Ramelta Tablet 8 mg
Ramelta Tablet 8 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Ramelta Tablet 8 mg is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2receptors, and lower selectivity for the MT3 receptor. Melatonin production is concurrent with nocturnal sleep, meaning that an increase in melatonin levels is related to the onset of self-reported sleepiness and an increase in sleep propensity. MT1 receptors are believed to be responsible for regulation of sleepiness and facilitation of sleep onset, and MT2 receptors are believed to mediate phase-shifting effects of melatonin on the circadian rhythm. While MT1 and MT2 receptors are associated with the sleep-wake cycle, MT3 has a completely different profile, and therefore is not likely to be involved in the sleep-wake cycle. Remelteon has no appreciable affinity for the gamma-aminobutyric acid (GABA) receptor complex or receptors that bind neuropeptides, cytokines, serotonin, dopamine, norepinephrine, acetylcholine, or opiates.
Ramelta Tablet 8 mg is the first selective melatonin agonist. It works by mimicking melatonin (MT), a naturally occuring hormone that is produced during the sleep period and thought to be responsible for the regulation of circadian rhythm underlying the normal sleep-wake cycle. Ramelta Tablet 8 mg has a high affinity for the MT1 and MT2 receptors. The MT1 and MT2 receptors are located in the brain's suprachiasmatic nuclei (SCN),which is known as the body's "master clock" because it regulates the 24-hour sleep-wake cycle. Ramelta Tablet 8 mg has an active metabolite that is less potent but circulates in higher concentrations than the parent compound. The metabolite also has weak affinity for the 5HT2b receptor.
Trade Name | Ramelta Tablet 8 mg |
Availability | Prescription only |
Generic | Ramelteon |
Ramelteon Other Names | Ramelteon |
Related Drugs | amitriptyline, lorazepam, melatonin, zolpidem, diphenhydramine, Ativan |
Weight | 8 mg |
Type | Tablet |
Formula | C16H21NO2 |
Weight | Average: 259.3434 Monoisotopic: 259.157228921 |
Protein binding | ~82% (in human serum) |
Groups | Approved, Investigational |
Therapeutic Class | Miscellaneous sedatives & hypnotics |
Manufacturer | Incepta Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
Uses
Ramelta Tablet 8 mgi s used for the treatment of insomnia characterized by difficulty with sleep onset
Ramelta Tablet 8 mg is also used to associated treatment for these conditions: Insomnia
How Ramelta Tablet 8 mg works
Ramelta Tablet 8 mg is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors, and lower selectivity for the MT3 receptor. Melatonin production is concurrent with nocturnal sleep, meaning that an increase in melatonin levels is related to the onset of self-reported sleepiness and an increase in sleep propensity. MT1 receptors are believed to be responsible for regulation of sleepiness and facilitation of sleep onset, and MT2 receptors are believed to mediate phase-shifting effects of melatonin on the circadian rhythm. While MT1 and MT2 receptors are associated with the sleep-wake cycle, MT3 has a completely different profile, and therefore is not likely to be involved in the sleep-wake cycle. Remelteon has no appreciable affinity for the gamma-aminobutyric acid (GABA) receptor complex or receptors that bind neuropeptides, cytokines, serotonin, dopamine, norepinephrine, acetylcholine, or opiates.
Dosage
Ramelta Tablet 8 mg dosage
Adult dose: 8 mg taken within 30 minutes of going to bed. Should not be taken with or immediately after a high-fat meal. The total daily dose should not exceed 8 mg.
Side Effects
Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia
Precaution
Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment.
Abnormal thinking, behavioral changes, complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes.
Depression: Worsening of depression or suicidal thinking may occur.
CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug.
Reproductive effects: Include decreased testosterone and increased prolactin levels. Effect on the reproductive axis in developing humans is unknown
Patients with severe sleep apnea: Rozerem is not recommended for use in this population
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 co administered with donepezil. Doxepin increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is co administered with doxepin.
Alcohol: Causes additive psychomotor impairment; should not be used in combination
Food Interaction
- Avoid alcohol.
- Do not take with or immediately after a high-fat meal.
[Moderate] GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of ramelteon.
Use in combination may result in additive central nervous system depression and In study subjects, administration of a 16 mg dose of ramelteon with a high-fat meal decreased the peak plasma drug concentration (Cmax) by 22% and delayed the median time to reach peak plasma drug concentration (Tmax) by approximately 45 minutes compared to administration in a fasted state. For faster sleep onset, ramelteon should not be administered with or immediately after a high-fat
ADJUST DOSING INTERVAL: Administration of ramelteon with or immediately after a high-fat
MANAGEMENT: Patients receiving ramelteon should be advised to avoid the consumption of alcohol.
