Levonorgestrel Tablets BP 1.5mg Technical Specification:
Product Name: | Levonorgestrel Tablets BP 1.5mg |
Brand Name: | G-pill |
Strength: | 0.75mg, 1.5mg |
Dosage Form: | Tablets (Film-coated) |
Route of Administration: | Via oral Route |
Packing: | 1s, 2s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Progestins |
Indication: | Levonorgestrel, in the single-agent emergency contraceptive form, is indicated for the prevention of pregnancy after the confirmed or suspected failure of contraception methods or following unprotected intercourse. It is distributed by prescription for patients under 17, and over the counter for those above this age. |
Storage: | Store in a dry place. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levonorgestrel Tablets BP 1.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Levonorgestrel Tablets BP 1.5mg
Each film coated tablet contains:
Levonorgestrel B.P. …………… 1.5mg
Excipients……………………………. q.s
Colours: Titanium Dioxide B.P.
THERAPEUTIC INDICATIONS:
Levonorgestrel, in the single-agent emergency contraceptive form, is indicated for the prevention of pregnancy after the confirmed or suspected failure of contraception methods or following unprotected intercourse. It is distributed by prescription for patients under 17, and over the counter for those above this age.
CAUTION & WARNING:
CAUTION: G- pill should not be used as a substitute for a condom or any other regular contraceptive method, G-pill does not prevent the transmission of sexually transmitted diseases or HIV/AIDS.
Emergency contraceptive pills.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store in a dry place. Protect from light.
Dosage:
1.5mg –
1 tablet of G-pill 1.5mg should be taken as soon as possible within 72 hours of unprotected sex.
Why Taj Pharmaceuticals?
The choice of a pharmaceutical manufacturer for a specific medication like Levonorgestrel Tablets BP, which is a hormonal contraceptive, can depend on various factors. While I don’t have specific information about Taj Pharma beyond my last knowledge update in September 2021, I can provide some general considerations that might influence the choice of a manufacturer:
- Quality Assurance: One of the primary concerns when selecting a pharmaceutical manufacturer is the quality of their products. Manufacturers like Taj Pharma are expected to adhere to Good Manufacturing Practices (GMP) and other regulatory standards to ensure the quality, safety, and efficacy of their medications.
- Regulatory Compliance: Pharmaceuticals must meet the regulatory standards of the countries in which they are sold. Choosing a manufacturer that complies with international and local regulatory requirements is essential to ensure that the medication meets safety and efficacy standards.
- Reputation: The reputation of a pharmaceutical manufacturer within the industry and among healthcare professionals can be a significant factor. Manufacturers known for producing reliable and effective medications may be preferred.
- Pricing and Affordability: The cost of medications can vary among manufacturers. Depending on factors like healthcare budgets and patient needs, healthcare providers and institutions may consider the pricing of medications when selecting a manufacturer.
- Availability and Supply Chain: Ensuring a consistent and reliable supply of medications is crucial. Some manufacturers may have more robust distribution networks and supply chain capabilities than others.
- Packaging and Presentation: The way the medication is packaged and presented can also be a consideration, especially for patient convenience and compliance.
- Geographic Considerations: The geographic location of the manufacturer can influence shipping times, import regulations, and other logistics. Some healthcare providers may prefer manufacturers with regional or local presence.
- Customer Support: The level of customer support and assistance provided by the manufacturer can be important. This includes factors like order processing, technical support, and responsiveness to inquiries.
- Regulatory Approvals: Healthcare providers and institutions may consider whether the manufacturer’s Levonorgestrel Tablets BP have received the necessary regulatory approvals in their region.
- Experience and Expertise: Manufacturers with a history of producing hormonal contraceptives and other related medications may be favored due to their experience and expertise in this therapeutic area.
Ultimately, the choice of a pharmaceutical manufacturer for Levonorgestrel Tablets BP or any medication should be made based on a combination of these factors, as well as the specific needs and priorities of healthcare providers, institutions, and patients. Due diligence, including assessing the manufacturer’s certifications, inspecting their facilities, and reviewing their product quality and safety records, is crucial when making such decisions. Additionally, consulting with regulatory agencies and seeking recommendations from trusted sources in the healthcare industry can help inform the decision-making process.
