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Rx80 mg • Capsule (Extended Release)
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Other strengths and forms by Renata PLC
Indications & Uses
Cipran is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is used to treat Major Depressive Disorder (MDD) in adults. Limitation of Use: Cipran is not approved for the management of fibromyalgia. The efficacy and safety of Cipran for fibromyalgia have not been established.
Pharmacology
Nobody knows exactly how levomilnacipran works as an antidepressant. It is thought to act by increasing the effect of serotonin and norepinephrine in the central nervous system, because it blocks their reuptake at the serotonin and norepinephrine transporters. Non-clinical studies have shown that levomilnacipran is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).
Levomilnacipran binds with high affinity to the human serotonin (5-HT) and norepinephrine (NE) transporters (Ki = 11 and 91 nM, respectively), and it strongly inhibits the reuptake of 5-HT and NE (IC50 = 16 to 19 and 11 nM, respectively). In the in vitro tests, it showed no significant affinity for any other receptors, ion channels or transporters. This included serotonergic (5HT1-7), α- and β-adrenergic, muscarinic and histaminergic receptors, and Ca2+, Na+, K+ or Cl- channels. Levomilnacipran also did not inhibit monoamine oxidase (MAO).
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Levomilnacipran is 40 mg to 120 mg once daily, with or without food. Start at 20 mg once daily for 2 days, then raise it to 40 mg once daily. After that, the dose can be increased in steps of 40 mg at intervals of 2 or more days, depending on how well it works and how well the patient tolerates it. The maximum recommended dose is 120 mg once daily. Swallow the capsules whole. Don't open, chew or crush them.
Renal Impairment
In moderate renal impairment, don't go above 80 mg once daily. In severe renal impairment, don't go above 40 mg once daily.
Discontinuation
When stopping the medicine, reduce the dose gradually whenever possible.
Side Effects
Levomilnacipran Hydrochloride can cause hypersensitivity. It is also linked with suicidal thoughts and behaviors in adolescents and young adults, serotonin syndrome, elevated blood pressure and elevated heart rate. Other effects include an increased risk of bleeding, angle closure glaucoma, and urinary hesitation or retention. The medicine can also bring on activation of mania/hypomania, seizure, discontinuation syndrome and hyponatremia.
Cautions & Contraindications
Contraindications
Don't give Levomilnacipran to anyone who is hypersensitive to levomilnacipran, to milnacipran HCl, or to any excipient in the formulation. It must not be used together with MAOIs that are meant to treat psychiatric disorders, or within 7 days of stopping Levomilnacipran treatment, because the risk of serotonin syndrome goes up. The reverse also applies. Levomilnacipran is contraindicated within 14 days of stopping an MAOI intended to treat psychiatric disorders. Starting Levomilnacipran in a patient who is already being treated with MAOIs such as linezolid or intravenous methylene blue is contraindicated too, again because of the increased risk of serotonin syndrome.
Pregnancy & Breastfeeding
Pregnancy: If levomilnacipran is used in the third trimester, the newborn may be at higher risk of poor adaptation symptoms. These include respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor and irritability.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use
Clinical studies of Cipran have not been done in children, so its safety and effectiveness in the pediatric population haven't been established. Cipran is not approved for use in pediatric patients.
Geriatric Use
No dose adjustment is recommended on the basis of age. In a multiple-dose clinical pharmacokinetic study, elderly subjects (> 65 years) had slightly higher exposure to levomilnacipran than younger subjects (18 to 45 years), with C max higher by 24% and AUC higher by 26%. Of all the subjects in the 8-week clinical studies of Cipran, 2.8% were age 65 or older. Levomilnacipran is mainly excreted by the kidney, so renal clearance should be considered when deciding the dose. SSRIs and SNRIs, Cipran included, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk of this adverse event.
Hepatic Impairment
The liver clears very little levomilnacipran. Dose adjustment is not recommended in subjects with mild (Child-Pugh score of 1 to 6), moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 13) hepatic impairment.
Renal Impairment
The kidney plays the main role in removing levomilnacipran from the body. For patients with mild renal impairment (creatinine clearance of 60 to 89 ml/min), no dose adjustment is recommended. For moderate impairment (creatinine clearance of 30 to 59 ml/min) or severe impairment (creatinine clearance of 15 to 29 ml/min), a dose adjustment is recommended. Cipran is not recommended for patients with end stage renal disease.
Storage
Store Levomilnacipran Hydrochloride below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Cipran 80 mg
What is Cipran 80 mg Capsule (Extended Release)?
Cipran 80 mg Capsule (Extended Release) is a medicine that contains Levomilnacipran Hydrochloride. It is made by Renata PLC. It belongs to the Serotonin-norepinephrine reuptake inhibitor (SNRI) group of medicines.
What is Cipran used for?
Cipran is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is used to treat Major Depressive Disorder (MDD) in adults.
What are the side effects of Cipran?
Levomilnacipran Hydrochloride can cause hypersensitivity. It is also linked with suicidal thoughts and behaviors in adolescents and young adults, serotonin syndrome, elevated blood pressure and elevated heart rate.
Can I take Cipran during pregnancy or while breastfeeding?
Pregnancy: If levomilnacipran is used in the third trimester, the newborn may be at higher risk of poor adaptation symptoms. These include respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor and irritability. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Cipran?
Store Levomilnacipran Hydrochloride below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Cipran?
Some medicines can interact with Levomilnacipran Hydrochloride, for example: Ketoconazole. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Cipran is already among the lowest-priced brands of Levomilnacipran Hydrochloride at this strength.
Do I need a prescription for Cipran?
Cipran is a prescription (Rx) medicine. Take it as your doctor advises.