Information about Lodiptan

Composition:

Each F.C. tablet contains:

Amlodipine besylate equivalent to 5 mg  Amlodipine free base, and 80 mg Valsartan .

Amlodipine besylate equivalent to 5 mg  Amlodipine free base, and 160 mg Valsartan .

Amlodipine besylate equivalent to 10 mg  Amlodipine free base, and 160 mg Valsartan .

Amlodipine besylate equivalent to 5 mg  Amlodipine free base, and 320 mg Valsartan .

Indications:

Lodiptan is indicated for the treatment of hypertension:

In patientsnot adequately controlled on monotherapy.

As initial therapy in patients likely to need multiple drugs to activate their blood pressure goals.

Contra-indications:

Hypersensitivity to amlodipine , valsartan or any component of the drug.

 Sever hepatic impairment/biliary cirrhosis and cholestasis.

 Pregnancy or breast feeding.

Side effects:

The most commonside effects that occurred in clinical trials (≥2% of patients) at a higher incidence than placebo included: peripheral edema, nasopharyngitis, upper respiratory tract infection and dizziness.

The most common reasons for discontinuation of the therapy with Lodiptan were peripheral edema and vertigo.

Dosage and administrations:

There commended dose is one tablet per day of either 5 /80 mg, 5 /160 mg, 10 /160mg.

Both amlodipine and valsartan monotherapy can be taken with or without food.

Lodiptan should be consistently taken with or without food.

 Lodiptan maybe administered with other anti-hypertensive agents.

The majorityof antihypertensive effect is attained within 2 weeks.

In patients ≥75 years old or in patients with hepatic impairment, treatment should be started with amlodipine 2.5 mg. No initial dosage adjustment is required for patients with mild or moderate renal impairment. The dose is titrated slowly for patients with severe renal impairment.

When it is as initial therapy with 5 /160 mg, then it will be titrated upwards as necessary to a maximum of 10/ 320 mg once daily.

Over dosage:

The most likely manifestations of over dosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.

Storage:

Lodiptan tablets should be stored below 30°C ,away from moisture.

It should be kept out of the reach of children.

Packing:

Packs of 14 F.C. tablets for all strengths.