What is Levonorgestrel Tablets BP and its uses:
Levonorgestrel Tablets BP (British Pharmacopoeia) contain the active ingredient levonorgestrel, which is a synthetic progestin hormone. Levonorgestrel is commonly used for various reproductive health purposes. Here’s an overview of Levonorgestrel Tablets BP and their uses:
Uses:
- Emergency Contraception: One of the most well-known uses of Levonorgestrel Tablets BP is as an emergency contraceptive. When taken within a specific timeframe (usually within 72 hours but up to 120 hours after unprotected intercourse), it can help prevent pregnancy by inhibiting or delaying ovulation, interfering with fertilization, or preventing implantation of a fertilized egg.
- Regular Contraception: Levonorgestrel is also used in certain oral contraceptive pills, commonly referred to as “mini-pills.” When taken daily as prescribed, these pills provide contraception by thickening cervical mucus, making it difficult for sperm to reach the egg, and altering the uterine lining to inhibit implantation.
- Treatment of Heavy Menstrual Bleeding: Levonorgestrel-releasing intrauterine devices (IUDs), such as Mirena, release a controlled amount of levonorgestrel directly into the uterus. This can help reduce heavy menstrual bleeding and relieve associated symptoms.
- Endometriosis Management: Levonorgestrel-releasing intrauterine devices (IUDs) may also be used to manage endometriosis-related pain and symptoms.
- Hormone Replacement Therapy (HRT): In some hormone replacement therapy regimens, levonorgestrel may be used in combination with estrogen to manage menopausal symptoms.
- Ectopic Pregnancy: In some cases, levonorgestrel may be used in combination with other medications to treat certain types of ectopic pregnancies (pregnancies outside the uterus).
- Other Off-Label Uses: In certain situations, healthcare providers may prescribe levonorgestrel for other off-label purposes, such as managing irregular menstrual cycles or addressing specific hormonal issues.
It’s important to note that the specific formulation and dosage of levonorgestrel may vary depending on the intended use. For emergency contraception, levonorgestrel is typically available as a single high-dose tablet. For regular contraception, it may be included in combination with other hormones in daily oral contraceptive pills or released gradually through an intrauterine device (IUD).
The use of levonorgestrel should be guided by a healthcare provider, as the choice of contraception or treatment depends on individual factors, medical history, and specific needs. Additionally, Levonorgestrel Tablets BP should not be relied upon as a regular method of contraception but rather as a backup or emergency option when other contraceptive measures fail or are not used.
How Does Levonorgestrel Tablets BP Work?
Levonorgestrel Tablets BP contain the active ingredient levonorgestrel, which is a synthetic progestin hormone. Levonorgestrel works in several ways, depending on its intended use:
- Emergency Contraception: When used for emergency contraception, levonorgestrel primarily works by preventing or delaying ovulation, the release of an egg from the ovary. By inhibiting ovulation, it reduces the chances of sperm meeting an egg and fertilization occurring. Levonorgestrel may also make the cervical mucus thicker, making it more difficult for sperm to penetrate and reach the egg. In some cases, it might affect the uterine lining, making it less receptive to a fertilized egg for implantation.
- Regular Contraception (Mini-Pills): When used as part of daily oral contraceptive pills, levonorgestrel works consistently to provide contraception. It primarily thickens cervical mucus, making it more challenging for sperm to reach the egg. Additionally, levonorgestrel can alter the uterine lining, potentially reducing the likelihood of implantation if fertilization does occur. In these mini-pills, levonorgestrel is taken daily to maintain a constant level of hormones in the body.
- Levonorgestrel Releasing Intrauterine Devices (IUDs): Levonorgestrel-releasing IUDs, such as Mirena, release a controlled amount of levonorgestrel directly into the uterus. This localized hormone release has several effects:
Thickening of cervical mucus hinders sperm movement.
Inhibition of sperm motility and function within the uterus.
Changes in the uterine lining, make it less receptive to implantation.
Suppression of ovulation in some women, although this effect is less pronounced than with other forms of contraception.
