Amfast AV Tablet
Amlodipine 5mg + Atorvastatin 10mg
50mg + 10mg
Vega Pharma
| Pack size | |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 13.60 NPR |
Indications
Amfast AV Tablet is used for:
Angina, Hyperlipidaemia, Hypertension, Stroke prevention
Adult Dose
Hypertension/Angina & Hyperlipidemia
Dosage must be individualized for each individual component for treatment of hypertension, angina, and/or hyperlipidemia; amlodipine dose may be titrated after 1-2 weeks and the atorvastatin dose after 2-4 weeks; not to exceed 10 mg amlodipine or 80 mg atorvastatin
2.5-10 mg amlodipine; 10-80 mg atorvastatin PO qDay
Hepatic Impairment: Contraindicated in active liver disease
Elderly: May initiate Amlodipine component at 2.5 mg once daily.
Child Dose
Hypertension & Hyperlipidemia
Dosage must be individualized for each individual component for treatment of hypertension/hyperlipidemia; amlodipine dose may be titrated after 1-2 weeks and the atorvastatin dose after 2-4 weeks; not to exceed 5 mg amlodipine or 20 mg atorvastatin
<6>6 years: 2.5-5 mg amlodipine; 10-20 mg atorvastatin PO qDay
Renal Dose
Dose adjustment not necessary
Administration
May be taken with or without food.
Contra Indications
Active liver disease or unexplained persistent elevated hepatic transaminases. Pregnancy and lactation.
Precautions
Atorvastatin may cause myopathy, and rarely rhabdomyolysis with acute renal failure secondary to myoglobinuria especially at high doses or in patients with history of renal impairment. Caution when used with CYP3A4 inhibitors which may increase plasma concentrations of Atorvastatin. Withhold/discontinue Atorvastatin if symptoms suggestive of myopathy or rhabdomyolysis are observed. Atorvastatin has been associated with biochemical abnormalities of liver; LFT should be monitored prior to and at 12 wk following treatment initiation and dosage increment; caution in patients who consume large amounts of alcohol or with history of liver disease.
Worsening of angina and/or myocardial infarction has been reported with use of dihydrophyridine calcium channel blockers, especially in patients with severe obstructive coronary artery disease. Amlodipine may cause dose-dependent peripheral oedema. Caution in patients with severe aortic stenosis, symptomatic hypotension may occur. Elderly.
Lactation: It is not known whether atorvastatin is excreted into human milk. Because statins have the potential for serious adverse reactions in nursing infants, women taking this drug should not breastfeed their infants
Pregnancy-Lactation
Interactions
Rifamycins may increase the metabolism of both Amlodipine and Atorvastatin. Atorvastatin may increase AUC of norethindrone and ethinyl estradiol.
Potentially Fatal: Atorvastatin: Increased risk of myopathy when used concurrently with fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4 inhibitors (e.g. clarithromycin, HIV protease inhibitors, itraconazole). Cyclosporine (OATP1B1 inhibitor) may significantly increase bioavailability of Atorvastatin.
Adverse Effects
Side effects of Amlodipine 5mg + Atorvastatin 10mg :
>10%
Amlodipine
Peripheral edema (2-15%)
Atorvastatin
Arthralgia (4-12%),Diarrhea (5-14%),Nasopharingitis (4-13%)
1-10%
Amlodipine
Palpitation (1-5%),Dizziness (1-3%),Flushing (1-5%),Somnolence (1-2%),Rash (1-2%),Fatigue (5%),Pruritus (1-2%),Male sexual dysfunction (1-2%),Nausea (3%),Dyspepsia (1-2%),Dyspnea (1-2%),Weakness (1-2%)
Atorvastatin
Nausea (4-7%),Dyspepsia (3-6%),Increased transaminases (2-3% with 80 mg/day),Urinary tract infection (4-8%),Insomnia (1-5%),Myalgia (3-8%),Musculoskeletal pain (2-5%),Respiratory pharyngeal pain (1-4%)
<1%
Amlodipine,Abnormal vision,Arthralgia,Chest pain,Abnormal dreams,Increased apetite,Acute interstitial nephritis,Alopecia,Conjunctivitis,Cough,Depression,Dysphagia,Flatulence,
Atorvastatin
Amnesia,Alopecia,Anorexia,Colitis,Confusion,Bullous rash,Biliary pain,Anemia,Cholestatic jaundice,Duodenal ulcer
Potentially Fatal: Rhabdomyolysis with acute renal failure.
Mechanism of Action
Amlodipine is a dihydropyridine calcium channel blocker which relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It reduces peripheral vascular resistance and hence resulting in a reduction of blood pressure. In vasospastic angina, Amlodipine also inhibits coronary spasm in patients with vasopastic angina.
Atorvastatin selectively and competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate which is a rate-limiting step in cholesterol biosynthesis.
Note
Amfast AV 50mg + 10mg Tablet manufactured by Vega Pharma. Its generic name is Amlodipine 5mg + Atorvastatin 10mg. Amfast AV is availble in Nepal.
Farmaco Nepal drug index information on Amfast AV Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.