Elinest
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Uses
ELINEST (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
| NA – not available | ||
| *Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998 | ||
| Method | Perfect Use | Typical Use |
| Levonorgestrel implants | 0.05 | 0.05 |
| Male sterilization | 0.1 | 0.15 |
| Female sterilization | 0.5 | 0.5 |
| Depo-Provera® (injectable progestogen) |
0.3 | 0.3 |
| Oral contraceptives | 5 | |
| Combined | 0.1 | NA |
| Progestin only | 0.5 | NA |
| IUD | ||
| Progesterone | 1.5 | 2.0 |
| Copper T 380A | 0.6 | 0.8 |
| Condom (male) without spermicide | 3 | 14 |
| (Female) without spermicide | 5 | 21 |
| Cervical cap | ||
| Nulliparous women | 9 | 20 |
| Parous women | 26 | 40 |
| Vaginal sponge | ||
| Nulliparous women | 9 | 20 |
| Parous women | 20 | 40 |
| Diaphragm with spermicidal cream or jelly |
6 | 20 |
| Spermicides alone (foam, creams, jellies, and vaginal suppositories) |
6 | 26 |
| Periodic abstinence (all methods) | 1-9* | 25 |
| Withdrawal | 4 | 19 |
| No contraception (planned pregnancy) | 85 | 85 |
History
There is currently no drug history available for this drug.
Other Information
ELINEST Tablets (Norgestrel and ethinyl estradiol tablets, 0.3 mg/0.03 mg) provide and oral contraceptive regimen consisting of 21 pale pink tablets followed by 7 white tablets.
Each pale pink tablet, for oral administration contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: FD&C Blue #1 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Each inactive, white tablet for oral administration, in the 28 day regimen contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-¬preg-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:
Therapeutic class: Oral contraceptive.
Sources
Elinest Manufacturers
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Northstar Rx Llc
![Elinest (Norgestrel And Ethinyl Estradiol) Kit [Northstar Rx Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Elinest | Northstar Rx Llc
To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals not exceeding 24 hours.
28-Day Schedule: For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (white) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (white) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (white) is taken each day at the same time for 21 days. Then the peach tablets are taken for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day.
INSTRUCTIONS TO PATIENTS
To achieve maximum contraceptive effectiveness, the oral contraceptive pill must be taken exactly as directed and at intervals not exceeding 24 hours.
Important: Women should be instructed to use an additional method of protection until after the first 7 days of administration in the initial cycle.
Due to the normally increased risk of thromboembolism occurring postpartum, women should be instructed not to initiate treatment with oral contraceptives earlier than 4-6 weeks after a full-term delivery. If pregnancy is terminated in the first 12 weeks, the patient should be instructed to start oral contraceptives immediately or within 7 days. If pregnancy is terminated after 12 weeks, the patient should be instructed to start oral contraceptives after 2 weeks.33,77
If spotting or breakthrough bleeding should occur, the patient should continue the medication according to the schedule. Should spotting or breakthrough bleeding persist, the patient should notify her physician.
If the patient misses 1 pill, she should be instructed to take it as soon as she remembers and then take the next pill at the regular time. The patient should be advised that missing a pill can cause spotting or light bleeding and that she may be a little sick to her stomach on the days she takes the missed pill with her regularly scheduled pill. If the patient has missed more than one pill, see DETAILED PATIENT LABELING: HOW TO TAKE THE PILL, WHAT TO DO IF YOU MISS PILLS.
Use of oral contraceptives in the event of a missed menstrual period:
If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.
If the patient has adhered to the prescribed regimen and misses 2 consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
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