Product Overview
[Drug Name]
Generic Name: Loperamide Hydrochloride Capsules
Trade Name: Jiajian Fulin Loperamide Hydrochloride Capsules 2mg x 6 capsules
Pinyin Full Code: JiaJianFuLin YanSuanLuoPaiDingAnJiaoNang
[Main Ingredient]
Loperamide hydrochloride.
[Properties]
This product is a white or yellowish-white powder.
[Indications/Main Functions]
Antidiarrheal drug used to control the symptoms of acute and chronic diarrhea. It can reduce bowel movement volume and frequency and increase stool consistency in patients undergoing ileostomy.
[Specifications]
2mg x 6 capsules
[Dosage and Administration]
This product is suitable for adults and children over 5 years old. For acute diarrhea: Starting dose: 2 capsules for adults, 1 capsule for children over 5 years old. Take 1 capsule after each unformed stool. For chronic diarrhea: Starting dose: 2 capsules for adults, 1 capsule for children over 5 years old. The daily dose can be adjusted to maintain 1-2 normal bowel movements daily. The typical maintenance dose is 1-6 capsules per day. Maximum daily dose: No more than 8 tablets for adults, no more than 3 tablets per 20 kg body weight for children.
[Adverse Reactions]
Adverse reactions are mild and may include allergic reactions such as rash, gastrointestinal symptoms such as constipation, dry mouth, abdominal distension, loss of appetite, gastrointestinal cramps, nausea, vomiting, as well as dizziness, headache, and fatigue. Adverse events from clinical trial data are summarized below (regardless of whether they are drug-induced): 1.) Adverse events with an incidence of 1.0% or greater in patients with acute diarrhea and an incidence at least equivalent in the loperamide hydrochloride group to that in the placebo group are listed in the table below. Adverse events with an incidence of 1.0% or greater in the placebo group and a greater incidence in the loperamide hydrochloride group include: dry mouth, flatulence, abdominal cramps, and colic. 2.) Adverse events with an incidence of 1.0% or more in patients with chronic diarrhea and an incidence in the loperamide hydrochloride group at least equivalent to that in the placebo group are listed in the table below: Adverse events with an incidence of 1.0% or more and an incidence in the placebo group greater than that in the loperamide hydrochloride group are: nausea, vomiting, headache, flatulence, abdominal pain, abdominal cramps, and colic. 3. Adverse events in 76 controlled or open-label studies in patients with acute and chronic diarrhea Adverse events with an incidence of 1.0% or more in all studies are listed in the table below: Post-marketing experience The following spontaneously reported adverse events are listed in order of body system and reporting frequency: Very common (>1/10); Common (>1/100, <1/100); Rare 1/0 <10 Very rare (<1/0), including reports that reflect the incidence of adverse event reports and do not reflect the actual incidence as shown in clinical trials and epidemiological studies. Skin and subcutaneous tissue abnormalities are very rare: rash, urticaria and Itching. There have been isolated reports of angioedema, herpes (including Stevens-Johnson syndrome), erythema multiforme, and toxic epidermal necrolysis. Immune system disorders: Isolated reports of allergic reactions, including very rare cases of severe allergic reactions (including anaphylactic shock) and anaphylactoid reactions. Very rare gastrointestinal disorders: abdominal pain, intestinal obstruction, abdominal distension, nausea, constipation, vomiting, megacolon (including toxic megacolon), bloating, and dyspepsia. Renal and urinary system disorders: Isolated reports of urinary retention. Very rare psychiatric disorders: drowsiness. Very rare nervous system disorders: loss of consciousness, Decreased blood levels and dizziness. Some adverse reactions reported in clinical studies and post-marketing experience are also common adverse reactions to diarrheal syndrome, such as abdominal pain, abdominal discomfort, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, and abdominal distension. It is often difficult to distinguish whether these reactions are due to diarrhea or drug side effects.
[Contraindications]
Imodium is contraindicated in children under 2 years of age. Imodium capsules should not be used in children under 5 years of age. This product is a symptomatic treatment; treatment of the cause of the diarrhea is still necessary. This product should not be used as a primary treatment for acute bacillary dysentery accompanied by high fever and bloody stools. It is contraindicated for acute ulcerative colitis. Patients with enteritis and pseudomembranous colitis caused by broad-spectrum antibiotics. This drug is contraindicated in patients who should avoid using intestinal motility inhibitors. If constipation, abdominal distension, or incomplete intestinal obstruction occurs, this drug should be discontinued immediately.
[Drug Interactions]
Preclinical data indicate that loperamide is a precursor of P-glycoprotein. Coadministration of loperamide (single dose 16 mg) with P-glycoprotein inhibitors such as quinidine and lenavir can increase loperamide plasma concentrations by 2-3 fold. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors at the recommended clinical dose (daily dose 2-16 mg) of loperamide is unknown. Clear. There are no reports of drug interactions with other medications.
[Precautions]
Patients with diarrhea, especially children, often experience water and electrolyte loss. Replenishing water and electrolytes is the most important treatment measure. For acute diarrhea, if clinical symptoms do not improve after 48 hours of taking this product, this product should be discontinued and consultation with a physician is recommended. If HIV patients experience early symptoms of abdominal distension while using this product to treat diarrhea, treatment should be discontinued. There have been reports of individual HIV patients developing toxic megacolon after using loperamide hydrochloride to treat viral and bacterial infectious colitis. Although there are no reports of this product in patients with liver dysfunction, Pharmacokinetic data for this drug in patients with renal failure are available. However, due to its high first-pass metabolism, liver dysfunction may lead to a relative overdose. Therefore, attention should be paid to central nervous system toxicity. Since this drug is largely metabolized, with metabolites and unchanged drug excreted in the feces, no dose adjustment is required in patients with renal disease. This drug may cause fatigue, dizziness, or drowsiness when used to treat diarrhea. Therefore, caution should be exercised when driving or operating machinery. Keep out of reach of children.
[Pediatric Use]
Patients with diarrhea, especially children, often experience water and electrolyte losses. Replenishing these fluids and electrolytes is the most important treatment measure. Children should use this product under a doctor's supervision. Loperamide hydrochloride is contraindicated in infants under 2 years of age. Children under 5 years of age should not be treated with loperamide hydrochloride capsules.
[Use in Elderly Patients]
The use of loperamide hydrochloride capsules in elderly patients is the same as for adults.
[Overdose]
Overdose may cause symptoms of poisoning such as drowsiness, constipation, muscle tension, miosis, and bradypnea. Naloxone can be used for detoxification, and the patient should be observed for at least 48 hours to detect central nervous system depressant effects.
[Pharmacology and Toxicology]
This product is chemically similar in structure to haloperidol and pethidine, but therapeutic doses have no significant effects on the central nervous system. No effect. Its effect on intestinal smooth muscle is similar to that of opioids. It can inhibit the contraction of intestinal smooth muscle and reduce intestinal peristalsis. It can also reduce the release of acetylcholine from the nerve endings of the intestinal wall, and directly inhibit the peristaltic reflex through the local interaction of cholinergic and non-cholinergic neurons. This product can prolong the residence time of food in the small intestine, promote the absorption of water, electrolytes and glucose, and inhibit intestinal excessive secretion caused by prostaglandins, cholera toxin and other enterotoxins. In addition, this product can also increase the tension of the anal sphincter and inhibit fecal incontinence or urgency. LD50105mg/kg (oral for mice, 185mg (oral for rats).
