Loette Special Precautions

levonorgestrel + ethinylestradiol




Zuellig Pharma


Full Prescribing Info
Special Precautions
Medical examinations: Before COC use is initiated, a thorough individual history, family history, and physical examination, including a blood pressure determination, should be performed. An examination of the breasts, liver, extremities, and pelvic organs should also be conducted. A Papanicolaou (Pap) smear should be performed if the patient has been sexually active or if it is otherwise indicated.
Such medical examinations should be repeated at least annually during the use of COCs.
The first follow-up visit should occur 3 months after COCs are prescribed. At each annual visit, examination should include those procedures that were performed at the initial visit, as described previously.
The following conditions require strict medical supervision during the use of oral contraceptives. Deterioration of some of these conditions may indicate that the oral contraceptive should be discontinued: diabetes mellitus or a tendency towards diabetes mellitus, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, migraine, epilepsy, porphyria, tetany, chorea, renal dysfunction, systemic lupus erythematosus, obesity, family history of breast cancer and patient history of breast nodules, history of clinical depression, and conditions aggravated by fluid retention.
In predispose women, use of an oral contraceptive may sometimes cause chloasma which is aggravated by exposure to the sun. Women who have this tendency should therefore avoid prolonged exposure to the sun.
Individual cases of intolerance to contact lenses have been reported in users of oral contraceptives. Contact lens wearers who develop changes in lens tolerance should be assessed by an ophthalmologist.
Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
Vomiting or diarrhea may reduce the efficacy of oral contraceptives. During these gastrointestinal disturbances, tablet taking should be continued in order to avoid premature withdrawal bleeding. Also, additional nonhormonal methods of contraception (with the exception of the rhythm or temperature methods) should be used for the duration of the gastrointestinal disturbances and for 7 days following the upset. If the 7 days run beyond the end of the pack, the tablet-free interval is disregarded, and a new pack is started on the day following the intake of the last tablet in the previous pack. The user is unlikely to have a withdrawal bleed until the end of the second pack, but the patient may experience spotting or breakthrough bleeding on tablet-taking days. If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming tablet-taking. If the gastrointestinal disturbance is protracted, other methods of contraception should be considered.
In women receiving long-term therapy with hepatic enzyme inducers, another method of contraception should be advised (see Interactions).
Women receiving short courses of therapy with hepatic enzyme inducers or certain broad spectrum antibiotics should use additional nonhormonal methods of contraception (with exception of the rhythm or temperature methods) in addition to regular intake of Loette during the time of concomitant administration of interacting drugs (see Interactions). The additional contraception should continue during the intake of the concurrent medication and for 7 days after its discontinuation.
If these 7 days run beyond the end of the pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the woman does not experience a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming with the next pack.
With rifampicin, additional contraceptive precautions should be continued for 4 weeks after the drug's discontinuation, even if only a short course was administered.
Carbohydrate and lipid effects: Glucose intolerance has been reported in COC users. Women with impaired glucose tolerance or diabetes mellitus who use COCs should be carefully monitored. (See Contraindications.)
A small proportion of women will have adverse lipid changes while taking OCs.
Nonhormonal birth control should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small proportion of COC users.
Elevations of plasma triglycerides in COC users may lead to pancreatitis and other complications.
Estrogens increase serum high-density lipoproteins (HDL cholesterol), whereas a decline in serum HDL cholesterol has been reported with many progestational agents. Some progestins may elevate low-density lipoprotein (LDL) levels and may render the control of hyperlipidemias more difficult. The net effect of a COC depends on the balance achieved between doses of estrogen and progestin and the nature and absolute amount of progestins used in the contraceptive. The amount of both hormones should be considered in the choice of a COC.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use COCs.
Genital bleeding: In some women withdrawal bleeding may not occur during the tablet-free interval. If the COC has not been taken according to directions prior to the first missed withdrawal bleed, or if two consecutive withdrawal bleeds are missed, tablet-taking should be discontinued and a nonhormonal back-up method of birth control should be used until the possibility of pregnancy is excluded.
Breakthrough bleeding/spotting may occur in women taking COCs, especially during the first three months of use. The type and dose of progestin may be important. If this bleeding persists or recurs, nonhormonal causes should be considered and adequate diagnostic measures may be indicated to rule out pregnancy, infection, malignancy, or other conditions. If pathology has been excluded, continued use of the COC or a change to another formulation may solve the problem.
Some women may encounter post-pill amenorrhea (possibly with anovulation) or oligomenorrhea, especially when such a condition was preexistent.
Depression: Women with a history of depression who use COCs should be carefully observed and the drug discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking COCs should stop the medication and use an alternative method of birth control in an attempt to determine whether the symptom is drug-related.
Other: Patients should be counseled that this product does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations (see Advise in case of vomiting and/or diarrhea under Dosage & Administration and Interactions).
Effects on activities requiring concentration and performance: Not applicable.
Use in Children: Safety and efficacy of COCs have been established in women of reproductive age. Use of these products before menarche is not indicated.
Use in Elderly: COCs are not indicated for use in postmenopausal women.
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