Amlodipine (As Besilate)
- Amlodipine (As Besilate)
- No Brand Name
- Tablet
- 5mg
- Blister
- 30 / 100 Tablets
-
• Hypertension
• Angina & Coronary Artery Disease
• Angina & Coronary Artery Disease
Mechanism of Action
Inhibits transmembrane influx of extracellular calcium ions across membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations; this inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries
Increases myocardial oxygen delivery in patients with vasospastic angina
Pharmacokinetics
Bioavailability: 64-90%
Onset: 24-96 hr
Excretion: Urine (70%)
Contraindications
• Hypersensitivity
Adverse Reactions
Edema, Headache, Fatigue, Palpitations, Dizziness, Nausea, Flushing, Abdominal pain, Somnolence, Asthenia, Pruritus, Skin rash, Muscle cramps, Male sexual dysfunction
Major Drug Interactions
Dantrolene
Warnings
• Symptomatic hypotension is possible, particularly with severe aortic stenosis; owing to gradual onset of action, acute hypotension unlikely
•
• Worsening of angina and acute myocardial infarction (MI) can develop after dose is started or increased, particularly with severe obstructive CAD
Recommendations for Patient
-
Pregnancy Considerations
Limited available data based on post marketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy
Breastfeeding Considerations
Limited information indicates that milk levels of amlodipine are usually low and plasma levels in breastfed infants are undetectable. Maternal use of amlodipine during breastfeeding has not caused any adverse effects in breastfed infants. If the mother requires amlodipine, it is not a reason to discontinue breastfeeding.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Inhibits transmembrane influx of extracellular calcium ions across membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations; this inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries
Increases myocardial oxygen delivery in patients with vasospastic angina
Pharmacokinetics
Bioavailability: 64-90%
Onset: 24-96 hr
Excretion: Urine (70%)
Contraindications
• Hypersensitivity
Adverse Reactions
Edema, Headache, Fatigue, Palpitations, Dizziness, Nausea, Flushing, Abdominal pain, Somnolence, Asthenia, Pruritus, Skin rash, Muscle cramps, Male sexual dysfunction
Major Drug Interactions
Dantrolene
Warnings
• Symptomatic hypotension is possible, particularly with severe aortic stenosis; owing to gradual onset of action, acute hypotension unlikely
•
• Worsening of angina and acute myocardial infarction (MI) can develop after dose is started or increased, particularly with severe obstructive CAD
Recommendations for Patient
-
Pregnancy Considerations
Limited available data based on post marketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy
Breastfeeding Considerations
Limited information indicates that milk levels of amlodipine are usually low and plasma levels in breastfed infants are undetectable. Maternal use of amlodipine during breastfeeding has not caused any adverse effects in breastfed infants. If the mother requires amlodipine, it is not a reason to discontinue breastfeeding.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: Maybe acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
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