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Product
Anti-asthmatic Products (Aerocort Inhaler)
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Pill 72 (Levonorgestrel Tablets)
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Pill 72
Levonorgestrel Tablets
COMPOSITION
Each coated tablet contains
Levonorgestrel IP…………0.75 mg
DOSAGE FORM
Tablets for oral use.
DESCRIPTION
PILL 72 is an emergency contraceptive tablet. Each Pill 72 tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 alpha)-(-)-], a totally synthetic progestogen.
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PHARMACOLOGY
Pharmacodynamics
Pill 72 is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. Pill 72 is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport or sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). Emergency contraceptive pills (like all oral contraceptives) do not protect against infection with HIV and other sexually transmitted diseases. Emergency contraceptives are not effective if the woman is already pregnant. It is not effective once the process of implantation has begun.
Pharmacokinetics
Absorption
Literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism.
Distribution
Levonorgestrel in serum is primarily protein bound. Approximately 50% is bound to albumin and 47.5% is bound to sex hormone binding globulin (SHBG).
Metabolism
Following a single oral dosage, levonorgestrel does not appear to be extensively metabolized by the liver. The primary metabolites are 3(alpha), 5(beta)- and 3(alpha), 5(infinity)-tetrahydrolevonorgestrel with 16(beta)-hydroxynorgestrel also identified. Together, these account for less than 10% of parent plasma levels. Urinary metabolites hydroxylated at the 2(alpha) and 16(beta) positions have also been identified. Small amounts of the metabolites are present in plasma as sulfate and glucuronide conjugates.
Excretion
The elimination half-life of levonorgestrel following single dose administration as levonorgestrel 0.75 mg is 24.4 ± 5.3 hours. Excretion following single dose administration as emergency contraception is unknown, but based on chronic, low-dose contraceptive use, levonorgestrel and its metabolites are primarily excreted in the urine, with smaller amounts recovered in the faeces.
INDICATIONS
Pill 72 is an emergency contraceptive that can be used within 72 hours to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
DOSAGE AND ADMINISTRATION
One tablet of Pill 72 should be taken orally within 72 hours after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Efficacy is better if Pill 72 is taken as directed as soon as possible after unprotected intercourse. Pill 72 can be used at any time during the menstrual cycle.
The user should be instructed that if she vomits within one hour of taking either dose of medication she should contact her doctor to discuss whether to repeat that dose.
CONTRAINDICATIONS
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Pill 72 regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions:
• Known or suspected pregnancy
• Hypersensitivity to any component of the product
• Undiagnosed abnormal genital bleeding
WARNINGS AND PRECAUTIONS
Pill 72 is not recommended for routine use as a contraceptive.
Pill 72 is not effective in terminating an existing pregnancy.
General
Effects on Menses
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for post coital and emergency contraceptive use. Some women may experience spotting a few days after taking Pill 72. At the time of expected menses, approximately 75% of women using Pill 72 had vaginal bleeding similar to their normal menses; 12-13% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their next menstrual period at the expected time or within ± 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of menses. If there is a delay in the onset of menses beyond 1 week, the possibility of pregnancy should be considered.
Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of reported pregnancies (19.7 per 1000 reported pregnancies). Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraceptive method. The doctor, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking PILL 72.
STD/HIV
Pill 72 , like progestin-only contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Carbohydrate Metabolism
The effects of Pill 72 on carbohydrate metabolism are unknown. Some users of progestin-only oral contraceptives (POPs) may experience slight deterioration in glucose tolerance, with increases in plasma insulin; however, women with diabetes mellitus who use POPs do not generally experience changes in their insulin requirements. Nonetheless, diabetic women should be monitored while taking Pill 72.
Physical Examination and Follow-up
A physical examination is not required prior to prescribing Pill 72 . A follow-up physical or pelvic examination, however, is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Pill 72.
Fertility Following Discontinuation
The limited available data indicates a rapid return of normal ovulation and fertility following discontinuation of progestin-only pills for emergency contraception and long-term contraception.
Drug Interactions
Theoretically, the effectiveness of low-dose progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics. It is not known whether the efficacy of Pill 72 would be affected by these or any other medications.
Hepatic Impairment
No formal studies have evaluated the effect of hepatic insufficiency on the deposition of emergency contraceptive tablets.
