Drug ID: 1d00000090
Drug Name: Amlodipine and Lisinopril
Generic Names: Aamin L | Acedip | Alis | Alis Plus | Amchek L | Amdepin-L | Amlace | Amlodac-L |Amodep L | Amlokath-L | Amlo-L | Amlod-L | Amlopres-L | Amom-L | Amlosafe-LS | Amlot-L | Amin L | Amlovas-L | Amlodac L | Amvik – L | Amtas-Lp | Amlozed LS | Axipin L | Biopril Am | Calchek-L | Carvasc-L | Dipin L | Dip-A | Hipril-A | Inace | Licard | Lipril-Am | Lismol | Listril-Am | Lis-Ten AM | Lisnovik A | Lisnop AM | Lisiriv A | Manage plus | Neocard-Li | Numlo-L | Nulis A | Oalcheck –L | Primodil-L | Pdpril AM | Zelis Am
Category: Anti- Hypertensives
Legal Status: Non opioid prescription only
Indication for Mother: Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Adult: Oral- Per tab contains amlodipine 5 mg and lisinopril 5 mg: 1 tab once daily, up to 2 tab/day if needed.
Recommended In: This combination medication contains ACE inhibitors, prescribed for hypertension.
Directions For Use: It comes as a tablet to take by mouth as directed by your physician.
Storage: Store it at controlled room temperature (15°-30°C).
Dosage Forms: Tablet
Side Effects: Nausea, headache, dizziness, cough, diarrhea, fatigue, rash, fluid retention, flushing, palpitation, chest pain, weakness, dry mouth; elevations in BUN, serum creatinine and potassium may occur.
In Case of Overdose: Lisinopril
The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis.
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 is limited.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As Amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
Avoid If: Caution should be exercised in patients with history of liver or kidney impairment, severe heart disease, heart attack, who are taking other medications, any allergy, children, during pregnancy and breastfeeding.
Contraindicated in patients with hereditary or idiopathic angioedema and hypersensitivity.
Drug Interaction: Amlodipine
Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors.
Hypotension - Patients on Diuretic Therapy
Patients on diuretics, and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Lisinopril. The possibility of hypotensive effects with Lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Lisinopril. If it is necessary to continue the diuretic, initiate therapy with Lisinopril at a dose of 5 mg daily, and provide close medical supervision after the initial dose until blood pressure has stabilized.
Epidemiological studies have suggested that concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood glucose-lowering effect with risk of hypoglycemia. This phenomenon appeared to be more likely to occur during the first weeks of combined treatment and in patients with renal impairment. In diabetic patients treated with oral antidiabetic agents or insulin, glycemic control should be closely monitored for hypoglycemia, especially during the first month of treatment with an ACE inhibitor.
Non-steroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 (COX-2) Inhibitors
Reports suggest that NSAIDs including selective COX-2 inhibitors may diminish the antihypertensive effect of ACE inhibitors, including lisinopril. This interaction should be given consideration in patients taking NSAIDs or selective COX-2 inhibitors concomitantly with ACE inhibitors. Therefore, monitor effects on blood pressure and renal function when administering the combination, especially in the elderly.
Dual Blockade of the Renin-angiotensin-aldosterone System
Dual blockade of the renin-angiotensinaldosterone system (RAAS) with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function, and electrolytes in patients on Lisinopril and other agents that affect the RAAS. Do not coadminister aliskiren with Lisinopril in patients with diabetes. Avoid use of aliskiren with Lisinopril in patients with renal impairment (GFR < 60ml/min).
Agents Increasing Serum Potassium
Lisinopril attenuates potassium loss caused by thiazide-type diuretics. Use of Lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium.
Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. It is recommended that serum lithium levels be monitored frequently if Lisinopril is administered concomitantly with lithium.
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Lisinopril.