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

Kelsee

Active Ingredient:
Dienogest, Ethinylestradiol | Lactose
Origin:
EU

Kelsee (Dienogest, Ethinylestradiol | Lactose)

Dienogest, the active ingredient in Kelsee, is a combined oral contraceptive presented as a 0.03 mg dienogest / 0.02 mg ethinylestradiol tablet for oral use. Together with ethinylestradiol, it works to prevent pregnancy in women of reproductive age by inhibiting ovulation and modifying cervical mucus.

GNH India supplies Kelsee as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product complies with EU regulatory standards and is manufactured under GMP conditions for global distribution.

Manufacturer / TM Owner

Exeltis Italia Srl

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Indications & Clinical Uses

  • Kelsee, a combined oral contraceptive, is indicated for hormonal contraception in women.
  • Prevention of pregnancy: provides reliable contraceptive protection when taken as directed.
  • Regulation of menstrual cycle: helps establish predictable bleeding patterns.
  • Treatment of moderate acne: reduces androgen‑driven skin lesions in some users.

How It Works

  • Kelsee combines dienogest, a progestogenic agent, with ethinylestradiol, an estrogen. The estrogen component suppresses the hypothalamic‑pituitary‑ovarian axis, stabilizing the endometrium, while dienogest inhibits the luteinizing hormone surge, preventing ovulation, thickens cervical mucus, and induces endometrial changes that are unfavorable for implantation.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Breast tenderness: temporary swelling or discomfort.
  • Headache: occasional tension‑type headache.
  • Breakthrough bleeding: spotting between periods.
  • Mood changes: irritability or mood swings.
  • Weight gain: slight increase in body weight.

Serious or Rare Side Effects

  • Venous thromboembolism: deep vein thrombosis or pulmonary embolism.
  • Arterial thrombosis: stroke or myocardial infarction.
  • Severe hypertension: sudden rise in blood pressure.
  • Hepatic adenoma: benign liver tumor.
  • Anaphylaxis: life‑threatening allergic reaction.
  • Visual disturbances: sudden loss of vision or blurred sight.

Precautions & Warnings

Before prescribing Kelsee, consider the following precautions:

  • Contraindicated in pregnancy: product is Category X and must not be used.
  • History of thromboembolic disorders: increased risk of clot formation.
  • Smoking over age 35: elevated cardiovascular risk.
  • Uncontrolled hypertension: may exacerbate blood pressure.
  • Liver disease: impaired metabolism may alter drug levels.
  • Store at room temperature below 25°C: keep in the original pack, protect from moisture and light.

Avoid Interactions

Kelsee may interact with other medicines as follows:

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce contraceptive efficacy.
  • Anticoagulants (e.g., warfarin): may increase clotting risk.
  • Hormonal breast cancer therapies (e.g., tamoxifen): may diminish contraceptive effect.

Moderate Interactions (Monitor Closely)

  • Antifungals such as ketoconazole: can raise hormone concentrations.
  • Certain antibiotics (e.g., tetracycline): may slightly lower effectiveness.
  • St. John’s wort: herbal inducer that may decrease plasma levels.

Frequently Asked Questions

Kelsee 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 create an environment unsuitable for implantation.

Dienogest is a progestogenic component that suppresses the luteinizing hormone surge, thereby preventing ovulation. It also thickens cervical mucus and induces endometrial changes, which together reduce the likelihood of fertilization and implantation when combined with the estrogen component.

The prescriber determines the dosing schedule for Kelsee. Typically, it is taken as one tablet daily at the same time for 21 consecutive days followed by a pill‑free interval, but the exact regimen must be set by a qualified healthcare professional.

Kelsee is classified as Pregnancy Category X, meaning it must not be used during pregnancy because it can cause fetal harm. Limited data exist for breastfeeding; generally, combined oral contraceptives are not recommended while nursing without medical advice.

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

Kelsee contains a low‑dose progestogen (dienogest) and a standard estrogen dose (ethinylestradiol), offering effective contraception with a potentially lower impact on lipid profiles compared with some older formulations. Its side‑effect profile is similar to other COCs, but individual tolerance may vary, making it a suitable alternative for patients seeking a newer progestogen.

Kelsee tablets should be stored at room temperature below 25 °C. Keep them in the original blister pack, protect from moisture and direct light, and ensure they are out of reach of children.

Kelsee is taken orally with a glass of water, preferably at the same time each day. Consistent daily intake helps maintain hormone levels and maximizes contraceptive effectiveness.

The most serious risks include venous thromboembolism (deep‑vein thrombosis or pulmonary embolism), arterial thrombosis (stroke or myocardial infarction), severe hypertension, and rare hepatic adenomas. Patients should be monitored for signs of clotting, sudden headache, visual changes, or unexplained abdominal pain.

Kelsee is contraindicated in women who are pregnant or planning pregnancy, have a history of thromboembolic disorders, are smokers over 35 years of age, have uncontrolled hypertension, active liver disease, or estrogen‑dependent tumors such as certain breast cancers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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