CADUET TABLETS 10MG/10MG

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2. Posology and method of administration** **General Consideration** The dosage range for amlodipine/atorvastatin is 5 mg/10 mg to a maximum dose of 10 mg/80 mg once daily. The starting dose and maintenance dose should be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and dyslipidemia. Current treatment guidelines should be consulted to establish treatment goals for patients based on their baseline characteristics. Doses may be taken at any time of day with or without food. As a component of multiple-risk factor intervention, amlodipine/atorvastatin should be used in addition to non-pharmacological measure, including an appropriate diet, exercise and weight reduction in obese patients, smoking cessation, and to treat underlying medical problems, when the response to these measures have been inadequate. **Initial Therapy** Amlodipine/atorvastatin may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. The recommended starting dose of amlodipine/atorvastatin should be based on the appropriate combination of recommendations for the amlodipine and atorvastatin components considered separately. The maximum dose of the amlodipine component of amlodipine/atorvastatin is 10 mg once daily. The maximum dose of the atorvastatin component of amlodipine/atorvastatin is 80 mg once daily. **Substitution Therapy** Amlodipine/atorvastatin may be substituted for its individually titrated components. Patients may be given the equivalent dose of amlodipine/atorvastatin or a dose of amlodipine/atorvastatin with increased amounts of amlodipine, atorvastatin or both for additional antianginal effects, BP-lowering, or lipid-lowering effect. Amlodipine/atorvastatin may be used to provide additional therapy for patients already on one of its components. As initial therapy for one indication and continuation of treatment of the other, the recommended starting dose of amlodipine/atorvastatin should be selected based on on continuation of the component being used previously and on the recommended starting dose for the component being added. **Concomitant Medication (see also section 4.5. Interaction with other medicinal products and other medicinal products and other forms of interaction** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **)** The amlodipine component of amlodipine/atorvastatin has been safely co-administered with thiazide diuretics, alpha blockers, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, long-acting nitrates, and with sublingual nitroglycerine. Amlodipine/atorvastatin has also been safely administered with eforementioned medicines. The atorvastatin component of amlodipine/atorvastatin may be used in combination with a bile acid-binding resin for additive effect on lipid-lowering. The combination of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors and fibrates should generally be avoided (see **sections 4.4. Special warnings and precautions for use** and **4.5. Interaction with other medicinal products and other forms of interaction** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Amlodipine (Hypertension or Angina)** For both hypertension and angina, the usual initial dose is 5 mg amlodipine once daily which may be increased to a maximum of 10 mg depending on the individual patient’s response. In general, titration should proceed over 7–14 days so that the physician can fully assess the patient’s response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently. **Coronary Artery Disease (Amlodipine Studies)** For patients with CAD the recommended dosage range is 5 mg to 10 mg of amlodipine once daily. In clinical studies, the majority of patients required 10 mg once daily (see **section 5.1. Pharmacodynamic properties – Amlodipine/Atorvastatin Pharmacodynamics -** Use in Patients with CAD – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Atorvastatin (Hyperlipidemia)** The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. The recommended starting dose of atorvastatin is 10 mg or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range is 10 mg to 80 mg once daily. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly. **Prevention of Cardiovascular Disease** For primary prevention, the recommended dose is 10 mg once daily. For secondary prevention, optimal dosing may range from 10 mg to 80 mg atorvastatin once daily, to be given at the discretion of the prescriber, taking into account the expected benefit and safety considerations relevant to the patient to be treated (see **section 5.1. Pharmacodynamic properties - Secondary Prevention of Cardiovascular Events** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia (Atorvastatin Studies)** The majority of patients are controlled with 10 mg of atorvastatin once daily. A therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 4 weeks. The response is maintained during chronic therapy. **Homozygous Familial Hypercholesterolemia (Atorvastatin Studies)** In a compassionate-use study of patients with homozygous FH, most patients responded to 80 mg of atorvastatin with a greater than 15% reduction in LDL-C (18%–45%). **Use in Patients with Impaired Hepatic Function** Amlodipine/atorvastatin should not be used in patients with hepatic impairment (see **sections 4.3. Contraindications** and **4.4. Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in Patients with Impaired Renal Function** No adjustment of the dose is required in patients with impaired renal function (see **section 4.4. Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Use in the Elderly** No adjustment of the dose is required in elderly patients. **Use in Children** Safety and effectiveness in children have not been established for amlodipine/atorvastatin. **Use in Combination with Other Medicinal Compounds** In cases where co-administration of atorvastatin with cyclosporine, telaprevir, or the combination tipranavir/ritonavir is necessary, the dose of atorvastatin should not exceed 10 mg. Dose of atorvastatin should not exceed 20 mg/day with concomitant use with elbasvir/grazoprevir (see **sections 4.4. Special warnings and precautions for use - Skeletal Muscle Effects** and **4.5. Interaction with other medicinal products and other forms of interaction** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use of atorvastatin is not recommended in patients taking letermovir co-administered with cyclosporine. Pharmacokinetic drug interactions that result in increased systemic concentration of atorvastatin have also been noted with other human immunodeficiency virus (HIV) protease inhibitors (lopinavir/ritonavir, saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir, fosamprenavir/ritonavir and nelfinavir), hepatitis C (HCV) protease inhibitors (boceprevir, elbasvir/grazoprevir, simeprevir), clarithromycin, itraconazole and letermovir. Caution should be used when co-prescribing atorvastatin and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed (see **sections 4.4. Special warnings and precautions for use - Skeletal Muscle Effects** and **4.5. Interaction with other medicinal products and other forms of interaction** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).