Combipack Of Mifepristone & Misoprostol Tablets

Description

Product Description: The Combipack of Mifepristone & Misoprostol Tablets is a comprehensive pharmaceutical solution designed for medical abortion in women up to 10 weeks gestation. This combination pack contains two types of tablets: mifepristone, which is a progesterone antagonist, and misoprostol, which is a prostaglandin analog.

Indications and Usage: The Combipack of Mifepristone & Misoprostol Tablets is indicated for the termination of early pregnancy in women up to 70 days (10 weeks) gestation. It offers a non-surgical alternative for medical abortion and is used under the guidance of a healthcare provider.

Dosage and Administration: The dosing regimen involves the sequential administration of mifepristone followed by misoprostol. Typically, a single tablet of mifepristone (200 mg) is administered orally, followed by a specific number of tablets of misoprostol (typically 800 mcg) administered buccally or vaginally after a specified interval. Detailed dosing instructions should be provided by a healthcare provider.

Dosage Forms and Strengths: The Combipack of Mifepristone & Misoprostol Tablets contains mifepristone tablets (200 mg) and misoprostol tablets (typically 200 mcg each). The pack may contain a specific number of each tablet depending on the prescribed regimen.

Contraindications: The Combipack of Mifepristone & Misoprostol Tablets is contraindicated in patients with known or suspected ectopic pregnancy, inherited porphyria, chronic adrenal failure, hemorrhagic disorders or concurrent anticoagulant therapy, and hypersensitivity to mifepristone, misoprostol, or any component of the formulation.

Warnings and Precautions: Healthcare providers should counsel patients on the potential risks associated with medical abortion, including incomplete abortion, excessive bleeding, and the need for surgical intervention in case of incomplete abortion or severe bleeding. Patients should be advised to seek immediate medical attention if they experience severe abdominal pain, persistent fever, or heavy bleeding.

Adverse Reactions/Side Effects: Common adverse reactions associated with the use of the Combipack of Mifepristone & Misoprostol Tablets may include abdominal pain, uterine cramps, nausea, vomiting, diarrhea, headache, and dizziness. Heavy bleeding and clotting are also expected as part of the medical abortion process.

Drug Interactions: There are no significant drug interactions reported with the Combipack of Mifepristone & Misoprostol Tablets. However, concurrent use of certain medications, such as corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs), may potentiate the effects of misoprostol and increase the risk of bleeding.

Use In Specific Populations Description: The Combipack of Mifepristone & Misoprostol Tablets is intended for use in women of reproductive age who are seeking to terminate an early pregnancy. Safety and efficacy in pregnant women beyond 10 weeks gestation have not been established. It is not recommended for use in women with certain medical conditions or contraindications to medical abortion.

How Supplied/Storage and Handling: The Combipack of Mifepristone & Misoprostol Tablets is supplied as a combination pack containing the specified number of mifepristone and misoprostol tablets. It should be stored at room temperature (20°C to 25°C) away from moisture and heat. Unused portions of the medication should be properly disposed of according to local regulations.