Lybalvi (Olanzapine and Samidorphan)
- Medicine Name: Lybalvi
- Generic Name: Olanzapine/Samidorphan
- Dosage Form & Strength: Tablets: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg
- Manufactured By: Alkermes Inc
Medical Uses
Lybalvi, a combination of olanzapine (an atypical antipsychotic) and samidorphan (an opioid antagonist), is used for the treatment of:
Schizophrenia in adults:
manic or mixed episodes that happen with Bipolar I disorder, either alone for acute (short term) or maintenance treatment or in combination with lithium or valproate in adults.
Recommended Dosage: The recommended dosage of Lybalvi tablets should be administered orally once a day with or without food as a single tablet. Do not divide tablets or combine strengths.
Recommended Dose in Schizophrenia: Start treatment with Lybalvi at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once a day. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once a day. Adjust dosage at weekly intervals of 5 mg (depending on olanzapine component of Lybalvi) on behalf of clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once a day.
Recommended Dose in Bipolar I Disorder (Manic or Mixed Episodes):
Monotherapy: Start treatment with Lybalvi tablets (Olanzapine/Samidorphan) at 10 mg/10 mg or 15 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once a day. The maximum recommended dosage is 20 mg/10 mg once a day. Adjust dosage at intervals of not less than 24 hours. If dosage adjustments are needed, dose increments/decrements of 5 mg (depending on olanzapine component of Lybalvi) are recommended.
Maintenance Monotherapy: Lybalvi (Olanzapine/Samidorphan) should be administered at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once a day.
In Combination with lithium or valproate: Start treatment with Lybalvi (Olanzapine/Samidorphan) at 10 mg/10 mg once a day. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg, once a day. Adjust dosage at weekly intervals of 5 mg (depending on olanzapine component of Lybalvi), on behalf of clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once a day.
Warning & Precautions
- Use of Olanzapine/Samidorphan tablet is not recommended in those with opioids or undergoing acute opioid withdrawal. In those who use opioids, delay the initiation of treatment for at least 1 week after last use of short-acting opioids and 2 weeks after the last use of long-acting opioids.
- Cerebrovascular side effects (such as transient ischemic attack, stroke), including fatalities, were observed in those in trials of Olanzapine in elderly patients with dementia-related psychosis. This medicinal product is not authorized to treat patients with dementia-related psychosis.
- Those with a history of chronic opioid use before treatment with Lybalvi may have scaled down opioid tolerance in case Lybalvi treatment is interrupted or discontinued. Advise patients that this scaled down tolerance may reduce the risk of opioid overdose in case opioids are resumed at the previously tolerated dosage.
- Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex may occur with the use of antipsychotic medicines. Clinical manifestations of NMS are muscle rigidity, delirium, hyperpyrexia, and autonomic instability. In case NMS is suspected, immediately discontinue this treatment and provide intensive symptomatic therapy and monitoring.
- DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur with exposure to olanzapine. DRESS may exist with a cutaneous reaction (such as exfoliative dermatitis or rash), fever, eosinophilia, or lymphadenopathy with systemic complications such as nephritis, hepatitis, myocarditis, pneumonitis, or pericarditis. Discontinue treatment in case DRESS is suspected.
- Atypical antipsychotic medicines, including Lybalvi, have been linked with metabolic changes that include hyperglycemia, body weight gain, diabetes mellitus, and dyslipidemia. Patients initiating treatment with Lybalvi should undergo fasting lipid profile testing at initial stage of treatment and periodically throughout treatment. Monitor weight before initiating treatment.
- Atypical antipsychotics drugs including Lybalvi 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg tablets can cause orthostatic hypotension and syncope. Generally, the risk is higher during initial dose titration and at the time of boosting the dose. Monitor orthostatic vital signs/symptoms in those who are vulnerable to hypotension.
