Aripen Tablet, Injection
Aripen is a Dihydropyridine Calcium antagonist that inhibits the transmembrane influx of Calcium ions into cardiac and vascular smooth muscle. It has greater affinity towards vascular smooth muscle than on cardiac muscle. Aripen is peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and thereby reduces blood pressure. Aripen reduces tone, decreases coronary vasoreactivity and lowers cardiac oxygen demand by reducing after load.
Patients with mild to moderate hypertension (alone or in combination with other antihypertensives).
The treatment of chronic stable and vasospastic angina.
Aripen is also used to associated treatment for these conditions: Anginal Pain, Cardiovascular Events, Chronic Stable Angina Pectoris, Coronary Artery Disease (CAD), High Blood Pressure (Hypertension), Homozygous Familial Hypercholesterolemia, Hypertension,Essential, Mixed Dyslipidemias, Primary Hypercholesterolemia, Vasospastic Angina
|Other Names||Amlodipine, Amlodipino, Amlodipinum|
|Weight||5mg, 10mg, 15mg, 9.75mg/1.3ml|
About 98% , .
|Therapeutic Class||Calcium-channel blockers|
|Manufacturer||Oyster Pharmaceuticals Ltd, Opsonin Pharma Ltd|
|Last Updated:||June 23, 2021 at 11:16 am|
Table Of contents
For treatment of both hypertension and angina pectoris, the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose may be increased to a maximum dose of 10 mg once daily. Aripen 10 mg once daily provides symptomatic improvement in patients with Raynaud's disease.
Use in children: Use of Aripen in children (under 12 years of age) is not recommended.
Aripen is generally well tolerated. The most commonly observed side effects are headache, peripheral oedema, palpitations, flushing, dizziness, nausea, abdominal pain.
Hypotension: Since the vasodilUse in renal failure
Although Aripen is excreted primarily via kidney, mild renal impairment does not appear to have an effect on the plasma concentrations. Severe renal impairment may however require a dosage reduction. Aripen is not dialyzable.
Use in patients with impaired hepatic function
Aripen half-life is prolonged in patient with impaired hepatic function. Aripen should therefore be administered at lower (5mg) initial dose in these patients.
Use in heart failure
An increased number of pulmonary oedema has been reported.atation induced by Aripen is gradual in onset, acute hypotension has rarely been reported after oral administration of Aripen. Nonetheless, caution should be exercised when administering the drug with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Cardiac failure: Patients with heart failure should be treated with caution. Calcium channel blockers, including Aripen, should be usedwith caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Beta blocker withdrawal: Aripen gives no protection against the danger of abrupt beta blocker withdrawal; any such withdrawal should be gradualreduction of the dose of beta blocker.
Hepatic failure: The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function. Aripen should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose. Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment.
Use of Aripen together with thiazide diuretics or angiotensin-converting-enzyme inhibitors in the treatment of hypertension is additive. There are no hazardous interaction of Aripen with Digoxin, Cimetidine, Warfarin and food.
- Avoid grapefruit products.
- Avoid natural licorice.
- Take with or without food. The absorption is unaffected by food.
Volume of Distribution
21 L/kg , .
The terminal elimination half-life of about 30–50 hours .
Plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering this drug to patients with severe hepatic impairment .
Total body clearance (CL) has been calculated as 7 ± 1.3 ml/min/kg (0.42 ± 0.078 L/ h/kg) in healthy volunteers , .
Elderly patients show a reduced clearance of amlodipine with an AUC (area under the curve) increase of about 40–60%, and a lower initial dose may be required .
Pregnancy & Breastfeeding use
Pregnancy: Safety in pregnancy has not been established.
Lactation: It is not known whether Aripen is excreted in breast milk. It is advised to stop breastfeeding during treatment with Aripen.
Aripen is contraindicated in patients with-
- Hypersensitivity to amlodipine, dihydropyridine derivatives or any of the excipients
- Shock (including cardiogenic shock)
- Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)
- Unstable angina
- Hemodynamically unstable heart failure after acute myocardial infarction (during the first 28 days)
- Severe hypotension
Children with hypertension from 6 years to 17 years of age: 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Children under 6 years old: The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Elderly: Aripen used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care.
Renal impairment: Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Aripen is not dialysable.
Hepatic impairment: Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautions and should start at the lower end of the dosing range. The pharmacokinetics of Aripen have not been studied in severe hepatic impairment. Aripen should be initiated at the lowest dose (2.5 mg once daily) and titrated slowly in patients with severe hepatic impairment.
There is no well documented experience with Aripen overdosage. In case of clinically significant hypotension due to Aripen over dosage, calls for active cardiovascular support including monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. Since Aripen is highly protein-bound, dialysis is unlikely to be of benefit.
Keep out of the reach of children. Store below 30° C. Keep in the original package in a cool & dry place in order to protect from light and moisture.