Generic Sertraline

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Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant used to treat depression, anxiety disorders, obsessive‑compulsive disorder, and other mood conditions. It works by increasing the levels of serotonin, a neurotransmitter, in the brain, which helps improve mood, sleep, appetite, and energy levels while reducing anxiety and fear.

Usual adult dose: The usual starting dose is 50 mg once daily, taken in the morning or evening with or without food. Depending on the condition and individual response, the dose may be increased by 50 mg increments at intervals of at least one week. The maximum recommended dose is 200 mg daily. For panic disorder and post‑traumatic stress disorder, a lower starting dose of 25 mg once daily is recommended for the first week before increasing to 50 mg daily.

Dosage form: Capsules: 25 mg, 50 mg, and 100 mg.

Onset of action: Some improvement in sleep, energy, or appetite may occur within the first 1–2 weeks; however, the full antidepressant effect usually requires 4–6 weeks of continuous therapy. In anxiety disorders, symptom relief may begin within 2–4 weeks but can take up to 8–12 weeks for maximal benefit.

Duration of action: Approximately 24 hours with once‑daily dosing; steady‑state plasma levels are reached after about 7 days.

Alcohol recommendation: Alcohol consumption should be avoided during treatment with Sertraline. Alcohol can worsen depression and anxiety symptoms, increase the risk of side effects such as drowsiness and dizziness, and may interfere with the effectiveness of the medication.

Most common side effects: Nausea, diarrhoea, dry mouth, loss of appetite, increased sweating, headache, dizziness, drowsiness, insomnia, and sexual dysfunction (decreased libido, delayed ejaculation, erectile dysfunction).

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General Information about Sertraline

• INN (International Nonproprietary Name): Sertraline (as sertraline hydrochloride)
• Brand names available in Canada: Zoloft® (BGP Pharma ULC, a division of Pfizer Canada Inc.), APO‑Sertraline (Apotex Inc.), TEVA‑Sertraline (Teva Canada Limited), Sandoz Sertraline (Sandoz Canada Inc.), PMS‑Sertraline (Pharmascience Inc.), M‑Sertraline (Mantra Pharma Inc.), JAMP‑Sertraline (JAMP Pharma Corporation), NRA‑Sertraline (Norak Pharma Inc.), AURO‑Sertraline (Auro Pharma Inc.), RAN‑Sertraline (Ranbaxy Pharmaceuticals Canada Inc.), GD‑Sertraline (GenMed, a division of Pfizer Canada Inc.), and many other generic manufacturers.
• ATC code: N06AB06
• Dosage forms and strengths: Capsules: 25 mg, 50 mg, and 100 mg (as sertraline hydrochloride). An oral concentrate solution (20 mg/mL) is also available.
• Manufacturers in Canada: BGP Pharma ULC (Pfizer), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., Mantra Pharma Inc., JAMP Pharma Corporation, Auro Pharma Inc., Norak Pharma Inc., Ranbaxy Pharmaceuticals Canada Inc., GenMed (Pfizer Canada division), and numerous other generic manufacturers.
• Registration status in Canada: Approved by Health Canada. First marketed in Canada in 1992.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act.

Mechanism of Action and Pharmacology

Sertraline is a potent and selective inhibitor of serotonin (5‑hydroxytryptamine, 5‑HT) reuptake into presynaptic neurons, thereby enhancing serotonergic neurotransmission. At therapeutic doses, it has minimal affinity for adrenergic (alpha₁, alpha₂, beta), cholinergic (muscarinic), dopaminergic, histaminergic, GABAergic, or benzodiazepine receptors, which accounts for its relatively favourable side‑effect profile compared with older tricyclic antidepressants. Sertraline is slowly absorbed after oral administration, with peak plasma concentrations occurring 4–10 hours after dosing. Steady‑state levels are achieved after approximately 7 days of once‑daily dosing. The drug is extensively metabolized in the liver, primarily by cytochrome P450 enzymes CYP2B6 and CYP2C19, and to a lesser extent by CYP3A4 and CYP2D6, to the active metabolite desmethylsertraline, which has about 5–10% of the pharmacological activity of the parent compound. The elimination half‑life of sertraline is approximately 22–36 hours, and that of desmethylsertraline is 62–104 hours. Approximately 40–45% of a radiolabelled dose is excreted in urine and 40–45% in faeces. Sertraline is approximately 98% bound to plasma proteins. The pharmacokinetics in the elderly are similar to those in younger adults; however, plasma levels may be elevated in patients with hepatic impairment, necessitating a lower dose or less frequent administration.

