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INVEGA: PRESCRIBING INFORMATION
Paliperidone, the active ingredient in Invega extended-release tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Invega contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (+-)-3-[2-[4-(6-fluoro-1,2benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4Hpyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49.
Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide.
Invega (Paliperidone) extended-release tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Invega utilizes OROSR osmotic drug-release technology.
Inactive ingredients are cellulose acetate, carnauba wax, hydroxyethyl cellulose, propylene glycol, polyethylene oxides, polyethylene glycol, povidone, stearic acid, sodium chloride, butylated hydroxytoluene, titanium dioxide, hypromellose, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.
Delivery System Components and Performance
Invega (Paliperidone) uses osmotic pressure to deliver paliperidone at a controlled rate. The delivery system, which resembles a capsule-shaped tablet in appearance, consists of an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each tablet strength has a different colored water-dispersible overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water then enters the tablet through the semipermeable membrane that controls the rate at which water enters the tablet core, which, in turn, determines the rate of drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.
INDICATIONS AND USAGE
Invega (Paliperidone) extended-release tablets are indicated for the treatment of schizophrenia.
The efficacy of Invega in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
Paliperidone (Invega) ER tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy. The efficacy of Invega in schizoaffective disorder was established in two 6-week trials in adults.
DOSAGE AND ADMINISTRATION
Invega dosage and administration
DOSAGE FORMS AND STRENGTHS
Invega extended-release tablets are available in the following strengths and colors: 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink). All tablets are capsule shaped and are imprinted with either "PAL 1.5", "PAL 3", "PAL 6", or "PAL 9".
Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone. Invega (Paliperidone) is a metabolite of risperidone and is therefore contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in Invega.
WARNINGS AND PRECAUTIONS
Invega warnings and precautions
Invega adverse reactions
Invega drug interactions
USE IN SPECIFIC POPULATIONS
Invega use in specific populations
DRUG ABUSE AND DEPENDENCE
Invega (Paliperidone) is not a controlled substance.
Paliperidone (Invega) has not been systematically studied in animals or humans for its potential for abuse. It is not possible to predict the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of Invega misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior).
Invega (Paliperidone) has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.
Invega clinical pharmacology
Invega nonclinical toxicology
Invega clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Invega (Paliperidone) extended-release tablets are available in the following strengths and packages. All tablets are capsule-shaped.
1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30.
3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 and hospital unit dose packs of 100.
6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 and hospital unit dose packs of 100.
9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 and hospital unit dose packs of 100.
Storage and Handling
Store up to 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). Protect from moisture. Keep out of reach of children.
Manufactured and distributed by Janssen, Ortho-McNeil Pharmaceutical, ALZA Corporation companies and its divisions.
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