Aspen Trazodone Capsule
Clinical Summary
Quick overview from the medicine insert
Indication
Management of major depressive disorder and anxiety disorders.
Dosage (summary)
Initial dose of 150 mg/day, which may be increased to a maximum of 400 mg/day based on clinical response.
Onset of Action / Duration
Effects may be observed within 1 to 2 weeks, with full therapeutic effects typically seen after 4 to 6 weeks.
Special Populations
- Elderly patients
- Patients with hepatic impairment
- Patients with renal impairment
Pregnancy & Breastfeeding
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Trazodone is excreted in breast milk; caution is advised when administered to nursing mothers.
Key Drug Interactions
- CNS depressants (e.g., alcohol, benzodiazepines) may enhance sedative effects.
- Monoamine oxidase inhibitors (MAOIs) can lead to serious interactions.
- Serotonergic drugs may increase the risk of serotonin syndrome.
Contraindications
- Hypersensitivity to trazodone or any of its components.
- Recent myocardial infarction.
- Concurrent use with MAOIs.
Common side effects
- Drowsiness
- Dizziness
- Dry mouth
- Nausea
- Constipation
- Blurred vision
Counselling Points
- Take trazodone at the same time each day to maintain an even level in your system.
- Avoid alcohol while taking this medication.
- Do not discontinue abruptly; consult your healthcare provider for a tapering schedule.
- Report any signs of serotonin syndrome, such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering, blurred vision, muscle spasm or stiffness.
Serious warnings
- May cause sedation; caution when driving or operating machinery.
- Risk of suicidal thoughts and behaviors in young adults.
- Monitor for signs of worsening depression or unusual changes in behavior.
Important Disclaimer
The Aspen Trazodone Capsule professional information leaflet below is the property of Pharmacare and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ASPEN TRAZODONE is indicated in the treatment of:
- Depression.
- Mixed anxiety and depression.
4.2 Posology and method of administration
The dosage is dependent upon the diagnosis and the severity of the condition and the individual patientu2019s response. The daily dosage is usually administered in 3 divided doses.
Adults: The optimal dosage is between 300 mg/day to 400 mg/day. It is suggested that a starting dose of 150 mg/day is given for the first week, increasing to 300 mg/day or higher according to the clinical response (600 mg dosage has been reported).
Mixed anxiety and depression: The recommended starting dose is between 100 mg/day to 150 mg/day. When depression is the predominant symptom, a dose of 300 mg to 400 mg daily may be required to obtain a satisfactory response.
Children: ASPEN TRAZODONE is not recommended for use in children.
4.3 Contraindications
- Myocardial infarction during the acute recovery phase.
- Combined use with other psychotropic medicines should only be undertaken with due recognition of the possibility of potentiation.
- Pregnancy and lactation (see HUMAN REPRODUCTION).
4.4 Special warnings and precautions for use
- Hypersensitivity to trazodone.
- Pregnancy and lactation: Safety in pregnancy and lactation has not been established.
- Use in children: Safety in children has not been established.
Special precautions: Risk-benefit should be considered when the following medical problems exist:
- Alcoholism, active (possible CNS depression).
- Cardiac disease, especially arrhythmias (ventricular arrhythmias, premature ventricular contractions and ventricular tachycardia may be potentiated).
- Hepatic function impairment (possible serum trazodone accumulation resulting in potentiation of side effects).
- Renal function impairment (may result in prolonged ASPEN TRAZODONE effects).
4.5 Interactions with other medicines
- Alcohol or CNS depression producing medications may result in potentiation of CNS depressant effects of ASPEN TRAZODONE such as drowsiness, dry mouth, tachycardia, blurred vision and constipation.
- Anticholinergics or medication with anticholinergic activity.
- Antidyskinetics.
- Antihistamines (concurrent use with ASPEN TRAZODONE may intensify anticholinergic effects because of secondary anticholinergic activity of ASPEN TRAZODONE).
- Antidepressants, tricyclic.
- Haloperidol.
- Loxapine.
- Maprotiline.
- Molindone.
- Phenothiazines.
- Pimozide.
- Thioxanthines (concurrent use may prolong and intensify the sedative and anticholinergic effects of either these medications or ASPEN TRAZODONE).
- Antihypertensives (concurrent use with ASPEN TRAZODONE may increase the likelihood of hypotension; dosage reduction of the antihypertensive medicine may be necessary; also, antihypertensives with CNS depressant effects, such as clonidine, guanabenz, methyldopa, metyrosine and rauwolfia alkaloids, may potentiate CNS depression when used concurrently with ASPEN TRAZODONE).
- Digoxin (concurrent use with ASPEN TRAZODONE may increase serum concentration of digoxin and may result in digoxin toxicity).
- Phenytoin and possibly other hydantoin anticonvulsants (increased plasma phenytoin concentrations have been reported when phenytoin was used concurrently with ASPEN TRAZODONE. Caution and close monitoring is suggested).
4.6 Fertility, pregnancy and lactation
The safety of ASPEN TRAZODONE during pregnancy and lactation has not been established (see CONTRAINDICATIONS).
4.7 Effects on ability to drive and use machines
There is a possibility that judgement may be impaired when operating dangerous machinery and when driving.
4.8 Undesirable effects
Frequent:
- Nervous system disorders - dizziness or lightheadedness, headache, drowsiness which disappears on continuation of treatment.
- Gastrointestinal disorders - dry mouth, nausea and vomiting, unpleasant taste.
Less frequent:
- Nervous system disorders - confusion, unusual tiredness.
- Musculoskeletal and connective tissue disorders - muscle tremors, arthralgia, weakness.
- Vascular disorders - hypotension (fainting).
- Immune system disorders - allergic reaction.
- Cardiac disorders - fast or slow heartbeat.
- Reproductive system and breast disorders - priapism, unusual excitement.
- Eye disorders - blurred vision.
- Gastrointestinal disorders - constipation, diarrhoea.
- Blood and lymphatic system disorders - agranulocytosis, thrombocytopenia and anaemia have been reported rarely.
- Hepatobiliary disorders - jaundice and hepatocellular damage have been reported rarely.
- Endocrine disorders - hyponatraemia possibly due to inappropriate secretion of antidiuretic hormone has been associated with the use of ASPEN TRAZODONE, particularly in the elderly.
4.9 Overdose
Symptoms: Drowsiness, dizziness, vomiting, priapism, respiratory arrest, seizures, and ECG changes.
Treatment: Treatment of overdosage involves gastric lavage followed by the administration of activated charcoal and symptomatic and supportive therapy.
