Indications
Levamolin Tablet is used for:
Hypertension
Adult Dose
Hypertension
Indicated as monotherapy or in combination with other antihypertensive agents for hypertension
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction
Initial: 2.5 mg PO qDay;: may increase to up to 5 mg PO qDay
Small, fragile, or elderly patients, or patients with hepatic insufficiency, may be started on 1.25 mg qDay and this dose may be used when adding to other antihypertensive therapy
Adjust dosage according to blood pressure goals
In general, wait 7-14 days between titration steps; titrate more rapidly, if clinically warranted, provided the patient is assessed frequently
Hepatic impairment
Patients with hepatic insufficiency may be started on 1.25 mg qDay
Elderly patient and patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of ~40-–60%, and a lower initial dose may be required
Child Dose
Renal Dose
Renal impairment
Pharmacokinetics of amlodipine are not significantly influenced
No dosage adjustment required in patients with renal failure
Administration
Take with or without food
Contra Indications
Hypersensitivity
Precautions
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis; owing to the gradual onset of action, acute hypotension is unlikely
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease
Amlodipine is extensively metabolized by the liver; plasma elimination half-life is 56 hr in patients with impaired hepatic function; titrate slowly when administering amlodipine to patients with severe hepatic impairment
Pregnancy-Lactation
Pregnancy
Limited available data based on postmarketing reports with use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy
Animal data
In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated with oral amlodipine during organogenesis at doses ~10 and 20 times the maximum recommended human dose (MRHD)
In rats, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold)
Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose
Clinical considerations
Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean delivery, postpartum hemorrhage)
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
Carefully monitor pregnant women with hypertension and managed 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 of 4.2%.
No adverse effects of amlodipine on the breastfed infant have been observed
No information available on the effects of amlodipine on milk production
Interactions
Levoamlodipine is a CYP3A4 substrate
Effects of other drugs on amlodipine
Coadministration with moderate or strong CYP3A inhibitors results in increased systemic exposure to amlodipine and may require dose reduction; monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
No information is available on the quantitative effects of CYP3A inducers on amlodipine; closely monitor blood pressure when amlodipine is coadministered with CYP3A inducers
Monitor for hypotension when sildenafil is coadministered with amlodipine
Effects of amlodipine on other drugs
Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin; limit simvastatin dose in patients on amlodipine to 20 mg/day
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered; frequently monitor trough blood levels of cyclosporine and tacrolimus and adjust dose when appropriate
Side Effects
Side effects of Levamlodipine :
>10%
Edema (5.4-14.6%)
1-10%
Fatigue (4.5%)
Flushing (1.5-4.5%)
Palpitations (0.7-4.5%)
Dizziness (1.1-3.4%)
Palpitations (1.4-3.3%)
Nausea (2.9%)
Flushing (0.7-2.6%)
Abdominal pain (1.6%)
Somnolence (1.3-1.6%)
Somnolence (1.4%)
Frequency Not Defined
Cardiovascular: Arrhythmia (eg, ventricular tachycardia, atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis
Central and peripheral nervous system: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo
Gastrointestinal: Anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia
General: Allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease
Musculoskeletal system: Arthralgia, arthrosis, muscle cramps, myalgia
Psychiatric: Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization
Respiratory system: Dyspnea, epistaxis
Skin and appendages: Angioedema, erythema multiforme, pruritus, rash, erythematous rash, maculopapular rash
Special senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus
Urinary system: Micturition frequency, micturition disorder, nocturia
Autonomic nervous system: Dry mouth, sweating increased
Metabolic and nutritional: Hyperglycemia, thirst
Hemopoietic: Leukopenia, purpura, thrombocytopenia
Mode of Action
Amlodipine, a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle
A peripheral arterial vasodilator that acts directly on vascular smooth muscle and causes a reduction in peripheral vascular resistance and reduction in blood pressure
Note
Levamolin 2.5 mg Tablet generic name is Levamlodipine. Levamolin 2.5 mg Tablet is manufactured by Pharmasia Ltd.Levamolin is availble in all over Bangladesh.
Mes BD drug index information on Levamolin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.