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Indications/Uses
For the treatment of patients at cardiovascular risk due to concomitant hypertension and dyslipidemia; For patients with angina and concomitant hypertension and dyslipidemia.
Dosage/Direction for Use
5/10 mg FC tab: Adult: Amlodipine 5 mg and Atorvastatin 10 mg once daily at initial phase. Maximum dose is Amlodipine 10 mg and Atorvastatin 10 mg once daily.
Or as prescribed by the physician.
10/10 mg FC tab: Adult: Amlodipine 10 mg and Atorvastatin 10 mg once daily at initial phase. Maximum dose is Amlodipine 10 mg and Atorvastatin 10 mg once daily.
Or as prescribed by the physician.
10/10 mg FC tab: Adult: Amlodipine 10 mg and Atorvastatin 10 mg once daily at initial phase. Maximum dose is Amlodipine 10 mg and Atorvastatin 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
If the patient has an allergy to Amlodipine/Atorvastatin tablets or any other ingredients of this medicine, then it should not be used. Do not take this medicine if the patient is suffering from lung disease, liver disease, heart disease, any hormone disorder (such as diabetes, under-active thyroid), seizures (convulsions), pregnancy or plan to be pregnant and breastfeeding without consulting the doctor.
Special Precautions
Amlodipine/Atorvastatin, should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. The patient should not use this medicine if had an allergic reaction to Amlodipine or Atorvastatin and if the patient is pregnant or breastfeeding and has liver disease.
Use In Pregnancy & Lactation
HMG-COA reductase inhibitors are contraindicated during pregnancy and in nursing mothers.
Adverse Reactions
Allergic reactions, dark yellow or brown urine, decreased urination, difficulty passing urine, fainting spells, dizziness, lightheadedness, fever, irregular heartbeat, chest pain, palpitations, muscle pain, tenderness, cramps, weakness, redness, blistering, peeling, loosening of the skin, including inside the mouth, skin rash, swelling of legs or ankles, unusual tiredness or weakness, yellowing of the skin or eyes, diarrhea, drowsiness, facial flushing, gas, headache, joint pain, nausea, vomiting, stomach upset or pain, tiredness, weakness and fatigue.
Drug Interactions
Cimetidine: did not alter the pharmacokinetics of Amlodipine.
Antacid: no significant effect on the pharmacokinetics of Amlodipine.
Sildenafil: no effect on the pharmacokinetic parameter of Amlodipine.
Digoxin: did not change serum digoxin levels or digoxin renal clearance in normal volunteers. Steady-state plasma digoxin concentrations increased approximately 20%.
Ethanol (alcohol): no significant effect on the pharmacokinetics of ethanol.
Warfarin: did not change the warfarin prothrombin response time.
Amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. The risk of myopathy during treatment with Hmg-CoA reductase inhibitors is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin or cytochrome P450 3A4 inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals).
Inhibitors of cytochrome P450 3A4: leads to increased plasma concentrations of Atorvastatin.
Clarithromycin: resulted in a 4.4-fold increase in Atorvastatin AUC.
Erythromycin: increased approximately 40% with co-administration of Atorvastatin and erythromycin, a known inhibitor of cytochrome P450 3A4.
Combination of Protease Inhibitors: resulted in a 3-fold increase in Atorvastatin AUC. Concomitant administration of Atorvastatin 20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) resulted in a 5.9-fold increase in Atorvastatin AUC.
Itraconazole: 2.5-3.3- fold increase in Atorvastatin AUC.
Diltiazem hydrochloride: higher plasma concentrations of Atorvastatin.
Cimetidine: Atorvastatin plasma concentrations and LDL-C reduction were not altered.
Grapefruit juice: Contains one or more components that inhibits CYP 3A4 and can increase plasma concentrations of Atorvastatin, especially with excessive grapefruit consumption (>1.2 liters per day).
Cyclosporine: 8.7-fold increase in Atorvastatin AUC.
Inducers of cytochrome P450 3A4: lead to variable reductions in plasma concentrations of Atorvastatin.
Colestipol: Plasma concentrations of Atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered.
Colestipol: Plasma concentrations of Atorvastatin decreased approximately 25% when colestipol and Atorvastatin were co-administered.
Oral contraceptives: increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%.
Warfarin: no clinical significant effect on prothrombin time.
Antacid: no significant effect on the pharmacokinetics of Amlodipine.
Sildenafil: no effect on the pharmacokinetic parameter of Amlodipine.
Digoxin: did not change serum digoxin levels or digoxin renal clearance in normal volunteers. Steady-state plasma digoxin concentrations increased approximately 20%.
Ethanol (alcohol): no significant effect on the pharmacokinetics of ethanol.
Warfarin: did not change the warfarin prothrombin response time.
Amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs. The risk of myopathy during treatment with Hmg-CoA reductase inhibitors is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin or cytochrome P450 3A4 inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals).
Inhibitors of cytochrome P450 3A4: leads to increased plasma concentrations of Atorvastatin.
Clarithromycin: resulted in a 4.4-fold increase in Atorvastatin AUC.
Erythromycin: increased approximately 40% with co-administration of Atorvastatin and erythromycin, a known inhibitor of cytochrome P450 3A4.
Combination of Protease Inhibitors: resulted in a 3-fold increase in Atorvastatin AUC. Concomitant administration of Atorvastatin 20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) resulted in a 5.9-fold increase in Atorvastatin AUC.
Itraconazole: 2.5-3.3- fold increase in Atorvastatin AUC.
Diltiazem hydrochloride: higher plasma concentrations of Atorvastatin.
Cimetidine: Atorvastatin plasma concentrations and LDL-C reduction were not altered.
Grapefruit juice: Contains one or more components that inhibits CYP 3A4 and can increase plasma concentrations of Atorvastatin, especially with excessive grapefruit consumption (>1.2 liters per day).
Cyclosporine: 8.7-fold increase in Atorvastatin AUC.
Inducers of cytochrome P450 3A4: lead to variable reductions in plasma concentrations of Atorvastatin.
Colestipol: Plasma concentrations of Atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered.
Colestipol: Plasma concentrations of Atorvastatin decreased approximately 25% when colestipol and Atorvastatin were co-administered.
Oral contraceptives: increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%.
Warfarin: no clinical significant effect on prothrombin time.
Storage
Store at temperature not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Calcium channel blocker, Amlodipine and HMG-COA reductase inhibitor, Atorvastatin are generally used for the treatment and relief of high blood pressure or hypertension and high cholesterol. The exact mechanism is not fully understood. Amlodipine works by blocking calcium which relaxes and widens the blood vessels. It is used to treat high blood pressure or chest pain (angina). Atorvastatin is used along with a proper diet to help lower cholesterol and fats (triglycerides) in the blood. It is usually prescribed after non-drug treatments (e.g., diet change, increase in exercise, weight loss if overweight) have not been fully successful at lowering cholesterol. Before starting product combination, girls must have had their first menstrual period. Reducing high blood pressure, cholesterol and triglycerides help prevent strokes and heart attacks. Reducing high blood pressure also helps prevent kidney problems.
MedsGo Class
Calcium Antagonists / Dyslipidaemic Agents
Features
Dosage
5 mg / 10 mg
Ingredients
- Amlodipine
- Atorvastatin
Packaging
Film-Coated Tablet 1's
Generic Name
Atorvastatin Calcium / Amlodipine Besilate
Registration Number
DRP-2511-03
Classification
Prescription Drug (RX)
Product Questions
Questions
