CILENTRA 10 ESCITALOPRAM OXALATE TABLET USP 10MG

SUN PHARMACEUTICAL INDUSTRIES LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Nov 15, 2024
Approval ID: 377153e2b9193d40
Company: SUN PHARMACEUTICAL INDUSTRIES LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 377153e2b9193d40
Drug Name: CILENTRA 10 ESCITALOPRAM OXALATE TABLET USP 10MG
Product Name: CILENTRA 10 ESCITALOPRAM OXALATE TABLET USP 10MG
Approval Number: SIN17140P
Approval Date: 2024-11-15
Registrant: RANBAXY (MALAYSIA) SDN. BHD.
Licence Holder: RANBAXY (MALAYSIA) SDN. BHD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: DOSE AND METHOD OF ADMINISTRATION 2 Safety of daily doses above 20 mg has not been demonstrated. CILENTRA is administered as a single daily dose and may be taken with or without food. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2–4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. Panic disorder with or without agoraphobia An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. Generalised anxiety disorder Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals. Obsessive-compulsive disorder (OCD) Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to 20 mg daily. Long-term treatment has been studied for a maximum of 40 weeks. Patients responding to a 16- week open-label treatment phase were randomized to a 24-week placebo-controlled relapse prevention phrase, receiving 10 or 20 mg escitalopram daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. This period may be several months or even longer. Elderly patients (> 65 years of age) Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Children and adolescents (<18 years) CILENTRA should not be used in the treatment of children and adolescents under the age of 18 years (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Reduced renal function Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min.) (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES; Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Discontinuation symptoms When stopping treatment with CILENTRA the dose should be gradually reduced over a period of at least one to two weeks in order to avoid possible discontinuations symptoms (see WARNINGS AND PRECAUTIONS and UNDESIRABLE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). USE IN SPECIAL POPULATIONS 2 Pregnancy For escitalopram, only limited clinical data are available regarding exposed pregnancies. Animal studies have shown reproductive toxicity (see PRECLINICAL SAFETY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). CILENTRA should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit. Newborns should be observed if maternal use of escitalopram continues into the later stages of pregnancy, particularly in the third trimester. If escitalopram is used until or shortly before birth, discontinuation effects in the newborn are possible. The following symptoms may occur in the newborn after maternal SSRI/SNRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either discontinuation effects or excess serotonergic activity. In a majority of instances, such complications begin immediately or soon (<24 hours) after delivery. Escitalopram should not be used during pregnancy unless clearly needed and after careful consideration of the risk/benefit ratio. Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur. Observational data reports indicate an increased risk (less than 2-fold) of postpartum haemorrhage following SSRI/SNRI exposure within the month prior to birth (see WARNINGS AND PRECAUTIONS, UNDESIRABLE EFFECTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Breast-feeding It is expected that escitalopram will be excreted into human milk and breastfeeding is not recommended during the treatment. <hr> REFERENCES <ol> <li value="2">Prescribing information of Lepax (Escitalopram) 10 mg film-coated tablets, H. Lundbeck A/S, Denmark, July 2021.</li> </ol>
Route Of Administration: ORAL
Indication Info: INDICATIONS 2 <ul> <li>Treatment of major depressive episodes.</li> <li>Treatment of panic disorder with or without agoraphobia.</li> <li>Treatment of generalised anxiety disorder.</li> <li>Treatment of obsessive-compulsive disorder.</li> </ul> <hr> REFERENCES <ol> <li value="2">Prescribing information of Lepax (Escitalopram) 10 mg film-coated tablets, H. Lundbeck A/S, Denmark, July 2021.</li> </ol>
Contraindications: CONTRAINDICATIONS 2 <ul> <li>Hypersensitivity to the active substance or to any of the excipients, listed in COMPOSITION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.</li> <li>Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Concomitant treatment with pimozide.</li> </ul> <hr> REFERENCES <ol> <li value="2">Prescribing information of Lepax (Escitalopram) 10 mg film-coated tablets, H. Lundbeck A/S, Denmark, July 2021.</li> </ol>
Atc Code: N06AB10
Pharma Manufacturer Name: RANBAXY (MALAYSIA) SDN. BHD.

Active Ingredients

Escitalopram Oxalate eqv Escitalopram

10mg

Escitalopram Oxalate eqv Escitalopram

10mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 15, 2024

Approval ID

377153e2b9193d40

Type

Therapeutic

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