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LANTUS SOLOSTAR INSULIN – 100IUML 3ML

Description for LANTUS SOLOSTAR INSULIN – 100IUML 3ML

LANTUS SOLOSTAR® is a high-quality, long-acting basal insulin analog designed to provide foundational blood sugar control for adult and pediatric patients (6 years and older) with type 1 diabetes and for adults with type 2 diabetes. Manufactured by Sanofi, a global leader in diabetes care, this product includes a state-of-the-art, disposable prefilled insulin pen (SoloStar) and a box of compatible pen needles for easy, precise, and comfortable administration. Each LANTUS SOLOSTAR pen contains 3 mL of insulin glargine at a concentration of 100 units per mL (U-100), offering a consistent and prolonged release of insulin to mimic the body's natural basal insulin secretion.


Indications and Mechanism of Action

LANTUS® (insulin glargine) is indicated to improve glycemic control. In type 1 diabetes, it is used alongside mealtime (bolus) insulin. In type 2 diabetes, it may be used alone or combined with oral anti-diabetic medications or other injectable therapies.

Its unique mechanism stems from a slight modification to the human insulin molecule, making it less soluble at physiological pH. After subcutaneous injection, the solution forms a micro-precipitate, allowing for a slow, steady, and predictable release of insulin glargine into the bloodstream. This action profile results in a relatively constant concentration/time profile with no pronounced peak, providing up to 24 hours of basal insulin coverage. This helps manage fasting blood glucose (FBG) and blood sugar levels between meals and overnight, forming the critical "basal" layer of diabetes management.


Key Features and Benefits of the LANTUS SOLOSTAR System

1. Consistent 24-Hour Glucose Control

LANTUS is engineered for a prolonged duration of action, offering a flat and stable pharmacokinetic profile. This consistency helps patients achieve lower and more predictable fasting blood glucose levels, which is a cornerstone of overall glycemic management as measured by A1C.

2. The User-Centric SoloStar® Prefilled Pen

Sanofi's SoloStar pen is widely recognized for its patient-friendly design, enhancing adherence and injection confidence.

  • Dose Accuracy: Delivers precise doses in 1-unit increments up to a maximum of 80 units per injection.

  • Easy Dose Setting: A large, easy-to-grip dial and clear, digital dose window (especially beneficial for users with visual or dexterity challenges) make dose selection straightforward.

  • Smooth Injection: Requires low injection force. An audible "click" confirms each unit dialed and a distinct sound confirms the full dose has been delivered.

  • End-of-Dose Indicator: Clearly shows the remaining insulin in the pen, preventing surprises.

  • Discreet and Portable: The slim, lightweight design is easy to carry and use discreetly.

3. Included Pen Needles for Complete Therapy

This offering includes a box of compatible pen needles, ensuring patients have everything needed to begin therapy immediately. It is crucial to use a new needle for every injection to ensure sterility, prevent contamination, reduce pain, and maintain dose accuracy. Needles are not included with the pen itself and must be purchased separately; this bundle provides convenience and peace of mind.

4. Dosing Flexibility

LANTUS SOLOSTAR offers dosing versatility. It is typically administered once daily at the same time each day. The time of administration can be adjusted to fit individual patient lifestyles, provided it is consistent daily. Dose adjustments should always be made under the guidance of a healthcare professional based on blood glucose monitoring patterns.


Important Safety Information and Warnings

BOXED WARNING: RISK OF HYPOGLYCEMIA, AND DO NOT DILUTE OR MIX WITH OTHER INSULINS.

  • Hypoglycemia (low blood sugar) is the most common adverse reaction. It can be severe and life-threatening, causing seizures, loss of consciousness, or death. Risk increases with intensive glycemic control, changes in meal patterns, physical activity, and concomitant use of other anti-diabetic drugs. Careful monitoring and patient education on recognition and treatment are essential.

  • LANTUS MUST NOT BE DILUTED OR MIXED with any other insulin or solution. Mixing can alter its time-action profile and cause precipitation.

Additional Warnings & Precautions:

  • Hypersensitivity Reactions: Severe, life-threatening allergy is possible. Discontinue use if reactions occur.

  • Hypokalemia: Insulin, including Lantus, can cause low potassium levels, which may be serious.

  • Fluid Retention & Heart Failure: May occur with concomitant use of TZDs (thiazolidinediones).

