Trazonil 100

TRAZONIL 100 by INTAS PHARMACEUTICALS LTD

Name

• Brand Name: TRAZONIL 100
• Common Name: Trazodone

Composition

TRAZONIL 100 contains Trazodone at a strength of 100 mg as its active ingredient.

Uses

TRAZONIL 100 is primarily used to manage symptoms of depression, including major depressive episodes. It is also prescribed for depression associated with anxiety. This medication helps by increasing the levels of certain chemical messengers like serotonin and noradrenaline in the brain, which play a role in regulating mood, improving sleep patterns, and reducing anxiety and agitation. It can also be used to treat other psychological problems such as insomnia.

Dosage and Administration

TRAZONIL 100 should be taken orally as directed by a physician. It is generally advised to take this medicine with or after food to prevent stomach upset, and at a fixed time each day to maintain stable levels in the body. Do not crush, chew, or break the tablet; swallow it whole with a glass of water. The dose and duration will be prescribed by the doctor based on age and health condition. Abruptly stopping the medication can lead to withdrawal symptoms.

Side Effects

Common side effects include nervousness, dizziness, sleepiness, dry mouth, changes in appetite or weight, constipation, stomach pain, headache, fatigue, confusion, blurred vision, and nausea or vomiting.

Serious side effects, though rare, warrant immediate medical attention and include allergic reactions (skin rash, swelling, breathing difficulties), priapism (prolonged and painful erection), sore throat, unexplained fever, flu-like symptoms, signs of severe liver disorders (jaundice, dark urine), and thoughts of self-harm or suicide.

Precautions

• Allergies: Contraindicated if allergic to Trazodone or any components of the tablet.
• Cardiac Conditions: Use with caution in patients with heart problems, including recent heart attack, irregular heartbeat, or high blood pressure, due to increased risk of side effects.
• Liver/Kidney Impairment: Should be used with caution in patients with severe kidney or liver disease.
• Suicidal Tendencies: May cause mood and behavioral changes, including suicidal thoughts, particularly in children and adolescents.
• Pregnancy & Breastfeeding: Use with caution in pregnant and breastfeeding women only if clearly necessary, as there is limited data on safety.
• Driving/Operating Machinery: May cause drowsiness, dizziness, or blurred vision; avoid driving or operating heavy machinery until you know how the medication affects you.
• Alcohol: Avoid alcohol consumption as it can increase the risk of side effects.
• Drug Interactions: Inform your doctor about all medications, supplements, and herbal products you are taking. Trazonil 100 should not be taken with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing them, as well as with certain other antidepressants, opioid painkillers, and blood thinners.

Storage

Store TRAZONIL 100 tablets below 30°C in a cool, dry place. Protect the medicine from wet surfaces, direct sunlight, and humid conditions. Keep it out of reach of children and pets. Do not use after the expiration date.

TRAZONIL 100 by INTAS PHARMACEUTICALS LTD is a medication primarily used for the treatment of depression and related conditions. Its active ingredient is Trazodone.

Here are some frequently asked questions about TRAZONIL 100:

What is TRAZONIL 100 used for?

TRAZONIL 100 (Trazodone) is primarily used to treat major depressive disorder in adults. It can also be prescribed for depression accompanied by anxiety. Additionally, it is sometimes used off-label for conditions like insomnia and generalized anxiety disorder.

How does TRAZONIL 100 work?

TRAZONIL 100 contains Trazodone, which belongs to a class of antidepressants called serotonin antagonist and reuptake inhibitors (SARIs). It works by increasing the levels of serotonin and noradrenaline, which are natural chemical messengers in the brain that help regulate mood, sleep, appetite, and energy levels. It specifically blocks certain serotonin receptors and inhibits serotonin reuptake, contributing to its antidepressant and anxiolytic effects.

What is the usual dosage of TRAZONIL 100?

For depression, the usual starting dose for adults is typically 150 mg per day, taken in divided doses. This dose may be gradually increased by 50 mg every 3 to 4 days, based on tolerability and therapeutic response. The maximum recommended dose for outpatients is generally 400 mg per day in divided doses, while inpatients may receive up to 600 mg per day. TRAZONIL 100 should be taken shortly after a meal or a light snack to enhance absorption and reduce the risk of dizziness. For insomnia, lower doses, often between 50 mg to 100 mg, are typically prescribed at bedtime.

What are the possible side effects of TRAZONIL 100?

Common side effects of TRAZONIL 100 include drowsiness, dizziness, headache, dry mouth, blurred vision, nausea, vomiting, constipation, or diarrhea. More serious, but less common, side effects can include changes in blood pressure (orthostatic hypotension), irregular heartbeats, serotonin syndrome (symptoms like confusion, agitation, sweating, muscle stiffness), priapism (prolonged and painful erection), and a low sodium level in the blood (hyponatremia). There is also a boxed warning regarding an increased risk of suicidal thoughts and behaviors in children, teenagers, and young adults (up to 24 years old) when taking antidepressants like trazodone.

Is TRAZONIL 100 safe during pregnancy or breastfeeding?

It is important to discuss the risks and benefits of taking TRAZONIL 100 during pregnancy with your doctor. Untreated depression can pose risks to both the mother and the baby. While studies have not consistently shown an increased risk of major birth defects with trazodone use during the first trimester, the overall safety data during pregnancy is limited. Trazodone passes into breast milk in very small amounts and has generally not been linked to side effects in breastfed babies. However, if you are breastfeeding, it is advisable to consult your doctor or health visitor, and monitor the baby for unusual sleepiness, irritability, or feeding difficulties.

Can TRAZONIL 100 be taken with other medications?

TRAZONIL 100 can interact with several medications. It should not be taken with monoamine oxidase inhibitors (MAOIs) due to the risk of serious side effects like serotonin syndrome. Combining it with other medications that increase serotonin levels, such as other antidepressants (SSRIs, SNRIs), certain opioid painkillers (e.g., tramadol), and St. John's wort, can also increase the risk of serotonin syndrome. It can also interact with blood thinners (anticoagulants/antiplatelets like warfarin, aspirin, ibuprofen), potentially increasing the risk of bleeding. Caution is also advised when taking it with medications that affect heart rhythm (QT prolongation), alcohol, benzodiazepines, and certain antibiotics or HIV medications. Always inform your doctor and pharmacist about all medications, supplements, and herbal products you are taking.

What precautions should be taken while using TRAZONIL 100?

Before starting TRAZONIL 100, inform your doctor about any history of heart disease (including irregular heartbeat or recent heart attack), liver or kidney conditions, glaucoma (especially angle-closure type), bipolar disorder, or a history of suicidal thoughts. Since TRAZONIL 100 can cause drowsiness, dizziness, or blurred vision, avoid driving or operating machinery until you know how the medication affects you. Alcohol consumption should be avoided as it can worsen sedating effects. Do not stop taking TRAZONIL 100 abruptly without consulting your doctor, as this can lead to withdrawal symptoms.

What happens if a dose is missed?

If you miss a dose of TRAZONIL 100, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one, as this can increase the risk of side effects. Missing a dose, especially if you've been on the medication for a while, can lead to withdrawal symptoms such as nausea, anxiety, restlessness, or trouble sleeping.

How should TRAZONIL 100 be stored?

TRAZONIL 100 should be stored in a tightly closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F), away from heat, moisture, and direct light. It should be kept out of the reach of children and pets. Do not store it in the bathroom. Dispose of any outdated or unneeded medication safely as instructed by your healthcare professional.