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MELLARIL (THIORIDAZINE HCL): PRESCRIBING INFORMATION

DESCRIPTION

Mellaril description


CLINICAL PHARMACOLOGY

The basic pharmacological activity of Mellaril (Thioridazine HCl) is similar to that of other phenothiazines, but is associated with minimal extrapyramidal stimulation.

However, thioridazine has been shown to prolong the QTc interval in a dose-dependent fashion. This effect may increase the risk of serious, potentially fatal, ventricular arrhythmias, such as torsade de pointes-type arrhythmias. Due to this risk, Mellaril is indicated only for schizophrenic patients who have not been responsive to or cannot tolerate other antipsychotic agents. However, the prescriber should be aware that Mellaril has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.


INDICATIONS AND USAGE

Mellaril (Thioridazine Hydrochloride) is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life-threatening, proarrhythmic effects with Mellaril treatment, this medication should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs.

Consequently, before initiating treatment with Mellaril, it is strongly recommended that a patient be given at least 2 trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration.

However, the prescriber should be aware that Mellaril (Thioridazine) has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.


CONTRAINDICATIONS

Mellaril (Thioridazine Hydrochloride) use should be avoided in combination with other drugs that are known to prolong the QTc interval and in patients with congenital long QT syndrome or a history of cardiac arrhythmias.

Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., paroxetine and fluoxetine) and certain other drugs (e.g., propranolol, fluvoxamine, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. The resulting elevated levels of thioridazine would be expected to augment the prolongation of the QTc interval associated with Thioridazine HCl (Mellaril) and may increase the risk of serious, potentially fatal, cardiac arrhythmias, such as torsade de pointes-type arrhythmias. Such an increased risk may result also from the additive effect of co-administering Thioridazine (Mellaril) with other agents that prolong the QTc interval. Therefore, this drug is contraindicated with these drugs as well as in patients, comprising about 7% of the normal population, who are known to have a genetic defect leading to reduced levels of activity of P450 2D6.

In common with other phenothiazines, Mellaril (Thioridazine) is contraindicated in severe central nervous system depression or comatose states from any cause including drug induced central nervous system depression. It should also be noted that hypertensive or hypotensive heart disease of extreme degree is a contraindication of phenothiazine administration.


WARNINGS

Mellaril warnings


PRECAUTIONS

Mellaril precautions


DRUG INTERACTIONS

Mellaril drug interactions


ADVERSE REACTIONS

Mellaril adverse reactions


OVERDOSAGE

Mellaril overdosage


DOSAGE AND ADMINISTRATION

Since Thioridazine (Mellaril) is associated with a dose-related prolongation of the QTc interval, which is a potentially life-threatening event, its use should be reserved for schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Dosage must be individualized and the smallest effective dosage should be determined for each patient.

Adults

The usual starting dose for adult schizophrenic patients is 50-100 mg three times a day, with a gradual increment to a maximum of 800 mg daily if necessary. Once effective control of symptoms has been achieved, the dosage may be reduced gradually to determine the minimum maintenance dose. The total daily dosage ranges from 200-800 mg, divided into two to four doses.

Pediatric Patients

For pediatric patients with schizophrenia who are unresponsive to other agents, the recommended initial dose is 0.5 mg/kg/day given in divided doses. Dosage may be increased gradually until optimum therapeutic effect is obtained or the maximum dose of 3 mg/kg/day has been reached.


STORAGE / HOW SUPPLIED

Mellaril storage / how supplied

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