-hour period in duodenal ulcer patients, but also reduces H + activity by 35% for an additional five hours into the following morning.
Cimetidine 400 mg twice daily and 300 mg four times daily decrease nocturnal acid secretion in a dose-related manner, i.e., 47% to 83% over a six- to eight-hour period and 54% over a nine-hour period, respectively. Food stimulated During the first hour after a standard experimental meal, oral cimetidine 300 mg inhibited gastric acid secretion in duodenal ulcer patients by at least 50%. During the subsequent two hours cimetidine inhibited gastric acid secretion by at least 75%.
The effect of a 300 mg breakfast dose of cimetidine continued for at least four hours and there was partial suppression of the rise in gastric acid secretion following the luncheon meal in duodenal ulcer patients. This suppression of gastric output was enhanced and could be maintained by another 300 mg dose of cimetidine given with lunch. In another study, cimetidine 300 mg given with the meal increased gastric pH as compared with placebo.
Table 1. Mean Gastric pH Cimetidine Placebo 1 hour 3.5 2.6 2 hours 3.1 1.6 3 hours 3.8 1.9 4 hours 6.1 2.2 24-Hour mean H + activity Cimetidine 800 mg at bedtime, 400 mg twice daily and 200 mg four times daily all provide a similar, moderate (less than 60%) level of 24-hour acid suppression. However, the 800 mg at bedtime regimen exerts its entire effect on nocturnal acid, and does not affect daytime gastric physiology.
Chemically stimulated Oral cimetidine significantly inhibited gastric acid secretion stimulated by betazole (an isomer of histamine), pentagastrin, caffeine and insulin as follows: Table 2 Stimulant Stimulant Dose Cimetidine % Inhibition Betazole 1.5 mg/kg (sc) 300 mg (po) 85% at 2 ½ hours Pentagastrin 6 mcg/kg/hr (iv) 100 mg/hr (iv) 60% at 1 hour Caffeine 5 mg/kg/hr (iv) 300 mg (po) 100% at 1 hour Insulin 0.03 units/kg/hr (iv) 100 mg/hr (iv) 82% at 1 hour When food and betazole were used to stimulate secretion, inhibition of hydrogen ion concentration usually ranged from 45 to 75% and the inhibition of volume ranged from 30 to 65%.
2) Pepsin Oral cimetidine 300 mg reduced total pepsin output as a result of the decrease in volume of gastric juice. 3) Intrinsic Factor Intrinsic factor secretion was studied with betazole as a stimulant. Oral cimetidine 300 mg inhibited the rise in intrinsic factor concentration produced by betazole, but some intrinsic factor was secreted at all times.
Other Lower Esophageal Sphincter Pressure and Gastric Emptying Cimetidine has no effect on lower esophageal sphincter (LES) pressure or the rate of gastric emptying. Pharmacokinetics Cimetidine is rapidly absorbed after oral administration and peak levels occur in 45 to 90 minutes. The half-life of cimetidine is approximately 2 hours.
Blood concentrations remain above that required to provide 80% inhibition of basal gastric acid secretion for 4 to 5 hours following a dose of 300 mg. The principal route of excretion of cimetidine is the urine. Following oral administration, the drug is extensively metabolized, the sulfoxide being the major metabolite.
Following a single oral dose, 48% of the drug is recovered from the urine af… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cimetidine tablets USP, 300 mg are dark-green, oval-shaped, film-coated tablets, debossed with N192 on one side and 300 on the reverse. They are supplied as follows: NDC 0093-8192-01 bottles of 100 NDC 0093-8192-05 bottles of 500 Cimetidine tablets USP, 400 mg are dark-green, oval-shaped, film-coated tablets, debossed with N vertical bisect 204 on one side and partial bisect 400 on the reverse. They are supplied as follows: NDC 0093-8204-01 bottles of 100 NDC 0093-8204-05 bottles of 500 Cimetidine tablets USP, 800 mg are white, oval-shaped, film-coated tablets, debossed with N vertical bisect 305 on one side and partial bisect 800 on the reverse.
They are supplied as follows: NDC 0093-8305-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
Brands listed are the trademarks of their respective owners. Manufactured In Canada By: Teva Canada Limited Toronto, Canada M1B 2K9 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. F 11/2022
📋 Description ▾
DESCRIPTION Cimetidine is a histamine H 2 -receptor antagonist. Chemically it is N” -cyano- N -methyl- N’ -[2-[[(5-methyl-1 H -imidazol-4-yl)methyl]thio]-ethyl], guanidine. The molecular formula for cimetidine is C 10 H 16 N 6 S; and the molecular weight is 252.35.
