Amovast Tablet

Amovast Tablet is used for: Angina, Hyperlipidaemia, Hypertension, Stroke prevention

Prevention of Cardiovascular Disease, 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

Hypertension & Heterozygous Familial Hypercholesterolemia 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 <10 years: Safety and efficacy not established >10 years: 2.5-5 mg amlodipine; 10-20 mg atorvastatin PO once daily

Renal Impairment Dose adjustment not necessary

May be taken with or without food.

Active liver disease or unexplained persistent elevated hepatic transaminases. Pregnancy and lactation.

Myopathy and Rhabdomyolysis: Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Amlodipine + Atorvastatin therapy should be discontinued if myopathy is diagnosed or suspected Hepatic Transaminitis: Monitor liver enzymes before and during treatment Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely Angina or myocardial infarction may occur with initiation or dose increase Symptomatic hypotension is possible with use of amlodipine, particularly in patients with severe aortic stenosis; because of gradual onset of action, acute hypotension is unlikely Use caution in congestive heart failure Persistent progressive dermatologic reactions Worsening angina and acute myocardial infarction can develop after starting or increasing dose of amlodipine, particularly in patients with severe obstructive coronary artery disease Heavy alcohol use, history of liver disease, renal failure Adverse reactions associated with atorvastatin therapy reported including anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease

Pregnancy Atorvastatin Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females; discontinue therapy as soon as pregnancy is recognized; limited published data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage Consider ongoing therapeutic needs of individual patient; treatment of hyperlipidemia is not generally necessary during pregnancy Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on outcome of long-term therapy of primary hyperlipidemia for most patients Published data from prospective and retrospective observational cohort studies in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage Animal data In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m2) In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses >6 times the MRHD Amlodipine Limited available data based on postmarketing reports with use in pregnant female are not sufficient to inform a drug-associated risk for major birth defects and miscarriage There are risks to mother and fetus associated with poorly controlled hypertension in pregnancy Animal data There was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times MRHD; respectively; however for rats, litter size was significantly decreased (by about 50%) and number of intrauterine deaths was significantly increased (about 5-fold); amlodipine has been shown to prolong both gestation period and duration of labor in rats at this dose Contraception Females of reproductive potential: Use effective contraception during treatment Lactation There is no information about presence of atorvastatin in human milk, effects on breastfed infant or on milk production; however, another drug in this class passes into human milk Studies in rats have shown that atorvastatin and/or its metabolites are present in breast milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk Statins, including atorvastatin, decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant Because of potential for serious adverse reactions in a breastfed infant, based on mechanism of action, advise patients that breastfeeding is not recommended during treatment Atorvastatin Breastfeeding is still not recommended if taking statins; drug may still pass through milk and pose a risk breastfed children For patients with lower risk, temporarily stop statin therapy until breastfeeding ends Patients who are at high risk of heart attack or stroke who require statins after delivery should not breastfeed and should use alternatives such as infant formula Amlodipine Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infant observed; there is no available information on effects of amlodipine on milk production

Risk of myopathy increased by coadministration with CYP3A4 inhibitors (eg, fibrates, niacin, cyclosporine, macrolides, azole antifungals); therapy should be discontinued if myopathy diagnosed or suspected Coadministration 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 need for dose adjustment Clarithromycin, itraconazole, HIV and HCV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) may increase risk of myopathy/rhabdomyolysis; do not exceed 20 mg atorvastatin Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when co-administered; frequent monitoring of trough blood levels of cyclosporine and tacrolimus recommended; adjust dose when appropriate Atorvastatin is a substrate of hepatic transporters; inhibitors of OATP1B1 (e.g., cyclosporine) can increase bioavailability of atorvastatin Concomitant administration of glecaprevir and pibrentasvir or elbasvir and grazoprevir may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy 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. Contraindicated (3) cyclosporine dantrolene gemfibrozil

Side effects of Amlodipine + Atorvastatin : >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.

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.

Amovast 5 mg + 10 mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Amlodipine + Atorvastatin. Amovast is availble in Bangladesh. Farmaco BD drug index information on Amovast Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.