GNH USA

Europe — EMA

Mistra (Dienogest, Ethinylestradiol)

GNH USA supplies Mistra (Dienogest/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy. Request a quote for global supply today.

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What is Dienogest, Ethinylestradiol?

Dienogest and Ethinylestradiol, the active ingredients in Mistra, are a combined oral contraceptive presented as a tablet for oral use. They work by inhibiting ovulation and altering cervical mucus, providing reliable pregnancy prevention for women of reproductive age. It is indicated for women seeking a reversible, hormone‑based method of contraception and is marketed throughout the European Union.

GNH USA supplies Mistra as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand.

What is Dienogest, Ethinylestradiol used for?

Mistra, a combined oral contraceptive, is used within the hormonal contraception pathway to prevent pregnancy. - Prevention of pregnancy: provides reliable contraception for women of reproductive age. - Family planning: enables controlled timing of pregnancies. - Menstrual cycle regulation: helps achieve more predictable bleeding patterns.

What are the side effects of Dienogest, Ethinylestradiol?

Mistra may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: tension‑type or migraine‑like pain. - Breast tenderness: swelling or discomfort of the breasts. - Irregular bleeding or spotting: changes in menstrual flow. - Weight gain: modest increase in body weight. - Mood changes: fluctuations in emotional state.

Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins. - Pulmonary embolism: clot migration to the lungs. - Stroke or myocardial infarction: rare cerebrovascular or cardiac events. - Severe hypertension: sudden, high blood pressure. - Hepatic adenoma: benign liver tumor. - Anaphylaxis: severe allergic reaction requiring immediate medical attention.

What precautions apply to Dienogest, Ethinylestradiol?

Before prescribing Mistra, clinicians should evaluate individual risk factors and contraindications. - Contraindicated in pregnancy: product is classified as pregnancy category X and must not be used. - History of thromboembolic disorders: increased risk of clotting events; avoid use. - Hypertension screening: monitor blood pressure regularly during therapy. - Liver disease assessment: hepatic impairment may alter hormone metabolism. - Smoking in women over 35: contraindicated due to elevated cardiovascular risk. - Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

What does Dienogest, Ethinylestradiol interact with?

Mistra can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid): - Enzyme‑inducing anticonvulsants (carbamazepine, phenytoin, phenobarbital): may reduce contraceptive effectiveness. - Rifampin or other strong CYP3A4 inducers: may decrease hormone levels and increase risk of unintended pregnancy. - St. John’s wort: may lower contraceptive effectiveness.

Moderate Interactions (Monitor Closely): - Antifungal azoles (ketoconazole, itraconazole): may increase hormone levels; monitor for side effects. - Macrolide antibiotics (erythromycin, clarithromycin): may slightly raise plasma concentrations; observe for increased adverse reactions.

Frequently asked questions

What is Mistra used for?+
Mistra is a combined oral contraceptive containing dienogest and ethinylestradiol. It is prescribed to prevent pregnancy in women of reproductive age by inhibiting ovulation and creating an environment that reduces the likelihood of fertilisation and implantation.
How does dienogest and ethinylestradiol work in Mistra?+
Dienogest acts as a progestogen, suppressing the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH), which blocks ovulation. Ethinylestradiol provides estrogenic activity that stabilises the endometrium and enhances negative feedback on the hypothalamic‑pituitary axis, further preventing the LH surge and thickening cervical mucus.
What is the usual dose of Mistra?+
The dosing regimen for Mistra is determined by the prescribing healthcare professional. Typically, combined oral contraceptives are taken once daily for a specified cycle, but the exact schedule and any missed‑dose instructions should be provided by the prescriber.
Is Mistra safe to use during pregnancy or breastfeeding?+
Mistra is classified as pregnancy category X, meaning it must not be used during pregnancy because it can cause harm to the fetus. It is also not recommended while breastfeeding, as hormonal contraceptives may affect milk production and infant exposure.
How do I order Mistra from GNH USA?+
To order Mistra, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details (including any cold‑chain requirements), and import documentation.
How does Mistra compare with other combined oral contraceptives?+
Mistra contains dienogest, a progestogen with a favorable bleeding profile, combined with ethinylestradiol. Compared with older COCs that use levonorgestrel, dienogest may result in fewer androgenic side effects and more stable menstrual cycles, while maintaining comparable contraceptive efficacy.
What are the storage and handling requirements for Mistra?+
Mistra tablets should be stored at ambient temperature, below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and keep out of reach of children.
How is Mistra administered?+
Mistra is taken orally, usually once daily at the same time each day. The tablets are swallowed with water and should be started according to the prescriber’s instructions, often on the first day of the menstrual period or after a hormone‑free interval.
What are the most serious risks associated with Mistra?+
The most serious risks include venous thromboembolism, pulmonary embolism, stroke, myocardial infarction, and severe hypertension. These events are rare but require immediate medical attention if symptoms such as chest pain, shortness of breath, severe headache, or leg swelling occur.
Who should not use Mistra?+
Mistra should not be used by women who are pregnant, have a history of thromboembolic disorders, uncontrolled hypertension, certain liver diseases, or who smoke cigarettes and are over 35 years of age. It is also contraindicated in individuals with known hypersensitivity to dienogest, ethinylestradiol, or any tablet excipients.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dienogest, Ethinylestradiol
Route
Oral Use
Manufacturer
Gedeon Richter Plc.
Origin
EU

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