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

Kelzyn

Active Ingredient:
Dienogest, Ethinylestradiol | Lactose
Origin:
EU

Kelzyn (Dienogest, Ethinylestradiol | Lactose)

Dienogest, the active ingredient in Kelzyn, is a combined oral contraceptive presented as an oral tablet for oral use. Together with ethinylestradiol, it provides hormonal regulation for contraception and menstrual cycle control in women of reproductive age, and the formulation includes lactose as an inactive filler complying with EU standards.

GNH India supplies Kelzyn as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality assurance, regulatory compliance, and reliable logistics for global distribution.

Manufacturer / TM Owner

Exeltis Healthcare S.L

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Indications & Clinical Uses

Kelzyn, a combined oral contraceptive, acts on the hormonal regulation of the female reproductive system.

  • Contraception: provides effective prevention of pregnancy by inhibiting ovulation.
  • Menstrual cycle regulation: helps achieve more predictable and lighter bleeding patterns.
  • Dysmenorrhea management: reduces menstrual pain and associated symptoms in women.

How It Works

  • Dienogest is a synthetic progestogen that binds to progesterone receptors, suppressing the mid‑cycle surge of luteinizing hormone and follicle‑stimulating hormone, thereby preventing ovulation. Ethinylestradiol, an estrogen, complements this effect and together they induce endometrial changes and thicken cervical mucus, creating an environment unfavorable for fertilization and implantation.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Headache: tension‑type or migraine‑like pain.
  • Breast tenderness: swelling or discomfort.
  • Spotting: irregular light bleeding.
  • Weight gain: mild fluid retention.
  • Mood changes: irritability or emotional fluctuations.

Serious or Rare Side Effects

  • Deep‑vein thrombosis: blood clot formation in legs.
  • Pulmonary embolism: clot traveling to lungs.
  • Stroke: cerebrovascular event.
  • Myocardial infarction: heart attack.
  • Severe allergic reaction: rash, swelling, difficulty breathing.
  • Liver dysfunction: jaundice or abnormal liver enzymes.

Precautions & Warnings

Kelzyn should be used only after a medical assessment of individual risk factors.

  • Smoking: avoid if over 35 years of age due to increased thrombotic risk.
  • Cardiovascular disease: assess history of hypertension, heart disease, or stroke before prescribing.
  • History of thromboembolism: contraindicated in patients with prior clotting events.
  • Liver disease: use with caution in active hepatic disorders.
  • Migraine with aura: contraindicated due to elevated stroke risk.
  • Store at ambient temperature: keep below 25 °C in the original pack, protect from moisture.

Avoid Interactions

Kelzyn may interact with several medicines that affect its efficacy or safety.

Major Interactions (Avoid)

  • Enzyme inducers (e.g., rifampin, carbamazepine): reduce contraceptive effectiveness.
  • Anticoagulants (e.g., warfarin): may alter clotting parameters.
  • Antiretrovirals (protease inhibitors): decrease hormone levels.
  • St. John’s wort: diminishes contraceptive protection.

Moderate Interactions (Monitor Closely)

  • Antifungals (e.g., ketoconazole): may increase hormone concentrations.
  • Antibiotics (e.g., tetracycline): possible reduced efficacy.
  • SSRIs (e.g., fluoxetine): may affect hormone metabolism.
  • Diuretics (e.g., hydrochlorothiazide): monitor blood pressure changes.

Frequently Asked Questions

Kelzyn is a combined oral contraceptive containing dienogest and ethinylestradiol. It is prescribed to prevent pregnancy and to regulate menstrual cycles in women of reproductive age. It may also be used to manage menstrual‑related symptoms such as irregular bleeding or dysmenorrhea under medical supervision.

Dienogest is a synthetic progestogen that binds to progesterone receptors, suppressing the mid‑cycle surge of luteinizing hormone and follicle‑stimulating hormone, thereby preventing ovulation. In combination with ethinylestradiol, it also induces changes in the endometrium and thickens cervical mucus, creating an environment that is unfavorable for fertilization and implantation.

The dosage regimen for Kelzyn is determined by the prescribing healthcare professional. Typically, the product is taken once daily at the same time for a 21‑day active phase followed by a 7‑day hormone‑free interval, but the exact schedule and any adjustments are individualized based on the patient’s medical history and response.

Kelzyn is intended for use by women who are not pregnant. If pregnancy occurs, the medication should be discontinued and alternative contraception considered. Use during breastfeeding is generally not recommended unless the benefits outweigh potential risks, and this decision should be made by a qualified healthcare provider.

To place an order, submit an enquiry on the Kelzyn product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, and will request verification of trade or institutional credentials. After confirmation, the team provides pricing, availability, shipping details, and assists with any necessary import documentation.

Kelzyn contains dienogest, a progestogen with a relatively low androgenic profile, combined with ethinylestradiol, which may offer a favorable bleeding pattern and reduced risk of certain side effects compared with some older formulations that use levonorgestrel. However, efficacy, safety, and tolerability are comparable across approved combined pills, and the choice depends on individual patient factors and clinician judgment.

Kelzyn tablets should be stored at ambient temperature, below 25 °C, in the original blister pack or container to protect them from moisture and light. Keep the medication out of reach of children and do not use if the packaging is damaged or the tablets appear discolored.

Kelzyn is taken orally, usually with water, once each day at the same time. The typical regimen consists of 21 consecutive days of active tablets followed by a 7‑day interval without active tablets, during which a withdrawal bleed occurs. Patients should not skip doses and should follow the schedule prescribed by their healthcare provider.

The most serious risks include thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, and myocardial infarction, especially in women who smoke, have a history of clotting disorders, or possess cardiovascular risk factors. Rare cases of severe allergic reactions and liver dysfunction have also been reported. Prompt medical attention is required if symptoms of these conditions appear.

Kelzyn is contraindicated in women with a known hypersensitivity to any component, a history of thromboembolic disorders, uncontrolled hypertension, active liver disease, breast cancer, or estrogen‑dependent tumors. It should also be avoided by smokers over 35 years of age and by those with migraine with aura. A thorough medical evaluation is essential before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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