effexor increasing dose
The rule for including events was to enumerate those that occurred at an incidence of 5% or more for at least one of the venlafaxine groups and for which the incidence was at least twice the placebo incidence for at least one Effexor group. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. Following discontinuation effexor increasing dose venlafaxine, symptoms resolved within approximately 72 hours. It is important to emphasize that, although the events reported occurred during treatment with venlafaxine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body as a whole—Frequent: accidental injury, chest pain substernal, neck pain; Infrequent: face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, withdrawal syndrome; Rare: appendicitis, effexor increasing dose carcinoma, cellulitis.
Cardiovascular system—Frequent: migraine; Infrequent: angina pectoris, arrhythmia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope, thrombophlebitis; Rare: aortic aneurysm, arteritis, first-degree effexor increasing dose block, bigeminy, bradycardia, bundle branch block, capillary fragility, cardiovascular disorder (mitral valve and circulatory disturbance), cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, mucocutaneous hemorrhage, myocardial infarct, pallor.
Digestive system—Frequent: eructation; Infrequent: bruxism, colitis, dysphagia, tongue edema, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration; Rare: cheilitis, cholecystitis, cholelithiasis, duodenitis, esophageal spasm, hematemesis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, parotitis, periodontitis, proctitis, increased salivation, soft stools, tongue effexor increasing dose system—Rare: goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis.
Hemic and lymphatic system—Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, thrombocytopenia; Rare: basophilia, bleeding time increased, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura.
Metabolic and nutritional—Frequent: edema, weight gain; Infrequent: alkaline phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypokalemia, SGOT (AST) increased, SGPT (ALT) increased, thirst; Rare: alcohol effexor increasing dose bilirubinemia, BUN increased, creatinine increased, diabetes effexor increasing dose glycosuria, gout, healing abnormal, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, uremia.
Musculoskeletal system—Infrequent: arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis; Rare: pathological fracture, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, tendon rupture.
Nervous system—Frequent: trismus, vertigo; Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor; Rare: akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, feeling drunk, abnormal gait, Guillain-Barre Syndrome, hyperchlorhydria, hypokinesia, impulse control difficulties, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes effexor increasing dose suicidal ideation, torticollis.
Respiratory system—Frequent: bronchitis, 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—Infrequent: acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin hypertrophy, maculopapular rash, psoriasis, urticaria; Rare: erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, petechial rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin striae.
Special senses—Frequent: abnormality of accommodation, effexor increasing dose vision; Infrequent: cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, eye pain, hyperacusis, otitis media, parosmia, photophobia, taste loss, visual field defect; Rare: blepharitis, chromatopsia, conjunctival edema, deafness, exophthalmos, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis externa, scleritis, uveitis.
Urogenital system—Frequent: metrorrhagia*, prostatic disorder (prostatitis and enlarged prostate)*, vaginitis*; Infrequent: albuminuria, amenorrhea*, cystitis, dysuria, hematuria, leukorrhea*, menorrhagia*, nocturia, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary urgency, vaginal hemorrhage*; Rare: abortion*, anuria, balanitis*, breast discharge, breast engorgement, breast enlargement, endometriosis*, fibrocystic breast, calcium crystalluria, cervicitis*, ovarian cyst*, prolonged erection*, gynecomastia (male)*, hypomenorrhea*, kidney calculus, kidney pain, kidney function abnormal, female lactation*, mastitis, menopause*, oliguria, orchitis*, pyelonephritis, salpingitis*, urolithiasis, uterine hemorrhage*, uterine spasm*, vaginal dryness*.
* Based on the number of men and women as appropriate.
Postmarketing Reports
Voluntary reports of other adverse events temporally associated with the use of venlafaxine that have been received since market introduction and that may have no causal relationship with the use of venlafaxine include the following: agranulocytosis, anaphylaxis, angioedema, aplastic anemia, catatonia, congenital anomalies, impaired coordination and balance, CPK increased, deep vein thrombophlebitis, delirium, EKG abnormalities such as QT prolongation; cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia, ventricular extrasystole, and rare reports of ventricular fibrillation and ventricular tachycardia, including torsade de pointes; toxic epidermal necrolysis/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), interstitial lung disease, involuntary movements, LDH increased, neutropenia, night sweats, pancreatitis, effexor increasing dose panic, prolactin increased, renal failure, rhabdomyolysis, shock-like electrical sensations or tinnitus (in some cases, subsequent to the discontinuation of venlafaxine or tapering of dose), and syndrome of inappropriate antidiuretic hormone secretion (usually in the elderly).
There have been reports of elevated clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. In premarketing trials, treatment with Effexor tablets was associated with a mean final on-therapy increase in total cholesterol of 3 mg/dL.
Patients treated with Effexor tablets for at least 3 months in placebo-controlled 12-month extension trials had a mean final effexor increasing dose increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. The frequencies presented, therefore, represent the proportion of the 5356 patients exposed to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while effexor increasing dose venlafaxine. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a effexor increasing dose ≥261 mg/dL effexor increasing dose 2) an average on‑therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients.
