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

Kelzy

Active Ingredient:
Dienogest, Ethinylestradiol | Lactose
Origin:
EU

Kelzy (Dienogest, Ethinylestradiol | Lactose)

Dienogest/Ethinylestradiol, the active ingredient in Kelzy, is a combined oral contraceptive presented as an oral tablet for oral use. It prevents pregnancy and can help regulate menstrual cycles in women of reproductive age. It is indicated for hormonal contraception and is approved for use in the European Union.

GNH India supplies Kelzy as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality, regulatory compliance and reliable delivery across global markets. Our distribution network covers Europe, Asia, Africa and the Americas, facilitating timely access to the product.

Manufacturer / TM Owner

Exeltis Healthcare S.L

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Indications & Clinical Uses

Kelzy, a combined oral contraceptive, acts on the hypothalamic‑pituitary‑ovarian axis to prevent ovulation.

  • Prevention of pregnancy: provides reliable hormonal contraception for women of reproductive age.
  • Regulation of menstrual cycle: helps achieve more predictable bleeding patterns and reduces dysmenorrhea.
  • Treatment of acne: reduces androgen‑driven acne severity in eligible patients.
  • Management of endometriosis‑associated pain: can alleviate pelvic pain symptoms.
  • Control of heavy menstrual bleeding: reduces volume of menstrual blood loss.

How It Works

  • Kelzy combines the estrogen ethinylestradiol with the progestogen dienogest. Ethinylestradiol binds to estrogen receptors and suppresses the hypothalamic release of gonadotropin‑releasing hormone, lowering follicle‑stimulating hormone levels. Dienogest binds to progesterone receptors, inhibiting the luteinizing hormone surge, preventing ovulation, and inducing changes in cervical mucus and endometrial tissue that hinder fertilization and implantation. The fixed‑dose combination ensures consistent plasma concentrations, providing effective contraception throughout the monthly cycle.

Side Effects

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

Common Side Effects

  • Nausea
  • Breast tenderness
  • Headache
  • Breakthrough bleeding

Serious or Rare Side Effects

  • Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
  • Severe hypertension
  • Liver tumor (hepatocellular adenoma)

Precautions & Warnings

Before prescribing Kelzy, clinicians should evaluate patient history and consider the following precautions.

  • Assess cardiovascular risk: review history of thrombosis, smoking status, hypertension, and obesity.
  • Contraindicated in estrogen‑dependent tumors: avoid use in patients with known breast or endometrial cancer.
  • Monitor liver function: use with caution in patients with active hepatic disease.
  • Review concomitant medications: enzyme‑inducing drugs may reduce contraceptive effectiveness.
  • Store at ambient temperature: keep below 25 °C in the original packaging, protect from moisture.

Avoid Interactions

Kelzy can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Potent enzyme inducers (e.g., rifampin, carbamazepine, phenytoin): may markedly reduce hormonal levels and increase risk of contraceptive failure.
  • Anticoagulants (e.g., warfarin): combined use can enhance bleeding risk.
  • Certain antiretrovirals (e.g., protease inhibitors): may affect hormone metabolism and reduce effectiveness.

Moderate Interactions (Monitor Closely)

  • Antihypertensives: may require blood pressure monitoring as hormonal changes can affect control.
  • Other hormonal therapies (e.g., hormone replacement therapy): may increase side‑effect burden.
  • Some antibiotics (e.g., macrolides, fluoroquinolones): may have variable impact on contraceptive reliability.

Frequently Asked Questions

Kelzy is a combined oral contraceptive containing dienogest and ethinylestradiol. It is prescribed to prevent pregnancy in women of reproductive age and may also be used to regulate menstrual cycles and treat hormone‑related acne. The medication works by inhibiting ovulation and altering cervical mucus and endometrial lining.

The ethinylestradiol component provides estrogenic activity that suppresses the pituitary release of follicle‑stimulating hormone, while dienogest, a progestogen, blocks luteinizing hormone surge and induces changes in cervical mucus and endometrium. Together they prevent ovulation and create an environment hostile to fertilization and implantation.

The dosing regimen for Kelzy is determined by the prescribing healthcare professional. Typically, combined oral contraceptives are taken once daily for a 21‑day active tablet sequence followed by a hormone‑free interval, but the exact schedule, tablet strength, and duration should be confirmed with the prescriber.

Kelzy is intended for use only when pregnancy is not desired; it should be discontinued if pregnancy occurs. The product is not recommended for use during pregnancy. Limited data are available for breastfeeding, and the decision to use hormonal contraception while nursing should be made by a qualified clinician based on individual risk‑benefit assessment.

To place an order, submit an enquiry on the Kelzy product page at gnhindia.com, specifying the required quantity. GNH India supplies 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 any necessary import documentation.

Kelzy contains the progestogen dienogest, which has a lower androgenic profile compared with older agents such as levonorgestrel, potentially offering better control of acne and less impact on lipid metabolism. Its estrogen component, ethinylestradiol, is similar to that in many other COCs, providing comparable contraceptive efficacy while differing in side‑effect tolerability.

Kelzy 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 product out of reach of children and do not use if the packaging is damaged or the tablets appear discolored.

Kelzy is taken orally, usually once each day at the same time, with or without food. The typical regimen consists of a series of active tablets followed by a hormone‑free interval, after which a new pack is started. Consistent daily intake is essential to maintain contraceptive effectiveness.

The most serious risks include venous thromboembolism, arterial thrombosis, and severe hypertension, which can be life‑threatening. Additional rare but serious concerns are liver tumors and allergic reactions such as anaphylaxis. Patients should seek immediate medical attention if they experience chest pain, shortness of breath, severe headache, visual changes, or swelling of the legs.

Kelzy is contraindicated in women with a history of thromboembolic disorders, estrogen‑dependent tumors (e.g., breast cancer), uncontrolled hypertension, active liver disease, or known hypersensitivity to any component. It should also be avoided in smokers over 35 years of age and in individuals taking medications that significantly reduce contraceptive efficacy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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