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SAVELLA (MILNACIPRAN): ADVERSE REACTIONS
Clinical Trial Data Sources
Savella (Milnacipran) was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with this medication and 652 patients treated with placebo) for a treatment period up to 29 weeks.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions Leading to Discontinuation
In placebo-controlled trials in patients with fibromyalgia, 23% of patients treated with Savella 100 mg per day, 26% of patients treated with Savella (Milnacipran HCl) 200 mg per day discontinued prematurely due to adverse reactions, compared to 12% of patients treated with placebo. The adverse reactions that led to withdrawal in >= 1% of patients in the Savella (Milnacipran Hydrochloride) treatment group and with an incidence rate greater than that in the placebo treatment group were nausea (milnacipran 6%, placebo 1%), palpitations (milnacipran 3%, placebo 1%), headache (milnacipran 2%, placebo 0%), constipation (milnacipran 1%, placebo 0%), heart rate increased (milnacipran 1%, placebo 0%), hyperhidrosis (milnacipran 1%, placebo 0%), vomiting (milnacipran 1%, placebo 0%), and dizziness (milnacipran 1% and placebo 0.5%). Discontinuation due to adverse reactions was generally more common among patients treated with Savella 200 mg per day compared to Savella 100 mg per day.
Most Common Adverse Reactions
In the placebo-controlled fibromyalgia patient trials the most frequently occurring adverse reaction in clinical trials was nausea. The most common adverse reactions (incidence >= 5% and twice placebo) in patients treated with Milnacipran (Savella) were hot flush, constipation, hyperhidrosis, palpitations, vomiting, heart rate increased, dry mouth, and hypertension.
In placebo-controlled fibromyalgia clinical trials, patients treated with Milnacipran HCl (Savella) for up to 3 months experienced a mean weight loss of approximately 0.8 kg in both the Savella 100 mg per day and the Savella 200 mg per day treatment groups, compared with a mean weight loss of approximately 0.2 kg in placebo-treated patients.
Genitourinary Adverse Reactions in Males
In the placebo-controlled fibromyalgia studies, the following treatment-emergent adverse reactions related to the genitourinary system were observed in at least 2% of male patients treated with Milnacipran Hydrochloride (Savella), and occurred at a rate greater than in placebo-treated male patients: ejaculation disorder, dysuria, erectile dysfunction, libido decreased, ejaculation failure, prostatitis, testicular pain, scrotal pain, testicular swelling, urinary retention, urinary hesitation, urethral pain, and urine flow decreased.
Other Adverse Reactions Observed During Clinical Trials of Savella in Fibromyalgia
Following is a list of frequent (those occurring on one or more occasions in at least 1/100 patients) treatment-emergent adverse reactions reported from 1824 fibromyalgia patients treated with Savella for periods up to 68 weeks. Those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening.
Adverse reactions are categorized by body system and listed in order of decreasing frequency.
Gastrointestinal Disorders: dyspepsia, diarrhea, gastroesophageal reflux disease, abdominal distension flatulence.
General Disorders: peripheral edema, fatigue, irritability, pyrexia.
Infections: urinary tract infection, cystitis.
Injury, Poisoning, and Procedural Complications: contusion, fall.
Investigations: weight decreased or increased.
Metabolism and Nutrition Disorders: hypercholesterolemia.
Nervous System Disorders: dysgeusia, somnolence.
Psychiatric Disorders: stress, depression.
Skin Disorders: night sweats
Postmarketing Spontaneous Reports
The following additional adverse reactions have been identified from spontaneous reports of Savella (Milnacipran HCl) received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella. However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:
Blood and Lymphatic System Disorders: neutropenia, leukopenia, thrombocytopenia.
Cardiac Disorders: supraventricular tachycardia.
Eye Disorders: accommodation disorder.
Endocrine Disorders: hyperprolactinemia.
Hepatobiliary Disorders: hepatitis.
Metabolism and Nutrition Disorders: hyponatremia, anorexia.
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis.
Nervous System Disorders: loss of consciousness, convulsions (including grand mal).
Parkinsonism Psychiatric Disorders: hallucination, delirium.
Renal and Urinary Disorders: acute renal failure.
Reproductive System and Breast Disorders: galactorrhea.
Skin Disorders: Stevens Johnson syndrome, erythema multiforme.
Vascular Disorders: hypertensive crisis.
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