Cipran ER Capsule

Cipran ER Capsule is used for: Major Depressive Disorders

Oral 20 mg PO once daily for 2 days initially; THEN Increase to 40 mg PO once daily Based on efficacy and tolerability, increase dose in increments of 40 mg/day at intervals of 2 or more days; not to exceed 120 mg/day Dosage range: 40-120 mg/day Hepatic impairment: Hepatic elimination is low, no dosage adjustment required with mild, moderate, or severe hepatic impairment

Renal impairment Mild (CrCl 60-89 mL/min): No dosage adjustment required Moderate (CrCl 30-59 mL/min): Not to exceed 80 mg/day maintenance dose Severe (CrCl 15-29 mL/min): Not to exceed 40 mg/day maintenance dose End-stage renal disease: Not recommended

May take with or without food Take at approximately the same time each day

Hypersensitivity

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years In children and young adults, risks must be weighed against the benefits of taking antidepressants Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments 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 other drugs that inhibit platelets or anticoagulants may increase this risk; inform patients about risk of bleeding associated with concomitant use of drug and NSAIDs, aspirin, or other drugs that affect coagulation Risk of mydriasis; may trigger angle closure attack in patients with angle-closure glaucoma with anatomically narrow angles without a patent iridectomy; pre- existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy; open-angle glaucoma is not a risk factor for angle-closure glaucoma Can affect urinary hesitation or retention; caution with obstructive urinary disorders and discontinue is symptoms present; the noradrenergic effect of the drug, can affect urethral resistance; if symptoms of urinary hesitation, urinary retention, or dysuria develop during treatment, consideration should be given to possibility that they might be drug-related, and discontinuation or other appropriate medical intervention should be considered May activate mania/hypomania in patients with bipolar disorder; screen patients for bipolar disorder prior to initiating; use cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania Caution with seizure disorders; not systematically evaluated in patients with seizure disorder

Pregnancy Available data on pregnant women are insufficient to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks associated with untreated depression in pregnancy and with exposure to SNRIs and SSRIs during pregnancy Clinical considerations Women who discontinued antidepressants during pregnancy were more likely to experience relapse of major depression than women who continued antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum Use of SNRIs in late pregnancy may be associated with an increased risk of postpartum hemorrhage Fetal/neonatal effects Neonates exposed to SNRIs or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications 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 Animal data In animal reproduction studies, drug was not associated with malformations in rats or rabbits when given during the period of organogenesis at doses up to 8 or 16 times maximum recommended human dose (MRHD) of 120 mg on a mg/m2 basis, respectively However, an increase in early post-natal rat pup mortality was seen at a dose equivalent to 5 times the MRHD given during pregnancy and lactation Lactation There are no available data on presence of drug in human milk; however, racemic milnacipran is present in human milk; there are no reports on effects of drug or milnacipran on breastfed infant or effects on milk production; however, there are reports of agitation, irritability, poor feeding and poor weight gain in infants exposed to SSRIs or SNRIs through breast milk The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal conditions Clinical considerations Infants exposed to drug should be monitored for agitation, irritability, poor feeding and poor weight gain

Contraindicated with an MAOI (or within 14 days of stopping an MAOI) intended to treat psychiatric disorders or within 7 days of stopping treatment with levomilnacipran; it is also contraindicated in patients treated with linezolid or IV methylene blue. Coadministration with strong CYP3A4 inhibitors may increase levomilnacipran levels; see Dosage Modifications. Avoid alcohol with levomilnacipran; concomitant use may result in accelerated release of levomilnacipran from the extended-release capsules. SSRIs and SNRIs may impair platelet aggregation and increase the risk of bleeding events; coadministration with other antiplatelet drug or anticoagulants may cause additive risk Coadministration with other serotonergic drugs may increase risk of serotonin syndrome.

Side effects of Levomilnacipran : >10% Nausea (17%) 1-10% Erectile dysfunction, dose-related (6-10%) Constipation (9%) Tachycardia (6%) Urinary hesitation, dose-related (4-6%) Palpitations (5%) Vomiting (5%) Hyperhidrosis (2%) Increased heart rate (1%) Increased blood pressure (1%) Hot flush (1%) Hypotension (1%) Decreased appetite (1%) <1% Testicular pain Ejaculation disorder

Active enantiomer milnacipran; potent inhibitor of neuronal serotonin and norepinephrine reuptake (SNRI); inhibits norepinephrine uptake with ~3-fold higher potency in vitro than serotonin without directly affecting the uptake of dopamine or other neurotransmitters

Cipran 80mg ER Capsule generic name is Levomilnacipran. Cipran 80mg ER Capsule is manufactured by Renata LimitedCipran is availble in all over Bangladesh. Mes BD drug index information on Cipran ER Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.