Duloxetine generic availability

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    Duloxetine generic availability


    Click on this link to read the French version BOUCHERVILLE, QC, May 17, 2016 (GLOBE NEWSWIRE) -- Sandoz Canada announced today that it has launched on the Canadian market Pr Sandoz® Duloxetine, a generic equivalent to Cymbalta*, a prescription medication used for the treatment of major depressive and general anxiety disorders. Pr Sandoz® Duloxetine is now available on the Canadian market in two strengths, 30 mg or 60 mg. "We are very pleased to provide a generic version of Cymbalta* for the Canadian market as part of our ongoing efforts to help people access high-quality medicine," said Michel Robidoux, President and General Manager of Sandoz Canada. "We also view our growing generics portfolio as an important contributor to improving our society's ability to support growing healthcare needs." In addition to depression, duloxetine can be used to treat anxiety that lasts for at least six months, pain from diabetic nerve damage, fibromyalgia, and long-term muscle or bone pain. Duloxetine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). * Cymbalta is a registered trademark of Eli Lilly & Company. ®: Registered trademark owned or used under license by Sandoz Canada. Before a company’s patent on a drug expires, generics manu­facturers often race to file lawsuits to challenge the patent. The company that wins gets a six-month exclusive to sell the drug, so prices don’t drop until there’s more competition. And, in some cases, the maker of the brand-name drug un­dercuts competitors by jumping into the generic market early. “They can come out with their own version—an ‘authorized generic’—just before the patent expires to keep prices higher,” Schondelmeyer said. Whoever is first wins big, he notes: Drugstores are likely to stick with one manufacturer for at least six months. Over the next year or so, a slew of big-name drugs will become available as generics (see chart below). Makers of brand-name drugs try to keep customers with special deals, but it still makes sense to go generic. Drugmakers sometimes discourage the use of generics by making subtle changes to the branded drug—switching from a tablet to a capsule, for example, or offering a higher or lower dose. If you take one and don’t see a notable price drop after six months of switching, ask your pharmacist about getting a cheaper version from another supplier. Even if a coupon cuts your price at the counter, your employer and insurance company still foot the bill for the full price, and that can cost you in higher premiums later on. By law, pharmacists cannot substitute a generic version if the drug is in a different dosage form or strength. Doctors might write prescriptions for drugs even after they are available over-the-counter.

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    Cymbalta and Celebrex are among the blockbuster drugs going generic. Over the next year or so, a slew of big-name drugs will become available as generics. A generic version of Cymbalta has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available. Dr. Reddy's generic version of Cymbalta will be the only one on the market for the first 180 days. After that, the other drug makers can release their versions.

