Levamlodipine

CONJUPRI ® is calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension CONJUPRI ® is indicated for the treatment of hypertension in adults and patients 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …

• Adult recommended starting dose: 2.5 mg once daily with maximum dose 5 mg once daily. ○ Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily. • Pediatric starting dose: 1.25 mg to 2.5 mg once daily
• Important Limitation : Doses in excess of 2.5 mg daily have not been studied
• In pediatric patients
• Adults The usual initial antihypertensive oral dose of levamlodipine is 2.5 mg once daily, and the maximum dose is 5 mg once daily
• Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily and this dose may be used when adding levamlodipine to other antihypertensive therapy
• Adjust dosage according to blood pressure goals
• In general, wait 7 to 14 days between titration steps
• Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently
• Children The effective antihypertensive oral dose
• In pediatric patients ages 6–17 years is 1.25 mg to 2.5 mg once daily
• Doses in excess of 2.5 mg daily have not been studied
• In pediatric patients [see Clinical Pharmacology , Clinical Studies ]

Tablet, 2.5 mg is white to off-white, capsule shaped, flat-faced tablet with functional score on each side, engraved with “OE” on one side and “B47” on the other side. Tablet of 2.5 mg can be split for 1.25 mg dose for medical conditions that need 1.25 mg dose. Tablet, 5 mg is white to off-white, soap shaped, flat-faced tablet, engraved with “OE” on one side and “B48” on the other side. …

• Levamlodipine (1.25 to 2.5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies ]
• Effect of levamlodipine on blood pressure in patients less than 6 years of age is not known

Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Levamlodipine is contraindicated in patients with known sensitivity to amlodipine
• Known sensitivity to amlodipine

Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology ( 12.3 )] CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. …

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) 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. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. …

Most common adverse reactions to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, call CSPC Ouyi Pharmaceutical Co., Ltd at 1-877-436-7220 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine 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 [see Clinical Considerations] . …

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine limited. Single oral doses of amlodipine equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.