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levonorgestrel and ethinyl estradiol
Overview
What is Falmina?
21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13 -ethyl-17 -ethinyl-17 -hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17 -ethinyl-1,3,5(10)-estratriene-3, 17 -diol.
The inactive ingredients present are FD&C Yellow #5 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), iron oxide black, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Each inactive, white tablet (7) contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
What does Falmina look like?
What are the available doses of Falmina?
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What should I talk to my health care provider before I take Falmina?
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How should I use Falmina?
FALMINA™ 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 II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.
Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.
1. Among couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets.
10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.
In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.
To achieve maximum contraceptive effectiveness, FALMINA™ (levonorgestrel and ethinyl estradiol tablets USP) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FALMINA™ is one orange tablet daily for 21 consecutive days, followed by one white inert tablet daily for 7 consecutive days, according to the prescribed schedule.
It is recommended that FALMINA™ tablets be taken at the same time each day.
What interacts with Falmina?
Combination oral contraceptives should not be used in women with any of the following conditions:
Thrombophlebitis or thromboembolic disorders
A history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Hepatic adenomas or carcinomas, or active liver disease
Known or suspected pregnancy
Hypersensitivity to any of the components of FALMINA
Combination oral contraceptives should not be used in women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see Warnings, ).
What are the warnings of Falmina?
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What are the precautions of Falmina?
1. General
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
2. Physical Examination and Follow-Up
A periodic history and physical examination are appropriate for all women, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
3. Lipid Disorders
Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. (See , , and .)
A small proportion of women will have adverse lipid changes while taking oral contraceptives. Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias. Persistent hypertriglyceridemia may occur in a small population of combination oral contraceptive users. Elevations of plasma triglycerides may lead to pancreatitis and other complications.
4. Liver Function
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
5. Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
6. Emotional Disorders
Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
7. Contact Lenses
Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. Gastrointestinal
Diarrhea and/or vomiting may reduce hormone absorption resulting in decreased serum concentrations.
9. Drug Interactions
Concomitant Use with HCV Combination Therapy-Liver Enzyme Elevation
Do not co-administer Falmina with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see )
Changes in Contraceptive Effectiveness Associated with Coadministration of Other Products:
Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, and modafinil. In such cases a back-up nonhormonal method of birth control should be considered.
Several cases of contraceptive failure and breakthrough bleeding have been reported in the literature with concomitant administration of antibiotics such as ampicillin and other penicillins, and tetracyclines. However, clinical pharmacology studies investigating drug interactions between combined oral contraceptives and these antibiotics have reported inconsistent results.
Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
Herbal products containing St. John's Wort (Hypericum perforatum) may induce hepatic enzymes (cytochrome P 450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
Increase in Plasma Levels Associated with Co-Administered Drugs:
Co-administration of atorvastatin and certain oral contraceptives containing ethinyl estradiol increases AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen increase the bioavailability of ethinyl estradiol since these drugs act as competitive inhibitors for sulfation of ethinyl estradiol in the gastrointestinal wall, a known pathway of elimination for ethinyl estradiol. CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole, and troleandomycin may increase plasma hormone levels. Troleandomycin may also increase the risk of intrahepatic cholestasis during coadministration with combination oral contraceptives.
Changes in Plasma Levels of Co-Administered Drugs:
Combination hormonal contraceptives containing some synthetic estrogens (eg, ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporin, prednisolone and other corticosteroids, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, due to induction of conjugation (particularly glucuronidation), have been noted when these drugs were administered with oral contraceptives.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
10. INTERACTIONS WITH LABORATORY TESTS
Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:
a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
b. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
c. Other binding proteins may be elevated in serum i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulins (SHBG) leading to increased levels of total circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged.
d. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
e. Glucose tolerance may be decreased.
f. Serum folate levels may be depressed by oral-contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
11. CARCINOGENESIS
See .
12. PREGNANCY
Pregnancy Category X. (See and sections.)
13. NURSING MOTHERS
Small amounts of oral-contraceptive steroids have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
14. PEDIATRIC USE
Safety and efficacy of levonorgestrel and ethinyl estradiol tablets have been established in women of reproductive age. 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 and ethinyl estradiol tablets before menarche is not indicated.
15. GERIATRIC USE
Levonorgestrel and ethinyl estradiol tablets have not been studied in women over 65 years of age and is not indicated in this population.
16. INFORMATION FOR THE PATIENT
See Patient Labeling Printed Below.
What are the side effects of Falmina?
To report SUSPECTED ADVERSE REACTIONS, contact Novast Laboratories, Ltd. Toll-Free at 1-877-966-8278 or FDA at 1-800-FDA-1088 or .
