What Are the Most Common Oxybutynin Side Effects?
Oxybutyn hydrochloride sustained-release tablets, the indication is an antispasmodic drug. It is used to treat overactive bladder (OAB) with symptoms of acute (urgent) incontinence, urgency, and frequent urination.
- Drug Name
- Oxybutyn hydrochloride sustained-release tablets
- Drug type
- prescription
- Use classification
- Urinary tract antispasmodics
- Oxybutyn hydrochloride sustained-release tablets, the indication is an antispasmodic drug. It is used to treat overactive bladder (OAB) with symptoms of acute (urgent) incontinence, urgency, and frequent urination.
Oxybutyn hydrochloride sustained-release tablets ingredients
- Oxybutyn hydrochloride
Properties of Oxybutyn Hydrochloride Sustained-release Tablets
- This product is a film-coated tablet, which appears white or almost white after removing the film coating.
Oxybutyn hydrochloride sustained-release tablets indications
- Antispasmodic drugs. It is used to treat overactive bladder (OAB) with symptoms of acute (urgent) incontinence, urgency, and frequent urination.
Oxybutyn hydrochloride sustained-release tablets specifications
- 10mg / tablet
Oxybutyn hydrochloride sustained-release tablets
- The initial recommended dose is once a day, 5 mg (half tablet) at a time, and then gradually increase the dose according to the efficacy and tolerability, each increase by 5 mg, the maximum dose is 30 mg / day, or as the doctor recommends, children reduce it. This product needs to be swallowed with the liquid, can not be chewed or crushed, but can be taken in half according to the half line.
Oxybutyn hydrochloride sustained-release tablets adverse reactions
- This product is a sustained-release preparation, with fewer adverse reactions than ordinary preparations, and is easily tolerated by patients. A few patients have mild side effects of anticholinergics after taking this product.
According to literature:
Adverse reactions with an incidence of 5% are:
1, general adverse: reaction headache, fatigue, pain;
2. Digestive tract: dry mouth, constipation, diarrhea, nausea, indigestion;
3. Nervous system: lethargy, dizziness;
4. Respiratory system: rhinitis;
5, special feeling: blurred vision, dry eyes;
6, urogenital system: urinary tract infection.
Adverse reactions with a incidence of 2-5% are:
1. General: abdominal pain, dry sinus mucosa, accidental injury, back pain, flu-like syndrome;
2. Cardiovascular: hypertension, palpitations, and vasodilation;
3. Digestive tract: bloating, gastroesophageal reflux;
4. Musculoskeletal system: arthritis;
5. Nervous system: lethargy, nervousness, and insanity;
6. Respiratory system: upper respiratory tract infection, cough, sinusitis, bronchitis, pharyngitis;
7. Skin: dry skin and rash;
8. Urogenital system: Affects urination, increased residual urine volume, urinary retention, and cystitis.
Other adverse reactions related to oxybutynin common preparations include hallucinations, dilated pupils, impotence, and inhibition of lactation.
Oxybutyn hydrochloride sustained-release tablets contraindications
- The following patients are disabled:
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.
Oxybutyn hydrochloride sustained-release tablets
- 1, liver and kidney dysfunction should be used with caution;
2. Use with caution in patients with bladder overflow obstruction;
3. Use with caution in patients with gastrointestinal hardening;
4. Use with caution in ulcerative colitis, intestinal weakness, and myasthenia gravis;
5. Use with caution in patients with gastroesophageal reflux and / or patients taking drugs that cause or exacerbate esophagitis at the same time;
6. Use with other solid foods that are not easy to change;
7. Inform patients that taking this product under high temperature environment may cause heat stroke;
8. People working at heights and engaged in dangerous work should use it in accordance with the doctor's advice;
9. Alcohol can aggravate drowsiness caused by oxybutynin and the like.
Oxybutyn hydrochloride sustained-release tablets for pregnant and lactating women
- The safety of pregnant women or women who are about to take this product has not yet been established. It is only used when the advantages outweigh the disadvantages. It is unclear whether oxybutynin can be secreted from breast milk. Because many drugs can be secreted into breast milk, so Lactating women should use this product with caution.
Oxybutyn hydrochloride sustained-release tablets for children
- The effectiveness and safety of this product for adolescents and children under the age of 18 have not been established.
Oxybutyn hydrochloride sustained-release tablets for elderly
- The pharmacokinetic parameters of elderly people aged 78 and younger after taking this product are roughly equivalent to young adults. The incidence and severity of anticholinergic effects reported by elderly patients around 65 are similar.
Oxybutyn hydrochloride sustained-release tablets drug interactions
- 1. Oxybutynin combined with other antispasmodics, other dry mouth, constipation, drowsiness drugs or other anticholinergic drugs will increase the frequency and severity of the above symptoms;
2. Anticholinergics affect the absorption of drugs taken at the same time because of their effects on gastrointestinal motility;
3.Oxybutynin interacts with P450 cytochromease inhibitors such as antifungal drugs (such as ketoconazole, itraconazole and miconazole), macrocyclic antibiotics (such as erythromycin, clarithromycin), etc. The role data has not been established.
