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NEXT CHOICE
Overview
What is NEXT CHOICE?
Emergency contraceptive tablet. Each levonorgestrel 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-, (17α)-(-)-], a totally synthetic progestogen. The inactive ingredients present are colloidal silicon dioxide, corn starch, FD&C Yellow #6, magnesium stearate, povidone, and lactose monohydrate. Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:
What does NEXT CHOICE look like?
What are the available doses of NEXT CHOICE?
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What should I talk to my health care provider before I take NEXT CHOICE?
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How should I use NEXT CHOICE?
Levonorgestrel tablets are a prescription-only emergency contraceptive, for women age 17 and younger, that can be used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure. This product is not approved for nonprescription use.
To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later.
One levonorgestrel tablet 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 levonorgestrel tablets are taken as directed as soon as possible after unprotected intercourse. Levonorgestrel tablets 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 health care professional to discuss whether to repeat that dose.
What interacts with NEXT CHOICE?
- 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 levonorgestrel tablets 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
What are the warnings of NEXT CHOICE?
Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death.
An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.
Effects on Menses
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking levonorgestrel tablets. At the time of expected menses, approximately 75% of women using levonorgestrel tablets had vaginal bleeding similar to their normal menses, 12% to 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 1,000 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. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of ower abdominal pain after taking levonorgestrel tablets.
What are the precautions of NEXT CHOICE?
Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins (POPs). The few studies of infant growth and development that have been conducted with POPs have not demonstrated significant adverse effects.
STD/HIV
Levonorgestrel tablets, like progestin-only contraceptives, do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Physical Examination and Follow-up
A physical examination is not required prior to prescribing levonorgestrel tablets. 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 levonorgestrel tablets.
Carbohydrate Metabolism
The effects of levonorgestrel tablets 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 levonorgestrel tablets.
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 levonorgestrel tablets would be affected by these or any other medications.
Nursing Mothers
Small amounts of progestin pass into the breast milk in women taking progestinonly pills for long-term contraception resulting in steroid levels in infant plasma of 1% to 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.
Pediatric 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 postpubertal adolescents under the age of 16 and for users 16 years and older. Use of levonorgestrel tablets emergency contraception before menarche is not indicated.
Fertility Following Discontinuation
The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only pills for emergency contraception and long-term contraception.
What are the side effects of NEXT CHOICE?
The most common adverse events in the clinical trial for women receiving levonorgestrel tablets included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in ≥5% of levonorgestrel tablets users.
Levonorgestrel tablets demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
| Most Common Adverse Events | |
| Nausea | 23.1 |
| Abdominal Pain | 17.6 |
| Fatigue | 16.9 |
| Headache | 16.8 |
| Heavier Menstrual Bleeding | 13.8 |
| Lighter Menstrual Bleeding | 12.5 |
| Dizziness | 11.2 |
| Breast Tenderness | 10.7 |
| Other complaints | 9.7 |
| Vomiting | 5.6 |
| Diarrhea | 5.0 |
Nausea: Occurred in 23% of women taking levonorgestrel tablets (compared to 50% with Yuzpe)
Vomiting: Occurred in 6% of women taking levonorgestrel tablets (compared to 19% with Yuzpe)
What should I look out for while using NEXT CHOICE?
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 levonorgestrel tablets regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions:
Levonorgestrel tablets are not recommended for routine use as a contraceptive.
Levonorgestrel tablets are not effective in terminating an existing pregnancy.
Effects on Menses
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking levonorgestrel tablets. At the time of expected menses, approximately 75% of women using levonorgestrel tablets had vaginal bleeding similar to their normal menses, 12% to 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 1,000 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. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of ower abdominal pain after taking levonorgestrel tablets.
What might happen if I take too much NEXT CHOICE?
There are no data on overdosage of levonorgestrel tablets, although the common adverse event of nausea and its associated vomiting may be anticipated.
How should I store and handle NEXT CHOICE?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320 Levonorgestrel Tablets, 0.75 mg are available for a single course of treatment in PVC/aluminum foil blister packages of two tablets each. Each tablet is peach, round, bevel edged, and flat faced embossed with “475” on one side and “WATSON” on the other side.Available as:Unit-of-use NDC 0591-0475-36Store levonorgestrel tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP].*The following are registered trademarks of their respective manufacturers: Reality is manufactured by Female Health Company and a registered trademark of Meijer, Inc.; Depo-Provera is manufactured by and a registered trademark of Pharmacia and Upjohn; Norplant is manufactured by and a registered trademark of Population Council; Ovral, Alesse, Triphasil and Lo Ovral/Wyeth Pharmaceuticals, Inc.; Nordette/Duramed Pharmaceuticals, Inc.; Levlen and Tri- Levlen/Bayer Healthcare.Watson Laboratories, IncRepackaged by:Rebel Distributors Corp.Thousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Absorption
No specific investigation of the absolute bioavailability of levonorgestrel tablets in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism. After a single dose of levonorgestrel tablets (0.75 mg) administered to 16 women under fasting conditions, maximum serum concentrations of levonorgestrel are 14.1 ± 7.7 ng/mL (mean ± SD) at an average of 1.6 ± 0.7 hours. No formal study of the effect of food on the absorption of levonorgestrel has been undertaken.