ECG Changes
In an analysis of ECGs obtained in 769 patients treated with Effexor and 450 patients treated with placebo in controlled clinical trials, the only statistically significant difference observed was for heart rate, ie, a mean increase from baseline of 4 beats per minute for Effexor. Although these events occurred during treatment with venlafaxine, causality has not been determined.
A case of effexor increasing dose increase of intraocular pressure caused by venlafaxine use has been reported.
Metabolic
Metabolic side effects have included weight loss (3%).
Metabolic side effects reported in premarketing Phase 3 trials have included weight gain, increased alkaline phosphatase, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia, increased SGOT (AST), increased SGPT (ALT), thirst, bilirubinemia, increased BUN, increased creatinine, diabetes mellitus, glycosuria, gout, abnormal healing, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hyponatremia, hypophosphatemia, hypoproteinemia, and uremia. In addition, at least one case of photo-induced telangiectasia has been associated with venlafaxine use.
Other
Other side effects have frequently included asthenia (up to 21%), headache (up to 34%), flu syndrome (6%), and accidental injury (5%).
Other side effects reported in premarketing Phase 3 trials have included edema, hyperacusis, otitis media, parosmia, loss of taste, deafness, labyrinthitis, otitis externa, substernal chest pain, chills, fever, neck pain, face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, appendicitis, bacteremia, carcinoma, and cellulitis. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Impaired coordination and balance have been reported in postmarketing studies.
Seizures have been reported in 0.26% of treated patients during premarketing testing. Angle-closure glaucoma has been reported rarely.
Ocular side effects reported in premarketing Phase 3 effexor increasing dose have included abnormality of accommodation, mydriasis, conjunctivitis, diplopia, dry eyes, eye pain, photophobia, visual field defect, blepharitis, cataract, chromatopsia, conjunctival edema, corneal effexor increasing dose exophthalmos, eye hemorrhage, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, miosis, papilledema, decreased pupillary reflex, scleritis, and uveitis. Dermatologic side effects reported in premarketing Phase 3 trials have included pruritus, acne, alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, psoriasis, urticaria, 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, and decreased sweating. This increase was duration dependent over the study period and tended to be greater with higher doses. Symptoms resolved following discontinuation of therapy.
Genitourinary side effects have frequently included male and female sexual dysfunction such as abnormal ejaculation in up to 16% of male patients, decreased libido (13%), impotence (13%), and organic dysfunction (anorgasmia or abnormal orgasm) in up to 8% of female patients.
Genitourinary side effects reported in premarketing Phase 3 trials have included prostatic disorder (prostatitis, enlarged prostate, and prostate irritability), impaired urination, albuminuria, amenorrhea, cystitis, dysuria, hematuria, leukorrhea, menorrhagia, metrorrhagia, nocturia, breast pain, polyuria, urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage, vaginitis, abortion, anuria, breast discharge, breast engorgement, balanitis, breast enlargement, endometriosis, female lactation, fibrocystic breast, calcium crystalluria, cervicitis, orchitis, ovarian cyst, bladder pain, prolonged erection, gynecomastia (male), hypomenorrhea, mastitis, menopause, oliguria, salpingitis, urolithiasis, uterine hemorrhage, uterine spasm, and vaginal dryness. The same study reported an increase in the average pulse rate of 1.1 to 4.5 beats per minute.
Another study (n=7) suggests that venlafaxine may promote adverse cardiovascular and cerebrovascular events by increasing platelet activity in susceptible patients.
An increase in heart rate of 4 beats per minute has been reported.
According to a retrospective review, in the overdose setting (up to 3 g of venlafaxine), tachycardia, hypertension, mydriasis, QTc prolongation, and transient arrhythmia can be expected. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Psychiatric
Psychiatric side effects have included visual hallucinations, hypomania, and mania.
Psychiatric side effects reported in premarketing Phase 3 trials have included emotional lability, delusions, euphoria, hallucinations, manic reaction, psychosis, suicidal ideation, abnormal/changed behavior, homicidal ideation, paranoid reaction, and psychotic depression. The rule for including events was to enumerate those that occurred effexor increasing dose an incidence of 5% or more for at least one of the venlafaxine groups and for which the incidence was at least twice the placebo incidence for at least one Effexor group. Although these effexor increasing dose occurred during treatment with venlafaxine, causality has not been determined.
Although rare, interstitial pneumonitis secondary to venlafaxine therapy has been reported. There are not sufficient data with the use of venlafaxine extended-release at doses above 300 mg/day to determine the incidence of sustained effexor increasing dose in blood pressure at these high doses.
One study has reported average systolic blood pressure increases of 1.7 to 3.4 mm Hg and average diastolic pressure increases of 0.4 to 2.6 mm Hg. Symptoms resolved following treatment with IV steroids and antidepressant therapy was safely switched to paroxetine. In premarketing trials, treatment with Effexor tablets was associated with a mean final on-therapy increase in total cholesterol of 3 mg/dL.
Patients treated with Effexor tablets effexor increasing dose at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment.
Online pharmacy Tags
170 171 172 173 174 175 176 177 178
.