Ropinirole Hydrochloride Tablets

The active ingredient of this product is ropinirole hydrochloride. Chemical name: 4-[2-di-n-propylaminoethyl]-1,3-dihydro-2H-indol-2-one hydrochloride Molecular weight: C16H24N2OHCl

This product is off-white to light yellow tablets.

Start with a low dose and gradually increase to the therapeutic dose, which can be taken alone or with food. The recommended starting dose is 0.25 mg three times a day, and then gradually increase the dose every other week according to the table below based on each patient's response. If necessary, after 4 weeks, you can increase 1.5 mg per day on a weekly basis until the daily dose reaches 9 mg, and then increase 3 mg per day again until the daily dose reaches 24 mg. Stopping the drug needs to be slow, and the time should be more than seven days. First, reduce the dose from three times a day to two times in the first four days, and then reduce it to once a day in the last three days.

1. Systemic manifestations: uncommon - cellulitis, peripheral edema, fever, flu-like symptoms, abdominal enlargement, precordial pain, nonspecific edema; rare - ascites. 2. Cardiovascular: uncommon - heart failure, bradycardia, tachycardia, supraventricular tachycardia, angina pectoris, conduction block, cardiac arrest, cardiac enlargement, aneurysm, mitral valve defect; rare - ventricular tachycardia. 3. Central/peripheral nervous system: common - neuralgia; uncommon - involuntary muscle contractions, hypertonia, dysphonia, ataxia, extrapyramidal abnormalities, migraine, choreoathetosis, coma, aphasia, convulsions, hypotonia, peripheral neuropathy, paralysis; rare - grand mal seizures, hemiplegia. 4. Endocrine: uncommon - hypothyroidism, gynecomastia, hyperthyroidism;

Patients with allergic reactions to this product are contraindicated.

Precautions for children: Efficacy and safety have not yet been determined. Precautions for pregnancy and lactation: Animal experiments have confirmed that ropinirole can affect embryonic development, such as teratogenic effects. There are not enough relevant studies at present, so pregnant women taking ropinirole should fully consider the risks of medication and weigh the pros and cons. Ropinirole can inhibit the secretion of prolactin in women and thus reduce lactation. Rat experiments have shown that breast milk contains ropinirole or its metabolites, but it is not clear whether ropinirole is excreted through human milk. Since many drugs are excreted through human milk and may affect infants, pregnant women should consider whether they need to stop breastfeeding or use ropinirole. Precautions for the elderly: Compared with patients under 65 years old, the clearance rate of ropinirole is reduced by 30% in patients over 65 years old, but because this drug is administered in cumulative doses, the dose is gradually increased until the therapeutic effect is satisfactory without toxic side effects, so there is no need to adjust the dose.

1. P450 action: In vitro studies have found that CYP1A2 is the enzyme that plays a major role in the metabolism of ropinirole. Taking substrates or inhibitors of CYP1A2 will change the clearance rate of ropinirole. Therefore, the dose of ropinirole should be adjusted accordingly when a strong CYP1A2 inhibitor is stopped or used. 2. Levodopa: The combination of ropinirole (2.0 mg, three times a day) with carbidopa and levodopa does not change the pharmacokinetics of ropinirole. Oral administration of ropinirole (2.0 mg, three times a day) and levodopa can increase the steady-state Cmax of levodopa by 20%, but the AUC is not affected. 3. Digoxin: The combination of ropinirole (2.0 mg, three times a day) with digoxin (0.125-0.25 mg four times a day) does not change the digoxin.

Store at room temperature.

0.5 mg x 30 tablets

24 months

Zein BIOTECHNOLOGY Co., Ltd.

• Founded in:

  2001-04-02

• Address:

  No. 1-6, Standard Factory Building, Jinfeng Biopharmaceutical Industrial Park, No. 28 Gaoxin Avenue, Jiulongpo District, Chongqing

• Tax NO.:

  91500107709356784W

• Registered Funds:

  93.526027 million yuan

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