    Cymbalta is an antidepressant that is primarily used to treat depression, but is also prescribed for other conditions. Food and Drug Administration (FDA) earlier today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules). Cymbalta has been one of the most commonly prescribed antidepressants in the past five years. Generic versions of the drug will be available for much lower cost than the name-brand version. Duloxetine will be available from multiple companies who have been licensed to provide the generic version of the drug. Generic versions of approved medications have the same active ingredients and must meet other stringent FDA guidelines before being approved. Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating and dizziness. 40-60 mg/day PO initially (in single daily dose or divided q12hr for 1 week if patient needs to adjust to therapy) Titrate dose in increments of 30 mg/day over 1 week as tolerated Target dosage: 60 mg/day PO (in single daily dose or divided q12hr); not to exceed 120 mg/day (safety of dosages Treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain 30 mg/day PO initially for 1 week to allow for therapy adjustment Target dosage: 60 mg/day PO; not to exceed 60 mg/day Dosages ≥60 mg/day have not been shown to offer additional benefits Major depressive disorder and generalized anxiety disorder: Acute episodes often necessitate several months of sustained therapy Diabetic peripheral neuropathic pain: Efficacy for 12 weeks has not been studied; if diabetes is complicated by renal disease, consider lower starting dosage with gradual increase to effective dosage Fibromyalgia: Efficacy for ≥12 weeks has not been studied; continue treatment on basis of individual patient response Chronic musculoskeletal pain: Efficacy for ≥13 weeks has not been studied Uncontrolled narrow-angle glaucoma: Use not recommended due to increased risk of mydriasis Constipation (10%) Dizziness (10%) Insomnia (10%) Diarrhea (9-10%) Anorexia (8%) Decreased appetite (7-8%) Abdominal pain (6%) Hyperhidrosis (6%) Increased sweating (6%) Agitation (5%) Nasopharyngitis (5%) Vomiting (3-5%) Male sexual dysfunction (2-5%) Abdominal pain (4%) Decreased libido (4%) Musculoskeletal pain (4%) Upper respiratory tract infection (URTI) (4%) Abnormal orgasm (3%) Agitation (3%) Anxiety (3%) Blurred vision (3%) Cough (3%) Influenza (3%) Muscle spasms (3%) Tremor (3%) Abnormal dreams (2%) Dyspepsia (2%) Hot flushes (2%) Nausea (2%) Oropharyngeal pain (2%) Palpitations (2%) Paresthesia (2%) Weight loss (2%) Yawning (2%) Dysuria ( General: Anaphylactic reaction, angioneurotic edema, hypersensitivity Cardiovascular: Hypertensive crisis, supraventricular arrhythmia, myocardial infarction, tachycardia, Takotsubo cardiomyopathy Endocrine: Galactorrhea, gynecologic bleeding, hyperglycemia, hyperprolactinemia Neurologic: Restless legs syndrome, seizures upon treatment discontinuance, extrapyramidal disorders Ophthalmic: Glaucoma Otic: Tinnitus (upon treatment discontinuance) Psychiatric: Aggression and anger (particularly early in treatment or after treatment discontinuance), hallucinations Musculoskeletal: Trismus, muscle spasm Skin: Serious skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome) necessitating drug discontinuance or hospitalization, urticaria, rash Gastrointestinal: Colitis (microscopic or unspecified),cutaneous vasculitis (sometimes associated with systemic involvement), acute pancreatitis Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients 24 yr There was a reduction in risk with antidepressant use in patients ≥65 yr In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors Advise families and caregivers of the need for close observation and communication with the prescriber CYP1A2 inhibitors or thioridazine should not be coadministered Use caution in severe renal impairment, ESRD Heavy alcohol use Suicidality; monitor for clinical worsening and suicide risk, especially in children, adolescents and young adults (18-24 years) during early phases of treatment and alterations in dosage Serotonin syndrome or neuroleptic malignant syndrome-like reactions may occur; discontinue and initiate supportive therapy; closely monitor patients concomitantly receiving triptans, antipsychotics and serotonin precursors Neonates exposed to serotonin-noreponephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) late in 3rd trimester of pregnancy have developed complications necessitating prolonged hospitalization, respiratory support, and tube feeding Screen patients for bipolar disorder; risk of mixed/manic episodes is increased in patients treated with antidepressants May cause activation of mania or hypomania Increased risk of hepatotoxicity, sometimes fatal; monitor for abdominal pain, hepatomegaly, elevations in hepatic transaminases exceeding 20 times upper limit of normal; jaundice; cholestatic jaundice with minimal elevations of hepatic transaminases have also been reported; use not recommended in patients with substantial alcohol use or chronic liver disease SSRIs and SNRIs may impair platelet aggregation and increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and GI hemorrhage to life-threatening hemorrhage; concomitant use of aspirin, NSAIDs, warfarin, other anticoagulants, or other drugs known to affect platelet function may add to this risk Severe skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome); discontinue at first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified Orthostatic hypotension and syncope, especially during week 1 of therapy; monitor patients taking drugs that increase risk of orthostatic hypotension; consider dose reduction or discontinue therapy in patients who experience symptomatic orthostatic hypotension, falls and/or syncope Hyponatremia due to syndrome of inappropriate antidiuretic hormone (SIADH); cases of serum sodium Exact mechanism of action unknown; inhibits reuptake of serotonin and norepinephrine; weakly inhibits reuptake of dopamine; has no MAOI activity; has no significant activity for histaminergic H1 receptor or alpha2-adrenergic receptor The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

    Duloxetine generic availability

    Duloxetine Oral Route Description and Brand Names - Mayo Clinic, Generic Cymbalta Availability -

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  3. May 17, 2016. PrSandoz® Duloxetine is now available on the Canadian market in two strengths, 30 mg or 60 mg. "We are very pleased to provide a generic.

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    • DULOXETINE - ORAL Cymbalta side effects, medical uses, and..

    The Food and Drug Administration FDA has approved the first generic versions of Cymbalta, duloxetine delayed-release capsules. Several. Dosage Forms & Strengths. capsule, delayed-release. 20mg Cymbalta, Irenka, generic; 30mg Cymbalta, Irenka, generic; 40mg Irenka; 60mg Cymbalta. Drug Information on Cymbalta, Irenka duloxetine includes drug pictures, side effects, drug interactions, directions for use, symptoms of. Generic Name duloxetine. What is. Do not crush, chew, break, or open an extended-release capsule.

     
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