(+977) 4110791, 01-4110761 info@opl.com.np
Pregno

Generic Name

 A combi pack of Mifepristone and Misoprostol                       

Therapeutic class

 Mifepristone: Abortifacient

Misprostol: Endocrine Metabolic Agent

Pharmacological Class

Mifepristone: Antiprogestational steroid

Misoprostol: Prostaglandin Analogue

Composition

Each uncoated tablet contains Mifepristone 200 mg.

Pregnancy category

‘X’

Presentation

 Available in the pack size as 1 tablet X 1 blister

What is Pregno?

Pregno, available as 200 mg tablets, contains Mifepristone, a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue.

In what conditions Pregno can be used?
Pregno can be used for the medical termination of intrauterine pregnancy.

How does Pregno work?

Pregno blocks the action of progesterone, which is needed to sustain a pregnancy. This results in:

  • Changes in the uterine lining and detachment of the pregnancy
  • Softening and opening of the cervix
  • Increased uterine sensitivity to prostaglandin(misoprostol)

How to take Pregno?

Dosing Considerations for Pregnancy Termination

  • 200 mg of Pregno orally as a single dose under physician supervision
  • Followed by 800 mcg of misoprostol ( Mistol)

See Pregno-Kit for detailed information on combination use of Pregno and Mistol.

What do you need to know before you take Pregno?

  • Tell your doctor and pharmacist if you are allergic to any component of the formulation.

Do not hesitate to provide information to your healthcare provider about the underlying health conditions that you have and also about other medicines that you are currently taking.

Warnings and Precautions:

  • If you are still pregnant after taking Pregno, there is a chance that your baby may be born with birth defects. In such situation, consult with your healthcare provider for other options to consider.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you have taken Pregno.
  • Another pregnancy can occur after this abortion treatment and before your normal period begins again. Birth control can be started as soon as this treatment is successfully completed. Consult your healthcare provider for more information.
  • Pregno may make you dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
  • Aspirin can increase the risk of bleeding when used with Pregno. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your healthcare provider for more details.

Can Pregno be taken during pregnancy?

Pregno is contraindicated in case of wanted pregnancies.

Can lactating mothers consume Pregno?

Pregno passes into breast milk. Since the effects of Pregno on infants are unknown, breast-feeding women should consult their healthcare provider on whether they should discard their breast milk for a few days following this treatment.

  • Possible Side effects:
    Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, and swelling of your face, lips, tongue, or throat.
    Call your doctor at once if you have:
  • a fever higher than 100.4 degrees F (38 degrees C) lasting longer than 4 hours;
  • a general ill feeling or fast heartbeats;
  • severe pelvic pain or tenderness;
  • severe or ongoing nausea, vomiting, diarrhea, weakness; or
  • no vaginal bleeding at all after taking Pregno.

Common side effects may include:

  • heavy vaginal bleeding for 2 days;
  • light vaginal bleeding or spotting for up to 16 days;
  • fever, chills, weakness;
  • dizziness; or
  • nausea, vomiting, diarrhea.
  • What special dietary instructions do you need to follow?
  • Avoid the use of grapefruit products shortly before or after taking Pregno.
  • Follow your healthcare provider’s instructions about any other restrictions on food, beverages, or activity.

Pharmacodynamics:

Mifepristone is a synthetic steroid with antiprogestational effects indicated for the medical termination of intrauterine pregnancy. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit and monkey), the compound inhibits the activity of endogenous or exogenous progesterone.

Pharmacokinetics:

Absorption: Peak Plasma Concentration is achieved in 2-8 hr and the absolute bioavailability is 69%.

Protein binding: Greater than 99%

Metabolism: Hepatic (Extensively metabolized by CYP3A4)

Route of elimination: 90% of the dose is excreted as metabolites in feces.

Half-life: The half life of elimination is about 20 hour following single dose of administration.

Drug Interactions:

Some products that may interact with this drug include:

  • long-term corticosteroid therapy (such as, prednisone)
  • drugs affecting liver enzymes that remove mifepristone from your body (for example, azole antifungals, macrolide antibiotics and certain anti-seizure medicines
  • other drugs that can cause bleeding/bruising
  • Mifepristone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, ergot alkaloids (such as dihydroergotamine, ergotamine), fentanyl, pimozide, quinidine, some statin drugs (such as fluvastatin, lovastatin, simvastatin), sirolimus, tacrolimus, warfarin, among others.

OUR PRODUCTS