Duoluton-L Side effects

• Side effects of Duoluton-L in details
• Duoluton-L contraindications
• Duoluton-L reviews

What are the possible side effects of Duoluton-L?

Get emergency medical help if you have any of these signs of an allergic reaction to Duoluton-L: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Duoluton-L and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;

• sudden and severe headache, confusion, problems with vision, speech, or balance;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• a change in the pattern or severity of migraine headaches;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious Duoluton-L side effects may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

• breast tenderness or swelling, nipple discharge;

• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

• changes in weight or appetite;

• problems with contact lenses;

• vaginal itching or discharge; or

• changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Duoluton-L in details

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

• Serious cardiovascular events and stroke
• Vascular events
• Liver disease

Adverse reactions commonly reported by COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

Clinical Trial Experience

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 the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The clinical trial that evaluated the safety and efficacy of Duoluton-L was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of Duoluton-L (345.14 woman-years of exposure).

Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the Duoluton-L group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).

Common Adverse Reactions (≥ 2% of women): headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).

Serious Adverse Reactions: pulmonary embolus, cholecystitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Duoluton-L. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis

What is the most important information I should know about Duoluton-L?

• Duoluton-L may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Duoluton-L with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
• If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Duoluton-L.
• You should usually not take Duoluton-L within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.
• Duoluton-L may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Use of Duoluton-L will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).
• Bleeding or spotting may occur while taking Duoluton-L. Do not stop taking Duoluton-L if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
• Smoking while using Duoluton-L may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
• Duoluton-L may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Duoluton-L.
• Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Duoluton-L may decrease the effectiveness of Duoluton-L. To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
• Duoluton-L may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Duoluton-L. Discuss any concerns with your doctor or pharmacist.
• Lab tests, such as PAP tests, may be performed while you use Duoluton-L. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Duoluton-L should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: Do not use Duoluton-L if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Duoluton-L is found in breast milk. Do not breast-feed while taking Duoluton-L.

Duoluton-L contraindications

Do not prescribe Duoluton-L to women who are known to have the following conditions:

•

A high risk of arterial or venous thrombotic disease. Examples include women who are known to:

o

Smoke, if over age 35.

o

Have deep vein thrombosis or pulmonary embolism, now or in the past.

o

Have inherited or acquired hypercoagulopathies.

o

Have cerebrovascular disease.

o

Have coronary artery disease.

o

Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation).

o

Have uncontrolled hypertension.

o

Have diabetes mellitus with vascular disease.

o

Have headaches with focal neurological symptoms or have migraine headaches with aura.

•

Women over age 35 with any migraine headaches.

•

Liver tumors, benign or malignant, or liver disease

•

Undiagnosed abnormal uterine bleeding.

•

Pregnancy, because there is no reason to use COCs during pregnancy.

•

Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.

•

Hypersensitivity to any of the components.

•

Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

References

1. DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "ESTRADIOL; LEVONORGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. DTP/NCI. "Levonorgestrel: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology