GENERIC NAME OF THE MEDICINAL PRODUCT:

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)
Each film-coated tablet contains:
Naltrexone hydrochloride …………………8mg
Equivalent to naltrexone ………………….7.2mg
Bupropion hydrochloride …………………90mg
Equivalent to bupropion …………………78mg
Lactose……………………………. 73.2mg

THERAPEUTIC INDICATIONS:

Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: Both Naltrexone and Bupropion have been used clinically before but Mysimtaj is the first time they have been used together in one treatment.
Nearly half of all Mysimtaj users lost at least 5% of their total body weight.
KEEP MEDICINE OUT OF REACH AND SIGHT OF CHILDREN
*This medicinal product is subject to additional monitoring. ***For Weight Loss Use.
TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place.
Protect from light & moisture.
DOSAGE:
The normal regimen is as follows:
Week 1: one tablet each morning for one week.
Week 2: one tablet in the morning and one in the evening.
Week 3: two tablets in the morning and a single tablet in the evening.
Week 4: two tablets in the morning and two in the evening.
NOTE:
Mysimtaj is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years)
With an initial Body Mass Index (BMI) of
≥ 30kg/m2 (obese), or
≥ 27kg/m2 to 30kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidemia, or controlled hypertension).
Mysimtaj should not be used by adults over 18 years old with a BMI of over 30 (or 27 if you have other health conditions like diabetes).
If do not lose 5% of your total body weight within 4 months of using the weight lose treatment Mysimtaj use should be stopped.

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg) Technical Specification:

Product Name:Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets
Brand Name:Mysimtaj
Strength:8mg/90mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidepressant, Opioid antagonist
Indication: Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant.
Storage:Store in cool & Dry place. Protect from light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (8mg/90mg)
    Each film-coated tablet contains:
    Naltrexone hydrochloride …………………8mg
    Equivalent to naltrexone ………………….7.2mg
    Bupropion hydrochloride …………………90mg
    Equivalent to bupropion …………………78mg
    Lactose……………………………. 73.2mg

THERAPEUTIC INDICATIONS:

Naltrexone hydrochloride and Bupropion hydrochloride is a fixed combination of naltrexone, an opioid antagonist, and bupropion, an aminoketone antidepressant, and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

WARNING: Both Naltrexone and Bupropion have been used clinically before but Mysimtaj is the first time they have been used together in one treatment.

Nearly half of all Mysimtaj users lost at least 5% of their total body weight.

Keep medicine out of reach and sight of children

*This medicinal product is subject to additional monitoring. ***For Weight Loss Use.

TAKE CHARGE OF YOUR HEALTH BY TAKING MEDICATION PROPERLY

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place. Protect from light & moisture.

DOSAGE:
The normal regimen is as follows:
Week 1: one tablet each morning for one week.
Week 2: one tablet in the morning and one in the evening.
Week 3: two tablets in the morning and a single tablet in the evening.
Week 4: two tablets in the morning and two in the evening.

NOTE:

Mysimtaj is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years)
With an initial Body Mass Index (BMI) of
≥ 30kg/m2 (obese), or
≥ 27kg/m2 to 30kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidemia, or controlled hypertension).

Mysimtaj should not be used by adults over 18 years old with a BMI of over 30 (or 27 if you have other health conditions like diabetes).
If do not lose 5% of your total body weight within 4 months of using the weight lose treatment Mysimtaj use should be stopped.

Why Taj Pharmaceuticals?

The benefits of Taj Pharma for Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets. Trust in our commitment to quality, affordability, and effectiveness for your healthcare needs. Taj Pharma stands out as your trusted choice. With a legacy of excellence in pharmaceuticals, Taj Pharma offers you a winning combination of quality, affordability, and effectiveness. Our commitment to your well-being is unwavering, and our products are meticulously crafted to meet the highest industry standards. Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets are no exception. We prioritize your health and strive to make these medications accessible to those who need them. At Taj Pharma, we understand the importance of finding a pharmaceutical partner you can rely on. Whether you’re seeking treatment or healthcare solutions, our dedication to excellence ensures that you receive the best possible care. Choose Taj Pharma for Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets and experience the difference in your journey towards well-being.

What is Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets and Its Use?

