Novex - The non Hormonal Contraceptive Pill - 1 strip of 10 tablets

Novex - Ormeloxifene 30 mg Tablets - Product Information

Ormeloxifene (Novex) is a unique product of the Central Drug Research Institute (CDRI). The development of this drug is a credit to the competence of our Indian Scientists.

It focused attention on discovery of a drug that was effective in preventing pregnancy, avoided the steroid hormonal side effect and needed less frequent dosage. After nearly two decades of research, Ormeloxifene was born and approved for use by the Drug Control Administration of the Government of India.

MECHANISM OF ACTION OF NOVEX (Ormeloxifene)

The mechanism of action of Novex (Ormeloxifene) as a contraceptive has been postulated to be due to the following:

1. Acceleration of the transport of the fertilized ovum through the fallopian tube causes an immature embryo to arrive at the endometrium. This immature embryo may not be suitable for implantation.

2. Inhibiting the effect of oestrogen on the endometrium causes a thinner endometrium that is again not suitable for implantation of the embryo. 

Thus, Novex (Ormeloxifene) effectively prevents development of a fetus and hence acts as a reliable contraceptive.

SIGNIFICANCE OF THIS MECHANISM OF ACTION:

The other oral contraceptives available on the market are steroids and contain synthetic Oestrogen and/or Progestogens. They inhibit the Hypothalamic-Pituitary-Ovarian axis and stop ovulation.

Though this acts as an effective contraceptive, it has many side effects like weight gain, migraine, formation of blood clots, nausea & vomiting, breast tenderness etc. Ormeloxifene being non-steroidal, and having anti-Oestrogenic activity only on the endometrium and the breast, overcomes all these unpleasant side effects.

Thus, Novex (Ormeloxifene)

• Does not inhibit ovulation

• No effect on platelet aggregation, lipid profile and cholesterol

• Can be safely used in patients with breast cancer

• No effect on libido, body weight, headaches

• No androgenic side effects like acne or hirsutism

CONTRACEPTIVE EFFICACY/ PEARL INDEX

          Novex (Ormeloxifene) has a Pearl Index of 1.17, which is comparable to most oral contraceptives available on the market.

DOSAGE OF NOVEX (ORMELOXIFENE)

The drug needs to be started on the first day of the period and continued thereafter, as above, regardless of the menstrual cycles. As Novex takes three months to show it's full contraceptive efficacy, it is advised to use condoms in addition to Novex during the first three months.

The long half-life of Novex (Ormeloxifene), which is 170 hours, is what makes this dosing schedule possible.

CONTRAINDICATIONS TO USAGE OF NOVEX

• Women with diagnosed Polycystic Ovarian Syndrome.

• Jaundice or liver diseases

• Cervical diseases

• Allergy to drug or constituents

• Chronic medical illness like TB, Renal diseases etc

• Breastfeeding mothers, upto 6 – 12 months after delivery of baby

SIDE EFFECTS OF NOVEX

Because of the local mechanism of action of Ormeloxifene, there are very few side effects. In all studies of this drug on the general population, there have been no known discontinuations due to side effects.

EFFECT ON MENSTRUAL CYCLES: Because of the anti-Oestrogenic effect of Ormeloxifene, delay of periods can occur. This needs to be informed to the women to ensure better compliance. However, the periods are lighter and the woman should be reassured that it is not harmful to her body. If the periods are delayed by more than 15 days, a pregnancy test might be done for reassurance.

EFFECT ON ACCIDENTAL PREGNANCY: In the event of contraceptive failures or user failure, Novex (Ormeloxifene) is not known to cause any harmful (Teratogenic) effects on the unborn baby. Safety profile of Ormeloxifene has been established through several long-term studies that have confirmed no physical or mental impairment in any of the children born to mothers on Ormeloxifene.

EFFECT ON BREAST FEEDING: The effect of Ormeloxifene on breast milk is yet to be established. However, the amount of Ormeloxifene secreted in breast milk is in minimal quantities and is unlikely to harm the suckling baby. Till more studies are available, to be on the safer side, we discourage prescribing Novex to breastfeeding mothers.

EFFECT ON RETURN OF FERTILITY AFTER DISCONTINUATION: There has been a natural return to fertility after discontinuation of Novex (Ormeloxifene) within six months.