Zytax Capsules / Delayed Release
Duloxetine
30mg
Abbott Laboratories S.A
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 85.00 AED |
Available as:
Indications
Zytax Capsules / Delayed Release is used for:
Major Depressive Disorder (MDD), Fibromyalgia, Diabetic neuropathy, Stress urinary incontinence, Generalized anxiety disorder, Interstitial cystitis, Musculoskeletal pain
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
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
Renal Dose
Renal Impairment
Avoid use in patients with severe renal impairment (GFR <30 mL/min)
Administration
May be taken with or without food. Swallow whole, do not chew/crush.
Contra Indications
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.
Precautions
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
Pregnancy-Lactation
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
Interactions
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).
Adverse Effects
Side effects of Duloxetine :
>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%)
Mechanism 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.
Note
Zytax 30mg Capsules / Delayed Release manufactured by Abbott Laboratories S.A. Its generic name is Duloxetine. Zytax is availble in United Arab Emirates.
Farmaco UAE drug index information on Zytax Capsules / Delayed Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.