In all these methods, the primary aim of levonorgestrel is to prevent fertilization by reducing the chances of sperm meeting an egg or by affecting the uterine environment to make implantation less likely. It does not have an abortifacient effect (i.e., it does not terminate an established pregnancy). The effectiveness of levonorgestrel for contraception or emergency contraception depends on factors such as the timing of administration and individual variation. For emergency contraception, it is most effective when taken as soon as possible after unprotected intercourse and ideally within the first 72 hours, although it can still be effective up to 120 hours (5 days) after intercourse. It’s important to use levonorgestrel as directed by a healthcare provider or as indicated on the product label. If you have specific questions about its mechanism of action or its use, consult with a healthcare professional for personalized guidance.
Benefits of Levonorgestrel Tablets:
- Contraception: Levonorgestrel Tablets are effective for preventing pregnancy. They can be used as a regular contraceptive method (mini-pills) or as emergency contraception when taken after unprotected intercourse.
- Emergency Contraception: When used as emergency contraception within a specific timeframe (typically within 72 hours but up to 120 hours after unprotected intercourse), Levonorgestrel Tablets can significantly reduce the risk of pregnancy. This is a valuable option for preventing unintended pregnancies after contraceptive failure or unprotected sex.
- Regular Menstrual Regulation: In some cases, healthcare providers may prescribe levonorgestrel-containing contraceptives to help regulate irregular menstrual cycles and reduce heavy menstrual bleeding.
- Management of Endometriosis: Levonorgestrel-releasing intrauterine devices (IUDs) are used to manage endometriosis-related pain and symptoms. The continuous release of levonorgestrel can help alleviate the discomfort associated with this condition.
- Long-Acting Contraception: Levonorgestrel-releasing IUDs provide long-lasting contraception (up to five years) without requiring daily attention, making them a convenient option for some individuals.
Side Effects of Levonorgestrel Tablets:
- Nausea and Vomiting: Some individuals may experience mild nausea and vomiting after taking Levonorgestrel Tablets, especially when used for emergency contraception. Taking the medication with food can help reduce these side effects.
- Menstrual Changes: Irregular bleeding, changes in menstrual flow, or missed periods can occur when using levonorgestrel-containing contraceptives, particularly in the first few months of use.
- Breast Tenderness: Some users may experience breast tenderness or enlargement as a side effect.
- Headache: Headaches can occur as a side effect of Levonorgestrel Tablets, but these are usually mild and temporary.
- Changes in Libido: Some individuals may notice changes in their sexual desire while using hormonal contraceptives containing levonorgestrel.
- Mood Changes: Mood swings, changes in mood, or feelings of depression may occur in some users. However, these effects are not common.
- Weight Changes: Some individuals may experience weight changes, including weight gain while using levonorgestrel-containing contraceptives.
- Ectopic Pregnancy: While rare, there is a slightly increased risk of ectopic pregnancy (pregnancy outside the uterus) in individuals using levonorgestrel-containing contraceptives. It’s important to seek prompt medical attention if you experience unusual pelvic pain or bleeding.
- Allergic Reactions: Although rare, severe allergic reactions to levonorgestrel can occur. Seek immediate medical help if you experience symptoms like severe rash, itching, swelling, severe dizziness, or difficulty breathing.
It’s essential to remember that individual responses to medications can vary, and not everyone will experience side effects. The benefits of effective contraception and the prevention of unintended pregnancies often outweigh the potential side effects for many individuals. However, it’s important to discuss the use of Levonorgestrel Tablets with a healthcare provider to determine the most suitable contraceptive method and to address any specific concerns or medical considerations.
Frequently Asked Questions About Levonorgestrel Tablets:
Frequently asked questions (FAQs) about Levonorgestrel Tablets often revolve around their uses, effectiveness, side effects, and proper usage. Here are some common questions and their answers:
- What are Levonorgestrel Tablets used for?
Levonorgestrel Tablets are used for contraception, including regular contraception (minipills) and emergency contraception to prevent pregnancy after unprotected sex or contraceptive failure.
- How does Levonorgestrel emergency contraception work?
Levonorgestrel emergency contraception primarily works by preventing or delaying ovulation, thickening cervical mucus to inhibit sperm movement, and potentially affecting the uterine lining to reduce the chances of implantation.
- When should I take Levonorgestrel emergency contraception?
Levonorgestrel emergency contraception is most effective when taken as soon as possible after unprotected intercourse and ideally within the first 72 hours, although it can still be effective up to 120 hours (5 days) after intercourse.
- How effective is Levonorgestrel emergency contraception at preventing pregnancy?
