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Estradiol and Levonorgestrel
Overview
What is Climara Pro?
Climara Pro (estradiol/levonorgestrel transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol and levonorgestrel, a progestational agent, continuously upon application to intact skin. The 22 cm Climara Pro system contains 4.4 mg estradiol and 1.39 mg levonorgestrel and provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel.
Estradiol USP has a molecular weight of 272.39 and the molecular formula is CHO.
Levonorgestrel USP has a molecular weight of 312.4 and a molecular formula of CHO.
The structural formulas for estradiol and levonorgestrel are:
The Climara Pro transdermal system comprises 3 layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are:
The active components of the transdermal system are estradiol and levonorgestrel. The remaining components of the transdermal system (acrylate copolymer adhesive and polyvinylpyrrolidone/vinyl acetate copolymer) are pharmacologically inactive.
What does Climara Pro look like?
What are the available doses of Climara Pro?
Climara Pro (estradiol/levonorgestrel transdermal system) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel.
What should I talk to my health care provider before I take Climara Pro?
How should I use Climara Pro?
Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for:
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual women. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
One Climara Pro transdermal system is available for use.
Initiation of Therapy
Women not currently using continuous estrogen-alone therapy or estrogen plus progestin therapy may start therapy with Climara Pro at any time. However, women currently using continuous estrogen-alone therapy or estrogen plus progestin therapy should complete the current cycle of therapy before initiating Climara Pro therapy. Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin Climara Pro therapy.
What interacts with Climara Pro?
Sorry No Records found
What are the warnings of Climara Pro?
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What are the precautions of Climara Pro?
Sorry No Records found
What are the side effects of Climara Pro?
Sorry No records found
What should I look out for while using Climara Pro?
Climara Pro is contraindicated in women with any of the following conditions:
What might happen if I take too much Climara Pro?
Overdosage of estrogen plus progestin may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Climara Pro therapy with institution of appropriate symptomatic care.
How should I store and handle Climara Pro?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.Isoniazid Tablets, USP, for oral administration, are available as following strength:300 mgWhite, round, biconvex, single-scored tablets, debossed “LAN” over "1109" and supplied as:Bottles of 30 tablets NDC 0527-1109-30Bottles of 100 tablets NDC 0527-1109-01Bottles of 1000 tablets NDC 0527-1109-10 StorageStore at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH, through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Levonorgestrel inhibits gonadotropin production resulting in retardation of follicular growth and inhibition of ovulation.
Studies to assess the potency of progestins using estrogen-primed postmenopausal endometrial biochemistry and morphologic features have shown that levonorgestrel counteracts the proliferative effects of estrogens on the endometrium.
Non-Clinical Toxicology
Climara Pro is contraindicated in women with any of the following conditions:Isoniazid should not be administered with food. Studies have shown that the bioavailability of isoniazid is reduced significantly when administered with food. Tyramine- and histamine-containing foods should be avoided in patients receiving isoniazid. Because isoniazid has some monoamine oxidase inhibiting activity, an interaction with tyramine-containing foods (cheese, red wine) may occur. Diamine oxidase may also be inhibited, causing exaggerated response (e.g., headache, sweating, palpitations, flushing, hypotension) to foods containing histamine (e.g., skipjack, tuna, other tropical fish).
A report of severe acetaminophen toxicity was reported in a patient receiving Isoniazid. It is believed that the toxicity may have resulted from a previously unrecognized interaction between isoniazid and acetaminophen and a molecular basis for this interaction has been proposed. However, current evidence suggests that isoniazid does induce P-450IIE1, a mixed-function oxidase enzyme that appears to generate the toxic metabolites, in the liver. Furthermore it has been proposed that isoniazid resulted in induction of P-450IIE1 in the patient's liver which, in turn, resulted in a greater proportion of the ingested acetaminophen being converted to the toxic metabolites. Studies have demonstrated that pretreatment with isoniazid potentiates acetaminophen hepatotoxicity in rats.
Isoniazid is known to slow the metabolism of carbamazepine and increase its serum levels. Carbamazepine levels should be determined prior to concurrent administration with isoniazid, signs and symptoms of carbamazepine toxicity should be monitored closely and appropriate dosage adjustment of the anticonvulsant should be made.
Potential interaction of Ketoconazole and Isoniazid may exist. When Ketoconazole is given in combination with isoniazid and rifampin the AUC of ketoconazole is decreased by as much as 88 percent after 5 months of concurrent Isoniazid and Rifampin therapy.
Isoniazid may increase serum levels of phenytoin. To avoid phenytoin intoxication, appropriate adjustment of the anticonvulsant should be made.
A recent study has shown that concomitant administration of isoniazid and theophylline may cause elevated plasma levels of theophylline and in some instances a slight decrease in the elimination of isoniazid. Since the therapeutic range of theophylline is narrow, theophylline serum levels should be monitored closely and appropriate dosage adjustments of theophylline should be made.
A recent case study has shown a possible increase in the plasma level of valproate when co-administered with isoniazid. Plasma valproate concentration should be monitored when isoniazid and valproate are co-administered and appropriate dosage adjustments of valproate should be made.
An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. An increased risk of stroke and DVT has been reported with estrogen-alone therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately.
Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.
The following serious adverse reactions are discussed elsewhere in the labeling:
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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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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