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Venlafaxine hcl (effexor xr)-0112

Once Daily

. See package insert for full prescribing information.

Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies
in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
Anyone considering the use of EFFEXOR XR or any other antidepressant in a child or adolescent must
balance this risk with the clinical need. Patients who are started on therapy should be observed closely
for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be
advised of the need for close observation and communication with the prescriber. EFFEXOR XR is not
approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use.)
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs
(SSRIs and others) in children and adolescents with Major Depressive Disorder (MDD), obsessive
compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400
patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior
(suicidality) during the first few months of treatment in those receiving antidepressants. The average
risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No
suicides occurred in these trials.
: Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation.
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs).

WARNINGS: Clinical Worsening and Suicide Risk—
Patients with major depressive disorder (MDD), both adult
and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and
behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications,
and this risk may persist until significant remission occurs. There has been a long-standing concern that
antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain
patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in
children and adolescents with MDD and other psychiatric disorders. It is unknown whether the suicidality risk in
pediatric patients extends to longer-term use, i.e., beyond several months. It is also unknown whether the
suicidality risk extends to adults. All pediatric patients being treated with antidepressants for any
indication should be observed closely for clinical worsening, suicidality, and unusual changes in
behavior, especially during the initial few months of a course of drug therapy, or at times of dose
changes, either increases or decreases. Adults with MDD or comorbid depression in the setting of other
psychiatric illness being treated with antidepressants should be observed similarly for clinical
worsening and suicidality, especially during the initial few months of a course of drug therapy, or at
times of dose changes, either increases or decreases.
Anxiety, agitation, panic attacks, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been
reported in adult and pediatric patients being treated with antidepressants for MDD and other indications, both
psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the
worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that
such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is
persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to
worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part
of the patient’s presenting symptoms. If the decision has been made to discontinue treatment, medication
should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated
with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION). Families and caregivers
of pediatric patients being treated with antidepressants for MDD or other indications, both psychiatric
and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of
agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well
as the emergence of suicidality, and to report such symptoms immediately to health care providers.
Such monitoring should include daily observation by families and caregivers.
Prescriptions for Effexor XR
should be written for the smallest quantity of capsules consistent with good patient management, in order to
reduce the risk of overdose. Families and caregivers of adults being treated for depression should be similarly
advised. Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation
of bipolar disorder. It is generally believed that treating such an episode with an antidepressant alone may
increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
Whether any of the symptoms described above represent such a conversion is unknown. Prior to initiating
antidepressant treatment, patients with depressive symptoms should be screened to determine if they are at
risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history
of suicide, bipolar disorder, and depression. Effexor XR is not approved for use in treating bipolar depression.
Potential for Interaction with MAOIs—Adverse reactions, some serious, have been reported in patients
who recently discontinued an MAOI and started on venlafaxine, or who recently discontinued
venlafaxine prior to initiation of an MAOI. These reactions included tremor, myoclonus, diaphoresis,
nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant
syndrome, seizures, and death. Effexor XR should not be used in combination with an MAOI, or within
at least 14 days of discontinuing treatment with an MAOI. At least 7 days should be allowed after
stopping venlafaxine before starting an MAOI. Sustained Hypertension
—Venlafaxine is associated with
sustained increases in blood pressure (BP) in some patients. Postmarketing cases of elevated BP requiring
immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular monitoring
of BP is recommended. For patients experiencing sustained increase in BP, consider either dose reduction or