Indications

• Major Depressive Disorder (MDD): For the acute and maintenance treatment of major depressive episodes in adults.
• Obsessive‑Compulsive Disorder (OCD): For the treatment of OCD in adults and children and adolescents aged 6–17 years.
• Panic Disorder: For the treatment of panic disorder with or without agoraphobia in adults.
• Post‑Traumatic Stress Disorder (PTSD): For the treatment of PTSD in adults.
• Social Anxiety Disorder (Social Phobia): For the treatment of social anxiety disorder in adults.
• Premenstrual Dysphoric Disorder (PMDD): For the treatment of PMDD in adult women.
• Generalized Anxiety Disorder (GAD): May be used for GAD, though not specifically indicated in all product monographs; prescribed off‑label.

Important Warnings and Precautions

At‑risk groups

• Elderly: No dose adjustment is required based on age alone; however, elderly patients may be more susceptible to hyponatraemia and other adverse effects. Caution is advised.
• Pregnancy: Sertraline should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Health Canada advises that newborns may experience complications such as feeding and breathing difficulties, seizures, muscle rigidity, jitteriness, and constant crying when exposed to SSRIs in late pregnancy. Some studies have examined a potential risk of autism spectrum disorder or persistent pulmonary hypertension of the newborn (PPHN); the evidence is not conclusive. Abrupt discontinuation should be avoided.
• Breastfeeding: Sertraline is excreted into human breast milk in small amounts. Most reports show no problems for breastfed infants; however, nursing mothers should discuss the risks and benefits with their healthcare provider. The infant should be monitored for drowsiness, irritability, and feeding difficulties.
• Children and Adolescents: Sertraline is indicated for OCD in children and adolescents aged 6–17 years. Safety and efficacy in children under 6 have not been established. In clinical trials, antidepressant use was associated with an increased risk of suicidal thinking and behaviour in children and adolescents. Close monitoring is required.
• Hepatic impairment: Use with caution. Lower doses or less frequent dosing may be required because sertraline is extensively metabolized by the liver.
• Renal impairment: No dose adjustment is required; however, caution is advised because sertraline is excreted in urine, and accumulation of metabolites may occur.
• Bipolar Disorder: Screen for bipolar disorder before initiating treatment. Sertraline may precipitate a manic or mixed episode in patients with undiagnosed bipolar disorder.
• Seizure Disorders: SSRIs may lower the seizure threshold; use with caution in patients with epilepsy or a history of seizures. Discontinue if seizures develop.
• Diabetes Mellitus: SSRIs may alter glycaemic control; blood glucose monitoring is recommended.
• Angle‑Closure Glaucoma: SSRIs may cause pupillary dilatation and trigger an acute attack in patients with narrow‑angle glaucoma.

Driving and alcohol

Sertraline may impair cognitive and motor skills, particularly during the first weeks of treatment or after dose increases. Patients should be cautious when driving, operating heavy machinery, or performing activities that require mental alertness until they know how the drug affects them. Alcohol should be avoided because it may potentiate the CNS depressant effects of sertraline and increase the risk of sedation and dizziness; it can also worsen depression and anxiety. Alcohol does not affect the metabolism of sertraline, but concomitant use is not recommended.

