Amdin Tablet
Amlodipine
5mg
Alco Pharma Limited
| Pack size | 50's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 4.00 AED |
Available as:
Indications
Amdin Tablet is used for:
Mild to moderate hypertension, Chronic stable and vasospastic angina, Raynaud's disease, Coronary Artery Disease, HTN, Stroke prevention
Adult Dose
Oral
Hypertension
Indicated for hypertension, to lower blood pressure
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day maintenance: 5-10 mg/day
Adjust dosage according to blood pressure goals
Angina & Coronary Artery Disease
Treatment of chronic stable angina, vasospastic angina (Prinzmetal or variant angina), and angiographically documented CAD in patients without heart failure or EF <40%
5-10 mg/day PO initially; maintenance: 10 mg/day PO
Child Dose
Hypertension
<6 years: Safety and efficacy not established
6-17 years
Indicated for hypertension, to lower blood pressure
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
2.5-5 mg/day PO; doses above 5 mg/day have not been studied
Renal Dose
Renal impairment
The Pharmacokinetics of amlodipine are not significantly affected by renal impairment; therefore no dosage adjustment necessary
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity to Amlodipine or other calcium channel antagonist, Severe hypertension.
Precautions
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 the dose is started or increased, particularly with severe obstructive CAD
Extensively metabolized by the liver and plasma elimination half-life is 56 hr in patients with hepatic impairment; titrate slowly when treating patients with severe hepatic impairment
Mild to moderate peripheral edema was the most common adverse event in the clinical trials. The incidence of peripheral edema was dose-dependent and ranged in frequency from 3.0 to 10.8% in the 5 to 10 mg dose range. Care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction.
Pregnancy-Lactation
Pregnancy
Limited available data based on postmarketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy
Clinical considerations
Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
Carefully monitor pregnant women with hypertension and manage accordingly
Lactation
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose
No adverse effects of amlodipine on breastfed infant reported
There is no available information on effects of amlodipine on milk production
Interactions
Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine
CYP3A4 Inhibitors
Coadministration with moderate or strong CYP3A inhibitors may increase systemic exposure to amlodipine and may require dose reduction
Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
CYP3A4 inducers
No information is available on the quantitative effects of CYP3A4 inducers on amlodipine
Closely monitor blood pressure when amlodipine is coadministered with CYP3A4 inducers
Simvastatin
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin
Limit simvastatin dose in patients on amlodipine 20 mg/day
Immunosuppressants
Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when coadministered
Frequent monitoring through blood levels of cyclosporine and tacrolimus and adjust dose when appropriate
Digoxin: Absence of any interaction between Amlodipine and Digoxin in healthy volunteers has been documented in a controlled clinical study.
Cimetidine: An unpublished clinical study indicated no interaction between, Amlodipine and Cimetidine in healthy volunteers.
Warfarin: An unpublished clinical study in healthy volunteers indicates that Amlodipine did not significantly alter the effect of Warfarin on prothrombin time.
Contraindicated (1)
dantrolene
Serious - Use Alternative (14)
apalutamide
chloramphenicol
chloroquine
conivaptan
diltiazem
enzalutamide
fexinidazole
idelalisib
ivosidenib
lofexidine
lonafarnib
nifedipine
simvastatin
voxelotor
Adverse Effects
Side effects of Amlodipine :
>10%
Edema (1.8-10.8%),Pulmonary edema (7-15%)
1-10%
Headache (7.3%),Fatigue (4.5%),Palpitations (0.7-4.5%),Dizziness (1.1-3.4%),Nausea (2.9%),Flushing (0.7-2.6%),Abdominal pain (1.6%),Somnolence (1.4%),Male sexual disorder (1-2%),Drowsiness (1%),Pruritus (1-2%),Skin rash (1-2%),Muscle cramps (1-2%),Muscle weakness (1-2%)
Potentially Fatal: Hypotension, bradycardia, conductive system delay and CCF.
Mechanism of Action
Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina.
Note
Amdin 5mg Tablet manufactured by Alco Pharma Limited. Its generic name is Amlodipine. Amdin is availble in Bangladesh.
Farmaco BD drug index information on Amdin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.