: GeneralDiscontinuation of Treatment with Effexor XR. Abrupt
discontinuation or dose reduction of venlafaxine at various doses is associated with new symptoms, the
frequency of which increased with increased dose level and longer duration of treatment. Symptoms include
agitation, anorexia, anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth, dysphoric mood,
emotional lability, fasciculation, fatigue, headaches, hypomania, insomnia, irritability, lethargy, nausea,
nervousness, nightmares, seizures, sensory disturbances (e.g., paresthesias such as electric shock
sensations), somnolence, sweating, tinnitus, tremor, vertigo, and vomiting. Monitor patients when
discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended. If
intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, consider
resuming the previously prescribed dose. Subsequently, continue decreasing the dose at a more gradual rate.
Insomnia and Nervousness: Treatment-emergent insomnia and nervousness have been reported. In Phase
3 trials, insomnia led to drug discontinuation in 1% of both depressed patients and Panic Disorder (PD) patients
and in 3% of both Generalized Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD) patients. Nervousness
led to drug discontinuation in 0.9% of depressed patients, in 2% of GAD patients, and in 0% of SAD and PD
patients. Changes in Weight: Adult Patients: In short-term MDD trials, 7% of Effexor XR patients had ≥5%
loss of body weight and 0.1% discontinued for weight loss. In 6-month GAD studies, 3% of Effexor XR patients
had ≥7% loss of body weight, and 0.3% discontinued for weight loss in 8-week studies. In 12-week SAD trials,
3% of Effexor XR patients had ≥7% loss of body weight and no patients discontinued for weight loss. In 12-
week PD trials, 3% of Effexor XR patients had ≥7% loss of body weight, and no patients discontinued for
weight loss. The safety and efficacy of venlafaxine in combination with weight loss agents, including
phentermine, have not been established. Coadministration of Effexor XR and weight loss agents is not
recommended. Effexor XR is not indicated for weight loss alone or in combination with other products.
Pediatric Patients:Weight loss was seen in patients aged 6-17 receiving Effexor XR. More Effexor XR patients
than placebo patients experienced weight loss of at least 3.5% in both MDD and GAD studies (18% vs. 3.6%;
P<0.001). Weight loss was not limited to patients with treatment-emergent anorexia (decreased appetite).
Children and adolescents in a 6-month study had increases in weight less than expected based on data from
age- and sex-matched peers. The difference between observed and expected weight gain was larger for
children <12 years old than for adolescents >12 years old. Changes in Height: Pediatric Patients: In 8-week
GAD studies, Effexor XR patients aged 6-17 grew an average of 0.3 cm (n=122), while placebo patients grew
an average of 1.0 cm (n=132); P=0.041. This difference in height increase was most notable in patients <12.
In 8-week MDD studies, Effexor XR patients grew an average of 0.8 cm (n=146), while placebo patients grew
an average of 0.7 cm (n=147). In a 6-month study, children and adolescents had height increases less than
expected based on data from age- and sex-matched peers. The difference between observed and expected
growth rates was larger for children <12 years old than for adolescents >12 years old. Changes in Appetite:
Adult Patients: Treatment-emergent anorexia was more commonly reported for Effexor XR (8%) than placebo
(4%) patients in MDD studies. The discontinuation rate for anorexia was 1.0% in MDD studies. Treatment
emergent anorexia was more commonly reported for Effexor XR (8%) than placebo (2%) patients in GAD
studies. The discontinuation rate for anorexia was 0.9% for up to 8 weeks in GAD studies. Treatment-emergent
anorexia was more commonly reported for Effexor XR (20%) than placebo (2%) patients in SAD studies. The
discontinuation rate for anorexia was 0.4% for up to 12 weeks in SAD studies. Treatment-emergent anorexia
was more commonly reported for Effexor XR (8%) than placebo (3%) patients in PD studies. The
discontinuation rate for anorexia was 0.4% for Effexor XR patients in 12-week PD studies.
Pediatric Patients: Decreased appetite was seen in pediatric patients receiving Effexor XR. In GAD and MDD
trials, 10% of Effexor XR patients aged 6-17 for up to 8 weeks and 3% of placebo patients had treatment-
emergent anorexia. None of the patients receiving Effexor XR discontinued for anorexia or weight loss.
Activation of Mania/Hypomania: Mania or hypomania has occurred during short-term depression and PD
studies. As with all drugs effective in the treatment of MDD, Effexor XR should be used cautiously in patients with a
history of mania. Hyponatremia: Hyponatremia and/or the syndrome of inappropriate antidiuretic hormone
(SIADH) may occur with venlafaxine. Consider this in patients who are volume-depleted, elderly, or taking
diuretics. Mydriasis: Mydriasis has been reported; monitor patients with raised intraocular pressure or at risk
of acute narrow-angle glaucoma (angle-closure glaucoma). Seizures: In all premarketing depression trials