The structural formula for cimetidine is: Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor. 1 Solubility Characteristics Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether.
Each tablet, for oral administration, contains 300 mg, 400 mg, or 800 mg cimetidine, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. The coating for the tablets contains: carnauba wax, hypromellose, polyethylene glycol, polysorbate 80, talc, titanium dioxide, and triethyl citrate.
The coating for the 300 mg and 400 mg tablets also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Yellow No.
6 Aluminum Lake.
⚠️ Precautions ▾
PRECAUTIONS General Rare instances of cardiac arrhythmias and hypotension have been reported following the rapid administration of cimetidine hydrochloride by intravenous bolus. Symptomatic response to cimetidine therapy does not preclude the presence of a gastric malignancy. There have been rare reports of transient healing of gastric ulcers despite subsequently documented malignancy.
Reversible confusional states (see ADVERSE REACTIONS ) have been observed on occasion, predominantly, but not exclusively, in severely ill patients. Advancing age (50 or more years) and preexisting liver and/or renal disease appear to be contributing factors. In some patients these confusional states have been mild and have not required discontinuation of cimetidine therapy.
In cases where discontinuation was judged necessary the condition was usually cleared within 3 to 4 days of drug withdrawal. Drug Interactions Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs. Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly.
Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects. However, a crossover study in healthy subjects receiving either cimetidine 300 mg four times daily or 800 mg at bedtime concomitantly with a 300 mg twice daily dosage of theophylline extended-release tablets (Theo-Dur ® *) demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg at bedtime regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available.
(Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.) Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping concomitantly administered cimetidine to maintain optimum therapeutic blood levels. Alteration of pH may affect absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.
Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24 month toxicity study conducted in rats, at dose levels of 150, 378 and 950 mg/kg/day (approximately 8 to 48 times the recommended human dose), there was a small increase in the incidence of benign Leydig cell tumors in each dose group; when the combined drug-treated groups and control groups were compared, this increase reached statistical significance.
In a subsequent 24 month study, there were no differences between the rats receiving 150 mg/kg/day and the untreated controls. However, a statistically significant increase in benign Leydig cell tumor incidence was seen in the rats that received 378 and 950 mg/kg/day. These tumors were common in control groups as well as treated groups and the difference became apparent only in aged rats.
Cimetidine has demonstrated a weak antiandrogenic effect. In animal studies this was manifested as reduced prostate and seminal vesicle weights. However, there was no impairment of mating performance or fertility, nor any harm to the fetus in these animals at doses 8 to 48 times the full therapeutic dose of cimetidine, as compared with controls.
The cases of gynecomoastia seen in patients tr… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Cimetidine is secreted in human milk and, as a general rule, nursing should not be undertaken while a patient is on this drug.
🧬 Pharmacokinetics ▾
Pharmacokinetics Cimetidine is rapidly absorbed after oral administration and peak levels occur in 45 to 90 minutes. The half-life of cimetidine is approximately 2 hours. Blood concentrations remain above that required to provide 80% inhibition of basal gastric acid secretion for 4 to 5 hours following a dose of 300 mg.
The principal route of excretion of cimetidine is the urine. Following oral administration, the drug is extensively metabolized, the sulfoxide being the major metabolite. Following a single oral dose, 48% of the drug is recovered from the urine after 24 hours as the parent compound.
🔬 Clinical Studies ▾
Clinical Trials Duodenal Ulcer Cimetidine has been shown to be effective in the treatment of active duodenal ulcer and, at reduced dosage, in maintenance therapy following healing of active ulcers. Active duodenal ulcer Cimetidine accelerates the rate of duodenal ulcer healing. Healing rates reported in U.S. and foreign controlled trials with oral cimetidine are summarized below, beginning with the regimen providing the lowest nocturnal dose.
Table 3. Duodenal Ulcer Healing Rates with Various Oral Cimetidine Dosage Regimens 1 Regimen 300 mg four times daily 400 mg times daily 800 mg at bedtime 1600 mg at bedtime week 4 68% 73% 80% 86% week 6 80% 80% 89% - week 8 - 92% 94% - 1. Averages from controlled clinical trials.
