Product image of Kelzyn (Dienogest, Ethinylestradiol | Lactose) supplied by GNH India

Kelzyn

Active Ingredient:
Dienogest, Ethinylestradiol | Lactose
Origin:
EU

Kelzyn (Dienogest, Ethinylestradiol | Lactose)

Dienogest/Ethinylestradiol, the active ingredient in Kelzyn, is a combined oral contraceptive presented as an oral tablet for oral use. It is indicated for prevention of pregnancy and for the treatment of menstrual disorders such as dysmenorrhea and irregular bleeding.

GNH India supplies Kelzyn as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution. Kelzyn is manufactured under EU GMP guidelines, ensuring consistent potency and safety for end‑users.

Manufacturer / TM Owner

Exeltis Healthcare S.L

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Indications & Clinical Uses

Kelzyn, a combined oral contraceptive, acts on the hypothalamic‑pituitary‑ovarian axis to prevent ovulation and regulate menstrual cycles.

  • Prevention of pregnancy: suppresses ovulation and creates an unfavorable uterine environment, providing reliable birth control.
  • Dysmenorrhea: reduces menstrual pain by stabilizing hormonal fluctuations.
  • Irregular menstrual bleeding: normalizes cycle length and flow, improving menstrual regularity.

How It Works

  • Dienogest/Ethinylestradiol combines a progestogenic component (dienogest) with an estrogen (ethinylestradiol). The estrogen suppresses the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH), while the progestogen reinforces the inhibition of ovulation, thickens cervical mucus, and induces endometrial changes that prevent fertilisation and implantation. It also provides negative feedback to the hypothalamus, reducing gonadotropin‑releasing hormone release, which further stabilises the hormonal milieu.

Side Effects

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

Common Side Effects

  • Nausea: mild stomach upset, often transient.
  • Breast tenderness: discomfort or swelling of the breasts.
  • Headache: mild to moderate intensity.
  • Weight gain: modest increase in body weight.
  • Mood changes: irritability or emotional fluctuations.
  • Breakthrough bleeding: spotting between periods.

Serious or Rare Side Effects

  • Venous thromboembolism: deep vein thrombosis or pulmonary embolism.
  • Arterial thrombosis: stroke or myocardial infarction.
  • Hypertension: significant increase in blood pressure.
  • Liver disorders: jaundice or hepatic dysfunction.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Visual disturbances: sudden loss of vision or eye pain.

Precautions & Warnings

Before prescribing Kelzyn, clinicians should evaluate several safety considerations.

  • Pregnancy contraindication: the product must not be used during pregnancy (Category X).
  • Smoking in women over 35: increases risk of cardiovascular events; avoid use.
  • History of thromboembolism: contraindicated due to elevated clotting risk.
  • Liver disease: impaired metabolism may increase adverse effects.
  • Hypertension: monitor blood pressure regularly.
  • Breast cancer history: avoid use as estrogen component may stimulate tumor growth.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Kelzyn can interact with other medicines, altering its effectiveness or safety profile.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., phenytoin, carbamazepine): markedly reduce contraceptive efficacy.
  • Antiretroviral agents (e.g., efavirenz): decrease hormone levels, risking breakthrough ovulation.
  • St John’s wort: herbal inducer that lowers plasma concentrations of the active ingredients.

Moderate Interactions (Monitor Closely)

  • Antibiotics (tetracycline, doxycycline): may slightly diminish contraceptive effect.
  • Antifungal agents (ketoconazole, itraconazole): can increase hormone levels, raising side‑effect risk.
  • SSRIs (e.g., fluoxetine): may affect bleeding patterns.
  • Diuretics (e.g., spironolactone): can alter fluid balance and blood pressure.
  • NSAIDs (e.g., ibuprofen): may increase risk of hypertension.

Frequently Asked Questions

Kelzyn is a combined oral contraceptive that contains dienogest and ethinylestradiol. It is prescribed to prevent pregnancy and to treat menstrual disorders such as dysmenorrhea and irregular bleeding by stabilising hormonal cycles.

The ethinylestradiol component suppresses the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH), preventing ovulation. Dienogest adds progestogenic activity that further inhibits ovulation, thickens cervical mucus, and alters the endometrium, making fertilisation and implantation unlikely.

The dosing regimen for Kelzyn is determined by the prescribing healthcare professional. Typically, the product is taken as one tablet daily at the same time each day, but the exact schedule should follow the prescriber’s instructions.

Kelzyn is contraindicated in pregnancy (Category X) and must not be used by women who are pregnant. It is also not recommended during breastfeeding because the hormones can pass into breast milk and may affect the infant.

To order Kelzyn, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Kelzyn contains the progestogen dienogest, which has a lower androgenic profile than some older progestins. This can result in fewer androgen‑related side effects such as acne. Efficacy in preventing pregnancy is comparable to other combined oral contraceptives, while the menstrual‑regulating benefits may be more pronounced for some users.

Kelzyn tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original blister pack, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain tablet integrity.

Kelzyn is taken orally as a tablet. The recommended practice is to swallow one tablet each day, preferably at the same time each day, with or without food. Consistent daily intake helps maintain stable hormone levels and maximises contraceptive effectiveness.

The most serious risks include venous or arterial thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, or myocardial infarction. Additional serious concerns are severe hypertension, liver dysfunction, and rare allergic reactions that may require immediate medical attention.

Kelzyn should not be used by women who are pregnant, have a history of thromboembolic disorders, uncontrolled hypertension, severe liver disease, known or suspected breast cancer, or who smoke cigarettes and are over 35 years of age. It is also contraindicated in individuals with known hypersensitivity to any component of the tablet.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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