Generic Zoloft ( Sertraline )

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Zoloft is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic disorder, and obsessive-compulsive disorder (OCD). It is also commonly prescribed for social anxiety disorder, post-traumatic stress disorder, and generalized anxiety disorder. The medication works by increasing the amount of serotonin, a natural chemical in the brain that helps regulate mood and anxiety.
The usual starting dose for adults is 50 mg once daily. Your doctor may increase the dose by 50 mg at weekly intervals if needed, up to a maximum of 200 mg per day. For panic disorder, the starting dose is often 25 mg once daily, increased after one week to 50 mg daily. Children aged 6 to 12 years start at 25 mg daily for OCD, with a maximum of 200 mg per day.
The administration form is capsules in 25 mg (yellow), 50 mg (white and yellow), and 100 mg (orange) strengths. Take the capsule with food to increase absorption and reduce stomach upset.
Zoloft does not work overnight. It may take up to 4 weeks before you notice the full therapeutic effect for depression or anxiety. Do not stop taking it just because you do not feel better in the first few days.
Alcohol should be avoided during treatment. It can increase the risk of drowsiness and dizziness, and it may worsen some of the side effects of the medication.
The most common side effects are headache, nausea, diarrhea, dry mouth, sweating, and tremor. Sexual side effects such as decreased desire or difficulty reaching orgasm are also common.
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Common Use Zoloft

Sertraline is a selective serotonin reuptake inhibitor. It works by blocking the reuptake of serotonin in the brain, which increases its availability in the spaces between nerve cells. This is thought to improve mood and reduce anxiety. Health Canada has approved Zoloft for the symptomatic relief of depressive illness, panic disorder with or without agoraphobia, and obsessive-compulsive disorder. The Notice of Compliance for Zoloft 50 mg (DIN 01962817) and 100 mg (DIN 01962779) was granted on January 30, 1992. The 25 mg capsule was approved later under DIN 02132702. Zoloft is also used off-label for social anxiety disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder. It is not approved for use in children under 6 years of age.

Basic Zoloft Information

• INN (International Nonproprietary Name): Sertraline hydrochloride
• Brand names available in Canada: Zoloft® (original brand, marketed by BGP Pharma ULC, a Viatris company); generics include Apo-Sertraline (Apotex Inc.), Teva-Sertraline (Teva Canada Limited), Sandoz Sertraline (Sandoz Canada Inc.), pms-Sertraline (Pharmascience Inc.), Pro-Sertraline (Pro Doc Limitée), Jamp Sertraline (Jamp Pharma Corporation), Sanis Sertraline (Sanis Health Inc.), Sivem Sertraline (Sivem Pharmaceuticals ULC), Auro-Sertraline (Auro Pharma Inc.), Mar-Sertraline (Marcan Pharmaceuticals Inc.), Mint-Sertraline (Mint Pharmaceuticals Inc.), NRA-Sertraline (Nora Pharma Inc.), and others.
• ATC Code: N06AB06
• Forms and dosages: Capsules – 25 mg, 50 mg, and 100 mg
• Manufacturers in Canada: BGP Pharma ULC (Zoloft, DIN 01962817 for 50 mg, DIN 01962779 for 100 mg, DIN 02132702 for 25 mg), Apotex Inc. (Apo-Sertraline), Teva Canada Limited (Teva-Sertraline, DIN 02240481 for 100 mg, DIN 02240485 for 25 mg, DIN 02240484 for 50 mg), Sandoz Canada Inc. (Sandoz Sertraline), Pharmascience Inc. (pms-Sertraline), Pro Doc Limitée (Pro-Sertraline, DIN 02241303 for 50 mg), Jamp Pharma Corporation (Jamp Sertraline), Sanis Health Inc. (Sertraline, DIN 02353520 for 25 mg, DIN 02353539 for 50 mg, DIN 02353547 for 100 mg), and others.
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 01962817 (Zoloft 50 mg), 01962779 (Zoloft 100 mg), 02132702 (Zoloft 25 mg), 02240481 (Teva-Sertraline 100 mg), 02240485 (Teva-Sertraline 25 mg), 02240484 (Teva-Sertraline 50 mg), 02241303 (Pro-Sertraline 50 mg), 02353520 (Sanis Sertraline 25 mg), 02353539 (Sanis Sertraline 50 mg), and 02353547 (Sanis Sertraline 100 mg).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Zoloft exactly as your doctor prescribes. The dose depends on what is being treated. For depression and obsessive-compulsive disorder in adults, the recommended starting dose is 50 mg once daily, taken with food. Your doctor may increase the dose by 50 mg at weekly intervals if needed. The usual maintenance range is 50 mg to 200 mg per day. For panic disorder, the recommended starting dose is 25 mg once daily for the first week, then increased to 50 mg once daily. The maximum dose is 200 mg per day. For children aged 6 to 12 years with OCD, the starting dose is 25 mg once daily, with increases of 25 mg at weekly intervals as needed, up to a maximum of 200 mg per day. For adolescents aged 13 to 17 with OCD, the starting dose is 50 mg once daily. Take the capsule with food to increase absorption and reduce gastrointestinal side effects. Swallow the capsule whole with water. Do not open, crush, or chew it. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Zoloft suddenly without talking to your doctor. Stopping abruptly can cause discontinuation syndrome, with symptoms such as flu-like feelings, dizziness, and "electric-shock" sensations. Your doctor will taper the dose gradually over at least one to two weeks, or longer if needed, to reduce the risk of withdrawal effects.