  • Administration: For subcutaneous injection onlyDo not administer intravenously or via an insulin pump. Rotate injection sites within the same region (abdomen, thigh, or upper arm) to reduce the risk of lipodystrophy.

  • Drug Interactions: Certain drugs may affect insulin requirements. Close monitoring is required when starting or stopping any medication.

Common Side Effects: Hypoglycemia, allergic reactions, injection site reactions (redness, swelling, itching), lipodystrophy, itching, rash, and weight gain.

Who Should Not Use Lantus? Patients experiencing hypoglycemia or with a hypersensitivity to insulin glargine or any excipients.


Directions for Use: A Step-by-Step Guide

  1. Preparation: Wash hands. Check the pen label to ensure it is Lantus and not expired. Attach a new pen needle. Perform a "safety test" (prime) by dialing 2 units, pointing the pen upward, and pressing the injection button until a drop of insulin appears at the needle tip.

  2. Dose Selection: Dial the exact number of units prescribed by your healthcare provider.

  3. Injection: Insert the needle into your chosen, clean injection site at a 90-degree angle. Press the injection button down fully and hold. Slowly count to 10 before withdrawing the needle to ensure the full dose is delivered.

  4. Disposal: Safely remove the needle using the outer cap and discard in an FDA-cleared sharps container. Do not store the pen with the needle attached, as this can lead to leakage, contamination, or air bubbles. Store the pen without the needle attached.

Storage:

  • Unopened (Refrigerated): Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Keep away from the cooling element.

  • In-Use: Once punctured with a needle, the pen can be kept at room temperature (below 86°F or 30°C) for up to 28 days. Do not refrigerate the pen you are currently using. Protect from direct heat and light. Discard after 28 days, even if insulin remains.


Why Choose LANTUS SOLOSTAR?

LANTUS SOLOSTAR represents a trusted, evidence-based choice in basal insulin therapy. Its proven efficacy in providing consistent 24-hour coverage, combined with the ergonomic and intuitive SoloStar delivery system, supports patients in achieving their glycemic targets. The inclusion of pen needles in this offering underscores a commitment to a complete patient experience, removing a potential barrier to proper injection technique and therapy initiation.

For over two decades, Lantus has been a foundational therapy for millions of patients worldwide, backed by Sanofi's extensive research and support programs. It is a critical tool in the diabetes management plan, working to reduce the risk of long-term complications associated with uncontrolled blood sugar.

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    1. Storage: Store both the lyophilized DSIP and bacteriostatic water vials in a cool, dark place at 2-8°C (36-46°F) prior to reconstitution. Avoid repeated temperature fluctuations.

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    Disclaimer: This information is for educational and research reference purposes only. The products offered are for laboratory research use only. They are not for human or veterinary use, nor for in-vivo diagnosis or treatment. All statements made herein have not been evaluated by any regulatory body. Researchers must operate within the ethical and legal guidelines of their institution and country.

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    1. Hypothalamic Stimulation: In a normal cycle, estrogen levels provide feedback to the hypothalamus in the brain. Clomid competes with the body’s natural estrogen for binding sites (estrogen receptors) in the hypothalamus.

    2. Blocking Negative Feedback: By blocking these receptors, Clomid "tricks" the brain into perceiving low estrogen levels. This disrupts the normal negative feedback loop.

    3. Release of Gonadotropins: In response, the hypothalamus signals the pituitary gland to secrete increased levels of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH).

    4. Ovarian Follicle Development: The elevated FSH stimulates the ovaries to mature and develop one or more ovarian follicles, each containing an egg.

    5. Triggering Ovulation: The subsequent surge in LH, triggered by the developed follicle, initiates ovulation—the release of a mature egg from the ovary, making it available for fertilization.

    This elegantly targeted mechanism makes Clomid an effective, non-invasive starting point for many couples on their fertility journey.

    Primary Indications and Clinical Use

    GenLabs Clomid 10mg is specifically indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Its use is justified when the following criteria are met:

    • Diagnosed Anovulation/Oligo-Ovulation: Confirmed through cycle charting, progesterone level testing, or ultrasound monitoring.

    • Intact Hypothalamic-Pituitary-Ovarian Axis: The patient's own hormonal pathways must be capable of responding to stimulation.