Oxybutyn hydrochloride sustained-release tablets overdose
- During the overdose treatment of this product, the sustained release characteristics of oxybutynin should be considered. Patients should be monitored for at least 24 hours and symptomatic and supportive treatments may be used. Activated carbon and laxatives may be required.
Oxybutyn hydrochloride sustained-release tablets pharmacology and toxicology
- Pharmacological effects:
Oxybutin hydrochloride has a direct antispasmodic effect on smooth muscle and can inhibit the muscarinic effect of acetylcholine on smooth muscle. It can selectively act on the detrusor of the bladder, reduce the bladder pressure, increase the bladder capacity, reduce involuntary bladder contraction and relieve urgency, frequent urination and urinary incontinence. The anticholinergic activity of this product on rabbit detrusor muscle is only 1/5 of atropine, but the antispasmodic effect is 4-10 times that of atropine. It has no blocking effect on skeletal muscle ganglia and autonomic ganglia.
Toxicology research:
Genotoxicity: Mutagenicity test results of human yeast, Saccharomyces cerevisiae and Salmonella typhimurium test system were all negative.
Reproductive toxicity: Reproductive toxicity tests in mice, rats, hamsters and rabbits have not shown that this product has any damaging effects on animal fertility or embryos.
However, the safety of this product for pregnant women or women who may be pregnant is uncertain. Therefore, pregnant women should not use this product unless the doctor believes that the potential clinical benefits of using this product outweigh its potential dangers. It is unclear whether oxybutynin is excreted from human milk. Because many drugs can be excreted from human milk, breastfeeding women should use this product with caution.
Carcinogenicity: In a long-term carcinogenicity test for two consecutive years in rats, the doses were 20, 80, and 160 mg / kg / day, respectively (based on body surface area, corresponding to the clinically recommended maximum doses of 6, 25, and 50 times), as a result, it did not show carcinogenicity.
Pharmacokinetics of Oxybutyn Hydrochloride Sustained-release Tablets
- According to foreign literature:
Absorption: After oral administration of the first dose of oxybutynin sustained-release tablets, the blood concentration continued to rise within 4-6 hours, maintaining a stable blood concentration for nearly 24 hours.
Compared with oxybutynin common preparations, the relative bioavailability of R-oxybutynin and S-oxybutynin in sustained-release tablets of oxybutynin were 156% and 187%, respectively. The blood concentration-time curve shapes of R-oxybutynin and S-oxybutynin are approximately the same. After multiple doses of oxybutynin sustained-release tablets, plasma reached steady-state concentration after 3 days, and no drug accumulation and changes in pharmacokinetic parameters of oxybutynin and desethyl oxybutynin were observed. Food does not affect the absorption and metabolism of oxybutynin extended-release tablets.
Distribution: Oxybutynin is administered intravenously or orally, and the plasma concentration decreases in a two-phase manner. Intravenous injection of 5 mg of oxybutynin hydrochloride has a volume of 193L. After a single oral oxybutynin sustained-release tablet of 10 mg, t max was 12.7 hours in R-oxibunin and 11.8 hours in S-oxybutynin, and their elimination half-life were 13.2 hours and 12.4 hours, respectively.
Metabolism: Oxybutynin is mainly metabolized by the cytochrome P450 enzyme system (especially CYP3A4 of the liver and intestinal wall). Its main metabolites are inactive phenylcyclohexyl glycolic acid and active deethyloxoxib rather. After taking oxybutynin sustained-release tablets, the blood concentrations of R-oxybutynin and S-oxybutynin were 72% and 93% of oxybutynin, respectively.
Excretion: Most of oxybutynin is metabolized in the liver, less than 0.1% of the drug is excreted from the urine as the original drug, and less than 0.1% of the drug is excreted from the urine as the metabolite deethyloxybutynin. In the dose range of 5-20 mg, the pharmacokinetic parameters of oxybutynin and its metabolite deethyl oxybutynin are dose-dependent.
Pharmacokinetics in special populations: The pharmacokinetics of oxybutynin sustained-release tablets for people under 78 years are the same.
Children: The pharmacokinetics of children under 18 years have not been evaluated. Gender: The pharmacokinetic characteristics of oxybutynin sustained-release tablets were not significantly different between male and female healthy subjects.
Race: The pharmacokinetic characteristics of oxybutynin sustained-release tablets were not significantly different among healthy subjects of different races.
Renal insufficiency: No medication experience with renal insufficiency.
Liver insufficiency: No experience with medications for liver insufficiency.
Oxybutyn hydrochloride sustained-release tablets storage
- Shaded and sealed.
Oxybutyn hydrochloride sustained-release tablets packaging
- Aluminum plastic packaging, 3 pieces / plate, 1 plate / box.
Oxybutyn hydrochloride extended-release tablets
- 36 months [1]