Product Overview
【Drug Name】
Generic Name: Cimetidine Capsules
Brand Name: Xin Huoli Cimetidine Capsules 0.2g*24 Capsules
Pinyin Code: XiZuoTiDingJiaoNang(XinHuoLi)
【Main Ingredients】
Each tablet contains 0.2g of cimetidine. Excipients include: starch, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium carboxymethyl starch, and magnesium stearate.
【Appearance】
This product is a white tablet.
【Indications/Main Functions】
Used to relieve stomach pain, heartburn, and acid reflux caused by excessive stomach acid.
【Specifications】
0.2g*24 Capsules (Xin Huoli)
【Dosage and Administration】
Oral administration. Adults: 1 capsule twice daily.
【Adverse Reactions】
1. Long-term use or increased dosage may cause: gynecomastia in men, galactorrhea, decreased libido, diarrhea, dizziness or headache, muscle spasms or myalgia, 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 product 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 hepatic or renal insufficiency.
4. If an overdose occurs or severe adverse reactions develop, 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 your 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. Concurrent use of this product with nitrazepam, diazepam, theophylline, propranolol, phenytoin sodium, or aspirin 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 cause respiratory depression or respiratory arrest.
4. Drug interactions may occur when used with other medications. Please consult your doctor or pharmacist for details.
【Pediatric Use】
Use with caution in young children.
【Geriatric Use】
Dosage should be reduced accordingly.
【Use in Pregnant and Lactating Women】
This drug can cross the placental barrier and enter breast milk. It is contraindicated in pregnant and lactating women.
【Overdosage】
Common side effects include shortness of breath or dyspnea and tachycardia. 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, β-adrenaline can be administered.
【Pharmacology and Toxicology】
This product significantly inhibits basal gastric acid secretion throughout the day and night, and also inhibits gastric acid secretion induced by food, histamine, pentagastrin, caffeine, and insulin.
【Pharmacokinetics】
After oral administration, approximately 60%–70% is rapidly absorbed by the intestine, with peak plasma concentration (tmax) reaching 45–90 minutes. Oral bioavailability (F) is approximately 70%, with younger individuals generally showing better absorption than older individuals. Plasma protein binding is low. The average peak concentration (Cmax) after a 300 mg dose is 1.44 μg/ml, inhibiting basal gastric acid secretion by 50% for 4–5 hours. This drug is widely distributed throughout the body (except the brain), metabolized in the liver, and primarily excreted by the kidneys. Approximately 48% of the oral dose is excreted unchanged by the kidneys after 24 hours; 10% is excreted in the feces. This drug can be removed by hemodialysis. With normal renal function, the half-life (t1/2) is 2 hours; with creatinine clearance of 20–50 ml/min, the half-life (t1/2) is 2.9 hours; when creatinine clearance is <20 ml/min, it is 3.7 hours; and with renal insufficiency, it is 5 hours. This product can be transported across the placenta and excreted in breast milk.
【Storage】
Store in a sealed container.
【Packaging】
0.2g/s × 12s/blister × 2 blisters/box.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H14021491
【Manufacturer】
Linfen Baozhu Pharmaceutical Co., Ltd.
