Ramelteon
Therapeutic Class: Melatonin Receptor Modulator/Miscellaneous sedatives & hypnotics
Indications:
Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Presentation:
Ramelteon Tablet: Each Tablet contains Ramelteon INN 8 mg.
Description:
Ramelteon is a melatonin (MT) receptor agonist with both high affinities 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. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind to neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine and opiates.
Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Presentation:
Ramelteon Tablet: Each Tablet contains Ramelteon INN 8 mg.
Description:
Ramelteon is a melatonin (MT) receptor agonist with both high affinities 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. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind to neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine and opiates.
Dosage & Administration:
Adults: One tablet (8 mg) taken within 30 minutes of going to bed. It should not be taken with or immediately after a high-fat meal. The total daily dose should not exceed 8 mg.
Elderly.
No overall differences in safety and efficacy between elderly and younger adult subjects.
Children: Safety and effectiveness not established.
Side Effects:
The most common adverse reactions are somnolence, dizziness, fatigue, nausea, headache, and exacerbated insomnia. Hallucinations, behavioural changes such as bizarre behaviour, agitation and mania have been reported with Ramelteon use. Amnesia, anxiety and other neuropsychiatric symptoms may also occur unpredictably.
Precautions:
There may be a chance of occurrence of angioedema, anaphylaxis, hallucinations, decreased testosterone level and increased prolactin level.
Use in Pregnancy & Lactation:
Pregnancy
Pregnancy Category C. Based on animal data it may cause fetal harm. Do not use Ramelteon unless the potential benefit justifies the potential risk.
Lactation: It is not known whether Ramelteon is secreted into human milk. Caution should be exercised when administered to a nursing woman.
Precautions:
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, behavioural changes, complex behaviours: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioural 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.
Use in Special Populations:
Pediatric use: Safety and effectiveness not established.
Geriatric use: No overall differences in safety and efficacy between elderly and younger adult subjects.
Hepatic impairment: This is not recommended in patients with severe impairment; use with caution in moderate impairment.
Storage:
Store at 25°C; excursions permitted to 15° to 30°C. Keep container tightly closed and protected from moisture and humidity.
Adults: One tablet (8 mg) taken within 30 minutes of going to bed. It should not be taken with or immediately after a high-fat meal. The total daily dose should not exceed 8 mg.
Elderly.
No overall differences in safety and efficacy between elderly and younger adult subjects.
Children: Safety and effectiveness not established.
Side Effects:
The most common adverse reactions are somnolence, dizziness, fatigue, nausea, headache, and exacerbated insomnia. Hallucinations, behavioural changes such as bizarre behaviour, agitation and mania have been reported with Ramelteon use. Amnesia, anxiety and other neuropsychiatric symptoms may also occur unpredictably.
Precautions:
There may be a chance of occurrence of angioedema, anaphylaxis, hallucinations, decreased testosterone level and increased prolactin level.
Use in Pregnancy & Lactation:
Pregnancy
Pregnancy Category C. Based on animal data it may cause fetal harm. Do not use Ramelteon unless the potential benefit justifies the potential risk.
Lactation: It is not known whether Ramelteon is secreted into human milk. Caution should be exercised when administered to a nursing woman.
Interaction:
Rifampin: Decreases exposure to and effects of Ramelteon.Ketoconazole: Increases AUC for Ramelteon.Fluconazole: Increases systemic exposure of Ramelteon. Donepezil: Increases systemic exposure of Ramelteon. Doxepin: Increases systemic exposure of Ramelteon.
Overdose:
General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. As in all cases of a drug overdose, respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures should be employed.
Rifampin: Decreases exposure to and effects of Ramelteon.Ketoconazole: Increases AUC for Ramelteon.Fluconazole: Increases systemic exposure of Ramelteon. Donepezil: Increases systemic exposure of Ramelteon. Doxepin: Increases systemic exposure of Ramelteon.
Overdose:
General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. As in all cases of a drug overdose, respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures should be employed.
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, behavioural changes, complex behaviours: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioural 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.
Use in Special Populations:
Pediatric use: Safety and effectiveness not established.
Geriatric use: No overall differences in safety and efficacy between elderly and younger adult subjects.
Hepatic impairment: This is not recommended in patients with severe impairment; use with caution in moderate impairment.
Store at 25°C; excursions permitted to 15° to 30°C. Keep container tightly closed and protected from moisture and humidity.
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