Renal Impairment
No formal studies have evaluated the effect of renal insufficiency on the deposition of emergency contraceptive tablets
Pregnancy
Many studies have found no effects on foetal development associated with long-term use of contraceptive doses of oral progestins (POPs).
Lactation
Small amounts of progestin pass into the breast milk in women taking progestin-only pills for long-term contraception resulting in steroid levels in infant plasma of 1-6% of the levels of maternal plasma. However, no adverse effects due to progestin-only pills have been found on breastfeeding performance, either in the quality or quantity of the milk, or on the health, growth or development of the infant.
Paediatric Use
Safety and efficacy of progestin-only pills have been established in women of reproductive age for long-term contraception. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of Pill 72 in emergency contraception before menarche is not indicated.
Geriatric use
Pill 72 is not intended for use in geriatric (age 65 years or older) populations and pharmacokinetic data are not available for this population.
UNDESIRABLE EFFECTS
The most common adverse events in the clinical trial for women receiving Pill 72 included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes.
Pill 72 demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
• Nausea: Occurred in 23% of women taking Pill 72
(compared to 50% with Yuzpe)
• Vomiting: Occurred in 6% of women taking Pill 72
(compared to 19% with Yuzpe)
OVERDOSAGE
There are no data on overdosage of Pill 72 , although the common adverse event of nausea and its associated vomiting may be anticipated.
STORAGE AND HANDLING INSTRUCTIONS
Store in a cool dry place . Protect from light.
PACKAGING INFORMATION
Pill 72 is available in a blister pack of 2 tablets.
What is Pill 72 ?
Pill 72 is a form of emergency contraception.
Emergency Contraception is a way to prevent pregnancy after unprotected sex (such as sex without contraception, or when a contraceptive fails). Because emergency contraception prevents pregnancy before it begins, it is not the same as abortion.
When would I use Emergency Contraception?
Emergency Contraception may be a choice if you had unprotected sex one or more times within the last 72 hours (3 days), and you don`t want to become pregnant (best results are obtained if you take the pill within 24 hours). You should not use emergency contraception if you are already pregnant, have unexplained vaginal bleeding, or are allergic to an ingredient in the pills.
Emergency Contraception is not as effective as other contraceptive methods, and therefore is not recommended for regular use. It should be used only in emergencies, such as when:
• Your contraceptive method failed:
• The condom tore
• You missed 2 or more birth control pills, or were 2 or more days late starting your pill pack
• Your diaphragm or cervical cap slipped
• You missed your regular contraceptive shot
• You had sex without using a contraceptive
• You were forced to have sex
How does Emergency Contraception work?
Emergency contraception may prevent pregnancy by temporarily stopping the release of an egg from a woman`s ovary, or it may prevent fertilization. It may also prevent fertilized ova from attaching to the uterus. Emergency contraception will not work if you are already pregnant.
Is Emergency Contraception safe?
Yes. The scientific and regulatory authorities have approved emergency contraception as a safe way to reduce the chance of pregnancy after unprotected sex.
Is Emergency Contraception effective?
Yes. Emergency Contraception reduces the average risk of pregnancy among users from about 8 percent to about 1 percent. After a single act of unprotected sex, correct use of Emergency Contraception reduces the risk of pregnancy by 89 percent.
Will Emergency Contraception have any side effects?
Nausea and vomiting are likely to occur in some women. If vomiting occurs within 1 hour of taking the tablets, contact your doctor, as you may need to repeat the dose.
If Emergency Contraception doesn`t work and I become pregnant, could it hurt the foetus?
No. There is no medical evidence that Emergency Contraception would harm a developing foetus. Emergency Contraception will not work once a pregnancy has started, so women who already are pregnant should not use it. (It does not cause abortion).
How often can I take Emergency Contraception?
You can take Emergency Contraception tablets as many times as you need it, but you should be aware that:
Emergency Contraception is not a substitute for regular contraception. If you need help choosing a regular contraceptive, contact your doctor.
Emergency Contraception does not protect you from HIV/AIDS or other sexually transmitted diseases. Only condoms provide protection against these diseases. If you are worried that you may have been infected with a sexually transmitted disease, talk to your doctor at the earliest.
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