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets are a medication commonly known by its brand name, Contrave. It is a prescription medication that combines two active ingredients, Naltrexone and Bupropion, in a prolonged-release tablet form. Here’s some information about its use:

  • Naltrexone Hydrochloride: Naltrexone is an opioid receptor antagonist. It works by blocking the effects of opioids in the brain. In the context of Contrave, Naltrexone is used to help reduce cravings for food.
  • Bupropion Hydrochloride: Bupropion is an atypical antidepressant and smoking cessation aid. It works on neurotransmitters in the brain, primarily norepinephrine and dopamine, to help improve mood and reduce the desire to smoke. In Contrave, Bupropion is included to address food cravings and enhance feelings of fullness.

Use:

Contrave, or Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets, is primarily prescribed to help manage weight in individuals who are struggling with obesity or overweight conditions. It’s intended for use as part of a comprehensive weight management plan, which includes a reduced-calorie diet and increased physical activity.

The exact mechanism of how Contrave helps with weight loss isn’t fully understood, but it is believed to work on the brain’s reward system to reduce food cravings and increase the feeling of fullness, making it easier for individuals to control their eating habits and lose weight.

How does Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets Work?

Naltrexone hydrochloride and Bupropion hydrochloride prolongedrelease Tablets, commonly known as Contrave, work through a combination of two active ingredients: Naltrexone and Bupropion. Each of these components plays a distinct role in the medication’s mechanism of action:

  • Naltrexone Hydrochloride (Opioid Receptor Antagonist):
    Naltrexone works by blocking opioid receptors in the brain. These receptors are responsible for the pleasurable and reinforcing effects of opioids. By blocking these receptors, Naltrexone reduces the rewarding sensations associated with consuming food, particularly highcalorie, palatable foods.
    In the context of Contrave, Naltrexone helps to decrease food cravings and the urge to overeat.
  • Bupropion Hydrochloride (Atypical Antidepressant and Smoking Cessation Aid):
    Bupropion primarily affects the levels of neurotransmitters in the brain, particularly norepinephrine and dopamine. It inhibits the reuptake of these neurotransmitters, increasing their availability in the brain.
    This increased availability of norepinephrine and dopamine is believed to have multiple effects on appetite and cravings. It can lead to improved mood, reduced appetite, and decreased desire to eat for pleasure or comfort.
    Bupropion’s impact on dopamine levels may also influence the brain’s reward system, potentially helping to regulate food intake.
  • Together, the combination of Naltrexone and Bupropion in Contrave is thought to target both the physiological and psychological aspects of overeating and obesity:
  • Physiological Aspect: By reducing the rewarding effects of food through Naltrexone’s action on opioid receptors, Contrave helps to decrease cravings for highcalorie foods.
  • Psychological Aspect: Bupropion’s effects on neurotransmitters like dopamine and norepinephrine may help regulate mood and appetite, making it easier for individuals to stick to a reduced calorie diet.

It’s important to note that the exact mechanisms of Contrave’s actions are still being studied, and individual responses to the medication may vary. It should only be used under the supervision of a healthcare provider who can monitor its effects and make adjustments as needed.

Benefits and Side effects of Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets:

Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets (Contrave) offer potential benefits for individuals struggling with obesity or weight management issues. However, like any medication, it also comes with possible side effects. Here’s an overview of both:

Benefits:

  • Weight Loss: The primary benefit of Contrave is weight loss. It can assist individuals in achieving and maintaining a healthier body weight, especially when used in conjunction with a reduced-calorie diet and increased physical activity.
  • Appetite Control: Contrave can help control appetite and reduce food cravings, particularly for high-calorie and pleasurable foods. This can make it easier for individuals to adhere to a calorie-restricted diet.
  • Improved Mood: Bupropion, one of the active ingredients in Contrave, is an antidepressant that can help improve mood. This can be particularly beneficial for individuals who experience emotional eating or mood-related overeating.
  • Smoking Cessation Aid (Bupropion): Bupropion is also used as a smoking cessation aid. For individuals who smoke and are looking to quit, Contrave can potentially provide dual benefits by helping with weight management and smoking cessation simultaneously.

