Xinolax DR 60

Introduction
Xinolax DR 60 is a prescription medicine used in the treatment of depression, anxiety disorder, diabetic nerve pain, fibromyalgia (a condition in which there are generalized pain and tenderness in the body), neuropathic pain and stress urinary incontinence. Xinolax DR 60 works by increasing the level of chemical messengers (serotonin and noradrenaline) in the brain that have a calming effect on the brain and relax the nerves, thus treating your illness. It may be taken with or without food. It is advised to take this medicine at a fixed time each day to maintain a consistent level in the blood. If you miss any doses, take it as soon as you remember. Do not skip any doses and finish the full course of treatment even if you feel better. It is important that this medication is not stopped suddenly as it may worsen your symptoms. Some common side effects of this medicine include nausea, headache, and dry mouth. It even causes dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you. However, these side effects are temporary and usually resolve on their own in some time. Please consult your doctor if these do not subside or bother you. Before taking Xinolax DR 60, inform your doctor if you have any problems with your kidneys, heart, liver, or have a history of seizures (epilepsy or fits). Inform your doctor if you develop any unusual changes in mood or behavior, new or worsening depression, or if you have any suicidal thoughts.

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Uses of Xinolax DR 60
Depression
Anxiety disorder
Diabetic nerve pain
Fibromyalgia
Neuropathic pain
Stress urinary incontinence
Side effects of Xinolax DR 60
Common
Nausea
Headache
Dryness in mouth
Sleepiness
Dizziness
How to use Xinolax DR 60
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Xinolax DR 60 may be taken with or without food, but it is better to take it at a fixed time.
How Xinolax DR 60 works
Xinolax DR 60 works by increasing the levels of chemical messengers (serotonin and noradrenaline), natural substances in the brain that help maintain mental balance and stop the movement of pain signals in the brain.
What if you forget to take Xinolax DR 60?
If you miss a dose of Xinolax DR 60, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
Duzela 20 Capsule DR helps in treating depression and anxiety.
It may also be used to treat nerve pain from diabetes and some other forms of chronic pain.
It may take 2 to 4 weeks for Duzela 20 Capsule DR to start working. Keep taking it as prescribed.
It may cause dizziness and sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
Avoid consuming alcohol when taking Duzela 20 Capsule DR as it may cause excessive drowsiness and increase the risk of liver damage.
It may cause an increase in blood pressure, especially during the first month of treatment. Monitor your blood pressure regularly.
It may cause a sensation of restlessness, especially when you first start taking it. Inform your doctor if this happens to you.
Talk to your doctor if you notice sudden mood changes or develop suicidal thoughts.
Do not stop taking the medication suddenly without talking to your doctor.
Brief Description
Indication
Major Depressive Disorder (MDD), Fibromyalgia, Diabetic neuropathy, Stress urinary incontinence, Generalized anxiety disorder, Interstitial cystitis, Musculoskeletal pain
Administration
May be taken with or without food. Swallow whole, do not chew/crush.
Adult Dose
Oral Major Depressive Disorder Adult: Initially, 20-30 mg bid or 60 mg once daily, then increase dose in increments of 30 mg/day over 1 wk as tolerated. Max: 120 mg/day. Diabetic Peripheral Neuropathic Pain Adult: 60 mg once daily. Max: 120 mg/day in divided doses. Generalized Anxiety Disorder Adult: 30 or 60 mg once daily. Max: 120 mg/day. Fibromyalgia Adult: Initially, 30 mg once daily for 1 wk, then increase to 60 mg once daily. Elderly Major Depressive Disorder May initiate at 20 mg PO qDay or divided BID; increase to 40-60 mg qDay or divided doses; alternatively, initiate at 30 mg/day for 1 week, then increase to 60 mg/day as tolerated Generalized Anxiety Disorder 30 mg/day PO qDay initially; after 2 weeks, consider increasing to target dose of 60 mg/day Some patients may benefit from doses >60 mg/day; if increased beyond 60 mg/day, use increments of 30 mg/day Maximum dose studied was 120 mg/day; safety of doses >120 mg/day has not been evaluated Hepatic Impairment Avoid use in patients with chronic liver disease or cirrhosis

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Child Dose
Generalized Anxiety Disorder <7 years: Safety and efficacy not established 7-17 years: 30 mg PO qDay initially; after 2 weeks, may consider increasing dose to 60 mg/day Recommended dosage range: 30-60 mg/day Some patients may benefit from doses >60 mg/day; if increased beyond 60 mg/day, use increments of 30 mg/day Maximum dose studied was 120 mg/day; safety of doses >120 mg/day has not been evaluated

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Renal Dose
Renal Impairment Avoid use in patients with severe renal impairment (GFR <30 mL/min) _ Contraindication Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients.. Uncontrolled narrow-angle glaucoma. Concomitant use or within 2 wk of MAOIs. Renal and hepatic impairment. Mode of Action Duloxetine is a potent inhibitor of neuronal reuptake of serotonin, norepinephrine and to a lesser extent dopamine. It has no significant affinity for adrenergic, muscarinic, cholinergic, histaminergic, opioid, glutamate and GABA receptors. It also does not inhibit monoamine oxidase. _ Precaution Avoid alcohol and abrupt cessation. May impair ability to drive or engage in task requiring alertness. Increased risk of suicidal thinking and behaviour when used in children and adolescents. Pregnancy, lactation. Lactation: Drug enters breast milk; use not recommended unless benefits greatly outweigh risks _ Side Effect >10% Nausea (23-25%),Dry mouth (13-15%),Headache (13-14%),Somnolence (10-12%),Fatigue (10-11%) 1-10% 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 (>1%),Gastritis (>1%),Rash (>1%)

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Pregnancy Category Note
Pregnancy There are no adequate and well-controlled studies administration in pregnant women Use in pregnancy only if the potential benefit justifies the potential risk to the fetus Clinical considerations Neonates exposed during pregnancy to serotonin – norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which can arise immediately upon delivery Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying These features are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome In some cases, the clinical picture is consistent with serotonin syndrome Data from the published literature report the presence of duloxetine in human milk There are no data on the effect of duloxetine on the breastfed infant or on milk production Women given 40 mg of duloxetine PO BID for 3.5 days; peak concentration measured in breast milk occurred at a median of 3 hrs post-dose Amount of duloxetine in breast milk was ~7 mcg/day while on that dose; estimated daily infant dose was ~2 mcg/kg/day, which is <1% of the maternal dose _ Interaction Increased risk of serotonin syndrome w/ TCA, SSRI, SNRI, lithium. May increase bleeding risk w/ aspirin, NSAIDs, warfarin and other anticoagulants. Potentially Fatal: Increased risk of serotonin syndrome w/ MAOIs, linezolid and methylene blue. Increased serum levels and risk of toxicity w/ potent CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin). _