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LOXITANE: PRESCRIBING INFORMATION
Loxitane (Loxapine Succinate), a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines.
Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt.
Each capsule for oral administration, contains loxapine succinate 6.8, 13.6, 34.0 or 68.1 mg equivalent to 5, 10, 25 or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: gelatin, silicon dioxide, NF, sodium lauryl sulfate, NF, anhydrous lactose, D & C Yellow 10, FD&C Blue 1, polacrilin potassium, magnesium stearate, talc, and titanium dioxide. Additionally, the 5 mg capsule contains D & C Red 33, the 10 mg capsule contains D & C Red 28 and D & C Red 33, and the 25 mg capsule contains FD & C Yellow 6.
Pharmacologically, Loxitane (Loxapine) is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such manifestations of tranquilization as calming effects and suppression of aggressive behavior.
In normal human volunteers, signs of sedation were seen within 20 to 30 minutes after administration, were most pronounced within one and one-half to three hours, and lasted through 12 hours. Similar timing of primary pharmacologic effects was seen in animals.
Absorption, Distribution, Metabolism, and Excretion
Absorption of loxapine following oral or parenteral administration is virtually complete. The drug is removed rapidly from the plasma and distributed in tissues. Animal studies suggest an initial preferential distribution in lungs, brain, spleen, heart, and kidney. Loxapine is metabolized extensively and is excreted mainly in the first 24 hours. Metabolites are excreted in the urine in the form of conjugates and in the feces unconjugated.
INDICATIONS AND USAGE
Loxapine Succinate (Loxitane) is indicated for the treatment of schizophrenia. The efficacy of this medication in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Loxapine (Loxitane) is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.).
This drug is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.
Loxitane adverse reactions
DOSAGE AND ADMINISTRATION
Loxitane (Loxapine Succinate) is administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient's needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs.
Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizoprenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizoprenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.
For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 to 60 mg daily.
Loxitane, Loxapine Succinate capsules, are available in the following strengths:
Loxapine Succinate 6.8 mg equivalent to 5 mg loxapine, hard shell, opaque, dark green capsules printed with "WATSON" on one half and "LOXITANE" over "5 mg" on the other, are supplied as follows: Bottle of 100s and 1000s
Loxapine Succinate 13.6 mg equivalent to 10 mg loxapine, hard shell, opaque, with yellow body and a dark green cap, printed with "WATSON" on one half and "LOXITANE" over "10 mg" on the other, are supplied as follows: Bottle of 100s and 1000s
Loxapine Succinate 34.0 mg equivalent to 25 mg loxapine, hard shell, opaque, with a light-green body and a dark green cap, printed with "WATSON" on one half and "LOXITANE" over "25 mg" on the other, are supplied as follows: Bottle of 100s and 1000s
Loxapine Succinate 68.1 mg equivalent to 50 mg loxapine, hard shell, opaque, with a blue body and a dark green cap, printed with "WATSON" on one half and "LOXITANE" over "50 mg" on the other, are supplied as follows: Bottle of 100s and 1000s
Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Dispense in a tight, childresistant container.
Manufactured and distributed by Watson Pharmaceuticals, Watson Laboratories, and its divisions.
Loxitane (Loxapine) related pharmaceutical drugs and medications
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