cimetidine

Therapeutic Classification: antiulcer agents

Pharmacologic Classification: histamine h2 antagonists

REMS

Short-term treatment of active duodenal ulcers and benign gastric ulcers.
Maintenance therapy for duodenal ulcers after healing of active ulcer(s).
Management of gastroesophageal reflux disease (GERD).
Treatment of heartburn, acid indigestion, and sour stomach (OTC use).
Management of gastric hypersecretory states (Zollinger-Ellison syndrome).

Unlabeled Use:

Management of GI symptoms associated with the use of NSAIDs.
Management of urticaria.

Inhibits the action of histamine at the H₂-receptor site located primarily in gastric parietal cells, resulting in inhibition of gastric acid secretion.

Therapeutic Effects:

Healing and prevention of ulcers.
Decreased symptoms of gastroesophageal reflux.
Decreased secretion of gastric acid.

Absorption: Well absorbed following oral administration.

Distribution: Enters breast milk and cerebrospinal fluid.

Metabolism/Excretion: 30% metabolized by the liver; remainder is eliminated unchanged by the kidneys.

Half-life: 2 hr.

ROUTE	ONSET	PEAK	DURATION
PO	30 min	45–90 min	4–5 hr

Contraindicated in:

Hypersensitivity
Lactation: Lactation.

Use Cautiously in:

Renal impairment (more susceptible to adverse CNS reactions; ↑ dose interval recommended if renal impairment is severe)
OB: Safety not established in pregnancy
Geri: Older adults are more susceptible to adverse CNS reactions (dose ↓ recommended).

CV: ARRHYTHMIAS.

Endo: gynecomastia.

GI: constipation, diarrhea, hepatitis, nausea.

GU: ↓ sperm count, erectile dysfunction.

Hemat: anemia, AGRANULOCYTOSIS, APLASTIC ANEMIA, neutropenia, thrombocytopenia.

Neuro: confusion, dizziness, drowsiness, hallucinations, headache.

Misc: hypersensitivity reactions.

Drug-Drug:

Cimetidine inhibits drug-metabolizing enzymes in the liver; may lead to ↑ blood levels and toxicity with the following—some benzodiazepines (especiallychlordiazepoxide, diazepam, and midazolam), some beta blockers (labetalol, metoprolol, propranolol), caffeine, calcium channel blockers, carbamazepine, chloroquine, lidocaine, metronidazole, pentoxifylline, phenytoin, propafenone, quinidine, quinine, metformin, sulfonylureas, theophylline, triamterene, tricyclic antidepressants, and warfarin.
May ↑ the effects of succinylcholine, flecainide, procainamide, carmustine, and fluorouracil.
↓ absorption of ketoconazole.
Antacids and sucralfate ↓ absorption.

Drug-Natural Products:

↑ caffeine levels and side effects with caffeine-containing herbs (cola nut, guarana, mate, tea, coffee).

PO (Adults): Short-term treatment of active ulcers: 300 mg 4 times daily or 800 mg at bedtime or 400–600 mg twice daily (not to exceed 2.4 g/day). Duodenal ulcer prophylaxis: 300 mg twice daily or 400 mg at bedtime. GERD: 800–1600 mg/day in divided doses. Gastric hypersecretory conditions: 300–600 mg every 6 hr (up to 12 g/day have been used). OTC use: up to 200 mg may be taken twice daily (for no more than 2 wk).
PO (Children): Short-term treatment of active ulcers: 20–40 mg/kg/day in 4 divided doses.

Renal Impairment

PO (Adults): 300 mg every 8–12 hr; further adjustment may be required for concurrent hepatic impairment.
PO (Children): 10–15 mg/kg/day given in divided doses every 8–12 hr.

(Generic available)

Tablets: 200 mg^OTC; 300 mg; 400 mg; 800 mg;

Assess patient for epigastric or abdominal pain and frank or occult blood in the stool, emesis, or gastric aspirate.
Geri: Assess geriatric and debilitated patients routinely for confusion. Report promptly.

Lab Test Considerations:

Monitor CBC with differential periodically during therapy.
- Antagonize effects of pentagastrin and histamine during gastric acid secretion testing. Avoid administration for 24 hr preceding the test.
- May cause false-negative results in skin tests using allergenic extracts. Histamine H antagonists should be discontinued 24 hr prior to the test.
- May cause ↑ serum transaminases and serum creatinine.