An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:
Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):
Acne
Amenorrhea
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Breast changes: tenderness, pain, enlargement, secretion
Budd-Chiari syndrome
Cervical erosion and secretion, change in Cholestatic jaundice
Chorea, exacerbation of Colitis
Contact lenses, intolerance to
Corneal curvature (steepening), change in
Dizziness
Edema/fluid retention
Erythema multiforme
Erythema nodosum
Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
Hirsutism
Infertility after discontinuation of treatment, temporary
Lactation, diminution in, when given immediately postpartum
Libido, change in
Melasma/chloasma which may persist
Menstrual flow, change in
Mood changes, including depression
Nausea
Nervousness
Pancreatitis
Porphyria, exacerbation of
Rash (allergic)
Scalp hair, loss of
Serum folate levels, decrease in
Spotting
Systemic lupus erythematosus, exacerbation of
Unscheduled bleeding
Vaginitis, including candidiasis
Varicose veins, aggravation of
Vomiting
Weight or appetite (increase or decrease), change in
The following adverse reactions have been reported in users of oral contraceptives:
Cataracts
Cystitis-like syndrome
Dysmenorrhea
Hemolytic uremic syndrome
Hemorrhagic eruption
Optic neuritis, which may lead to partial or complete loss of vision
Premenstrual syndrome
Renal function, impaired
What should I look out for while using Falmina?
Combination oral contraceptives should not be used in women with any of the following conditions:
Thrombophlebitis or thromboembolic disorders
A history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Hepatic adenomas or carcinomas, or active liver disease
Known or suspected pregnancy
Hypersensitivity to any of the components of FALMINA
Combination oral contraceptives should not be used in women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see Warnings, ).
What might happen if I take too much Falmina?
Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
NONCONTRACEPTIVE HEALTH BENEFITS
The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses:
Increased menstrual cycle regularity
Decreased blood loss and decreased incidence of iron-deficiency anemia
Decreased incidence of dysmenorrheal
Effects related to inhibition of ovulation:
Decreased incidence of functional ovarian cysts
Decreased incidence of ectopic pregnancies
Effects from long-term use:
Decreased incidence of fibroadenomas and fibrocystic disease of the breast
Decreased incidence of acute pelvic inflammatory disease
Decreased incidence of endometrial cancer
Decreased incidence of ovarian cancer
How should I store and handle Falmina?
FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).FALMINA™ tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows:21 active tablets: orange, round tablet debossed with "A3" on one side.7 inert tablets: white, round tablet debossed with "P" on one side and "" on the other side.FALMINA™ Tablets are available in the following: Carton of 1 NDC 16714-359-02 Carton of 3 NDC 16714-359-03 Carton of 6 NDC 16714-359-04Store at controlled room temperature 20° to 25°C (68° to 77°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
Non-Clinical Toxicology
Combination oral contraceptives should not be used in women with any of the following conditions:Thrombophlebitis or thromboembolic disorders
A history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Hepatic adenomas or carcinomas, or active liver disease
Known or suspected pregnancy
Hypersensitivity to any of the components of FALMINA
Combination oral contraceptives should not be used in women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations (see Warnings, ).
Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
Calcium channel blockers may also have an additive effect when given with atenolol (see
Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.
Beta blockers may exacerbate the rebound hypertension, which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.
Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta blockers.
Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.
While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.
Both digitalis glycosides and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
To report SUSPECTED ADVERSE REACTIONS, contact Novast Laboratories, Ltd. Toll-Free at 1-877-966-8278 or FDA at 1-800-FDA-1088 or .
An increased risk of the following serious adverse reactions (see section for additional information) has been associated with the use of oral contraceptives:
Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):
Acne
Amenorrhea
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Breast changes: tenderness, pain, enlargement, secretion
Budd-Chiari syndrome
Cervical erosion and secretion, change in Cholestatic jaundice
Chorea, exacerbation of Colitis
Contact lenses, intolerance to
Corneal curvature (steepening), change in
Dizziness
Edema/fluid retention
Erythema multiforme
Erythema nodosum
Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
Hirsutism
Infertility after discontinuation of treatment, temporary
Lactation, diminution in, when given immediately postpartum
Libido, change in
Melasma/chloasma which may persist
Menstrual flow, change in
Mood changes, including depression
Nausea
Nervousness
Pancreatitis
Porphyria, exacerbation of
Rash (allergic)
Scalp hair, loss of
Serum folate levels, decrease in
Spotting
Systemic lupus erythematosus, exacerbation of
Unscheduled bleeding
Vaginitis, including candidiasis
Varicose veins, aggravation of
Vomiting
Weight or appetite (increase or decrease), change in
The following adverse reactions have been reported in users of oral contraceptives:
Cataracts
Cystitis-like syndrome
Dysmenorrhea
Hemolytic uremic syndrome
Hemorrhagic eruption
Optic neuritis, which may lead to partial or complete loss of vision
Premenstrual syndrome
Renal function, impaired
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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