Presentation

Ramelta Tablet: Each Tablet contains Ramelteon INN 8 mg.

Description

Ramelteon is a melatonin (MT) 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. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind to neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine and opiates.

Indications

Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

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. 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

Most common adverse reactions are somnolence, dizziness, fatigue, nausea, headache, and exacerbated insomnia. Hallucinations, behavioral changes such as bizarre behavior, agitation and mania have been reported with Ramelteon use. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably.

Precautions

There may be a chance of occurrence of angioedema, anaphylaxis, hallucinations, decreased testosterone level and increased prolactine 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.

Drug 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.

Over Dose

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 drug overdose, respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures should be employed.

Commercial Pack

Ramelta Tablet: Each box contains 1 blister strip of 10 Tablets.