Indications & Uses
Aleena 4 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Drospirenone (white active and light pink inert tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days; one white active tablet daily during the first 24 days and one light pink inert tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.Instructions for starting of Drospirenone: Starting in females with no current use of hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Drospirenone active tablets are white (Day 1 to Day 24). Drospirenone inert tablets are light pink (Day 25 to Day 28).Day 1 Start : Take the first white active tablet on the first day of menses. Take subsequent white active tablets once daily at the same time each day for a total of 24 days. Take one light pink inert tablet daily for 4 days and at time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). Instructions for switching of Drospirenone: Switching from another contraceptive method to Drospirenone: Start Drospirenone. A Combined Oral Contraceptive (COC): On the day when the new pack of the previous COC would have started. Transdermal Patch: On the day when next application would have been scheduled. Vaginal ring: On the day when next insertion would have been scheduled. Injection: On the day when next injection would have been scheduled. Intrauterine contraceptive: On the day of removal. Implant: On the day of removal. Refer to the Patient Information and Instructions for Use for additional instructions for counseling patient concerning proper use.
Side Effects
The following clinically significant Side Effects are described elsewhere in other sections of the labeling: Hyperkalemia Bleeding Irregularities and Amenorrhea Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions: Acne Metrorrhagia Headache Breast pain Weight increased Dysmenorrhea Nausea Vaginal hemorrhage Libido decreased Breast tenderness Menstruation irregularity
Cautions & Contraindications
Warnings & Precautions
Hyperkalemia: Droslyn, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. Droslyn is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Females receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked prior to starting treatment and during the first treatment cycle. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with Droslyn. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin. Monitor females taking Droslyn who later develop medical conditions and/or begin medication that put them at an increased risk for hyperkalemia.Thromboembolic Disorders: Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism. It is unknown whether the risk of VTE is increased with Droslyn alone; however, if there is a risk, it is expected to be lower than that of Droslyn in combination with ethinyl estradiol. When prescribing Drosperinone, consider the increased risk of thromboembolism inherent in the postpartum period and in females with a history of thromboembolism. Discontinue Drosperinone if arterial or venous thromboembolic events occur. Consider discontinuing Droslyn, if feasible, in case of Droslyn prolonged immobilization due to surgery or illness.Bone Loss: Treatment with Droslyn leads to decreased estradiol serum levels. It is unknown if this may cause a clinically relevant loss of bone mineral density.Liver Disease: Discontinue Droslyn if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and Droslyn causation has been excluded. Droslyn is contraindicated in females with liver tumors, benign or malignant, or hepatic impairment.Ectopic Pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on Droslyn.Risk of Hyperglycemia in Patients with Diabetes: Some patients receiving progestins, including Droslyn, may exhibit a decrease in insulin sensitivity. Therefore, patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring.Bleeding Irregularities and Amenorrhea: Females using Droslyn may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy. If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two active tablets or started taking them on a day later than she should have, consider the possibility of pregnancy at the time of the first missed period and perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.Depression: Carefully observe females for a history of depression and discontinue Droslyn if depression recurs to a serious degree. Data on the association of progestin-oacontraceptive products with onset of depression and exacerbation of depression are limited.
Contraindications
Renal impairment Adrenal insufficiency Presence or history of progestin sensitive cancers Liver tumors, benign or malignant, or hepatic impairment Undiagnosed abnormal uterine bleeding