Hapytab ER ER Tablet
Desvenlafaxine
50mg
Eskayef Pharmaceuticals Ltd.
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| Retail Price | 10.00 AED |
Indications
Hapytab ER ER Tablet is used for:
Depression
Adult Dose
Oral
Major Depressive Disorder
Adult: 50 mg once daily.
Doses up to 400 mg once daily have been studied and shown to be effective, but no additional benefit was observed with doses >50 mg once daily.
Child Dose
Renal Dose
Renal impairment:
CrCl (ml/min)
30-50 mL/min 50 mg once daily.
<30 mL/min or ESRD 50 mg every other day. Additional doses should not be given after dialysis.
Administration
Take whole with fluid; do not divide, crush, chew, or dissolve
Take at approximately the same time every day
Contra Indications
Hypersensitivity to Desvenlafaxine, venlafaxine or any component of the formulation.
Concomitant/recent (within preceeding 14 days) use of MAOI.
Do not initiate MAOI at least 7 days after discontinuing Desvenlafaxine.
Precautions
Suicidal thoughts and behaviors
Antidepressants increase risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years) in short-term studies
Increased risk not observed in patients >24 years; slight decrease observed in patients >65 years
In children and young adults, initiate only if benefits greatly outweigh risks
Patient’s family should communicate any abrupt behavioral changes to healthcare provider
Worsening behavior and suicidal tendencies that are not part of presenting symptoms may necessitate discontinuance of therapy
Not approved for use in pediatric patients
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Desvenlafaxine and initiate supportive treatment.
Elevated Blood Pressure: Control hypertension before initiating treatment.
Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk.
Angle Closure Glaucoma: Avoid use of antidepressants, including Desvenlafaxine, in patients with untreated anatomically narrow angles treated.
Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania.
Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms.
Seizure: Can occur. Use cautiously in patients with seizure disorder.
Hyponatremia: Can occur in association with SIADH.
Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur.
Monitoring Parameter
Monitor closely for changes in behavior, clinical worsening, and suicidal tendencies during initial 1-2 months of therapy and dosage adjustments.
Monitor blood pressure regularly during treatment.
Monitor for the emergence of serotonin syndrome.
Pregnancy-Lactation
Pregnancy
No published studies on desvenlafaxine in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes
Exposure to SNRIs in mid to late pregnancy may increase the risk for preeclampsia, and exposure to SNRIs near delivery may increase the risk for postpartum hemorrhage
Exposure to SNRIs or SSRIs in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding; monitor neonates who were exposed to desvenlafaxine in the third trimester of pregnancy for drug discontinuation syndrome
Lactation
Available limited data from published literature show low levels of desvenlafaxine in human milk, and have not shown adverse reactions in breastfed infants
There are no data on the effects of desvenlafaxine on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for desvenlafaxine and any potential adverse effects on the breastfed child from desvenlafaxine or from the underlying maternal condition
Interactions
Desvenlafaxine may diminish the therapeutic effect of Iobenguane I-123.
May enhance adverse effects of other CNS depressants.
Sibutramine and MAOI may enhance the serotonergic effect of Desvenlafaxine; increase risk of development of serotonin syndrome.
Concomitant use with alpha-/beta-agonists may enhance tachycardic and vasopressor effect.
Desvenlafaxine may increase concentration of CYP2D6 substrates (e.g. desipramine); decrease exposure of CYP3A4 substrates (e.g. midazolam).
CYP3A4 inhibitors (e.g. ketoconazole) may increase concentration of desvenlafaxine.
May enhance the antiplatelet effect of nonselective NSAIDs, aspirin; and anticoagulant effect of warfarin.
Potentially Fatal: Concurrent use with MAOIs may lead to fatal serotonin syndrome or NMS-like reactions. Do not use within at least 14 days of discontinuing MAOI treatment and start MAOI at least 7 days after stopping desvenlafaxine. Increased risk of serotonin syndrome with sibutramine.
Contraindicated (11)
iobenguane I 123
isocarboxazid
linezolid
methylene blue
phenelzine
procarbazine
rasagiline
safinamide
selegiline
selegiline transdermal
tranylcypromine
Adverse Effects
Side effects of Desvenlafaxine :
>10%
Nausea (22-41%),Headache (20-29%),Dry mouth (11-25%),Hyperhidrosis (10-21%),Dizziness (13-16%),Insomnia (9-15%),Constipation (9-14%),Fatigue (7-11%),Diarrhea (5-11%)
1-10%
Decreased appetite (5-10%),Anxiety (0-10%),Elevated cholesterol and triglycerides (0-10%),Insomnia (0-10%),Tremor (2-9%),Proteinuria (5-8%),Mydriasis (2-6%),Male sexual dysfunction (0-6%),Anxiety (3-5%),Vertigo (1-5%),Blurred vision (3-4%),Abnormal dreams (2-4%),Urinary hesitation (2-4%),Yawning (1-4%),Feeling jittery (1-3%),Female sexual dysfunction (0-3%),Irritability (2%)
Other (eg, abnormal liver function tests, increased blood prolactin, convulsion, syncope, extrapyramidal disorders, musculoskeletal stiffness, depersonalization, hypomania, bruxism, epistaxis, orthostatic hypotension) (<2%)
Asthenia (1-2%),Nervousness (1-2%),Hot flush (1-2%),Rash (1-2%)
Frequency Not Defined
Ischemic cardiac events in patients with multiple underlying cardiac risk factors
Gastrointestinal (GI) bleeding, hallucinations, photosensitivity reactions and severe cutaneous reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have occurred with other serotonin-norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs)
Suicidal thoughts and behaviors in adolescents and young adults
Hyponatremia,Interstitial lung disease and eosinophilic pneumonia,Serotonin syndrome,Elevated blood pressure,Abnormal bleeding,Narrow-angle glaucoma,Activation of mania or hypomania,Discontinuance syndrome,Seizure
Potentially Fatal: Serotonin syndrome or neuroleptic malignant syndrome-like reactions.
Mechanism of Action
Desvenlafaxine, the major active metabolite of venlafaxine, is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). Clinical efficacy of desvenlafaxine is thought to be related with the drug's potentiation of serotonergic and noradrenergic activity in the CNS. It does not have monoamine oxidase (MAO) inhibitory activity; and has not shown significant affinity for muscarinic cholinergic, H1-histaminergic, alpha-adrenergic, dopaminergic, gama-aminobutyric acid (GABA), glutamate, and opiate receptors in vitro. At concentrations that inhibit serotonin and norephinephrine reuptake, inhibition of dopamine reuptake appears to be unlikely.
Note
Hapytab ER 50mg ER Tablet manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Desvenlafaxine. Hapytab ER is availble in Bangladesh.
Farmaco BD drug index information on Hapytab ER ER Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.