Primidone (Mysoline)

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Trade Name: Mysoline

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Bausch Health US, LLC

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 250 mg/1

Storage and handling

PRIMIDONE Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula:
MYSOLINE (primidone) is a white, crystalline, highly stable substance, M.P. 279-284u00b0C. It is poorly soluble in water (60 mg per 100 mL at 37u00b0C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.
MYSOLINE 50 mg and 250 mg tablets contain the following inactive ingredients: lactose
monohydrate, NF; magnesium stearate, NF; methylcellulose, USP; microcrystalline cellulose, NF;
purified water, USP; sodium lauryl sulfate, NF; sodium starch glycolate, NF; and talc, USP.MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF.
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MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ).

The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed.

The total daily dosage should not exceed 2 g. Since MYSOLINE therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made every 6 months.

The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to MYSOLINE and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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MYSOLINE Tablets
Modified square, flat faced, beveled edge, compressed light yellow color tablet. One face is debossed (impressed) with u201cMYSOLINEu201d and u201c250u201d that are divided by a debossed bisect line. The opposite side is embossed with the letter u201cMu201d, in bottles of 100 (NDC 66490-691-10).
Modified square, flat faced, beveled edge, compressed white color tablet. One face is debossed (impressed) with u201cMYSOLINEu201d and u201c50u201d that are divided by a debossed bisect line. The opposite side is embossed with the letter u201cMu201d, in bottles of 100 (NDC 66490-690-10).
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F)n- [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
Distributed by:
Manufactured by:
Bausch Health Companies Inc.Steinbach, MB R5G 1Z7, Canada
MYSOLINE is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2020 Bausch Health Companies Inc. or its affiliates

MYSOLINE (My-so-lean)n- (primidone tablets, USP), 50 mg and 250 mg
What is the most important information I should know about MYSOLINE?
Like other antiepileptic drugs, MYSOLINE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
What is MYSOLINE?
MYSOLINE is a prescription medicine used alone or with other medicines to treat people with:
Who should not take MYSOLINE?
Do not take MYSOLINE if you:
What should I tell my healthcare provider before taking MYSOLINE?
Before you take MYSOLINE, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take MYSOLINE?
Take MYSOLINE exactly as prescribed. Your healthcare provider will tell you how much MYSOLINE to take and when to take it.
What should I avoid while taking MYSOLINE?
What are the possible side effects of MYSOLINE?
See u201cWhat is the most important information I should know about MYSOLINE?u201d
MYSOLINE may cause other serious side effects including:
The most common side effects of MYSOLINE include:
These are not all the possible side effects of MYSOLINE. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store MYSOLINE?
Store MYSOLINE at room temperature between 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C) in a tight, light-resistant container.
Keep MYSOLINE and all medicines out of reach of children.
General Information about MYSOLINE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MYSOLINE for a condition for which it was not prescribed. Do not give MYSOLINE to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about MYSOLINE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about MYSOLINE that is written for health professionals.
For more information, go to www.bauschhealth.com or call 1-800-321-4576.
What are the ingredients in MYSOLINE?
Active Ingredient: primidone, USP
Inactive Ingredients: lactose monohydrate, NF; magnesium stearate, NF;
methylcellulose, USP; microcrystalline cellulose, NF; purified water, USP; sodium lauryl
sulfate, NF; sodium starch glycolate, NF; and talc, USP.
MYSOLINE 250 mg tablets also contain ferric oxide yellow, NF.
Distributed by:
Manufactured by:
MYSOLINE is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2020 Bausch Health Companies Inc. or its affiliates
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 07/2020

NDC
Rx Only
Mysolinen
250 mg
100 Tablets
Each tabletcontains 250 mgof primidone, USP
PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
BAUSCH Health

NDC
Rx Only
Mysolinen
50 mgn- 100 Tablets
Each tabletcontains 50 mgof primidone, USP
PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
BAUSCH Health

Select Strength and Packaging*

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Primidone (Mysoline) which is also known as Mysoline and Manufactured by Bausch Health US, LLC. It is available in strength of 250 mg/1.

Primidone (Mysoline) 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.