Brand Name: SB-Amloator 5/10

Generic Name: Amlodipine+Atorvastatin

Strenght: 5/10 mg

Composition: Each film coated tablet contains Amlodipine Besylate USP equivalent to Amlodipine 5 mg and Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg.

INDICATIONS:

SB-Amloator is indicated in patients for whom treatment with both Amlodipine and  Atorvastatin is appropriate.

Amlodipine is indicated for the patients with mild to moderate hypertension (alone or in combination with other antihypertensives), the treatment of chronic stable and vasospastic angina, Raynaud’s disease.

Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and triglycerides (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; as an adjunct to diet for the treatment of patients with elevated serum triglycerides (TG) levels; for the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet; to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prior to initiating therapy with atorvastatin, secondary cause for hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinemia, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.

DOSAGE AND ADMINISTRATION:

SB-Amloator  may be substituted for its individually titrated components. Patients may be given the equivalent dose of  SB-Amloator  or a dose of SB-Amloator  with increased amounts of amlodipine, atorvastatin or both for additional antianginal effects, blood pressure lowering or lipid lowering effect.

SB-Amloator 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 SB-Amloator  should be selected based on the continuation of the component being used and the recommended starting dose for the added monotherapy.

SB-Amloator may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. The recommended starting dose of SB-Amloator should be based on the appropriate combination of recommendations for the monotherapies.

The maximum dose of the amlodipine component of SB-Amloator is 10 mg once daily. The maximum dose of the atorvastatin component of SB-Amloator is 80 mg once daily

SIDE EFFECTS:

In general, treatment with amlodipine and atorvastatin combination is well tolerated. Some common side effects include headache, dizziness, tiredness, sleepiness, stomach pain, nausea, stomach upset, diarrhea, edema, flushing, arrhythmia, palpitation, muscle and joint pain etc.

CONTRAINDICATION:

Combination of amlodipine and atorvastatin is contraindicated in patients with known hypersensitivity to any component of this medication. Combination of amlodipine and atorvastatin contains atorvastatin and is therefore contraindicated in patients with active liver disease which may include unexplained persistent elevations of serum transaminases.

Pregnancy:

Pregnancy Category  X.

Use in pregnant women clearly outweighs potential benefits.

Combination of amlodipine and atorvastatin, which includes 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.

Lactation:

Adequate human data are not available in case of lactation.

Use in children: There have been no studies conducted to determine the safety or effectiveness of combination of amlodipine and atorvastatin in pediatric populations.

Pack Size: 30’s (10×3)