Precautions

Zoloft carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Closely monitor all patients for clinical worsening and the emergence of suicidal thoughts, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Zoloft can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when Zoloft is taken with other serotonergic drugs, including MAO inhibitors, other SSRIs, SNRIs, triptans, tramadol, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Zoloft can increase the risk of bleeding, especially when taken with aspirin, NSAIDs, warfarin, or other anticoagulants. Tell your doctor if you take any of these medications. Zoloft can cause angle-closure glaucoma in patients with untreated anatomically narrow angles. Tell your doctor if you have a history of glaucoma. Zoloft should be used with caution in patients with a history of seizures. The medication can cause hyponatremia (low sodium in the blood), especially in older adults and people taking diuretics. Symptoms include headache, difficulty concentrating, memory problems, confusion, and weakness. Zoloft can cause QTc prolongation, a change in heart rhythm. Use with caution if you have risk factors for QTc prolongation or take other drugs that affect heart rhythm. Zoloft is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause withdrawal symptoms in a newborn if used in the third trimester. It passes into breast milk, so breastfeeding is not recommended without medical advice. Women who could become pregnant should discuss the risks and benefits with their doctor. Zoloft should not be used in children under 6 years of age. Older adults may be more sensitive to the side effects of Zoloft and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed. Zoloft can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Contraindications

Do not take Zoloft if you have had an allergic reaction to sertraline or any of the inactive ingredients in the capsule. Zoloft is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including phenelzine, tranylcypromine, and moclobemide. Do not start an MAOI within 14 days of stopping Zoloft, and do not start Zoloft within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Zoloft is contraindicated in patients taking pimozide, an antipsychotic medication, because the combination can cause serious heart rhythm problems. Do not take Zoloft if you have a history of angle-closure glaucoma. Zoloft should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Do not take Zoloft if you have severe liver impairment. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 1 in 10 people experience headache, nausea, diarrhea, dry mouth, sweating, and tremor. These effects are often most noticeable when starting treatment or increasing the dose. Other common side effects include insomnia, drowsiness, fatigue, dizziness, and decreased appetite. Sexual side effects such as decreased desire or difficulty reaching orgasm are common but often not discussed. These effects may fade as your body adjusts, but if they persist or bother you, tell your doctor. Serious side effects require immediate medical attention. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Increased bleeding risk can cause easy bruising or unusual bleeding. Hyponatremia can cause headache, confusion, and weakness. Angle-closure glaucoma presents with sudden eye pain, blurred vision, and redness. QTc prolongation can cause palpitations, fainting, or sudden collapse. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. If you develop any of these serious effects, stop the medication and seek medical help right away. Discontinuation syndrome can occur if the medication is stopped suddenly, causing flu-like symptoms, dizziness, and "electric-shock" sensations.

Drug Interaction

Zoloft interacts with several medications. MAO inhibitors are strictly contraindicated and must not be used with Zoloft. Pimozide is also contraindicated because the combination can cause serious heart rhythm problems. Other serotonergic drugs, including other SSRIs, SNRIs, tricyclic antidepressants, triptans, fentanyl, tramadol, and St. John's wort, can increase the risk of serotonin syndrome. Drugs that affect bleeding, such as aspirin, NSAIDs, warfarin, and other anticoagulants, can increase the risk of bleeding when taken with Zoloft. Zoloft is a weak inhibitor of CYP2D6, so it can increase the levels of drugs metabolized by this enzyme, including certain antidepressants, antipsychotics, beta-blockers, and opioids. If you take one of these, your doctor may need to adjust the dose. Zoloft can also interact with diuretics, increasing the risk of hyponatremia. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Zoloft, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same time each day.

Overdose

Overdose with Zoloft can cause drowsiness, nausea, vomiting, fast heart rate, and tremor. In severe cases, it can cause serotonin syndrome, seizures, and changes in heart rhythm. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Zoloft capsules at controlled room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Brief exposure to temperatures between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit) is acceptable. Protect from light. Keep the container tightly closed and store it in a dry place. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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