If antacids or sucralfate are used concurrently for relief of pain, avoid administration of antacids within 30 min–1 hr of cimetidine and take sucralfate 2 hr after cimetidine; may decrease the absorption of cimetidine.
PO: Administer with meals or immediately afterward and at bedtime to prolong effect.
- Doses administered once daily should be administered at bedtime to prolong effect.
- Cimetidine tablets have a characteristic odor.

Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses.
- Advise patients taking OTC cimetidine preparations not to take the maximum dose continuously for more than 2 wk without consulting health care professional. Notify health care professional if difficulty swallowing occurs or abdominal pain persists.
- Inform patient that smoking interferes with the action of histamine antagonists. Encourage patient to quit smoking or at least not to smoke after last dose of the day.
- May cause drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to the drug is known.
- Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
- Inform patient that increased fluid and fiber intake and exercise may minimize constipation.
- Advise patient to report onset of black, tarry stools; fever; sore throat; diarrhea; dizziness; rash; confusion; or hallucinations to health care professional promptly.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Decrease in abdominal pain, heartburn, acid indigestion, and sour stomach.
Prevention of gastric irritation and bleeding. Healing of duodenal ulcers can be seen by endoscopy. Therapy is continued for at least 6 wk in treatment of ulcers but not usually longer than 8 wk.
Decreased symptoms of esophageal reflux.

NDC Code^*

0093- Teva Pharmaceuticals USA, Inc.
0093-8192- Cimetidine 0093-8192-01- 100 TABLET, FILM COATED in 1 BOTTLE (0093-8192-01)

0093- Teva Pharmaceuticals USA, Inc.
0093-8192- Cimetidine 0093-8192-05- 500 TABLET, FILM COATED in 1 BOTTLE (0093-8192-05)

0093- Teva Pharmaceuticals USA, Inc.
0093-8204- Cimetidine 0093-8204-01- 100 TABLET, FILM COATED in 1 BOTTLE (0093-8204-01)

0093- Teva Pharmaceuticals USA, Inc.
0093-8204- Cimetidine 0093-8204-05- 500 TABLET, FILM COATED in 1 BOTTLE (0093-8204-05)

0093- Teva Pharmaceuticals USA, Inc.
0093-8305- Cimetidine 0093-8305-01- 100 TABLET, FILM COATED in 1 BOTTLE (0093-8305-01)

0113- L. Perrigo Company
0113-0022- Good Sense Heartburn Relief 0113-0022-39- 1 BOTTLE in 1 CARTON (0113-0022-39) > 30 TABLET in 1 BOTTLE

0363- Walgreen Company
0363-0022- cimetidine acid reducer
0363-0022-72- 1 BOTTLE in 1 CARTON (0363-0022-72) > 60 TABLET in 1 BOTTLE

0378- Mylan Pharmaceuticals Inc.
0378-0053- Cimetidine 0378-0053-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01)

0378- Mylan Pharmaceuticals Inc.
0378-0317- Cimetidine 0378-0317-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0317-01)

0378- Mylan Pharmaceuticals Inc.
0378-0372- Cimetidine 0378-0372-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0372-01)

0378- Mylan Pharmaceuticals Inc.
0378-0541- Cimetidine 0378-0541-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0541-01)

24385- Amerisource Bergen
24385-111- Good Neighbor Pharmacy Heartburn Relief 24385-111-65- 1 BOTTLE in 1 CARTON (24385-111-65) > 30 TABLET in 1 BOTTLE

30142- Kroger Company
30142-323- Acid Reducer 30142-323-39- 1 BOTTLE in 1 CARTON (30142-323-39) > 30 TABLET in 1 BOTTLE

33261- Aidarex Pharmaceuticals LLC
33261-024- Cimetidine 33261-024-60- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-024-60)

36800- Topco Associates LLC
36800-022- TopCare Heartburn Relief 36800-022-39- 1 BOTTLE in 1 CARTON (36800-022-39) > 30 TABLET in 1 BOTTLE

42291- AvKARE, Inc.
42291-217- Cimetidine 42291-217-90- 90 TABLET, FILM COATED in 1 BOTTLE (42291-217-90)

42291- AvKARE, Inc.
42291-218- Cimetidine 42291-218-01- 100 TABLET, FILM COATED in 1 BOTTLE (42291-218-01)

49035- Wal-Mart Stores Inc
49035-820- Equate Cimetidine 49035-820-72- 1 BOTTLE in 1 CARTON (49035-820-72) > 60 TABLET in 1 BOTTLE

