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Liana

Drospirenone and Esterol

Dosage Form: Tablet
Pack Size: 28's


Allygest



Indications:

LIANA® is a combination of Drospirenone, a progestin, and Estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. 


Dosage & Administration:

The recommended dosage of LIANA® is one tablet daily for 28 consecutive days: one pink active tablet daily at the same time during the first 24 days followed by one white inactive tablet daily during the 4 following days.


Contraindications:

LIANA® is contraindicated in females who develop or are known to have the following conditions: 

• A high risk of arterial or venous thrombotic diseases 

• Current or history of a hormonally-sensitive malignancy (e.g., breast cancer) 

• Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis

• Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir 

• Abnormal uterine bleeding that has an undiagnosed etiology

• Renal impairment 

• Adrenal insufficiency


Warning & Precautions:

• Thromboembolic Disorders and Other Vascular Problems: Stop LIANA® if a thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors. 

• Hyperkalemia: Check serum potassium concentration during the first LIANA® treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration. 

• Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly. 

• Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur. 

• Hormonally-Sensitive Malignancy: Discontinue LIANA® if a hormonally-sensitive malignancy is diagnosed.

• Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes. 

• Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia. 

• Gallbladder Disease and Cholestasis: Consider discontinuing LIANA® in females with symptomatic gallbladder or cholestatic disease. 

• Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

5 ADVERSE REACTIONS 

Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased.


Overdose:

Overdosage of CHCs may cause nausea, vomiting, and severe headaches. Individual reports of thromboembolic complications and vaginal bleeding have occurred from overdosage. Pediatric patients with unintended CHC ingestion have reported nausea and vomiting and some developed irritability and drowsiness; rare reports described vaginal bleeding. 

Overdosage Management Recommendations Consider short-term prophylactic anticoagulation therapy for patients with high risk of VTE. Monitor serum potassium and sodium levels, and for evidence of metabolic acidosis. 


Storage Conditions:

Store at 20°C to 25°C & frost free place. Keep away from light. (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. 


Commercial Pack:

LIANA® (Drospirenone and Estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister cards containing 28 tablets. 

• 24 pink active tablets: Each tablet contains Drospirenone USP 3 mg and Estetrol Monohydrate INN equivalent to Estetrol 14.2 mg. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen. 

• 4 white inert tablets.