Oxybutynin Hydrochloride Extended Release Tablets

Pharmacological action: Oxybutynin hydrochloride has a direct spasmolytic effect on smooth muscle, and can inhibit the muscarinic effect of acetylcholine on smooth muscle. It can selectively act on the detrusor muscle of the bladder, reduce intravesical pressure, increase bladder capacity, reduce involuntary bladder contractions and relieve urinary urgency, frequent urination and urinary incontinence. The anticholinergic activity of this product on the detrusor muscle of rabbits is only 1/5 of that of atropine, but the spasmolytic effect is 4-10 times that of atropine. It has no blocking effect on skeletal muscle ganglia and autonomic ganglia. Toxicological studies: Genetic toxicity: The results of mutagenicity tests in human yeast, brewer's yeast and Salmonella typhimurium test systems were all negative. Reproductive toxicity: Reproductive toxicity tests in mice, rats, hamsters and rabbits did not show any effect of this product on animal fertility or embryos.

Oxybutynin Hydrochloride

This product is a film-coated tablet, which appears white or off-white after removing the film coating.

Antispasmodic drugs. Used to treat overactive bladder (OAB) with symptoms such as urge incontinence, urgency, and frequent urination.

Adults: The initial recommended dose is 5 mg (half a tablet) once a day, and then gradually increase the dose by 5 mg each time according to the efficacy and tolerance, with a maximum dose of 30 mg/day. Dose adjustment generally requires an interval of about one week. Children over 6 years old: The initial recommended dose is 5 mg (half a tablet) once a day, and then gradually increase the dose by 5 mg each time according to the efficacy and tolerance, with a maximum dose of 20 mg/day. This product needs to be swallowed with liquid and cannot be chewed or crushed, but it can be taken in half according to the half line.

This product is a sustained-release preparation with fewer adverse reactions than ordinary preparations and is easily tolerated by patients. A small number of patients have mild side effects of anticholinergic drugs after taking this product. According to literature data: 1. Adverse reactions with an incidence rate ≥ 5% include: 1. General adverse reactions: headache, fatigue, pain; 2. Digestive tract: dry mouth, constipation, diarrhea, nausea, indigestion; 3. Nervous system: drowsiness, dizziness; 4. Respiratory system: rhinitis; 5. Special senses: blurred vision, dry eyes; 6. Urogenital system: urinary tract infection.

The following patients are contraindicated for use: 1. Patients with urinary retention, gastric retention, and uncontrolled angle-closure glaucoma; 2. Patients who are allergic to this product or any of its excipients.

Precautions for children: The effectiveness and safety of this product for children under 6 years old have not been established. Precautions for pregnancy and lactation: The safety of this product for pregnant women or women who are about to become pregnant has not been established. It should only be used when the benefits outweigh the risks. It is not clear whether oxybutynin can be secreted in breast milk. Since many drugs can be secreted into breast milk, lactating women should use this product with caution. Precautions for the elderly: The pharmacokinetic parameters of this product after taking it in the elderly aged 78 years and below are roughly equivalent to those in young adults. The incidence and severity of anticholinergic effects reported in elderly patients around 65 years old are similar.

1. The combined use of oxybutynin with other antispasmodics, other drugs that cause dry mouth, constipation, drowsiness or other anticholinergic drugs will increase the frequency and severity of the above symptoms; 2. Anticholinergic drugs affect the absorption of drugs taken at the same time due to their effects on gastrointestinal motility; 3. The data on the interaction between oxybutynin and P450 cytochrome enzyme inhibitors such as antifungal drugs (such as ketoconazole, itraconazole and miconazole), macrocyclic antibiotics (such as erythromycin, clarithromycin), etc. have not been established.

Keep in a light-proof and airtight container. Valid for 36 months.

10mg

36 months

Nanjing Yewin Pharmaceutical Co., Ltd.

• Founded in:

  2002-12-24

• Address:

  No. 18, Xingang Avenue, Nanjing Economic and Technological Development Zone

• Tax NO.:

  91320192745358509L

• Registered Funds:

  15 million yuan

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