Dosage Instructions

• Major Depressive Disorder and Obsessive‑Compulsive Disorder: Starting dose: 50 mg once daily. May be increased in 50 mg increments at intervals of at least one week to a maximum of 200 mg/day.
• Panic Disorder and Post‑Traumatic Stress Disorder: Starting dose: 25 mg once daily for the first week, then increase to 50 mg once daily. Further dose escalation as tolerated up to 200 mg/day.
• Social Anxiety Disorder: Starting dose: 25 mg once daily for the first week, then increase to 50 mg once daily. Maximum 200 mg/day.
• Premenstrual Dysphoric Disorder: Starting dose: 50 mg once daily, either continuously or only during the luteal phase (intermittent dosing). Intermittent dosing: start 50 mg/day 14 days before expected menses and continue through the first full day of menses; may be increased to a maximum of 150 mg/day during the luteal phase only.
• Paediatric (OCD, age 6–12): Starting dose: 25 mg once daily. May be increased to 50 mg once daily after one week.
• Adolescents (OCD, age 13–17): Starting dose: 50 mg once daily. Maximum 200 mg/day.
• Elderly: No specific dose adjustment; use the lowest effective dose and monitor closely.
• Hepatic impairment: Reduce dose or prolong dosing interval.
• Administration: Take once daily, in the morning or evening, with or without food. Taking with food may reduce gastrointestinal side effects. If a dose is missed, take it as soon as remembered unless it is close to the next scheduled dose; do not double doses.
• Discontinuation: Gradual tapering is recommended to avoid withdrawal symptoms (dizziness, paraesthesia, headache, anxiety, nausea). Do not abruptly discontinue.

Side Effects and Contraindications

• Common side effects: Nausea, diarrhoea, loose stools, dyspepsia, dry mouth, decreased appetite, weight loss, increased sweating, headache, dizziness, drowsiness, insomnia, somnolence, agitation, tremor, and sexual dysfunction (decreased libido, delayed ejaculation, anorgasmia, erectile dysfunction).
• Less common but serious side effects: Hyponatraemia (especially in elderly and volume‑depleted patients), abnormal bleeding (gastrointestinal, bruising, epistaxis), serotonin syndrome, mania/hypomania, seizures, akathisia, increased risk of suicidal ideation and behaviour (particularly in young adults and adolescents), QT prolongation, and severe hepatic events.
• Post‑marketing reports: Pancreatitis, angioedema, Stevens‑Johnson syndrome, toxic epidermal necrolysis, and extrapyramidal symptoms.
• Serotonin syndrome: A potentially life‑threatening condition that may occur with SSRIs, particularly when used concurrently with other serotonergic drugs. Symptoms include mental status changes (agitation, confusion), autonomic instability (hyperthermia, diaphoresis, tachycardia), neuromuscular abnormalities (tremor, clonus, hyperreflexia), and gastrointestinal symptoms. Immediate medical attention is required.
• Discontinuation syndrome: Abrupt cessation may lead to withdrawal symptoms including dizziness, sensory disturbances (paraesthesia, electric shock sensations), anxiety, agitation, confusion, headache, lethargy, emotional lability, insomnia, and irritability. A gradual taper is recommended.
• Contraindications: Hypersensitivity to sertraline or any component of the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use with pimozide. Concomitant use with linezolid or intravenous methylene blue (risk of serotonin syndrome).

Drug Interactions

• Major interactions (avoid concomitant use): Monoamine oxidase inhibitors (MAOIs) – risk of serotonin syndrome; allow at least 14 days washout. Pimozide – increased pimozide levels and risk of QT prolongation. Linezolid and intravenous methylene blue – serotonin syndrome risk.
• Serotonergic drugs (monitor closely): Triptans, fentanyl, lithium, tramadol, buspirone, St. John’s wort, tryptophan, and other SSRIs/SNRIs – additive serotonergic effects may precipitate serotonin syndrome.
• Anticoagulants and antiplatelets: Warfarin, clopidogrel, aspirin, NSAIDs – sertraline may increase bleeding risk through platelet serotonin depletion.
• CYP450 interactions: Sertraline is metabolized by CYP2B6, CYP2C19, CYP3A4, and CYP2D6. It is a mild inhibitor of CYP2D6 and may increase plasma levels of drugs metabolized by this enzyme (e.g., tricyclic antidepressants, certain antipsychotics, beta‑blockers, Type 1C antiarrhythmics). It is a weak inhibitor of CYP3A4. Drugs that induce CYP3A4 (e.g., rifampin) may reduce sertraline levels.
• Alcohol/food interactions: Alcohol should be avoided because of additive CNS depression and potential worsening of mood disorders. Grapefruit juice has minimal effect on sertraline pharmacokinetics. A low‑salt diet may increase the risk of hyponatraemia.
• Drug‑disease interactions: Bleeding disorders, seizure disorders, glaucoma, cardiac disease (QT prolongation), and conditions predisposing to hyponatraemia.

