Reboxetine Mesylate Tablets

Reboxetine mesylate is a selective norepinephrine (NE) reuptake inhibitor. It selectively blocks NE reuptake and increases the activity of NE in the central nervous system, thereby improving the patient's mood. It is clinically used to treat depression. It has no affinity for serotonin and dopamine reabsorption sites, and has almost no affinity for muscarinic, histamine or adrenaline receptors.

The main ingredient of this product: Reboxetine mesylate, chemical name: (±)-(2RS)-2-[(RS)-(2-ethoxyphenoxy)benzyl]morpholine mesylate.

This product is white or off-white tablets.

For the treatment of depression in adults.

Oral administration, 1 tablet (4 mg) at a time, twice a day. It will gradually take effect in 2 to 3 weeks. After 3 to 4 weeks of medication, it can be increased to 3 tablets (12 mg) a day as needed, taken in three times. The maximum daily dose should not exceed 3 tablets (12 mg).

1. Very common adverse reactions (more than 1/10 patients): ① Difficulty falling asleep (insomnia); ② Dry mouth; ③ Constipation; ④ Hyperhidrosis. 2. Common adverse reactions (less than 1/10 patients): ① Headache; ② Dizziness; ③ Increased heart rate, palpitations, vasodilation, orthostatic hypotension; ④ Blurred vision; ⑤ Anorexia or loss of appetite, nausea; ⑥ Difficulty urinating or urinary retention, urinary tract infection; ⑦ Erectile dysfunction, ejaculation pain or testicular pain, delayed ejaculation; ⑻ Chills. In addition, spontaneous reports include restlessness, anxiety, irritability, aggressive behavior, hallucinations, cold limbs, nausea, vomiting, paresthesia, increased blood pressure, Raynaud's phenomenon, allergic dermatitis or rash, hyponatremia, and testicular pain. Most adverse reactions are mild and usually disappear after the first few weeks of treatment.

The following situations should not be used: women who are pregnant, giving birth, or breastfeeding; those who are allergic to this product or its ingredients; patients with liver or kidney dysfunction; those with a history of convulsions, such as epilepsy; patients with increased intraocular pressure (glaucoma); those with dysuria caused by prostatic hyperplasia; patients with low blood pressure (hypotension) or those who are taking antihypertensive drugs; patients with heart disease, such as those who have recently had a cardiovascular accident; and patients who have had a manic episode.

Precautions for children: This product is contraindicated for children and adolescents under 18 years of age. When patients under 18 years of age receive this type of drug treatment, the risk of adverse reactions increases, such as suicide attempts, suicidal thoughts and hostility (mainly aggressive, confrontational behavior and anger). There is currently a lack of long-term safety data on the effects on the growth, maturation, cognitive and behavioral development of children and adolescents. Precautions for pregnancy and lactation: There is no clinical data for this product for pregnant women. Animal reproductive toxicity studies have shown that this product has no effect on the reproductive capacity, fertility and delivery of rats, and has no teratogenic effect on rats and rabbits, but perinatal use of rats will reduce the survival rate of offspring. This product will be secreted into breast milk in small amounts. There is a potential risk of affecting infants. Therefore, pregnant and lactating women are prohibited. Precautions for the elderly: Elderly patients have large individual differences in this product, the content in the body increases, and the dosage is difficult to control. It is not recommended for elderly patients at present.

This product is mainly metabolized by CYP3A4 isoenzyme. Drugs that can reduce the activity of CYP3A4, such as antifungal agents ketoconazole and fluconazole, may increase the blood concentration of this product. This product may interact with the following drugs: azole antifungal agents, such as fluconazole and ketoconazole; antibiotics, such as erythromycin; ergot derivatives used to treat migraine or Parkinson's disease; monoamine oxidase inhibitors, such as moclobemide and phenelzine; tricyclic antidepressants, such as imipramine; phenothiazine antipsychotics, such as chlorpromazine; nefazodone; selective serotonin reuptake inhibitors, such as fluvoxamine; lithium; potassium-depleting diuretics, such as thiazides; antiarrhythmic drugs, such as propranolol, alprenolol, and flecainide; immunosuppressants, such as cyclosporine; antihypertensive drugs, as well as methadone, lidocaine and other drugs.

Sealed and stored at room temperature. The validity period is tentatively set at two years

4mg (as reboxetine)

24 months

Nanjing Zenkom Pharmaceutical Co., Ltd.

• Founded in:

  2001-07-30

• Address:

  No. 3 Huimei Road, Nanjing Economic and Technological Development Zone

• Tax NO.:

  91320192730543007A

• Registered Funds:

  72.8182 million yuan

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