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Methylin
Overview
What is Methylin?
Methylin (methylphenidate HCl) oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Each mL of Methylin Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP.
Each mL of Methylin Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.
In addition, Methylin Oral Solution also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.
What does Methylin look like?
What are the available doses of Methylin?
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What should I talk to my health care provider before I take Methylin?
Sorry No records found
How should I use Methylin?
Attention Deficit Disorders
Methylin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Dosage should be individualized according to the needs and responses of the patient.
What interacts with Methylin?
Sorry No Records found
What are the warnings of Methylin?
Sorry No Records found
What are the precautions of Methylin?
Sorry No Records found
What are the side effects of Methylin?
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss; serotonin syndrome in combination with serotonergic drugs. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.
In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
What should I look out for while using Methylin?
Marked anxiety, tension, and agitation are contraindications to Methylin, since the drug may aggravate these symptoms. Methylin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.
Methylin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
What might happen if I take too much Methylin?
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, and rhabdomyolysis.
Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.
Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.
How should I store and handle Methylin?
Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.Methylin Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-750-50 Methylin Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid. Bottles of 500 mL . . . . . . . . NDC 59630-755-50 Dispense in tight container with child-resistant closure. Storage:Methylin is a trademark of Mallinckrodt LLC. Ritalin is a registered trademark of Novartis Corporation. Distributed by:Shionogi Inc.Florham Park, NJ 07932 Manufactured by:SpecGx LLCWebster Groves, MO 63119 USMOS-PI-07L20M21Rev 08/2017An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20M31.pdf or by calling 1-800-778-7898 for alternate delivery options.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Methylphenidate is a racemic mixture comprised of the and enantiomers. The enantiomer is more pharmacologically active than the enantiomer.
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
There is neither specific evidence which clearly establishes the mechanism whereby Methylin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Non-Clinical Toxicology
Marked anxiety, tension, and agitation are contraindications to Methylin, since the drug may aggravate these symptoms. Methylin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome.Methylin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
Methylin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.
Human pharmacologic studies have shown that Methylin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylin.
Patients with an element of agitation may react adversely; discontinue therapy if necessary.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Methylin should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with Methylin is usually not indicated.
Long-term effects of Methylin in children have not been well established.
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolysis. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss; serotonin syndrome in combination with serotonergic drugs. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.
In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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