with Effexor, seizures were reported in 0.3% of venlafaxine patients. Use cautiously in patients with a history
of seizures. Discontinue in any patient who develops seizures. Abnormal Bleeding: Abnormal bleeding (most
commonly ecchymosis) has been reported. Serum Cholesterol Elevation: Clinically relevant increases in
serum cholesterol were seen in 5.3% of venlafaxine patients and 0.0% of placebo patients treated for at least
3 months in trials. Consider measurement of serum cholesterol levels during long-term treatment. Use in
Patients With Concomitant Illness
: Use Effexor XR cautiously in patients with diseases or conditions that
could affect hemodynamic responses or metabolism. Venlafaxine has not been evaluated in patients with
recent history of MI or unstable heart disease. Increases in QT interval (QTc) have been reported in clinical
studies. Exercise caution in patients whose underlying medical conditions might be compromised by increases
in heart rate. In patients with renal impairment or cirrhosis of the liver, the clearances of venlafaxine and its
active metabolites were decreased, prolonging the elimination half-lives. A lower dose may be necessary; use
with caution in such patients.
Information for Patients—Prescribers or other health professionals should inform patients, their families, and
their caregivers about the benefits and risks associated with treatment with Effexor XR and should counsel them in
its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available
for Effexor XR. The prescriber or health professional should instruct patients, their families, and their caregivers to
read the Medication Guide and should assist them in understanding its contents. Patients should be given the
opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
The complete text of the Medication Guide is available at or in the approved prescribing
information. Patients should be advised of the following issues and asked to alert their prescriber if these occur
while taking Effexor XR. Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers
should be encouraged to be alert to the emergence of symptoms listed in WARNINGS: Clinical Worsening and
Suicide Risk
, especially those seen early during antidepressant treatment and when the dose is adjusted up or
down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a
day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or
health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting
symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior
and indicate a need for very close monitoring and possibly changes in the medication. Caution patients about
operating hazardous machinery, including automobiles, until they are reasonably sure that venlafaxine does not
adversely affect their abilities. Tell patients to avoid alcohol while taking Effexor XR and to notify their physician 1)
if they become pregnant or intend to become pregnant during therapy, or if they are nursing; 2) about other
prescription or over-the-counter drugs, including herbal preparations, they are taking or plan to take; 3) if they
develop a rash, hives, or related allergic phenomena. Laboratory Tests—No specific laboratory tests are
recommended. Drug InteractionsAlcohol: A single dose of ethanol had no effect on the pharmacokinetics
(PK) of venlafaxine or O-desmethylvenlafaxine (ODV), and venlafaxine did not exaggerate the psychomotor and
psychometric effects induced by ethanol. Cimetidine: Use caution when administering venlafaxine with
cimetidine to patients with pre-existing hypertension or hepatic dysfunction, and the elderly. Diazepam: A
single dose of diazepam did not appear to affect the PK of either venlafaxine or ODV. Venlafaxine did not have
any effect on the PK of diazepam or its active metabolite, desmethyldiazepam, or affect the psychomotor and
psychometric effects induced by diazepam. Haloperidol: Venlafaxine decreased total oral-dose clearance of
haloperidol, resulting in a 70% increase in haloperidol AUC. The haloperidol Cmax increased 88%, but the
haloperidol elimination half-life was unchanged. Lithium: A single dose of lithium did not appear to affect the
PK of either venlafaxine or ODV. Venlafaxine had no effect on the PK of lithium. Drugs Highly Bound to Plasma
: Venlafaxine is not highly bound to plasma proteins; coadministration of Effexor XR with a highly
protein-bound drug should not cause increased free concentrations of the other drug. Drugs That Inhibit
Cytochrome P450 Isoenzymes
: CYP2D6 Inhibitors: Venlafaxine is metabolized to its active metabolite, ODV,
by CYP2D6. Drugs inhibiting this isoenzyme have the potential to increase plasma concentrations of
venlafaxine and decrease concentrations of ODV. No dosage adjustment is required when venlafaxine is
coadministered with a CYP2D6 inhibitor. Concomitant use of venlafaxine with drug treatment(s) that potentially
inhibits both CYP2D6 and CYP3A4, the primary metabolizing enzymes for venlafaxine, has not been studied.
Use caution if therapy includes venlafaxine and any agent(s) that produces simultaneous inhibition of these
two enzyme systems. Drugs Metabolized by Cytochrome P450 Isoenzymes: Venlafaxine is a relatively weak
inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2 and CYP3A4, CYP2C9 (in vitro), or CYP2C19.
Imipramine: Venlafaxine did not affect the PK of imipramine and 2-OH-imipramine. However, desipramine
AUC, Cmax and Cmin increased by ~35% in the presence of venlafaxine. The 2-OH-desipramine AUCs increased
by 2.5-4.5 fold. Imipramine did not affect the PK of venlafaxine and ODV. Risperidone: Venlafaxine slightly
inhibited the CYP2D6-mediated metabolism of risperidone to its active metabolite, 9-hydroxyrisperidone,
resulting in a ~32% increase in risperidone AUC. Venlafaxine coadministration did not significantly alter the PK
profile of the total active moiety (risperidone plus 9-hydroxyrisperidone). CYP3A4: Venlafaxine did not inhibit
CYP3A4 in vitro and in vivo. Indinavir: In a study of 9 healthy volunteers, venlafaxine administration resulted
in a 28% decrease in the AUC of a single dose of indinavir and a 36% decrease in indinavir Cmax. Indinavir did
not affect the PK of venlafaxine and ODV. CYP1A2: Venlafaxine did not inhibit CYP1A2 in vitro and in vivo.
CYP2C9: Venlafaxine did not inhibit CYP2C9 in vitro. In vivo, venlafaxine 75 mg by mouth every 12 hours did
not alter the PK of a single 550-mg dose of tolbutamide or the CYP2C9-mediated formation of 4-
CYP2C19: Venlafaxine did not inhibit the metabolism of diazepam, which is partially metabolized
by CYP2C19 (see Diazepam above). MAOIs: See CONTRAINDICATIONS and WARNINGS. CNS-Active Drugs:
Use caution with concomitant use of venlafaxine and other CNS-active drugs. Based on its mechanism of
action and the potential for serotonin syndrome, use caution when coadministering venlafaxine with other
drugs affecting the serotonergic neurotransmitter systems, such as triptans, serotonin reuptake inhibitors, or
lithium. Electroconvulsive Therapy (ECT): There are no clinical data establishing the benefit of ECT combined
with Effexor XR treatment.
Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesis: There was no increase in tumors in
mice and rats given up to 1.7 times the maximum recommended human dose (MRHD) on a mg/m2 basis.
Mutagenesis: Venlafaxine and ODV were not mutagenic in the Ames reverse mutation assay in Salmonella
bacteria or the CHO/HGPRT mammalian cell forward gene mutation assay. Venlafaxine was not clastogenic in
several assays. ODV elicited a clastogenic response in the in vivo chromosomal aberration assay in rat bone
marrow. Impairment of Fertility: No effects on reproduction or fertility in rats were noted at oral doses of up to
2 times the MRHD on a mg/m2 basis.
PregnancyTeratogenic EffectsPregnancy Category C. Reproduction studies in rats given 2.5 times, and
rabbits given 4 times the MRHD (mg/m2 basis) revealed no malformations in offspring. However, in rats given 2.5
times the MRHD, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths
during the first 5 days of lactation when dosing began during pregnancy and continued until weaning. There are no
adequate and well-controlled studies in pregnant women; use Effexor XR during pregnancy only if clearly
needed. Nonteratogenic Effects. Neonates exposed to Effexor XR late in the third trimester have developed
complications requiring prolonged hospitalization, respiratory support, and tube feeding. Complications can
arise immediately upon delivery. Reports include respiratory distress, cyanosis, apnea, seizures, temperature
instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness,
irritability, and constant crying. This is consistent with a direct toxic effect of SNRIs or a drug discontinuation
syndrome. In some cases, it is consistent with serotonin syndrome. When treating a pregnant woman with
Effexor XR during the third trimester, carefully consider the potential risks and benefits of treatment and
consider tapering Effexor XR in the third trimester.
Labor, Delivery, Nursing—The effect on labor and delivery in humans is unknown. Venlafaxine and ODV have
been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing
infants from Effexor XR, a decision should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
Pediatric Use—Safety and effectiveness in the pediatric population have not been established (see BOX
and WARNINGS: Clinical Worsening and Suicide Risk). No studies have adequately assessed the
impact of Effexor XR on growth, development, and maturation of children and adolescents. Studies suggest
Effexor XR may adversely affect weight and height (see PRECAUTIONS-General, Changes in Height and
Changes in Weight ). Should the decision be made to treat a pediatric patient with Effexor XR, regular monitoring
of weight and height is recommended during treatment, particularly if long term. The safety of Effexor XR for
pediatric patients has not been assessed for chronic treatment >6 months. In studies in patients aged 6-17, blood
pressure and cholesterol increases considered to be clinically relevant were similar to that observed in adult
patients. The precautions for adults apply to pediatric patients. Geriatric Use—No overall differences in
effectiveness or safety were observed between geriatric and younger patients. Greater sensitivity of some older
individuals cannot be ruled out. Hyponatremia and SIADH have been reported, usually in the elderly.

