Orodipine Tablet (Amlodipine Orotate)

Adult dose

For amlodipine, 5 mg is administered orally once daily, and it may be increased to a maximum of 10 mg daily depending on the patient's response. Adjustments should be made according to age and symptoms.

Child dose

The oral dosage of amlodipine for effective blood pressure reduction is once daily 2.5 mg-5 mg. A dosage exceeding 5 mg daily in pediatric patients has not been studied.

This medication should not be administered to certain patients. For instance, it is contraindicated for those allergic to this medication or similar classes of drugs, nursing women, people with severe liver dysfunction, patients with severe aortic stenosis, and those in shock. Moreover, patients with severe hypotension, those requiring dialysis for renal failure, elderly individuals, and women who are pregnant or may become pregnant should take this medication cautiously. Various side effects such as skin rash, headache, dizziness, palpitations, fatigue, edema, and nausea can occur. Rarely, decreased blood pressure, vasculitis, neurological abnormalities, gastrointestinal issues, and liver function abnormalities have also been reported. In patients with heart failure, this medication can exacerbate pulmonary edema; thus, caution is required. For patients with liver impairment, the half-life of this drug may be prolonged, necessitating dosage adjustments. The antihypertensive effect of this medication appears gradually, making it unsuitable for emergencies such as acute angina. While this medication is known not to significantly affect driving or operating machinery, individual variations may apply, so care should be taken. This drug can interact with several other medications. Particularly, co-administration with grapefruit juice may enhance its effects, so it is advisable to avoid it. Additionally, when taking it with certain antibiotics, antihypertensives, anticoagulants, etc., it is essential to follow a physician's instructions. The safety of this medication has not been established for women who are pregnant or breastfeeding and should be avoided if possible, or a physician should be consulted before use. For children, efficacy has only been confirmed in those 6 years and older, with safety and efficacy in younger age groups not known. For elderly patients, the general dosage is recommended, but they should be monitored for bodily responses. In case of overdose, severe hypotension, tachycardia, and shock may occur, necessitating an immediate visit to a medical institution, and gastric lavage or activated charcoal may be needed if necessary. This medication is known to have a low risk of carcinogenicity or mutagenicity even when administered long-term.

Serious side effects

• Hives
• severe swelling (edema)
• difficulty breathing
• skin peeling
• pain in oral/ocular mucosa
• yellowing of skin or eyes (jaundice)
• profound lethargy
• severe allergic reactions
• severe dermatological reactions
• respiratory issues

Mild side effects

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

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is vital to maintain a temperature between 1°C and 30°C for proper storage to preserve its efficacy and safety over time.

Appearance

It is a white or slightly yellowish octagonal tablet.

Package unit

30 tablets/PTP, 500 tablets/bottle