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LOPID CAPSULES 300MG-PFIZER

LOPID CAPSULES 300MG-PFIZER
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Offer: US$ 0.8 Per CAP
Manufacturer: PFIZER

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LOPID 300 MG CAPSULES-PFIZER
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LOPID 300 MG CAPSULES-PFIZER
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$85.00
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LOPID 300 MG CAPSULES-PFIZER
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LOPID 300 MG CAPSULES-PFIZER
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$240.00
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Description

Lopid 300mg: fine white powder contained in hard gelatine capsule with a white opaque body and a maroon opaque cap imprinted 'Lopid 300' on each capsule half.

 

 

4. Clinical particulars

 

 

4.1 Therapeutic indications

Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

- Primary hypercholesterolaemia when a statin is contraindicated or not tolerated.

Primary prevention

Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event when a statin is contraindicated or not tolerated (see section 5.1).

 

 

4.2 Posology and method of administration

Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment. Lopid should be taken orally.

 

Posology

Adult

The dose range is 900 mg to 1200 mg daily.

The only dose with documented effect on morbidity is 1200 mg daily.

The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.

The 900 mg dose is taken as a single dose half an hour before the evening meal.

 

Elderly (over 65 years old):

As for adults

Children and adolescents

Gemfibrozil therapy has not been investigated in children. Due to the lack of data the use of Lopid in children is not recommended.

 

Patients with renal impairment

In patients with mild to moderate renal impairment (Glomerular filtration rate 50 - 80 and 30 - < 50 ml/min/1.73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose. Lopid should not be used in patients with severely impaired renal function (see section 4.3).

 

Patients with hepatic impairment

Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).

 

 

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

Hepatic impairment.

Severe renal impairment.

History of/or pre-existing gall bladder or biliary tract disease, including gallstones

Concomitant use of repaglinide (see section 4.5) or simvastatin (see sections 4.4 and 4.5).

Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.

 

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