    • Normal Partner Semen Analysis: To ensure male factor infertility is not the primary issue.

    • Patent Fallopian Tubes: Confirmed via hysterosalpingogram (HSG).

    • Adequate Ovarian Reserve: As suggested by normal Anti-Müllerian Hormone (AMH) or antral follicle count.

    Important Note: Clomid is not effective for women with primary ovarian failure (premature menopause) or those with blocked fallopian tubes. Its use in men for testosterone deficiency is off-label and requires extreme caution due to significant side effect profiles and limited evidence for efficacy in many cases.

    Dosage, Administration, and the 200-Tablet Advantage

    The standard recommended starting dose of Clomiphene Citrate is 50mg (one 50mg tablet) daily for 5 days, typically beginning on day 3, 4, or 5 of the menstrual cycle (with day 1 being the first day of menses). Treatment is usually not recommended beyond 5 days per cycle.

    The GenLabs 10mg tablet strength and 200-count pack offer distinct advantages for precise, flexible, and long-term therapy:

    • Dosage Titration: The 10mg strength allows healthcare providers to make fine-tuned adjustments. For example, if a patient experiences side effects on 50mg or requires a subtle increase from a 50mg dose, the protocol can be adjusted using combinations of 10mg tablets (e.g., 40mg or 60mg) to find the minimal effective dose.

    • Extended Treatment Cycles: A 200-tablet pack provides medication for multiple treatment cycles, ensuring continuity of care and convenience for the patient without the need for frequent pharmacy visits.

    • Cost-Effectiveness: Purchasing a larger pack from a reputable manufacturer like GenLabs can be more economical per milligram over the course of a treatment plan.

    Crucially, dosing MUST be individualized by a fertility specialist. Response is monitored via mid-cycle ultrasound (to track follicle growth) and/or a day 21 progesterone blood test (to confirm ovulation). The dose may be increased in subsequent cycles if ovulation does not occur. Therapy is generally limited to 3-6 ovulatory cycles due to diminishing efficacy and cumulative endometrial thinning effects.

    Potential Side Effects and Important Safety Considerations

    While generally well-tolerated, Clomid is a potent hormonal agent and can cause side effects. Patients should be fully informed and monitored.

    Common Side Effects (usually mild and transient):

    • Vasomotor flushes ("hot flashes")

    • Abdominal discomfort or bloating

    • Breast tenderness

    • Nausea

    • Headaches

    • Mood swings

    • Visual disturbances (e.g., blurring, spots). Visual symptoms necessitate immediate discontinuation and medical review.

    Serious Risks and Considerations:

    • Multiple Pregnancy: The risk of twins is approximately 5-10%. The risk of triplets or higher-order multiples is rare but possible.

    • Ovarian Hyperstimulation Syndrome (OHSS): A rare but serious condition where the ovaries become overly enlarged and fluid leaks into the abdomen. Symptoms include severe pelvic pain, rapid weight gain, abdominal distension, nausea, and shortness of breath. This requires urgent medical attention.

    • Thinning of the Endometrial Lining: Long-term or high-dose use can sometimes thin the uterine lining, potentially impairing embryo implantation.

    • Ovarian Torsion: An extremely rare complication where an enlarged ovary twists on itself, causing severe pain and a surgical emergency.

    Why Choose GenLabs Clomid 10mg?

    • Consistent Quality: GenLabs adheres to strict Good Manufacturing Practice (GMP) standards, ensuring each 10mg tablet delivers precise, reliable dosing.

    • Treatment Flexibility: The 10mg strength and 200-tablet quantity empower your physician with unparalleled dosing flexibility for a personalized fertility plan.

    • Proven Active Ingredient: Contains the authentic, clinically-validated compound, Clomiphene Citrate.

    • Comprehensive Supply: Reduces treatment interruptions, supporting consistent and managed therapy cycles.

    Final Disclaimer and Patient Empowerment

    This product description is for informational purposes only and does not constitute medical advice. Clomid (Clomiphene Citrate) is a prescription-only medication.

    Consultation with a qualified reproductive endocrinologist or fertility specialist is absolutely essential before considering this treatment. A thorough diagnostic workup is required to confirm its appropriateness for your specific condition. Your doctor will determine the correct dosage, monitor your response through ultrasound and blood tests, and manage any potential side effects to ensure the safest and most effective path toward achieving pregnancy.



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