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 a tablet for oral use. It works together with ethinylestradiol to prevent pregnancy in women of reproductive age by inhibiting ovulation and altering cervical mucus during the menstrual cycle.

GNH India supplies Kelzyn as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and other healthcare providers worldwide, ensuring consistent quality and regulatory compliance across markets through robust supply chain management and validated manufacturing processes.

Manufacturer / TM Owner

Exeltis Healthcare S.L

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Indications & Clinical Uses

Kelzyn, a combined oral contraceptive, is used to prevent pregnancy by modulating the hormonal axis.

  • Prevention of pregnancy: provides reliable hormonal contraception for women of child‑bearing potential.
  • Regulation of menstrual cycles: helps achieve more predictable bleeding patterns and reduces menstrual discomfort.
  • Treatment of moderate acne: may improve skin condition by decreasing androgenic activity in some women.

How It Works

  • Kelzyn combines dienogest, a progestogen, with ethinylestradiol, an estrogen. The combination suppresses the hypothalamic‑pituitary‑ovarian axis, reducing luteinizing hormone (LH) and follicle‑stimulating hormone (FSH) secretion, which prevents follicular development and ovulation. It also thickens cervical mucus and induces endometrial changes that hinder implantation, thereby providing contraceptive efficacy.

Side Effects

Kelzyn may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Breast tenderness: discomfort or swelling of the breasts.
  • Headache: occasional throbbing or tension‑type pain.
  • Spotting or breakthrough bleeding: irregular light bleeding between periods.
  • Mood changes: irritability or mild mood swings.
  • Weight gain: modest increase in body weight.

Serious or Rare Side Effects

  • Venous thromboembolism: blood clots in deep veins or lungs.
  • Arterial thrombosis: clot formation in arteries, potentially leading to stroke or heart attack.
  • Severe hypertension: sudden rise in blood pressure.
  • Liver dysfunction: abnormal liver enzymes or jaundice.
  • Anaphylaxis: rare severe allergic reaction.
  • Visual disturbances: sudden changes in vision or eye pain.

Precautions & Warnings

Before prescribing Kelzyn, clinicians should evaluate individual risk factors and counsel patients on safe use.

  • Cardiovascular assessment: review history of thromboembolic events or clotting disorders.
  • Smoking status: avoid use in women over 35 who smoke.
  • Liver function: assess hepatic disease before initiation.
  • Pregnancy screening: confirm patient is not pregnant before starting therapy.
  • Contraindications: do not use in known thrombophilia, breast cancer, or uncontrolled hypertension.
  • Drug interactions: review concomitant medications that may affect efficacy.
  • Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Kelzyn can interact with several medicines, altering its contraceptive effectiveness or increasing adverse risk.

Major Interactions (Avoid)

  • Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): markedly reduce hormonal levels.
  • Rifampin and other strong CYP3A4 inducers: may cause contraceptive failure.
  • St. John's wort: herbal inducer that lowers estrogen exposure.

Moderate Interactions (Monitor Closely)

  • Certain antibiotics (e.g., tetracycline, metronidazole): may slightly reduce effectiveness.
  • Antifungal agents (e.g., ketoconazole, itraconazole): can increase hormone concentrations.
  • Protease inhibitors and some antiretrovirals: may require additional non‑hormonal contraception.

Frequently Asked Questions

Kelzyn is a combined oral contraceptive containing dienogest and ethinylestradiol. It is prescribed to prevent pregnancy in women of reproductive age by inhibiting ovulation, thickening cervical mucus, and altering the endometrium to prevent implantation.

The ethinylestradiol component suppresses the release of follicle‑stimulating hormone, while dienogest provides progestogenic activity that blocks the luteinizing hormone surge. Together they stop ovulation, make cervical mucus less permeable to sperm, and create an endometrial environment unsuitable for implantation.

The dosing regimen for Kelzyn is determined by the prescribing healthcare professional. Typically, it is taken as a daily oral tablet following the specific schedule indicated on the prescription label.

Kelzyn is intended for use only when pregnancy is not present. It should be discontinued if pregnancy occurs. Safety during breastfeeding has not been fully established; clinicians usually advise weighing benefits against potential risks and may recommend alternative contraception.

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

Kelzyn contains the progestogen dienogest, which offers a lower androgenic profile compared with some older progestins. This may result in fewer acne‑related side effects while maintaining contraceptive efficacy similar to other estrogen‑progestin combinations.

Store Kelzyn tablets 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.

Kelzyn is taken orally, usually once daily at the same time each day, with or without food, following the prescribed cycle (typically 21 active tablets followed by a hormone‑free interval).

Serious risks include venous or arterial thromboembolism, severe hypertension, liver dysfunction, and rare allergic reactions such as anaphylaxis. Patients should seek immediate medical attention if they experience symptoms like chest pain, shortness of breath, severe headache, or unusual bruising.

Kelzyn is contraindicated in women with a history of thromboembolic disorders, uncontrolled hypertension, known or suspected breast cancer, active liver disease, or those who are pregnant. It should also be avoided by smokers over 35 years of age.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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