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New invega 3 Mg 28 Extended Release Tablets ingredient paliperidone View larger

invega 3 Mg 28 Extended Release Tablets ingredient paliperidone

IG8858

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invega 3 Mg 28 Extended Release Tablets ingredient paliperidone

NAME OF HUMAN MEDICINE
6 mg 30 mg INVEGA 6 mg prolonged release tablet

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Active ingredient:
paliperidone
Sodium chloride

4.1. Therapeutic indications

INVEGA is indicated in the treatment of schizophrenia.
4.2. Posology and application form

Dosage:

Adults (> 18 years): Schizophrenia

The recommended dose of INVEGA for schizophrenia treatment is once a day, 6 mg in the morning. Initially dose titration is not necessary. Some patients may benefit from higher or lower doses in the 3-12 mg dose recommended daily. Where necessary, dose adjustment should only be performed after clinical reassessment. When dose escalation is required, an increase of 3 mg per day is recommended, usually over 5 days.

Schizoaffective Disorder

The recommended dose of INVEGA for treatment of schizoaffective disorder is once a day, 6 mg in the morning. Initially dose titration is not necessary. Some patients may benefit from higher or lower doses in the 3-12 mg dose recommended daily. At higher doses, a general trend towards stronger effects has been observed. Where necessary, dose adjustment should only be performed after clinical reassessment. When dose escalation is required, an increase of 3 mg per day is recommended, usually over 4 days.

Transition to other antipsychotic agents:

There is no systematic collection of special data regarding the transition of patients from INVEGA to other antipsychotic agents. Because of the different pharmacodynamic and pharmacokinetic profiles of antipsychotic agents, there is a medical need for counseling of a physician when switching to another antipsychotic product.

Application frequency and duration:

The recommended dose for INVEGA is 6 mg for morning treatment of schizophrenia once a day. Dose adjustments can be made where necessary.

Method of Application:

INVEGA is for oral use and can be administered on an empty or full stomach. INVEGA as a whole must not be swallowed, chewed, divided or crushed by any liquid.

Administration of INVEGA should be standardized according to nutrient intake (see Section 5.2 Pharmacokinetic Properties). Patients should always be informed that they should always take INVEGA with hunger or always with breakfast and not to make changes in practice on hunger or toughness conditions.

The drug is designed to release the active substance at a controlled rate within an unabsorbed shell. Tablet shell is discarded together with insoluble core components; they should not be worried when they see something resembling a tablet in a patient's stool.

Additional information on special populations:

Kidney / Liver failure:

• In patients with mild renal insufficiency (creatinine clearance> 50 to <80 mL / min) the recommended initial dose is 3 mg once daily. The dose may be increased to 6 mg per day depending on clinical response and tolerability.

• In patients with moderate to severe renal insufficiency (creatinine clearance> 10 to <50 mL / min) the recommended dose of INVEGA is 3 mg once daily. INVEGA

Since creatinine clearance is not studied in patients below 10 ml / min, use in these patients is not recommended.

• Dose adjustment is not required for patients with mild to moderate hepatic insufficiency. INVEGA has not been studied in patients with severe hepatic insufficiency.

Pediatric population:

INVEGA has not examined the safety and efficacy of patients under the age of 18 years.
Geriatric population:

In elderly patients with normal renal function (> 80 ml / min), the same recommended dose for adults with normal renal function is recommended. However, since renal function may be reduced in elderly patients, dose adjustment may be required depending on renal function status (see Section 4.2 Posology and Application, Kidney / Liver failure).

Other special populations:

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