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 a tablet for oral use. It works by inhibiting ovulation and altering cervical mucus and endometrial lining, thereby preventing fertilisation and implantation in women of reproductive age seeking reliable contraception.

GNH India supplies Kelzyn as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing consistent quality and regulatory‑aligned sourcing for global contraceptive needs. Our distribution network ensures timely delivery and compliance with local import regulations.

Manufacturer / TM Owner

Exeltis Healthcare S.L

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Indications & Clinical Uses

  • Kelzyn, a combined oral contraceptive, is indicated for hormonal contraception in women.
  • Prevention of pregnancy: provides reliable contraceptive protection by suppressing ovulation and altering cervical mucus.
  • Hormonal contraception: maintains regular menstrual cycles while preventing fertilisation.
  • Family planning: offers a reversible, user‑controlled method for women seeking to avoid unintended pregnancy.

How It Works

  • Dienogest/Ethinylestradiol combines a progestogen (dienogest) with an estrogen (ethinylestradiol) to suppress the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH), thereby inhibiting ovulation. The progestogen also thickens cervical mucus and induces endometrial changes that reduce the likelihood of fertilisation and implantation.

Side Effects

Kelzyn may cause a range of adverse reactions. Most are mild and transient, but serious events can occur.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Breast tenderness: discomfort or swelling of the breasts.
  • Headache: occasional throbbing or tension‑type pain.
  • Breakthrough bleeding: spotting between periods.
  • Weight gain: modest increase in body weight.
  • Mood changes: irritability or emotional fluctuations.

Serious or Rare Side Effects

  • Deep vein thrombosis: blood clot formation in deep veins.
  • Pulmonary embolism: clot migration to the lungs.
  • Stroke or myocardial infarction: severe cardiovascular events.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.
  • Liver dysfunction: abnormal liver enzyme levels.
  • Vision changes: rare ocular disturbances.

Precautions & Warnings

  • Before prescribing Kelzyn, clinicians should assess individual risk factors and advise patients accordingly.
  • Contraindicated in pregnancy: product is classified as Category X and must not be used by pregnant women.
  • Avoid in smokers over 35: increased risk of cardiovascular events.
  • Screen for thromboembolic risk: assess history of clotting disorders before prescribing.
  • Monitor blood pressure: oral contraceptives may elevate BP.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine): reduced contraceptive efficacy.
  • Rifampicin and other strong inducers: may decrease hormone levels.
  • HIV protease inhibitors: potential pharmacokinetic interactions.

Moderate Interactions (Monitor Closely)

  • St. John’s wort: may lower hormone concentrations.
  • Antifungal azoles (e.g., ketoconazole): may increase hormone exposure.
  • Selective serotonin reuptake inhibitors: possible mood‑related effects.

Frequently Asked Questions

Kelzyn is a combined oral contraceptive indicated for the prevention of pregnancy in women of reproductive age. It provides a reversible, hormone‑based method of birth control by suppressing ovulation and creating cervical mucus conditions that hinder fertilisation.

The formulation contains dienogest, a progestogen, and ethinylestradiol, an estrogen. Together they inhibit the mid‑cycle surge of luteinising hormone (LH) and follicle‑stimulating hormone (FSH), preventing ovulation. Additionally, they thicken cervical mucus and alter the endometrium, reducing the chance of fertilisation and implantation.

The dosing regimen for Kelzyn is determined by the prescribing healthcare professional. Typically, combined oral contraceptives are taken once daily for a defined cycle, but the exact schedule, tablet strength and duration should follow the prescriber's instructions and the product label.

Kelzyn is classified as pregnancy category X, meaning it must not be used during pregnancy because it can cause harm to the fetus. Safety during breastfeeding has not been established; women should consult their healthcare provider before using any hormonal contraceptive while nursing.

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 (including any cold‑chain requirements) and the necessary import documentation.

Kelzyn contains the specific progestogen dienogest combined with ethinylestradiol, offering a distinct hormonal profile that may provide better cycle control and lower androgenic side effects compared with some older formulations. Efficacy in preventing pregnancy is comparable to other approved combined pills, while the side‑effect profile may differ slightly.

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

Kelzyn is taken orally, usually once daily at the same time each day, following the regimen outlined by the prescriber (e.g., 21 active tablets followed by a placebo week). Swallow the tablet whole with water; do not split, crush, or chew the tablet.

Serious risks include thromboembolic events such as deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. Rare but severe reactions can involve severe allergic responses, liver dysfunction, and vision changes. Patients should seek immediate medical attention if they experience symptoms like chest pain, shortness of breath, severe headache, or leg swelling.

Kelzyn should not be used by women who are pregnant, have a known hypersensitivity to any component, have a history of thromboembolic disorders, uncontrolled hypertension, active liver disease, or are smokers over the age of 35. It is also contraindicated in individuals with certain hormone‑sensitive cancers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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