: Associated with Discontinuation of Treatment —The most common events leading to
discontinuation in MDD, GAD, SAD, and PD trials included nausea, anorexia, anxiety, impotence, dry mouth,
dizziness, insomnia, somnolence, hypertension, diarrhea, paresthesia, tremor, abnormal (mostly blurred) vision,
abnormal (mostly delayed) ejaculation, asthenia, vomiting, nervousness, headache, vasodilatation, thinking
abnormal, decreased libido, and sweating. Commonly Observed Adverse Events in Controlled Clinical Trials
for MDD, GAD, SAD, and PD
—Body as a Whole: asthenia, headache, flu syndrome, accidental injury, abdominal
pain. Cardiovascular: vasodilatation, hypertension, palpitation. Digestive: nausea, constipation, anorexia, vomiting,
flatulence, diarrhea, eructation. Metabolic/Nutritional: weight loss. Nervous System: dizziness, somnolence,
insomnia, dry mouth, nervousness, abnormal dreams, tremor, depression, hypertonia, paresthesia, libido
decreased, agitation, anxiety, twitching. Respiratory System: pharyngitis, yawn, sinusitis. Skin: sweating. Special
Senses: abnormal vision. Urogenital System: abnormal ejaculation, impotence, orgasmic dysfunction (including
anorgasmia) in females. Vital Sign Changes: Effexor XR was associated with a mean increase in pulse rate of
about 2 beats/min in depression and GAD trials and a mean increase in pulse rate of 4 beats/min in SAD trials.
(See WARNINGS-Sustained Hypertension). Laboratory Changes: Clinically relevant increases in serum
cholesterol were noted in Effexor XR clinical trials. Increases were duration dependent over the study period and
tended to be greater with higher doses. Other Events Observed During the Premarketing Evaluation of
Effexor and Effexor XR
—N=6,670. “Frequent”=events occurring in at least 1/100 patients; “infrequent”=1/100
to 1/1000 patients; “rare”=fewer than 1/1000 patients. Body as a whole - Frequent: chest pain substernal, chills,
fever, neck pain; Infrequent: face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain,
photosensitivity reaction, suicide attempt, withdrawal syndrome; Rare: appendicitis, bacteremia, carcinoma,
cellulitis. Cardiovascular system - Frequent: migraine, postural hypotension, tachycardia; Infrequent: angina
pectoris, arrhythmia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands),
syncope, thrombophlebitis; Rare: aortic aneurysm, arteritis, first-degree atrioventricular block, bigeminy, bundle
branch block, capillary fragility, cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest,
hematoma, cardiovascular disorder (mitral valve and circulatory disturbance), mucocutaneous hemorrhage,
myocardial infarct, pallor, sinus arrhythmia. Digestive system - Frequent: increased appetite; Infrequent:
bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis,
glossitis, rectal hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration; Rare: abdominal
distension, biliary pain, cheilitis, cholecystitis, cholelithiasis, esophageal spasms, duodenitis, hematemesis,
gastroesophageal reflux disease, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice,
intestinal obstruction, liver tenderness, parotitis, periodontitis, proctitis, rectal disorder, salivary gland
enlargement, increased salivation, soft stools, tongue discoloration. Endocrine system - Rare: galactorrhoea,
goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis. Hemic and lymphatic system - Frequent:
ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia; Rare:
basophilia, bleeding time increased, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura,
thrombocytopenia. Metabolic and nutritional - Frequent: edema, weight gain; Infrequent: alkaline
phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypoglycemia,
hypokalemia, SGOT increased, SGPT increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased,
creatinine increased, diabetes mellitus, glycosuria, gout, healing abnormal, hemochromatosis, hypercalcinuria,
hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hyponatremia, hypophosphatemia,
hypoproteinemia, uremia. Musculoskeletal system - Frequent: arthralgia; Infrequent: arthritis, arthrosis, bone
spurs, bursitis, leg cramps, myasthenia, tenosynovitis; Rare: bone pain, pathological fracture, muscle cramp,
muscle spasms, musculoskeletal stiffness, myopathy, osteoporosis, osteosclerosis, plantar fasciitis,
rheumatoid arthritis, tendon rupture. Nervous system - Frequent: amnesia, confusion, depersonalization,
hypesthesia, thinking abnormal, trismus, vertigo; Infrequent: akathisia, apathy, ataxia, circumoral paresthesia,
CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia,
incoordination, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech,
stupor, suicidal ideation; Rare: abnormal/changed behavior, adjustment disorder, akinesia, alcohol abuse,
aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of
consciousness, delusions, dementia, dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barré
syndrome, homicidal ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, libido
increased, motion sickness, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes
decreased, reflexes increased, torticollis. Respiratory system - Frequent: cough increased, dyspnea;
Infrequent: asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice
alteration; Rare: atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus,
sleep apnea. Skin and appendages - Frequent: pruritus; Infrequent: acne, alopecia, contact dermatitis, dry
skin, eczema, maculopapular rash, psoriasis, urticaria; Rare: brittle nails, erythema nodosum, exfoliative
dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma,
miliaria, petechial rash, pruritic rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin
hypertrophy, skin striae, sweating decreased. Special senses - Frequent: abnormality of accommodation,
mydriasis, taste perversion; Infrequent: conjunctivitis, diplopia, dry eyes, eye pain, hyperacusis, otitis media,
parosmia, photophobia, taste loss, visual field defect; Rare: blepharitis, cataract, chromatopsia, conjunctival
edema, corneal lesion, deafness, exophthalmos, eye hemorrhage, glaucoma, retinal hemorrhage,
subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis
externa, scleritis, uveitis. Urogenital system - Frequent: prostatic disorder (prostatitis, enlarged prostate, and
prostate irritability), urination impaired; Infrequent: albuminuria, amenorrhea, breast pain, cystitis, dysuria,
hematuria, kidney calculus, kidney pain, leukorrhea, menorrhagia, metrorrhagia, nocturia, polyuria, pyuria,
urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage, vaginitis; Rare: abortion, anuria,
balanitis, bladder pain, breast discharge, breast engorgement, breast enlargement, endometriosis, female
lactation, fibrocystic breast, calcium crystalluria, cervicitis, orchitis, ovarian cyst, prolonged erection,
gynecomastia (male), hypomenorrhea, kidney function abnormal, mastitis, menopause, pyelonephritis, oliguria,
salpingitis, urolithiasis, uterine hemorrhage, uterine spasm, vaginal dryness.

