Product Overview
【Drug Name】
Generic Name: Cimetidine Tablets
Brand Name: Te Yi Cimetidine Tablets 0.2g*100 tablets
Pinyin Code: BangMinZhiYao XiZuoTiDingPian
【Main Ingredients】
Each tablet contains 0.2g of the main ingredient, cimetidine. Excipients include starch, hydroxypropyl cellulose, sodium carboxymethyl starch, sodium lauryl sulfate, and magnesium stearate. Chemical name: N-methyl-N”-[2[[(5-methyl-1H-imidazol-4-yl)methyl]thio]ethyl]-N-cyanoguanidine. Molecular formula: C10H16N6S. Molecular weight: 252.34
【Indications/Main Functions】
Used to relieve stomach pain, heartburn, and acid reflux caused by excessive stomach acid.
【Specifications】
0.2g*100 tablets
【Dosage and Administration】
Oral administration. Adults: 1 tablet twice daily, not exceeding 4 times in 24 hours.
【Adverse Reactions】
1. Long-term use or increased dosage may cause: gynecomastia in men, galactorrhea, decreased libido, diarrhea, dizziness or headache, muscle cramps or pain, rash, hair loss, etc.
2. Occasional adverse reactions include:
① mental confusion, more common in elderly or seriously ill patients, which usually resolves within 48 hours after discontinuation;
② sore throat and fever;
③ unexplained bleeding or ecchymosis, and unusual fatigue and weakness;
④ granulocytopenia or other abnormal blood counts, more common in patients with severe complications.
【Contraindications】
This medication is contraindicated in pregnant and lactating women.
【Precautions】
1. This product should not be used continuously for more than 7 days. If symptoms do not improve, please consult a doctor or pharmacist.
2. Children and elderly patients should use this product under the guidance of a physician.
3. Use with caution in the following situations: severe heart and respiratory diseases, systemic lupus erythematosus, organic brain disease, and liver or kidney dysfunction.
4. If an overdose occurs or serious adverse reactions appear, seek medical attention immediately.
5. This product is contraindicated in patients with known hypersensitivity to it; use with caution in patients with allergic constitutions.
6. Do not use this product if its appearance changes.
7. Keep this product out of reach of children.
8. Children must use this product under adult supervision.
9. If you are currently using other medications, please consult a doctor or pharmacist before using this product.
【Drug Interactions】
1. If this product is used in combination with antacids such as aluminum hydroxide or magnesium oxide, its absorption may be reduced; therefore, concurrent use is generally not recommended.
2. Concomitant use of this product with nitrazepam, diazepam, theophylline, propranolol, phenytoin sodium, aspirin, etc., may increase the blood concentration of these drugs, enhance their effects, and cause adverse reactions, or even toxic reactions. Therefore, this product should not be used concurrently with these drugs.
3. Concomitant use of this product with aminoglycoside antibiotics such as gentamicin may lead to respiratory depression or respiratory arrest.
4. Drug interactions may occur when used with other medications. Please consult your doctor or pharmacist for details.
【Use in Children】
Young children are prone to central nervous system toxicity; therefore, this product should be used with caution.
【Use in Elderly Patients】
The kidneys are a vital organ for the metabolism of this product. The renal clearance rate of this product decreases with age. Therefore, the dosage should be reduced in elderly patients to prevent toxic delirium.
【Use in Pregnant and Lactating Women】
Because it can cross the placental barrier and enter breast milk, it is contraindicated in pregnant and lactating women to avoid causing liver dysfunction in the fetus and infant.
【Overdosage】
1. Clinical signs of overdosage include: shortness of breath or dyspnea, and tachycardia.
2. Treatment: First, remove any unabsorbed drug from the gastrointestinal tract, and provide clinical monitoring and supportive therapy. For respiratory failure, immediately perform artificial respiration. For tachycardia, administer beta-adrenaline blockers.
【Pharmacology and Toxicology】
This is an H2 receptor antagonist that significantly inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine, and insulin. It has a preventive and protective effect against corrosive gastritis caused by chemical irritants and is also effective against stress-induced gastric ulcers and upper gastrointestinal bleeding. It has anti-androgenic effects and is valuable in the treatment of hirsutism. It can weaken the activity of immunosuppressive cells and enhance immune responses, thereby inhibiting tumor metastasis and prolonging survival.
【Pharmacokinetics】
This product is rapidly absorbed by the small intestine after oral administration, with a bioavailability of approximately 60-70%. Effective plasma concentrations (0.5 μg/ml) are reached within half an hour, peak concentrations are reached within 45-90 minutes, and the average Cmax is 1.44 μg/ml. Effective plasma concentrations can be maintained for 4 hours. Plasma protein binding is 15-20%, with a half-life (t1/2) of approximately 2 hours (t1/2 is significantly prolonged in patients with chronic renal insufficiency, approximately 4.9 hours; dosage reduction or adjustment of dosing intervals should be considered). The vitamin D (Vd) is 2.1 ± 1 L/kg, and renal clearance is 12 ± 3 ml/kg/min. This product is widely distributed throughout the body (except the brain), metabolized in the liver, and mainly excreted via the kidneys. 44-70% is excreted unchanged in the urine, and 10% is excreted in the feces. 80-90% of the oral dose is eliminated within 12 hours.
【Storage】
Store in a sealed container.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H44020894
【Manufacturer】
Guangdong Taicheng Pharmaceutical Co., Ltd.
