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Levonorgestrel / Ethinyl Estradiol
Overview
What is Jolessa?
JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen , and 7 white inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
What does Jolessa look like?
What are the available doses of Jolessa?
JOLESSA consists of 84 round, pink tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, white inert tablets.
What should I talk to my health care provider before I take Jolessa?
Nursing Mothers: Advise use of another contraceptive method. JOLESSA can decrease milk production. ()
How should I use Jolessa?
JOLESSA (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
JOLESSA is dispensed in an Extended-Cycle Tablet Dispenser []. JOLESSA should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
Instruct patients to take JOLESSA once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, JOLESSA should be taken exactly as directed and at intervals not exceeding 24 hours. For patient instructions regarding missed pills, see FDA-approved patient labeling.
What interacts with Jolessa?
Sorry No Records found
What are the warnings of Jolessa?
Sorry No Records found
What are the precautions of Jolessa?
Sorry No Records found
What are the side effects of Jolessa?
Sorry No records found
What should I look out for while using Jolessa?
Do not prescribe JOLESSA to women who are known to have the following conditions:
What might happen if I take too much Jolessa?
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
How should I store and handle Jolessa?
Store under normal lighting conditions at 20-25°C (68-77°F); excursions permitted to 15-30°C (59- 86°F) ODEFSEY tablets are gray, capsule-shaped, and film coated with "GSI" debossed on one side and "255" on the other side. Each bottle contains 30 tablets (NDC 61958-2101-1), a silica gel desiccant, and a polyester coil, and is closed with a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Non-Clinical Toxicology
Do not prescribe JOLESSA to women who are known to have the following conditions:FUROSEMIDE TABLET may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
FUROSEMIDE TABLET should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with FUROSEMIDE TABLET, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and FUROSEMIDE TABLET are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if FUROSEMIDE TABLET is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
FUROSEMIDE TABLET has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
FUROSEMIDE TABLET combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of FUROSEMIDE, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
FUROSEMIDE TABLET may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and FUROSEMIDE TABLET may reduce the natriuretic and antihypertensive effects of FUROSEMIDE TABLET. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of FUROSEMIDE TABLET is achieved. The intake of FUROSEMIDE TABLET and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of FUROSEMIDE TABLET within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of FUROSEMIDE TABLET concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of FUROSEMIDE TABLET. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of FUROSEMIDE TABLET, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like FUROSEMIDE TABLET, undergo significant renal tubular secretion may reduce the effect of FUROSEMIDE TABLET. Conversely, FUROSEMIDE TABLET may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both FUROSEMIDE TABLET and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of FUROSEMIDE TABLET.
FUROSEMIDE TABLET can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and FUROSEMIDE TABLET is associated with increased risk of gouty arthritis secondary to FUROSEMIDE TABLET- induced hyperurecemia and cyclosporine impairment of renal urate excretion.
High doses (>80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of FUROSEMIDE TABLET (furosemide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and FUROSEMIDE TABLET should be observed closely to determine if the desired diuretic and/or antihypertensive effect of FUROSEMIDE TABLET is achieved.
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The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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