Postmarketing Reports
agranulocytosis, anaphylaxis, aplastic anemia, catatonia, congenital anomalies, CPK increased, deep vein
thrombophlebitis, delirium, EKG abnormalities such as QT prolongation; cardiac arrhythmias including atrial
fibrillation, supraventricular tachycardia, ventricular extrasystoles, and rare reports of ventricular fibrillation
and ventricular tachycardia, including torsades de pointes; epidermal necrosis/Stevens-Johnson syndrome,
erythema multiforme, extrapyramidal symptoms (including dyskinesia and tardive dyskinesia), angle-closure
glaucoma, hemorrhage (including eye and gastrointestinal bleeding), hepatic events (including GGT elevation;
abnormalities of unspecified liver function tests; liver damage, necrosis, or failure; and fatty liver), involuntary
movements, LDH increased, neuroleptic malignant syndrome-like events (including a case of a 10-year-old
who may have been taking methylphenidate, was treated and recovered), neutropenia, night sweats, pancreatitis,
pancytopenia, panic, prolactin increased, pulmonary eosinophilia, renal failure, rhabdomyolysis, serotonin
syndrome, shock-like electrical sensations or tinnitus (in some cases, subsequent to the discontinuation of
venlafaxine or tapering of dose), and SIADH (usually in the elderly). Elevated clozapine levels that were temporally
associated with adverse events, including seizures, have been reported following the addition of venlafaxine.
Increases in prothrombin time, partial thromboplastin time, or INR have been reported when venlafaxine was given
to patients on warfarin therapy.

: Effexor XR is not a controlled substance. Evaluate patients carefully for history
of drug abuse and observe such patients closely for signs of misuse or abuse.

: Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS
prolongation), sinus and ventricular tachycardia, bradycardia, hypotension, altered level of consciousness (ranging
from somnolence to coma), rhabdomyolysis, seizures, vertigo, liver necrosis, and death have been reported.
Treatment should consist of those general measures employed in the management of overdosage with any
antidepressant. Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs.
General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.
Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if
performed soon after ingestion or in symptomatic patients. Activated charcoal should be administered. Due to the
large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are
unlikely to be of benefit. No specific antidotes for venlafaxine are known. In managing overdosage, consider the
possibility of multiple drug involvement. Consider contacting a poison control center for additional information on
the treatment of overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk
Reference® (PDR).

: Consult full prescribing information for dosing instructions.

Switching Patients to or From an MAOI
—At least 14 days should elapse between discontinuation of an MAOI
and initiation of therapy with Effexor XR. At least 7 days should be allowed after stopping Effexor XR before
starting an MAOI.

This brief summary is based on Effexor XR Prescribing Information
W10404C019, revised November 2005.
2005, Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101 116601-01


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