49348- Strategic Sourcing Services LLC
49348-246- SunMark heartburn relief acid reducer
49348-246-44- 1 BOTTLE in 1 CARTON (49348-246-44) > 30 TABLET, FILM COATED in 1 BOTTLE

50090- A-S Medication Solutions
50090-0499- Cimetidine 50090-0499-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-0499-0)

50090- A-S Medication Solutions
50090-3574- Cimetidine 50090-3574-0- 30 TABLET, FILM COATED in 1 BOTTLE (50090-3574-0)

55289- PD-Rx Pharmaceuticals, Inc.
55289-581- Cimetidine 55289-581-10- 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10)

55289- PD-Rx Pharmaceuticals, Inc.
55289-581- Cimetidine 55289-581-20- 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20)

55289- PD-Rx Pharmaceuticals, Inc.
55289-581- Cimetidine 55289-581-30- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30)

55289- PD-Rx Pharmaceuticals, Inc.
55289-581- Cimetidine 55289-581-60- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60)

55289- PD-Rx Pharmaceuticals, Inc.
55289-581- Cimetidine 55289-581-90- 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90)

59779- CVS Pharmacy
59779-022- heartburn relief 59779-022-72- 1 BOTTLE in 1 CARTON (59779-022-72) > 60 TABLET in 1 BOTTLE

63029- Medtech Products Inc.
63029-222- Tagamet 63029-222-01- 1 BLISTER PACK in 1 BOX (63029-222-01) > 30 TABLET in 1 BLISTER PACK

63029- Medtech Products Inc.
63029-222- Tagamet 63029-222-02- 1 BLISTER PACK in 1 BOX (63029-222-02) > 6 TABLET in 1 BLISTER PACK

63029- Medtech Products Inc.
63029-222- Tagamet 63029-222-03- 1 BLISTER PACK in 1 BOX (63029-222-03) > 50 TABLET in 1 BLISTER PACK

63029- Medtech Products Inc.
63029-222- Tagamet 63029-222-04- 4 BLISTER PACK in 1 BOX (63029-222-04) > 10 TABLET in 1 BLISTER PACK

63029- Medtech Products Inc.
63029-222- Tagamet 63029-222-05- 4 BLISTER PACK in 1 BOX (63029-222-05) > 9 TABLET in 1 BLISTER PACK

63187- Proficient Rx LP
63187-333- Cimetidine 63187-333-30- 30 TABLET, FILM COATED in 1 BOTTLE (63187-333-30)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-1- 20 TABLET, FILM COATED in 1 BOTTLE (63629-1497-1)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-2- 30 TABLET, FILM COATED in 1 BOTTLE (63629-1497-2)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-3- 60 TABLET, FILM COATED in 1 BOTTLE (63629-1497-3)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-4- 40 TABLET, FILM COATED in 1 BOTTLE (63629-1497-4)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-5- 56 TABLET, FILM COATED in 1 BOTTLE (63629-1497-5)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-6- 90 TABLET, FILM COATED in 1 BOTTLE (63629-1497-6)

63629- Bryant Ranch Prepack
63629-1497- Cimetidine 63629-1497-7- 28 TABLET, FILM COATED in 1 BOTTLE (63629-1497-7)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-1- 30 TABLET, FILM COATED in 1 BOTTLE (63629-1783-1)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-2- 60 TABLET, FILM COATED in 1 BOTTLE (63629-1783-2)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-3- 20 TABLET, FILM COATED in 1 BOTTLE (63629-1783-3)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-4- 21 TABLET, FILM COATED in 1 BOTTLE (63629-1783-4)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-5- 90 TABLET, FILM COATED in 1 BOTTLE (63629-1783-5)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-6- 120 TABLET, FILM COATED in 1 BOTTLE (63629-1783-6)

63629- Bryant Ranch Prepack
63629-1783- Cimetidine 63629-1783-7- 28 TABLET, FILM COATED in 1 BOTTLE (63629-1783-7)

66267- NuCare Pharmaceuticals, Inc.
66267-057- Cimetidine 66267-057-30- 30 TABLET, FILM COATED in 1 BOTTLE (66267-057-30)

66267- NuCare Pharmaceuticals, Inc.
66267-057- Cimetidine 66267-057-60- 60 TABLET, FILM COATED in 1 BOTTLE (66267-057-60)

69256- Harris Teeter, LLC
69256-022- harris teeter acid reducer 69256-022-39- 1 BOTTLE in 1 CARTON (69256-022-39) > 30 TABLET in 1 BOTTLE

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