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Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Ramelta.
CONSULT YOUR DOCTOR
Ramelta may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Ramelta is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Monitor the baby for sleepiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed babies.
UNSAFE
Ramelta may cause side effects which could affect your ability to drive.
SAFE IF PRESCRIBED
Ramelta is safe to use in patients with kidney disease. No dose adjustment of Ramelta is recommended.
CAUTION
Ramelta should be used with caution in patients with liver disease. Dose adjustment of Ramelta may be needed. Please consult your doctor.
Use of Ramelta is not recommended in patients with severe liver disease.
Medicine Overview of Ramelta 8mg Tablet
Introduction
Ramelta is a prescription medicine used in the treatment of insomnia. It helps to synchronize the body’s biological day-night rhythm. It resolves trouble falling asleep and ensures sound sleep. Unlike other medicines, it is not habit-forming. Ramelta may be taken with or without food. However, it is advised to take it at a fixed time each day to maintain a consistent level of medicine in the blood. You should never skip any doses and finish the full course of treatment even if you feel better. This medicine should not be stopped suddenly without talking to your doctor. Some common side...
... Show moreUses of Ramelta
- Insomnia
Side effects of Ramelta
Common
- Dizziness
- Sleepiness
- Fatigue
- Insomnia (difficulty in sleeping)
- Nausea
How to use Ramelta
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Ramelta may be taken with or without food, but it is better to take it at a fixed time.
How Ramelta works
Ramelta is a melatonin receptor agonist. Ramelta works like melatonin, a chemical messenger in the brain that helps regulate the sleep-wake cycle.
What if you forget to take Ramelta?
If you miss a dose of Ramelta, skip it and continue with your normal schedule. Do not double the dose.
Quick Tips
- You have been prescribed Ramelta to treat difficulty in falling asleep.
- Take it without food at least 30 minutes before you sleep.
- It may cause increased sleepiness. Do not drive or do anything requiring mental focus until you know how it affects you.
- Avoid taking alcohol while taking this medicine as that may increase the side effects of this medicine.
- Consult with a doctor if your sleep doesn’t improve after 7 to 10 days of treatment.
- Inform your doctor if you notice behavioral changes or new or worsening depression while taking this medicine.
- Stop taking medication and inform your doctor If you experience sleep-driving or memory loss.
Brief Description
Indication
Ramelteon is indicated for the, treatment of insomnia, characterized by difficulty with sleep onset.
Administration
Take within 30 min of going to bed.
Should not be taken with or immediately after a high-fat meal.
Adult Dose
Adult:
Tablet
8 mg taken within 30 minutes of going to bed.
Total daily dose should not exceed 8 mg.
Child Dose
Safety and efficacy not established
Contraindication
Hypersensitivity
Ramelteon is not recommended in patients with severe hepatic impairment.
Patients who develop angioedema after treatment with Ramelteon should not be re-challenged with the drug.
Mode of Action
Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and selectivity over the MT3 receptor.
The activity of ramelteon at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle.
Precaution
In rare cases, severe anaphylactic and anaphylactoid reactions have occurred following use of Ramelteon. Angioedema involving the tongue, glottis, or larynx has been reported. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Reactions may require emergency treatment and may be fatal. Patients who develop such reactions should not be rechallenged. Ramelteon should not be used in patients with severe hepatic impairment or in combination with fluvoxamine. Failure of insomnia to remit after 7–10 days, worsening of insomnia, or emergence of new cognitive or behavioral abnormalities should be medically evaluated, as...
... Show moreSide Effect
Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.
Interaction
Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon.
Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution.
Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution.
Donepezil increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil.
Doxepin increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin.
Alcohol: Causes additive psychomotor impairment; should not be used in combination.
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