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 3α,5β- and 3α,5α-tetrahydrolevonorgestrel with 16β-hydroxynorgestrel also identified. Together, these account for less than 10% of parent plasma levels. Urinary metabolites hydroxylated at the 2α and 16β 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 tablets (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 feces.
Non-Clinical Toxicology
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 levonorgestrel tablets regimen consisting of the emergency use of two progestin pills. POPs however, are not recommended for use in the following conditions:Levonorgestrel tablets are not recommended for routine use as a contraceptive.
Levonorgestrel tablets are not effective in terminating an existing pregnancy.
Effects on Menses
Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking levonorgestrel tablets. At the time of expected menses, approximately 75% of women using levonorgestrel tablets had vaginal bleeding similar to their normal menses, 12% to 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 1,000 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. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of ower abdominal pain after taking levonorgestrel tablets.
Drug Interactions
CNS-Active Drugs
Imipramine: Coadministration of single doses of zaleplon 20 mg and imipramine 75 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Paroxetine: Coadministration of a single dose of zaleplon 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. Additionally, paroxetine did not alter the pharmacokinetics of zaleplon, reflecting the absence of a role of CYP2D6 in zaleplon's metabolism.
Thioridazine: Coadministration of single doses of zaleplon 20 mg and thioridazine 50 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Venlafaxine: Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of either zaleplon of venlafaxine. In addition, there was no pharmacodynamic interaction as a result of coadministration of zaleplon and venlafaxine ER.
Promethazine: Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. however, the pharmacodynamics of coadministration of zaleplon and promethazine have not been evaluated. Caution should be exercised when these 2 agents are coadministered.
Drugs That Induce CYP3A4Rifampin: CYP3A4 is ordinarily a minor metabolizing enzyme of zaleplon. Multiple-dose administration of the potent CYP3A4 inducer rifampin (600 mg every 24 hours, q24h, for 14 days), however, reduced zaleplon C and AUC by approximately 80%. The coadministration of a potent CYP3A4 enzyme inducer, although not posing a safety concern, thus could lead to ineffectiveness of zaleplon. An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital.
Drugs That Inhibit CYP3A4CYP3A4 is a minor metabolic pathway for the elimination of zaleplon because the sum of desethylzaleplon (formed via CYP3A4 in vitro) and its metabolites, 5-oxo-desethylzaleplon and 5-oxo-desethylzaleplon glucuronide, account for only 9% of the urinary recovery of a zaleplon dose. Coadministration of single, oral doses of zaleplon with erythromycin (10 mg and 800 mg respectively), a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's maximal plasma concentrations and a 20% increase in the area under the plasma concentration-time curve. The magnitude of interaction with multiple doses of erythromycin is unknown. Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon. A routine dosage adjustment of zaleplon is not considered necessary.
Drugs That Inhibit Aldehyde Oxidase
The aldehyde oxidase enzyme system is less well studied than the cytochrome P450 enzyme system. Diphenhydramine: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug. However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4
Cimetidine: Cimetidine inhibits both aldehyde oxidase (in vitro) and CYP3A4 (in vitro and in vivo), the primary and secondary enzymes, respectively, responsible for zaleplon metabolism. Concomitant administration of zaleplon (10 mg) and cimetidine (800 mg) produced an 85% increase in the mean Cmax and AUC of zaleplon. An initial dose of 5 mg should be given to patients who are concomitantly being treated with cimetidine (see ).
Drugs Highly Bound to Plasma Protein
Zaleplon is not highly bound to plasma proteins (fraction bound 60%±15%); therefore, the disposition of zaleplon is not expected to be sensitive to alterations in protein binding. In addition, administration of zaleplon to a patient taking another drug that is highly protein bound should not cause transient increase in free concentrations of the other drug.
Drugs with a Narrow Therapeutic Index Digoxin: zaleplon (10 mg) did not affect the pharmacokinetic or pharmacodynamic profile of digoxin (0.375 mg q24h for 8 days).Warfarin: Multiple oral doses of zaleplon (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25-mg oral dose of warfarin.
Drugs That Alter Renal ExcretionIbuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. There was no apparent pharmacokinetic interaction between zaleplon and ibuprofen following single dose administration (10 mg and 600 mg, respectively) of each drug. This was expected because zaleplon is primarily metabolized and renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins (POPs). The few studies of infant growth and development that have been conducted with POPs have not demonstrated significant adverse effects.
The most common adverse events in the clinical trial for women receiving levonorgestrel tablets included nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), and menstrual changes. The table below shows those adverse events that occurred in ≥5% of levonorgestrel tablets users.
Levonorgestrel tablets demonstrated a superior safety profile over the Yuzpe regimen for the following adverse events:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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