Lipz/Lipz ED Special Precautions

Use of estrogen-progestin oral contraceptives is associated with an increased risk of several serious conditions including thromboembolism, arterial thrombosis (e.g., stroke, myocardial infarction), liver tumor, gallbladder disease, visual disturbance, fetal abnormalities, and hypertension.
Adverse cardiovascular and cerebral effects: Cigarette smoking increases the risk of serious adverse cardiovascular effects during oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes daily) and is markedly greater in women older than 35 years of age. Women older than 35 years of age who smoke, and women with ischemic heart disease or a history of this disease, should not use estrogen-progestin contraceptives.
Women receiving LIPZ and LIPZ ED should be advised to notify their clinician if signs or symptoms of thromboembolic or thrombotic disorders occur, including sudden severe headache or vomiting, disturbance of vision and speech, sudden partial or complete loss of vision, dizziness or faintness, weakness or numbness in an extremity, sharp or crushing chest pain, unexplained cough, hemoptysis, sudden shortness of breath, calf pain, or heaviness in the chest. The drugs should be discontinued if an arterial or venous thrombotic event occurs during therapy.
Additionally, because the use of oral contraceptives reportedly increases the risk of postsurgery thromboembolic complications by 2 to 4-fold, it is advised to discontinue LIPZ and LIPZ ED at least 4 weeks before and 2 weeks after surgery and during and following prolonged immobilization.
Hypertriglyceridemia, hypertension, fluid retention, and decreased glucose tolerance have been reported following the use of oral contraceptives. Women with a history of hypertension, hypertension-related diseases, or renal diseases should be encouraged to use another method of contraception.
Carcinomas: There are no conclusive evidences whether the use of oral contraceptives correlate with the incidences of breast, endometrial, ovarian, and cervical cancer or not. However, women with history of or current aforementioned cancers should not use LIPZ and LIPZ ED as a form of contraception. In addition, annual clinical surveillance, including medical history and physical examination, breast radiographic or mammographic findings, pap smear, and relevant laboratory tests for those who use them are advised.
Benign and malignant hepatic adenomas have been associated with the use of oral contraceptives. Women receiving LIPZ and LIPZ ED should also be advised to inform their clinician if severe abdominal pain or mass (indicating a possible liver tumor), jaundice, severe mental depression, edema, or unusual bleeding occurs.
Hyperkalemia: LIPZ and LIPZ ED contains the progestin drospirenone that has antimineralocorticoid activity. They should not be used in patients with conditions that predispose to hyperkalemia (e.g., renal insufficiency, hepatic dysfunction, adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium level checked during the first treatment cycle.
Bleeding between periods: With all Pills, for the first few months, there might be irregular vaginal bleeding (spotting or breakthrough bleeding) between periods. It is advised to use sanitary protection while continuing taking the tablets as normal. Irregular bleeding usually stops once the body adjusts to the Pill (usually after about 3 tablets-taking cycles). If it continues, becomes heavy or starts again, contact the doctor.
What to do if no bleeding occurs: If the patient takes all the tablets correctly, have not had any vomiting or severe diarrhea, or have not taken any other medications, it is highly unlikely for the patient to be pregnant. It is advised to continue taking LIPZ and LIPZ ED as usual.
If the patient has taken the tablets incorrectly, or, if they have taken the tablets correctly but the expected bleeding does not happen twice in a row, they might be pregnant. Instruct the patient to contact their doctor immediately as they may be pregnant. It is recommended to not start the next pack until it is certain that they are not pregnant. In the meantime, use non-hormonal contraceptive measures.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.