Ramelta Tablet 8 mg Drug Interaction
Moderate: aripiprazole, zolpidem, lorazepam, suvorexant, diphenhydramine, duloxetine, venlafaxine, lamotrigine, pregabalin, quetiapine, alprazolam, sertraline, cetirizineUnknown: amphetamine / dextroamphetamine, omega-3 polyunsaturated fatty acids, metoprolol, metoprolol, polyethylene glycol 3350, cyanocobalamin, cholecalciferol
Ramelta Tablet 8 mg Disease Interaction
Major: depression, severe renal impairment, sleep apneaModerate: glaucoma, liver disease
Volume of Distribution
- 73.6 L
Elimination Route
Rapid, total absorption is at least 84%.
Half Life
~1-2.6 hours
Elimination Route
Following oral administration of radiolabeled ramelteon, 84% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 88%. Less than 0.1% of the dose was excreted in urine and feces as the parent compound.
Pregnancy & Breastfeeding use
Pregnancy: Based on animal data may cause fetal harm. Do not use unless the potential benefit justifies the potential risk.
Nursing mothers: Use with caution.
Contraindication
- History of angioedema while taking Ramelta Tablet 8 mg.
- Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination
Special Warning
Pediatric use: Safety and effectiveness not established.
Geriatric use: No overall differences in safety and efficacy between elderly and younger adult subjects.
Hepatic impairment: Is not recommended in patients with severe impairment; use with caution in moderate impairment.
Storage Condition
Store at 25°C; excursions permitted to 15° to 30°C. Keep container tightly closed and protected from moisture and humidity.
Innovators Monograph
You find simplified version here Ramelta Tablet 8 mg
Ramelta Tablet 8 mg contains Ramelteon see full prescribing information from innovator Ramelta Tablet 8 mg Monograph, Ramelta Tablet 8 mg MSDS, Ramelta Tablet 8 mg FDA label
FAQ
What is Ramelta Tablet 8 mg used for?
Ramelta Tablet 8 mg is used to help patients who have sleep-onset insomnia fall asleep more quickly.
How safe is Ramelta Tablet 8 mg?
Ramelta Tablet 8 mg is safe and effective for decreasing the time to persistent sleep in patients with chronic insomnia. It does not have the potential for abuse or dependence that sedative hypnotics have and is not a controlled substance.
How does Ramelta Tablet 8 mg work?
Ramelta Tablet 8 mg work by stimulating receptors for melatonin in the brain.
How long does Ramelta Tablet 8 mg take to work?
Your insomnia should improve within 7 to 10 days after you begin treatment with ramelteon. Call your doctor if your insomnia does not improve during this time or gets worse at any time during your treatment.
Is Ramelta Tablet 8 mg safe during pregnancy?
Ramelta Tablet 8 mg is not recommended for nursing mothers.You should be used only when prescribed during pregnancy.
Is Ramelta Tablet 8 mg safe during breastfeeding?
It is unknown if Ramelta Tablet 8 mg passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.
What are the common side effects of Ramelta Tablet 8 mg?
Common side effects of Ramelta Tablet 8 mg include:
- dizziness,
- tiredness,
- daytime drowsiness,
- nausea, or.
- worsening sleep problems.
How long before bed should you take Ramelta Tablet 8 mg?
Ramelta Tablet 8 mg should be taken 30 minutes before going to bed.
Can I drink alcohol with Ramelta Tablet 8 mg?
Avoid drinking alcohol while using this medicine. Ramelta Tablet 8 mg will add to the effects of alcohol.
How long does Ramelta Tablet 8 mg stay in my system?
Ramelta Tablet 8 mg significantly reduced wakefulness over a wide dosage range with effects lasting up to 6 hours, in contrast to the effects of exogenous melatonin lasting up to 2 hours.
How does Ramelta Tablet 8 mg make me feel?
The most common side effects of Ramelta Tablet 8 mg are dizziness, sleepiness, nausea and exacerbated insomnia.
Can you cut Ramelta Tablet 8 mg in half?
Do not break the tablet.It should be swallowed whole.
Does Ramelta Tablet 8 mg cause memory loss?
Ramelta Tablet 8 mg did not produce cognitive or memory impairment when assessed about 9 hours after administration.
Can I have too much Ramelta Tablet 8 mg?
If you take too much Ramelta Tablet 8 mg or overdose, call your doctor or poison control center right away, or get emergency treatment.
Can Ramelta Tablet 8 mg affect blood pressure?
Acute and chronic Ramelta Tablet 8 mg did not affect blood pressure.
Who should not take Ramelta Tablet 8 mg?
You should not use Ramelta Tablet 8 mg if you are also taking fluvoxamine, or if you have ever had a severe allergic reaction to Ramelta Tablet 8 mg.
What happens if I miss a dose?
Since Ramelta Tablet 8 mg is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medication if you do not have 7 to 8 hours to sleep before being active again.
What should I avoid while taking Ramelta Tablet 8 mg?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.Do not drink alcohol with Ramelta Tablet 8 mg.
Does Ramelta Tablet 8 mg cause vivid dreams?
Shortly after initiation of Ramelta Tablet 8 mg, he described vivid nightmares leading to discontinuation of Ramelta Tablet 8 mg.