Practical Advice

• Administration: Take once daily at the same time each day, either in the morning or evening. If drowsiness occurs, take at bedtime. Taking with food may reduce gastrointestinal upset. Swallow the capsule whole with water.
• Monitoring: Regular follow‑up is essential to assess therapeutic response, tolerability, and the emergence of suicidal ideation, especially during the first weeks of therapy and after dose changes. Monitor for signs of serotonin syndrome, bleeding, hyponatraemia, and manic activation. Blood pressure should be monitored periodically.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from light. Keep the container tightly closed and out of reach of children.
• Lifestyle: Engage in regular physical activity, maintain a balanced diet, and practice good sleep hygiene. Avoid alcohol and the use of recreational drugs. Do not stop the medication abruptly; if discontinuation is needed, contact the healthcare provider for a gradual tapering schedule.
• Missed dose: If a dose is missed, take it as soon as remembered unless it is close to the time for the next dose. Do not double the dose to make up for a missed one.

Alternative Medications

• Other SSRIs: Escitalopram (Cipralex), fluoxetine (Prozac), paroxetine (Paxil), citalopram (Celexa), and fluvoxamine (Luvox) share a similar mechanism of action and are first‑line treatments for depression and anxiety disorders. Escitalopram may offer a slightly better tolerability profile; fluoxetine has a longer half‑life that may reduce discontinuation symptoms.
• Serotonin‑Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine (Effexor), desvenlafaxine (Pristiq), and duloxetine (Cymbalta) are alternative antidepressants that may be particularly useful when pain or fatigue is a prominent symptom.
• Other antidepressants: Bupropion (Wellbutrin) lacks sexual side effects and is often used as an alternative or add‑on; mirtazapine (Remeron) is effective for depression with insomnia or weight loss; vortioxetine (Trintellix) has a unique multimodal profile.
• Benzodiazepines: Used short‑term for acute anxiety, but not recommended for long‑term management due to risk of dependence (e.g., lorazepam, clonazepam).
• Buspirone: A non‑benzodiazepine anxiolytic used for generalized anxiety disorder; may be combined with an SSRI for augmentation.
• Psychotherapy: Cognitive behavioural therapy (CBT) and interpersonal therapy (IPT) are effective non‑pharmacological alternatives or adjuncts for depression and anxiety disorders.

Clinical Efficacy

Sertraline has been extensively studied in numerous randomized controlled trials and is well established as a first‑line treatment for major depressive disorder and anxiety disorders. In large‑scale meta‑analyses, sertraline has demonstrated comparable or superior efficacy and acceptability relative to other SSRIs. The Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 guidelines list sertraline among the first‑line antidepressants with evidence of superior efficacy for the treatment of major depression. In OCD, sertraline is one of the most studied SSRIs, with significant reductions in obsessions and compulsions compared with placebo. For panic disorder, sertraline reduces the frequency and severity of panic attacks and anticipatory anxiety. Evidence also supports its effectiveness in PTSD, social anxiety disorder, and PMDD. Clinical trials have shown that sertraline improves quality of life, reduces disability, and prevents relapse when continued long‑term. The number needed to treat (NNT) for response in depression is approximately 6–8 compared with placebo. Sertraline may be particularly effective in patients with anxious depression and is generally well tolerated, with a side‑effect profile that is manageable for most patients.

Important:

Sertraline is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It may increase the risk of suicidal thoughts and behaviour, particularly in children, adolescents, and young adults under 24 years of age. Close monitoring by family, friends, and healthcare providers is essential during the first weeks of treatment and after dosage changes. Do not discontinue the medication abruptly, as this may cause withdrawal symptoms. If you experience symptoms such as agitation, hallucinations, rapid heartbeat, severe dizziness, muscle stiffness, confusion, unusual bleeding, or signs of an allergic reaction (e.g., rash, swelling of the face, tongue, or throat, difficulty breathing), seek immediate medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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