Buy Desvenlafaxine (Pristiq) online

Buy Pristiq (Desvenlafaxine) antidepressant medication online
Cheap qualitative Desvenlafaxine Succinate 50 mg, 100 mg tablets



HOW AND WHERE TO BUY DESVENLAFAXINE (PRISTIQ) 50 MG, 100 MG TABLETS OR CAPSULES ONLINE:

PRISTIQ: FULL PRESCRIBING INFORMATION

DESCRIPTION

Pristiq is an extended-release tablet for oral administration that contains Desvenlafaxine Succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-Desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat generalized anxiety, major depressive, social anxiety and panic disorders.

Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2xC4H6O4xH2O (Succinate Monohydrate). Desvenlafaxine Succinate Monohydrate has a molecular weight of 399.48.

Desvenlafaxine Succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21.

Pristiq is formulated as an extended-release tablet for once-a-day oral administration.

Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively.

Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, and iron oxides.

Inactive ingredients for the 100 mg tablet consist of hypromellose, talc, microcrystalline cellulose, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, iron oxide and FD & C yellow #6.


INDICATIONS AND USAGE

Pristiq (Desvenlafaxine Succinate), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD). The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.


DOSAGE AND ADMINISTRATION

  • Pristiq dosage and administration


    DOSAGE FORMS AND STRENGTHS

    Pristiq (Desvenlafaxine Succinate) extended-release tablets are available as 50 and 100 mg tablets.
    50 mg, light pink, square pyramid tablet debossed with "W" over "50" on the flat side.
    100 mg, reddish-orange, square pyramid tablet debossed with "W" over "100" on the flat side.


    CONTRAINDICATIONS

    Hypersensitivity

    Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the Pristiq formulation.

    Monoamine Oxidase Inhibitors

    Pristiq (Desvenlafaxine) must not be used concomitantly in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions with SNRI or SSRI treatment or with other serotonergic drugs. These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Based on the half-life of desvenlafaxine, at least 7 days should be allowed after stopping desvenlafaxine before starting an MAOI.


    WARNINGS AND PRECAUTIONS

  • Pristiq warnings and precautions


    ADVERSE REACTIONS

  • Pristiq adverse reactions


    DRUG INTERACTIONS

  • Pristiq drug interactions


    USE IN SPECIFIC POPULATIONS

  • Pristiq use in specific populations


    DRUG ABUSE AND DEPENDENCE

    Controlled Substance

    Desvenlafaxine (Pristiq) is not a controlled substance.

    Abuse and Dependence

    Although Pristiq has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies. However, it is not possible to predict on the basis of pre-marketing experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of this drug.


    OVERDOSAGE

  • Pristiq overdosage


    CLINICAL PHARMACOLOGY

  • Pristiq clinical pharmacology


    NONCLINICAL TOXICOLOGY

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis

    Pristiq (Desvenlafaxine Succinate) administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study.

    Mice received desvenlafaxine succinate at dosages up to 500 / 300 mg / kg per day (dosage lowered after 45 weeks of dosing). The 300 mg / kg day day dose is 15 times a human dose of 100 mg day day on a mg / m2 basis.

    Rats received desvenlafaxine succinate at dosages up to 300 mg / kg day day (males) or 500 mg / kg day day (females). The highest dose is 29 (males) or 48 (females) times a human dose of 100 mg day day on a mg / m2 basis.

    Mutagenesis

    Desvenlafaxine (Pristiq) was not mutagenic in the in vitro bacterial mutation assay (Ames test) and was not clastogenic in an in vitro chromosome aberration assay in cultured CHO cells, an in vivo mouse micronucleus assay, or an in vivo chromosome aberration assay in rats. Additionally, desvenlafaxine was not genotoxic in the in vitro CHO mammalian cell forward mutation assay and was negative in the in vitro BALB/c-3T3 mouse embryo cell transformation assay.

    Impairment of fertility

    Reduced fertility was observed in a study in which both male and female rats received desvenlafaxine succinate. This effect was noted at oral doses approximately 10 times a human dose of 100 mg per day on a mg / m2 basis. There was no effect on fertility at oral doses approximately 3 times a human dose of 100 mg per day on a mg / m2 basis.


    CLINICAL STUDIES

    The efficacy of Pristiq (Desvenlafaxine) as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day to 400 mg per day) in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. In the first study, patients received 100 mg (n = 114), 200 mg (n = 116), or 400 mg (n = 113) of this drug once daily, or placebo (n = 118). In a second study, patients received either 200 mg (n = 121) or 400 mg (n = 124) of Pristiq once daily, or placebo (n = 124). In two additional studies, patients received 50 mg (n = 150 and n = 164) or 100 mg (n = 147 and n = 158) of this medication once daily, or placebo (n = 150 and n = 161).

    Pristiq (Desvenlafaxine Succinate) showed superiority over placebo as measured by improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score in four studies and overall improvement, as measured by the Clinical Global Impressions Scale - Improvement (CGI-I), in three of the four studies. In studies directly comparing 50 mg per day and 100 mg per day there was no suggestion of a greater effect with the higher dose and adverse events and discontinuations were more frequent at higher doses.

    Analyses of the relationships between treatment outcome and age and treatment outcome and gender did not suggest any differential responsiveness on the basis of these patient characteristics. There was insufficient information to determine the effect of race on outcome in these studies.


    HOW SUPPLIED / STORAGE AND HANDLING

    Pristiq (Desvenlafaxine) extended-release tablets are available as follows:
    50 mg, light pink, square pyramid tablet debossed with "W" (over) "50" on the flat side
    100 mg, reddish-orange, square pyramid tablet debossed with "W" (over) "100" on the flat side

    Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F).

    Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively.

    The unit-of-use package is intended to be dispensed as a unit.

    The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.

    Manufactured and Distributed by:

    Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

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