Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Camrese Lo)

Trade Name : camrese Lo

Teva Pharmaceuticals USA, Inc.

KIT

Strength

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Camrese Lo) which is also known as camrese Lo and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of per ml. Read more

Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Camrese Lo) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Contraindications ()t9/2017Warnings and Precautions ()t9/2017
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. n
  • WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
  • See full prescribing information for complete boxed warning.
  • Women who are over 35 years old and smoke should not use CAMRESE LO. ()
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
  • CAMRESE LO (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.
  • CAMRESE LO is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ()
  • Take one tablet by mouth at the same time every day. The dosage of CAMRESE LOu00a0is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, CAMRESE LO must be taken exactly as directed and at intervals not exceeding 24 hours.
  • Instruct the patient to begin taking CAMRESE LO on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the yellow tablets are taken.
  • Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of CAMRESE LO, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.
  • If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
  • For patient instructions regarding missed pills, .
  • For postpartum women who are not breastfeeding, start CAMRESE LOu00a0no earlier than four to six weeks postpartum. If the patient starts on CAMRESE LO postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.
  • Take one tablet daily by mouth at the same time every day for 91 days. ()
  • CAMRESE LO tablets are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 84 orange tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The orange tablets are round, film-coated, unscored tablets with a debossed stylized on one side and on the other side. The yellow tablets are round, film-coated, unscored tablet with a debossed stylized on one side and u00a0on the other side.
  • CAMRESE LO consists of 84 orange tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. ()
  • Do not prescribe CAMRESE LO to women who are known to have the following conditions:
  • A high risk of arterial or venous thrombotic diseases ()
  • Breast cancer or other estrogen-or progestin-sensitive cancer ()
  • Liver tumors or liver disease ()
  • Pregnancy ()
  • Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()
  • No data
  • Vascular risks: Stop CAMRESE LO if a thrombotic event occurs. Stop CAMRESE LO at least 4 weeks before and through 2 weeks after major surgery. Start CAMRESE LO no earlier than 4 weeks after delivery, in women who are not breastfeeding. ()
  • Liver disease: Discontinue CAMRESE LO if jaundice occurs. ()
  • High blood pressure: Do not prescribe CAMRESE LO for women with uncontrolled hypertension or hypertension with vascular disease. ()
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking CAMRESE LO. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias. ()
  • Headache: Evaluate significant change in headaches and discontinue CAMRESE LO if indicated. (n
  • Uterine bleeding: Evaluate irregular bleeding or amenorrhea. ()
  • The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
  • Adverse reactions commonly reported by COC users are:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The clinical trial that evaluated the safety and efficacy of CAMRESE LO was a 12-month, multicenter, non-comparative open-label study, which enrolled women aged 18-41, of whom 2,185 took at least one dose of CAMRESE LO.
  • Adverse Reactions Leading to Study Discontinuation:
  • Common Treatment-Emergent Adverse Reactions (u22655% of women):
  • The most common adverse reactions for COCs are irregular uterine bleeding, nausea, breast tenderness, and headaches. (6)
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or n
  • No formal drug-drug interaction studies were conducted with CAMRESE LO.
  • Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs. ()
  • No data
  • Nursing: Not recommended for nursing mothers; can decrease milk production. ()
  • There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
  • CAMRESE LO (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol.
  • The structural formulas for the active components are:
  • CHO MW: 312.4
  • Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17u03b1)-, (-)-.
  • CHO MW: 296.4
  • Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17u03b1)-.
  • Inactive ingredients
  • Inactive ingredients
  • No data
  • [See WARNINGS AND PRECAUTIONS (, )]
  • In a 12-month multicenter open-label clinical trial, 2,185 women aged 18-41 were studied to assess the safety and efficacy of CAMRESE LO, completing the equivalent of 20,937 28-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (75%), African-American (12%), Hispanic (10%), Asian (2%), and Other (2%). There were no exclusions for body mass index (BMI) or weight. The weight range for those women treated was 87 to 381 lbs., with a mean weight of 159 lbs. Among the women in the trial, 59% were current or recent hormonal contraceptive users, 30% were prior users (had used hormonal contraceptives in the past but not in the 6 months prior to enrollment) and 11% were new starts. Of treated women, 14.2% were lost to follow-up, 11.6% discontinued due to an adverse event, and 10.3% discontinued by withdrawing their consent.
  • The pregnancy rate (Pearl Index [PI]) in women aged 18 to 35 years was 2.74 pregnancies per 100 women-years of use (95% confidence interval 1.92 u2013 3.78), based on 36 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.
  • CAMRESE LO (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in an Extended-Cycle Tablet Dispenser that contains 84 round, orange tablets and 7 round, yellow tablets. Each orange tablet (debossed stylized on one side and on the other side) contains 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol. Each yellow tablet (debossed stylized on one side and on the other side) contains 0.01 mg ethinyl estradiol. The tablets should not be removed from the protective blister packaging and outer plastic dispenser to avoid damage to the product. The plastic dispenser should be kept in the foil pouch until dispensed to the patient.
  • Box of 2 Extended-Cycle Tablet Dispensers NDC 0093-6148-82
  • Storage
  • Store at 20 to 25u00b0C (68 to77u00b0F) [See USP Controlled Room Temperature].
  • See FDA-APPROVED PATIENT LABELING ()
  • No data
  • 2 Extended-Cyclen- 91 Tablets Each / NDCn- 6148
  • Arrayn- levonorgestrel/ethinyl estradiol 0.1 mg/0.02 mg tabletsu00a0n- ethinyl estradiol 0.01 mg tablets
  • Rx only
  • Contains 2 Extended-Cycle Tablet Dispensers, each containing 91 tablets: 84 orange tablets, each containing 0.1 mg levonorgestrel with 0.02 mg ethinyl estradiol, and 7 yellow tablets, each containing 0.01 mg ethinyl estradiol.
  • TEVA
  • TEVA WOMENu2019S HEALTH
  • TEVA WOMENu2019S HEALTH, INC.
  • Subsidiary of TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • No data

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.