Levonorgestrel emergency contraception is generally highly effective when taken as directed. However, no contraceptive method is 100% guaranteed, and the effectiveness may decrease if taken closer to the 72hour cutoff.
- Are Levonorgestrel Tablets the same as birth control pills?
Levonorgestrel Tablets can be used as regular contraception (minipills), but they are also available for use as emergency contraception. The dosage and timing differ for emergency contraception.
- What are the common side effects of Levonorgestrel Tablets?
Common side effects may include nausea, vomiting, changes in menstrual bleeding, breast tenderness, headache, and fatigue. These effects are usually mild and temporary.
- Will Levonorgestrel Tablets protect against sexually transmitted infections (STIs)?
No, Levonorgestrel Tablets do not provide protection against STIs. They are solely intended for pregnancy prevention.
- Can I use Levonorgestrel Tablets while breastfeeding?
Levonorgestrel is generally considered safe for breastfeeding mothers, but it’s essential to consult a healthcare provider for guidance and to discuss any potential effects on milk supply.
- Do Levonorgestrel Tablets affect future fertility?
Levonorgestrel Tablets do not have a lasting impact on future fertility. Most individuals can return to their regular menstrual cycles and fertility shortly after discontinuing their use.
- Can I use Levonorgestrel emergency contraception more than once in a menstrual cycle?
While Levonorgestrel emergency contraception can be used more than once, it should not be relied upon as a regular contraceptive method. Frequent use may lead to menstrual irregularities.
- Are Levonorgestrel Tablets available without a prescription?
In many regions, Levonorgestrel emergency contraception is available without a prescription from a healthcare provider and can be purchased over the counter at pharmacies.
- Are there any contraindications or interactions with other medications?
Levonorgestrel Tablets may interact with certain medications, and they may not be suitable for individuals with certain medical conditions. It’s important to consult with a healthcare provider and provide a complete medical history before use.
These FAQs provide general information about Levonorgestrel Tablets, but individual circumstances may vary. It’s essential to consult with a healthcare provider or pharmacist for personalized guidance and to address specific questions or concerns about these tablets.
As Levonorgestrel Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Levonorgestrel Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Levonorgestrel Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Levonorgestrel Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Levonorgestrel Tablets BP 0.75mg
B. Levonorgestrel Tablets BP 1.5mg
B. Levonorgestrel Tablets BP 1.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Levonorgestrel Tablets BP 0.75mg
Each film coated tablet contains:
Levonorgestrel B.P. …………… 0.75mg
Excipients……………………………. q.s
Colours: Indigo Carmine Lake
B. Levonorgestrel Tablets BP 1.5mg
Each film coated tablet contains:
Levonorgestrel B.P. …………… 1.5mg
Excipients……………………………. q.s
Colours: Titanium Dioxide B.P.
Each film coated tablet contains:
Levonorgestrel B.P. …………… 0.75mg
Excipients……………………………. q.s
Colours: Indigo Carmine Lake
B. Levonorgestrel Tablets BP 1.5mg
Each film coated tablet contains:
Levonorgestrel B.P. …………… 1.5mg
Excipients……………………………. q.s
Colours: Titanium Dioxide B.P.
THERAPEUTIC INDICATIONS:
Levonorgestrel, in the single-agent emergency contraceptive form, is indicated for the prevention of pregnancy after the confirmed or suspected failure of contraception methods or following unprotected intercourse. It is distributed by prescription for patients under 17, and over the counter for those above this age.
CAUTION & WARNING:
CAUTION: G- pill should not be used as a substitute for a condom or any other regular contraceptive method, G-pill does not prevent the transmission of sexually transmitted diseases or HIV/AIDS.
Emergency contraceptive pills.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Emergency contraceptive pills.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store in a dry place. Protect from light.
Dosage:
0.75mg –
1 tablet to be taken within 72 hours of unprotected sex, followed by the second tablet after 12 hours.
Consult your pharmacist or GP first.
1.5mg –
1 tablet of G-pill 1.5mg should be taken as soon as possible within 72 hours of unprotected sex.
Dosage:
0.75mg –
1 tablet to be taken within 72 hours of unprotected sex, followed by the second tablet after 12 hours.
Consult your pharmacist or GP first.
1.5mg –
1 tablet of G-pill 1.5mg should be taken as soon as possible within 72 hours of unprotected sex.