Product Overview
[Drug Name]
Generic Name: Propiverine Hydrochloride Sustained-Release Capsules
Trade Name: Maitongnuo Propiverine Hydrochloride Sustained-Release Capsules, 30mg*7 capsules
Pinyin Code: MaiTongNuo YanSuanBingZuoWeiLinHuanShiJiaoNang 30mg*7Li
[Main Ingredient]
The main ingredient of this product is propiverine hydrochloride. Chemical Name: 1-Methyl-4-piperidinyldiphenylpropoxyacetate hydrochloride. Molecular Formula: C23H29NO3•HCl. Molecular Weight: 403.95
[Properties]
This product consists of white or off-white pellets.
[Indications/Main Functions]
This product is indicated for the symptomatic treatment of urinary incontinence and/or urinary frequency and urgency caused by overactive bladder.
[Precautions]
This product should be used with caution in the following conditions: 1. Patients with autonomic nervous system disorders and severe renal impairment should use with caution. 2. This product may aggravate the symptoms of the following conditions: severe congestive heart failure, prostatic hypertrophy, hiatal hernia with reflux esophagitis, arrhythmias, and tachycardia. 3. Like other anticholinergic drugs, this product can cause pupil dilation in patients taking it. Therefore, it may increase the risk of acute angle-closure glaucoma in patients with narrow anterior angles susceptible to infection. Cases of this class of drugs have been reported to induce acute angle-closure glaucoma. 4. Before taking this product, patients with frequent urination and nocturia caused by renal disease or congestive heart failure, as well as organic bladder diseases (e.g., urinary tract infections, malignant tumors), must be excluded. 5. This product contains lactose monohydrate. Patients with rare genetic disorders of galactose intolerance, lactose deficiency, or glucose-galactose malabsorption should not take this product. 6. This product may cause drowsiness and decreased vision. Patients taking this medication should not drive a car or operate hazardous machinery. Sedatives may worsen the drowsiness caused by this drug.
[Drug Interactions]
This drug is contraindicated in the following situations: • Patients with intestinal obstruction; • Patients with significant bladder discharge in areas where urinary retention may occur; • Patients with myasthenia gravis; • Patients with intestinal atony; • Patients with severe ulcerative colitis; • Patients with toxic megacolon; • Patients with poorly controlled angle-closure glaucoma; • Patients with moderate to severe hepatic impairment; • Patients with tachyarrhythmias.
[Specifications]
30mg*7 tablets
[Dosage and Administration]
Administer orally. Do not crush or chew the capsules. Take one tablet once daily. This drug should be used with caution, and clinicians should carefully monitor patients for adverse reactions in the following situations. Patients with Renal Impairment: No dose adjustment is required for the treatment of patients with mild to moderate renal impairment (see [Pharmacokinetics] for details). Patients with Hepatic Impairment: No dose adjustment is required for patients with mild hepatic impairment, but caution is advised. Due to a lack of research data, this drug is not recommended for patients with moderate to severe hepatic impairment (see [Pharmacokinetics] for details). Patients receiving concomitant treatment with a strong CYP3A4 inhibitor and methimazole: Patients receiving concomitant treatment with a strong FMO inhibitor, such as methimazole, and a strong CYP3A4/5 inhibitor should begin with a dose of 15 mg/day, with dose increases possible. However, caution is advised, and clinicians should carefully monitor patients for side effects (see [Precautions], [Drug Interactions], and [Pharmacokinetics] for details). Food has no clinically important effect on the pharmacokinetics of propiverine hydrochloride (see [Pharmacokinetics] for details). Therefore, there are no specific requirements for the concomitant administration of propiverine with food.
Adverse Reactions: For each system organ class, adverse reactions are classified according to the following frequency: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, 1 <1000), very rare (1 <10000), and unknown (unable to assess based on available data). Within each frequency group, adverse reactions are listed in order of decreasing severity as follows: Psychiatric disorders • Very rare: Restlessness, confusion • Unknown: Hallucinations Nervous system disorders • Common: Headache • Rare: Tremor, dizziness, taste disturbances Ophthalmologic disorders • Common: Abnormal eye accommodation, eye accommodation disorder, abnormal vision Cardiac disorders • Very rare: Palpitations Vascular disorders • Rare: Decreased blood pressure accompanied by drowsiness, flushing Gastrointestinal disorders • Very common: Dry mouth • Common: Constipation, abdominal pain, dyspepsia • Rare: Nausea/vomiting Skin and subcutaneous tissue disorders • Rare: Rash due to atopic (propiverine hydrochloride) hypersensitivity reaction (excipients, such as colorants) Renal and urinary disorders • Rare: Urinary retention General disorders and application site conditions • Common: Fatigue Therefore, these adverse reactions are transient and resolve within a maximum of 1-4 days after dose reduction or discontinuation of the drug. Because reversible changes in liver enzymes have been reported, long-term treatment with Maitonor should monitor liver enzyme levels. Intraocular pressure should also be monitored in patients at risk for glaucoma. If a patient experiences a urinary tract infection, the residual urine volume in the bladder should also be monitored.
[Contraindications]
This product is contraindicated in the following situations: • Patients with intestinal obstruction; • Patients with significant bladder discharge in areas where urinary retention may occur; • Patients with myasthenia gravis; • Patients with intestinal atony; • Patients with severe ulcerative colitis; • Patients with toxic megacolon; • Patients with poorly controlled angle-closure glaucoma; • Patients with moderate to severe hepatic impairment; • Patients with tachyarrhythmias.