A U.S., double-blind, placebo-controlled, dose-ranging study demonstrated that all once-daily at bedtime cimetidine regimens were superior to placebo in ulcer healing and that cimetidine 800 mg at bedtime healed 75% of patients at four weeks. The healing rate with 800 mg at bedtime was significantly superior to 400 mg at bedtime (66%) and not significantly different from 1600 mg at bedtime (81%). In the U.S. dose-ranging trial, over 80% of patients receiving cimetidine 800 mg at bedtime experienced nocturnal pain relief after one day.
Relief from daytime pain was reported in 70% of patients after two days. As with ulcer healing, the 800 mg at bedtime dose was superior to 400 mg at bedtime and not different from 1600 mg at bedtime. In foreign, double-blind studies with cimetidine 800 mg at bedtime, 79 to 85% of patients were healed at four weeks.
While short-term treatment with cimetidine can result in complete healing of the duodenal ulcer, acute therapy will not prevent ulcer recurrence after cimetidine has been discontinued. Some follow-up studies have reported that the rate of recurrence once therapy was discontinued was slightly higher for patients healed on cimetidine than for patients healed on other forms of therapy; however, the cimetidine-treated patients generally had more severe disease. Maintenance therapy in duodenal ulcer Treatment with a reduced dose of cimetidine has been proven effective as maintenance therapy following healing of active duodenal ulcers.
In numerous placebo-controlled studies conducted worldwide, the percent of patients with observed ulcers at the end of one year’s therapy with cimetidine 400 mg at bedtime was significantly lower (10% to 45%) than in patients receiving placebo (44% to 70%). Thus, from 55% to 90% of patients were maintained free of observed ulcers at the end of one year with cimetidine 400 mg at bedtime. Factors such as smoking, duration and severity of disease, gender, and genetic traits may contribute to variations in actual percentages.
Trials of other anti-ulcer therapy, whether placebo-controlled, positive-controlled or open, have demonstrated a range of results similar to that seen with cimetidine. Active Benign Gastric Ulcer Cimetidine has been shown to be effective in the short-term treatment of active benign gastric ulcer. In a multicenter, double-blind U.S. study, patients with endoscopically confirmed benign gastric ulcer were treated with cimetidine 300 mg four times a day or with placebo for six weeks.
Patients were limited to those with ulcers ranging from 0.5 to 2.5 cm in size. Endoscopically confirmed healing at six weeks was seen in significantly a more cimetidine-treated patients than in patients receiving the placebo, as shown below: Table 4. Rate of Endoscopically Confirmed Gastric Ulcer Healing Cimetidine Placebo week 2 14/63 (22%) 7/63 (11%) total at week 6 43/65 (66%) 1 30/67 (45%) 1. p <
0.05In a similar multicenter U.S. study of the 800 mg at bedtime oral regimen, the endoscopically confirmed healing rates were: Table 5. Rate of Endoscopically Confirmed Gastric Ulcer Healing Cimetidine Placebo total at week 6 63/83 (76%) 1 44/80 (55%) 1. p = 0.005 Similarly, in worldwide double-blind clinical studies, endoscopically evaluated benign gastr… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility In a 24 month toxicity study conducted in rats, at dose levels of 150, 378 and 950 mg/kg/day (approximately 8 to 48 times the recommended human dose), there was a small increase in the incidence of benign Leydig cell tumors in each dose group; when the combined drug-treated groups and control groups were compared, this increase reached statistical significance. In a subsequent 24 month study, there were no differences between the rats receiving 150 mg/kg/day and the untreated controls.
However, a statistically significant increase in benign Leydig cell tumor incidence was seen in the rats that received 378 and 950 mg/kg/day. These tumors were common in control groups as well as treated groups and the difference became apparent only in aged rats. Cimetidine has demonstrated a weak antiandrogenic effect.
In animal studies this was manifested as reduced prostate and seminal vesicle weights. However, there was no impairment of mating performance or fertility, nor any harm to the fetus in these animals at doses 8 to 48 times the full therapeutic dose of cimetidine, as compared with controls. The cases of gynecomoastia seen in patients treated for one month or longer may be related to this effect.
In human studies, cimetidine has been shown to have no effect on spermatogenesis, sperm count, motility, morphology or in vitro fertilizing capacity.
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 0093-8192-01 Cimetidine Tablets, USP 300 mg Rx only 100 Tablets 1
Package/Label Display Panel NDC 0093-8204-01 Cimetidine Tablets, USP 400 mg Rx only 100 Tablets 1
Package/Label Display Panel NDC 0093-8305-01 Cimetidine Tablets, USP 800 mg Rx only 100 Tablets 1