Agomelatine Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Agomelatine Tablet, known generically as Agomelatine, is an atypical antidepressant that acts on melatonin receptors and blocks a serotonin receptor, rather than directly raising serotonin levels. It is used to treat major depressive disorder in adults and may help improve mood and regulate sleep patterns. It is taken once daily in the evening, and regular liver monitoring is needed during treatment.

What is Agomelatine Tablet

Agomelatine is an antidepressant medication used in the treatment of depression in adults. It works differently from most other antidepressants by acting on melatonin receptors and blocking a serotonin receptor, rather than directly raising serotonin levels.

Agomelatine Tablet uses

• Treatment of major depressive disorder in adults.
• Management of persistent low mood associated with depression.
• Treatment of loss of interest or pleasure associated with depression.
• Management of depressive symptoms affecting daily activities.
• Prevention of relapse of depression where approved.

Benefits of Agomelatine Tablet

• May improve mood.
• May help regulate sleep patterns.
• May reduce depressive symptoms.
• May improve daily functioning.
• May help restore emotional well-being.

How Agomelatine Tablet works

Agomelatine acts like melatonin at melatonin receptors in the brain, which helps reset the body's sleep-wake cycle. It also blocks a serotonin receptor (5-HT2c), and this indirectly increases the release of two other brain chemicals, noradrenaline and dopamine, which can improve mood.

Agomelatine Tablet dosage

Swallow the tablets whole with some water in the evening at bedtime. They can be taken with or without food. Take the medicine regularly at the same time each day. If you forget a dose, skip the missed dose and take your next dose at the usual time; do not take a double dose. It is recommended to leave a missed tablet in the strip and continue with the next day's tablet as shown on the calendar pack.

Do not change your dose without your doctor's advice, even if you feel better, and do not stop taking this medicine suddenly without talking to your doctor. Treatment for at least six months or longer gives the best chance of long-term recovery. There is no need to gradually reduce (taper) the dose when stopping, as this medicine does not cause discontinuation symptoms.

Available forms and strengths

• Film-coated tablet

Side effects of Agomelatine Tablet

Common

• Headache
• Migraine
• Dizziness
• Abnormal dreams
• Sleepiness (somnolence)
• Difficulty sleeping (insomnia)
• Pins and needles in fingers and toes
• Restless legs syndrome
• Feeling sick (nausea)
• Diarrhoea
• Constipation
• Abdominal pain
• Vomiting
• Increased liver enzyme levels
• Eczema, itching, hives
• Excessive sweating
• Back pain, muscle pain
• Weight increase or decrease
• Tiredness
• Blurred vision
• Ringing in the ears

Serious

• Severe liver reactions, especially with excessive alcohol consumption or other medicines processed by the liver
• Yellow colouring of the skin or whites of the eyes (jaundice)
• Abnormal bleeding or bruising
• Confusion, loss of consciousness or hallucinations
• Severe allergic reaction with itching, skin rash or hives, shortness of breath, wheezing or trouble breathing
• Swelling of the face, lips, tongue or other parts of the body causing difficulty swallowing or breathing
• Agitation, irritability, restlessness, aggressive behaviour
• Mania or hypomania
• Suicidal thoughts or behaviour
• Hepatitis, hepatic failure (isolated cases of death or liver transplantation have been reported in patients with liver risk factors)

Warnings and precautions

• Tell your doctor if you are pregnant, planning to become pregnant, or become pregnant while taking this medicine. There is limited information on its safety in pregnancy, so your doctor needs to discuss the benefits and risks with you.
• Talk to your doctor if you are breastfeeding or plan to breastfeed, as it is not known whether this medicine passes into breast milk.
• Caution is advised in people with moderate or severe kidney impairment because there is limited clinical data.
• Do not use this medicine if you have liver disease or know your liver does not work properly. Liver function blood tests are needed before starting treatment and at regular intervals afterward, because this medicine can raise liver enzymes and, rarely, cause serious liver injury.
• It is recommended to avoid alcohol while taking this medicine. People who drink excessive amounts of alcohol should not take it, as this can increase the risk of liver problems and may make depression or anxiety worse.
• Make sure you know how this medicine affects you before you drive or operate machinery, as it may cause drowsiness or dizziness.
• Do not take this medicine with fluvoxamine or ciprofloxacin, as these can greatly increase the levels of this medicine in your body and raise the risk of side effects.
• Do not take this medicine if routine blood tests show your liver enzyme levels are more than three times the upper limit of normal.
• You may be at higher risk of liver problems if you are overweight, obese, have diabetes, or take other medicines that can affect the liver.
• Tell your doctor if you have ever had an episode of bipolar disorder, mania, or hypomania, as this medicine should be used with caution in these cases.
• Tell your doctor if you have a history of dementia.
• Tell your doctor if you smoke more than 15 cigarettes a day, since heavy smoking can reduce how well this medicine works, and stopping smoking can increase the medicine's levels in your body.
• As with other antidepressants, this medicine carries a risk of triggering suicidal thoughts or mania, particularly in young adults under 25, especially before the full effect of the medicine is felt.
• Do not take this medicine together with the herbal remedy St John's Wort, as it does not mix well with any antidepressant.

Storage

• Keep your tablets in the pack until it is time to take them
• Keep them in a cool, dry place where it stays below 30°C
• Store away from moisture, heat or sunlight; do not store in the bathroom, near a sink, in the car, or on windowsills
• Keep where children cannot reach it
• Discard the medicine when the expiry date (EXP) printed on the pack has passed
• If you no longer need the medicine or it is out of date, take it to any pharmacy for safe disposal

When to see a doctor

• Seek medical advice right away if you notice signs of liver problems such as dark urine, pale stools, yellowing of the skin or eyes, pain in the upper right abdomen, or unexplained tiredness.
• If you have any thoughts about suicide or harming yourself, call your doctor immediately and also contact someone you trust.
• Get help right away if you or someone you know shows worsening depression or anxiety, talk of death or suicide, talk of self-harm or harming others, any recent self-harm attempts, or increased aggression, irritability, or agitation.
• Call your doctor right away or go to the Emergency Department if you notice signs of a severe liver reaction, such as yellowing of the skin or eyes, unusual bleeding or bruising, confusion, loss of consciousness, or hallucinations.
• Seek urgent medical attention if you think you have taken too much of this medicine, even if you feel fine, as overdose can cause stomach pain, drowsiness, tiredness, agitation, anxiety, dizziness, or bluish discoloration of the skin.
• If you breastfeed while taking this medicine and your baby becomes restless, very sleepy, or has feeding problems, seek medical advice urgently.

Alternatives

• Fluoxetine
• Sertraline
• Mirtazapine