Floren Tablet

Floren tablet is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:

• A co-existing medical or psychiatric condition
• Problems within the relationship, or
• The effects of a medication or other drug substance

The mechanism of action of Flibanserin in the treatment of premenopausal women with hypoactive sexual desire disorder is not known. Flibanserin demonstrated high affinity for 5-HTIA & 5-HT2A receptors, showing agonist activity on 5-HTIA & antagonist on 5-HT2A, resulting in lowering of serotonin in the brain as well as effect on increasing norepinephrine and dopamine neurotransmitters.

Recommended dosage of Flibanserin: 100 mg taken once daily at bedtime.

Pediatric Use: Not recommended in patients below 18 years of age.

Geriatric Use: Flibanserin is not indicated for use in geriatric patients. Safety and effectiveness have not been established in geriatric patients.

Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases Floren exposures and incidence of adverse reactions.

Strong CYP2C19 Inhibitors: Increases Floren exposure which may increase risk of hypotension, syncope, and CNS depression.

CYP3A4 Inducers: Use of Floren not recommended; Floren concentrations substantially reduced.

Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.

Flibanserin is contraindicated:

• With use of alcohol,
• With concomitant use with moderate or strong CYP3A4 inhibitors,
• In patients with hepatic impairment.

Most common side effects are Dizziness, Somnolence, Nausea, Fatigue, Insomnia, Dry mouth.

There are no studies of Flibanserin in pregnant women to inform whether there is a drug-associated risk in humans. Flibanserin is excreted in rat milk. It is unknown whether flibanserin is present in human milk, whether Flibanserin has effects on the breastfed infant, or whether Flibanserin affects milk production. Because of the potential for serious adverse reactions including sedation in a breastfed infant, breastfeeding is not recommended during treatment with Flibanserin.

Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. Exacerbated by other CNS depressants and in settings where Floren concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least 6 hours after each dose and until they know how Floren affects them.

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.