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Product Line:

Cardiometabolism Line

Patient Product Information

Formulation:
Each Amlodipine Besilate (Pelmec) tablet contains: Amlodipine Besilate (equivalent to 5.000 mg Amlodipine) 6.933 mg; Excipients  q.s.; Each Losartan Potassium and Hydrochlorothiazide coated tablet (Loplac-D) contains: Losartan Potassium 50.00 mg; Hydrochlorothiazide 12.50 mg; Excipients  q.s.

Therapeutic Action:
Antihypertensive.
PELMEC 5 (Amlodipine Besilate)
LOPLAC-D 50 (Losartan Potassium/Hydrochlorothiazide)

Indications:
Treatment of blood hypertension when more than two active ingredients are required for satisfactory control.

Dosage and Administration
Blood Hypertension
Usual Dose: 5 mg amlodipine, 12.5 mg hydrochlorothiazide, and 50 mg losartan (1 Pelmec 5 tablet and one Loplac-D tablet).
Maximum Dose: According to the therapeutic response and the physician’s judgment, this dose may be doubled (maximum Pelmec dose 10 mg, Loplac-D 100 mg/25 mg).
The peak antihypertensive action is achieved gradually, usually after two weeks of treatment.
Special Populations
No dosage adjustments are required in case of mild to moderate renal failure (creatinine clearance > 30 mL/min) nor in patients with mild hepatic failure.
The safety and efficacy of Pelmec 5 and Loplac-D in children have not been established.
In elderly patients requiring a triple therapeutic association for blood hypertension control, the suggested dose is the usual one.

Contraindications

Amlodipine besilate (PELMEC) is contraindicated in patients with known hypersensitivity to dihydropyridines.
Losartan potassium/hydrochlorothiazide (LOPLAC-D): Known hypersensitivity to losartan or hydrochlorothiazide. Pregnancy and lactation. Children. Severe renal failure. Hypersensitivity to sulfonamide-derived drugs.

How Supplied
PELMEC MAX D: Packages containing 30 tablets of amlodipine 5 mg and 30 coated tablets of losartan potassium 50 mg and hydrochlorothiazide 12.50 mg, respectively.