Nobaten Injection 5 mg (Amlodipine Besilate)

Adult dose

Adults: Amlodipine 5 mg should be taken orally once daily, and can be increased to a maximum of 10 mg daily based on the patient's response. Adjustments should be made according to age and symptoms.

This drug should not be used in certain patients. Individuals who have had allergies to this medication or similar medications should avoid taking it. Additionally, it should not be used in women who are breastfeeding, patients with severely impaired liver function, patients with severe aortic stenosis, or patients in a state of shock. Care should be taken when using this medication in patients with very low blood pressure, those with very poor kidney function requiring dialysis, elderly patients, and women who are pregnant or may become pregnant. While this drug is usually well tolerated, occasional side effects can include flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, serious side effects such as overly low blood pressure, vasculitis, sensory disturbances, erectile dysfunction, dyspepsia, liver dysfunction, skin rash, etc., have been reported. In case of severe side effects, immediate consultation with a physician is necessary, especially when cardiac issues or allergic reactions are suspected. Caution should be exercised with this medicine in patients with heart failure, as it may cause pulmonary edema. Patients with decreased liver function may require dosage adjustments due to prolonged retention of the drug in the body. As this medication takes time to work, it may not be suitable for urgent treatment needs. While it is generally safe to drive or operate machinery while taking this drug, caution should be exercised if dizziness or drowsiness occurs. There may be interactions when this drug is taken alongside various other medications. Particularly, grapefruit juice should be avoided as it may enhance the blood pressure-lowering effect excessively. Furthermore, when used in conjunction with certain antibiotics, blood pressure medications, immunosuppressants, etc., careful monitoring as directed by a physician is necessary. During pregnancy, the safety of this drug is not well established, thus it should only be used when there are no safer alternatives and is deemed necessary. Women who are breastfeeding are advised to discontinue breastfeeding while taking this medication as it may be passed into breast milk. This medication can be used in children aged 6 years and older; efficacy and safety in younger children have not been confirmed. For elderly patients, the usual dosage can be used, and tolerability is generally similar to that of younger adults. In cases of overdose, there may be a risk of excessively low blood pressure, rapid heartbeat, or shock, requiring immediate emergency treatment. To reduce drug absorption in cases of overdose, activated charcoal may be administered or gastric lavage performed, and blood pressure and cardiac function should be continuously monitored. This drug has not been shown to have carcinogenic or mutagenic potential and its long-term use has been established as safe.

Serious side effects

• Hives
• severe swelling (edema)
• difficulty breathing
• yellowing of the skin or eyes (jaundice)
• extreme fatigue
• toxic epidermal necrolysis

Mild side effects

• Flushing
• fatigue
• swelling
• palpitations
• dizziness
• headache
• drowsiness
• abdominal pain
• nausea
• weakness

This medication is sensitive to light and should be stored in a tightly closed container that blocks light. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 300 tablets/bottle