- Tardive dyskinesia may develop in those treated with antipsychotic medicinal products. If signs and symptoms of tardive dyskinesia occur in a patient on Lybalvi, discontinue this treatment. However, a few patients may require treatment with Lybalvi tablets despite the existence of the syndrome.
- Neutropenia and leukopenia have been reported during treatment with antipsychotic agents, including Lybalvi. Monitor those with clinically significant neutropenia for fever or other signs or symptoms of infection and treat promptly in case such signs/symptoms occur.
Documentation & Availability
What documents are required to import LYBALVI to India?
LYBALVI (olanzapine/samidorphan) tablets can be imported by patients or government hospitals on the name of the patients only.
The following documentation is required to import the product:
- A valid prescription from a qualified doctor.
- Patient’s diagnostic reports.
- Patient’s ID proof (issued by the Government of India).
How is the order confirmed?
The order will be confirmed only after the receipt of:
- A valid prescription from a doctor.
- Import permit if applicable.
Is LYBALVI available in India?
LYBALVI (olanzapine/samidorphan tablets) is a (prescription drug, prescription medication or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
S S Healthcare (S S Healthcare) helps import cancer medicines on the named patient supply (NPS). Indian Pharma Network is the facilitator providing input
- On availability in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore and Pune etc.)
- Medicine Price.
- Finding Genuine and reliable source from Canada, Europe, USA and Australia
- Ensuring 100% transparency.
LYBALVI can be made available to patients, doctors, and hospitals in Mumbai, Kolkata, Hyderabad, Pune, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and an import permit.
S S Healthcare (S S Healthcare) can facilitate the supply of LYBALVI (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable).
Please contact +91-7575883015 | Number: +91-7575883015 or write us at sshealthcare1012@gmail.com for Lybalvi tablets price in India.
We take to guarantee quality and delivery anywhere in the world as per the buyer’s requirements.
Sourcing & Delivery
S S Healthcare is able to source the LYBALVI (Cancer Treatment Medicines) from across the globe and has the ability to supply. S S Healthcare offers its customers worldwide access to the best available treatment.
S S Healthcare is able to dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.
FAQ
What is the Generic Name for the trade name drug Lybalvi®?
Olanzapine/Samidorphan is a Generic Name for the trade name drug Lybalvi®.
What is the Manufacturer Name of Lybalvi®?
Lybalvi® is manufactured by Alkermes Inc.
Is Lybalvi® approved by the FDA?
Yes, Lybalvi® is approved by the FDA. Date of first/initial approval: May 28, 2021.
What is the dosage and form of Lybalvi® supplied?
Lybalvi® is supplied as Tablets (olanzapine/samidorphan): 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg for oral administration.
Where can I get Lybalvi® Tablets at the best price in India?
To get the best Lybalvi tablets price in India, kindly contact S S Healthcare (a WHO GDP & ISO 9001 : 2008 certified company). For Lybalvi, a valid medical prescription is required from your treating physician.
What are the most common side effects of Lybalvi®?
Schizophrenia (Lybalvi): most common side effects are somnolence, weight increased, dry mouth, and headache.
Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): most common side effects are asthenia, dry mouth, somnolence, dizziness, constipation, increased appetite, and tremor.
Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): most common side effects are dyspepsia, weight gain, dry mouth, increased appetite, dizziness, constipation, back pain, increased salivation, amnesia, speech disorder, paresthesia.
How much does Lybalvi® cost in India?
The medicine Lybalvi cost in India is less and can vary. In order to buy/procure this combination medicine authentically, you can Call or WhatsApp +91-7575883015 or send mail to sshealthcare1012@gmail.com.
What are the storage conditions of Lybalvi®?
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Store in the original bottle with desiccant. Keep the bottle properly closed and protect it from moisture.
Is it safe to buy Lybalvi® tablets online from India?
Yes, you can buy Lybalvi tablets online at the best price from the S S Healthcare if Lybalvi has not been approved or is not available in your home country.
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