mph Bangladesh


 

P  - Contraindicated in pregnancy

L  - Contraindicated in lactation

Molecule Info

Indication & Dosage

Oral
Hypertension or angina and hyperlipidaemia
Adult: As combination tab containing Amlodipine (mg)/Atorvastatin (mg): 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80. May be used to substitute individual titrated components; or to provide additional therapy for patients currently receiving one of its components; or as initial therapy in patients whom treatment with both Amlodipine and Atorvastatin is appropriate. Amlodipine: Initially 5 mg once daily, titrate over 1-2 wk to maximum of 10 mg once daily. Atorvastatin: Initially 10-20 mg once daily (anytime of the day), patients who require >45 % reduction in LDL cholesterol may be initiated at 40 mg once daily. Titrate dose at intervals of at least 4 week to maximum of 80 mg once daily. 
Child: HTN: Amlodipine: 2.5-5 mg once daily in children ages 6-17 yr. Heterozygous familial hypercholesterolaemia: Atorvastatin: Initially 10 mg once daily in children ages 10-17 yr; maximum recommended dose is 20 mg once daily. 
Elderly: May initiate Amlodipine component at 2.5 mg once daily. 
Hepatic impairment: May initiate Amlodipine component at 2.5 mg once daily.

 

Administration

Should be taken with food.

 

Overdosage

Amlodipine overdosage may cause marked hypotension and possibly reflex tachycardia due to excessive peripheral vasodilation. Actively monitor cardiac and respiratory function, provide CV support if hypotension occur. Both Amlodipine and Atorvastatin are highly protein bound, haemodialysis is unlikely to be useful to enhance clearance.

 

Contraindications

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

 

Special 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. Special Precautions also for use in elderly.

 

Adverse Drug Reactions

Amlodipine: Headache, dizziness, fatigue, somnolence, peripheral oedema, flushing, palpitations, nausea, abdominal pain; rarely pruritus, rash, dyspnoea, asthenia and muscle cramps. Atorvastatin: Nasopharyngitis, arthralgia, diarrhoea, pain in extremity, UTI, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia, increased transaminases, abnormal liver function test, increased creatinine phosphokinase, thrombocytopenia, malaise, hepatitis, cholestasis, bullous rashes.
Potentially Fatal: Rhabdomyolysis with acute renal failure.

 

Drug 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.

Food Interaction

The serum levels of both Amlodipine and Atorvastatin may be increased by grapefuit juice (especially with excessive consumption >1.2 L daily). St John's wort may decrease Atorvastatin levels. Patients receiving Atorvastatin should avoid consumption of large amounts of alcohol.

Pregnancy Category (US FDA)

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

 

Storage

Store at 15 to 30°C.

 

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.
Absorption: Amlodipine: Plasma concentrations peak between 6-12 hr; absolute bioavailability: About 64- 90%. Atorvastatin: Rapidly absorbed; plasma concentrations peak within 1-2 hr; absolute bioavailability of parent drug (Atorvastatin): About 14%.
Distribution: Amlodipine: Protein-binding: Abt 93%; steady-state concentrations reached after 7-8 days of consecutive daily dosing. Atorvastatin: Vd: 381 L; Protein-binding: ≥98 %.
Metabolism: Amlodipine: About 90% is metabolised to inactive metabolite in the liver. Atorvastatin: Extensively metabolised mainly by CYP3A4 in the liver to ortho- and parahydroxylated derivatives (active metabolites); and various beta-oxidation products.
Excretion: Amlodipine: Biphasic elimination; terminal half-life: About 30-50 hr. Atorvastatin: Atorvastatin and its metabolites are removed mainly in the bile; mean elimination half-life: About 14 hr (parent drug), 20-30 hr (equipotent active metabolites).

 

mph Class

Anti-Anginal Drugs / Calcium Antagonists / Dyslipidaemic Agents

 

ATC Classification

C08CA01 - amlodipine ; Belongs to the class of selective dihydropyridine derivative calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases. 
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

 


 

Brand/Product Info


Total Products : 11           
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AMDOVA Beximco Pharmaceuticals Ltd Amlodipine Besilate BP eq. to Amlodipine 5mg + Atorvastatin calcium INN eq. to Atorvastatin 10mg Tablet 30's: 330.00 MRP
AMITOR Opsonin Pharma Limited Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 30's: 330.00 MRP
AMLIP Eskayef Bangladesh Ltd Amlodipine Besilate BP 5mg + Atorvastatin calcium INN 10mg Film Coated Tablet 30's MRP: 330.00
AMOVAST Beacon Pharmaceuticals Limited Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 20's: 220.00 MRP
ATV Plus Delta Pharma Limited Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 10's: 80.00 MRP
CAMLOTOR 5/10 Square Pharmaceuticals Ltd. Amlodipine 5mg + Atorvastatin 10mg Tablet 3x10's: 332.10 MRP
CARDUAL ACI Ltd. Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 30's: 331.20 MRP
LIPICHEK General Pharmaceuticals Ltd Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 20's: 220.00 MRP
LIPIGENT Plus Pacific Pharmaceuticals Ltd. Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 30's: 330.00 MRP
LOCOL Plus Popular Pharmaceuticals Ltd. Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 30's: 331.20 MRP
RAKLOPIN-AT R A K Pharmaceuticals Pvt. Ltd. Amlodipine Besilate 5mg + Atorvastatin calcium 10mg Film Coated Tablet 30's: 300.00 MRP

 

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