Methylphenidate 10 mg/5mL
Methylphenidate Hydrochloride · SOLUTION · KVK-Tech, Inc.
Methylphenidate is a solution containing methylphenidate hydrochloride at 10 mg/5mL, taken oral. Manufactured by KVK-Tech, Inc..
Key Facts
- Brand Name
- Methylphenidate
- Generic Name
- Methylphenidate Hydrochloride
- NDC Code (Product)
10702-164- Manufacturer
- KVK-Tech, Inc.
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA207485
- Marketing Start
- 01/23/2017
Recall History
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Noven Pharmaceuticals, Inc.
Defective Delivery System: One lot exceeded the mechanical peel specification
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Pfizer Inc
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Noven Therapeutics, LLC
Defective Delivery System: Out of specification for mechanical peel and shear.
KVK-Tech, Inc.
Presence of Foreign Substance; Fiber particles.
Noven Pharmaceuticals Inc
Defective Delivery System: customer complaints exceeded respective action limits.
Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer orally once daily in the morning. ( 2.2 ) Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce. ( 2.2 ) Should not be crushed, chewed, or divided. ( 2.2 ) Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended. ( 2.3 ) For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets: Dosage is based on current dose regimen. ( 2.4 ) If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules. ( 2.4 ) 2.1 Pretreatment Screening Prior to initiating treatment with central nervous system (CNS) stimulants, including methylphenidate hydrochloride extended-release capsules, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions ( 5.2 )] . Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on t…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee Adverse Reactions ( 6.1 )]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [ s ee Drug Interactions ( 7.1 )]. Known hypersensitivity to methylphenidate or product components. ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Antihypertensive drugs: Monitor blood pressure and heart. Adjust dosage of antihypertensive drug as needed. ( 7 ) Avoid use of methylphenidate hydrochloride extended-release capsules on the day of surgery if halogenated anesthetics will be used. ( 7 ) 7.1 Clinically Important Interactions with Methylphenidate Hydrochloride Extended-Release Capsules Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules. Table 3: Drugs Having Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release capsules, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )] . Intervention Concomitant use of methylphenidate hydrochloride extended-release capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylc…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride extended-release capsules [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] Serious cardiovascular reactions [see Warnings and Precautions ( 5.2 )] Blood pressure and heart rate increases [see Warnings and Precautions ( 5.3 )] Psychiatric adverse reactions [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.5 )] Peripheral vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] Long-term suppression of growth [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain, decreased appetite, and anorexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-F…
Frequently Asked Questions
What is Methylphenidate used for?
Methylphenidate contains Methylphenidate Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.
Is Methylphenidate a controlled substance?
Yes, Methylphenidate is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Methylphenidate?
The generic name for Methylphenidate is Methylphenidate Hydrochloride. There are 12 other brand versions of Methylphenidate Hydrochloride.
What is the NDC code for Methylphenidate 10 mg/5mL?
The NDC (National Drug Code) for Methylphenidate 10 mg/5mL is 10702-164, listed by KVK-Tech, Inc..
Other Methylphenidate Brands
See all →- Methylphenidate Hydrochloride5 mg/5mL72162-1992
- Methylphenidate Hydrochloride27 mg/172162-2395
- Methylphenidate Hydrochloride54 mg/10527-3313
- METHYLPHENIDATE HYDROCHLORIDE5 mg/116729-478
- QuilliChew ER40 mg/124478-076
- Methylphenidate Hydrochloride5 mg/143386-571
- Methylphenidate Hydrochloride5 mg/5mL43386-930
- Methylphenidate Hydrochloride27 mg/150268-546
- Methylphenidate Hydrochloride10 mg/155466-102
- Methylphenidate Hydrochloride5 mg/164980-222
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)