Side Effects:

It’s important to note that not everyone will experience side effects, and the severity of side effects can vary from person to person. Common side effects of Naltrexone hydrochloride and Bupropion hydrochloride prolonged-release Tablets may include:

  • Nausea: Gastrointestinal discomfort, including nausea, is a common side effect. Taking the medication with food may help reduce this symptom.
  • Headache: Some individuals may experience headaches while taking Contrave.
  • Insomnia: Bupropion is known to be stimulating and may cause difficulty sleeping in some individuals. Taking the medication earlier in the day or adjusting the dosage may help.
  • Dry Mouth: Dry mouth can occur as a side effect of Bupropion.
  • Dizziness: Some people may experience dizziness or lightheadedness.
  • Increased Blood Pressure: Bupropion can sometimes lead to increased blood pressure. Regular monitoring of blood pressure is typically recommended during treatment.
  • Seizures (Rare): In very rare cases, Bupropion can lower the seizure threshold, potentially leading to seizures, particularly in individuals with a history of seizures or certain medical conditions.
  • Mood Changes: While Bupropion can improve mood in many individuals, it may also lead to mood changes or agitation in some cases.
  • Suicidal Thoughts (Rare): Like many antidepressants, Bupropion carries a warning about the possibility of increased risk of suicidal thoughts, especially in young adults.

It’s crucial to discuss the potential benefits and risks of Contrave with a healthcare provider. They can assess whether it is a suitable option for an individual based on their medical history, current health status, and weight management goals. Additionally, healthcare providers can monitor and adjust the medication as needed to minimize side effects and optimize its effectiveness. Contrave should only be used under medical supervision.

Frequently asked questions (FAQs) about Naltrexone hydrochloride and Bupropion hydrochloride prolonged release Tablets (Contrave):

  1. What is Contrave, and how does it work?

Contrave is a prescription medication that combines two active ingredients, Naltrexone and Bupropion. It is used to assist with weight management by reducing appetite and cravings for high calorie foods. Naltrexone acts as an opioid receptor antagonist, while Bupropion affects neurotransmitters in the brain.

  1. Who is a suitable candidate for Contrave?

Contrave is typically prescribed to adults who are struggling with obesity or overweight conditions and have difficulty losing weight through diet and exercise alone. A healthcare provider will evaluate an individual’s medical history and weight management goals to determine if Contrave is appropriate.

  1. How is Contrave taken?

Contrave is taken in the form of oral tablets. The dosing regimen may vary depending on the individual’s specific needs and the healthcare provider’s recommendations. It is often taken twice daily.

  1. Can Contrave be used as a standalone weight loss solution?

Contrave is most effective when used as part of a comprehensive weight management plan that includes a reduced calorie diet and increased physical activity. It is not intended to be a standalone solution.

  1. Are there any common side effects of Contrave?

Yes, common side effects of Contrave may include nausea, headache, dry mouth, insomnia, dizziness, and increased blood pressure. However, side effects can vary from person to person.

  1. Is Contrave safe for everyone?

No, Contrave is not safe for everyone. It may not be suitable for individuals with certain medical conditions, such as a history of seizures, eating disorders, or uncontrolled hypertension. A healthcare provider will assess the individual’s medical history before prescribing Contrave.

  1. Does Contrave have any interactions with other medications?

Contrave can interact with certain medications, so it’s important to inform your healthcare provider about all the medications, supplements, and herbal products you are taking. In particular, Contrave may interact with other antidepressants and medications that lower the seizure threshold.

  1. How long should Contrave be taken?

The duration of Contrave treatment varies depending on individual weight loss goals and progress. A healthcare provider will provide guidance on the appropriate duration of treatment.

  1. Can Contrave help with smoking cessation?

Bupropion, one of the active ingredients in Contrave, is also used as a smoking cessation aid. For individuals who smoke and are looking to quit, Contrave can potentially provide dual benefits by helping with weight management and smoking cessation simultaneously.

  1. Is Contrave covered by insurance?

Coverage for Contrave under health insurance plans may vary. It’s advisable to check with your insurance provider to determine if Contrave is covered and what, if any, out-of-pocket costs may apply.

As Naltrexone hydrochloride and Bupropion hydrochloride prolonged release Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Naltrexone hydrochloride and Bupropion hydrochloride prolonged release 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

Naltrexone hydrochloride and Bupropion hydrochloride prolonged release 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 Naltrexone hydrochloride and Bupropion hydrochloride prolonged release 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