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Methylphenidate Hydrochloride - (Cd) (Methylphenidate Hydrochloride)

Trade Name : Methylphenidate Hydrochloride

Teva Pharmaceuticals USA, Inc.

CAPSULE, EXTENDED RELEASE

Strength 50 mg/1

METHYLPHENIDATE HYDROCHLORIDE Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Methylphenidate Hydrochloride - (Cd) (Methylphenidate Hydrochloride) which is also known as Methylphenidate Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 50 mg/1 per ml. Read more

Methylphenidate Hydrochloride - (Cd) (Methylphenidate Hydrochloride) 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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Methylphenidate hydrochloride extended-release capsules (CD) are a central nervous system (CNS) stimulant. The extended-release capsules provide 30% of the dose by an immediate-release (IR) component and 70% of the dose by an extended-release (ER) component in a single bead type. Methylphenidate capsules (CD) are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration.
  • Chemically, methylphenidate hydrochloride, USP is methyl u03b1-phenyl-2-piperidineacetate hydrochloride. Its structural formula is:
  • CHNOu2022HCl M.W. 269.77
  • Methylphenidate hydrochloride, USP is a white to off-white 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.
  • Methylphenidate capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.
  • No data
  • A methylphenidate capsule (CD) formulation was evaluated in a double-blind, parallel-group, placebo-controlled trial in which 321 untreated or previously treated pediatric patients with a DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), 6 to 15 years of age, received a single morning dose for up to 3 weeks. Patients were required to have the combined or predominantly hyperactive-impulsive subtype of ADHD; patients with the predominantly inattentive subtype were excluded. Patients randomized to the methylphenidate capsule (CD) group received 20 mg daily for the first week. Their dosage could be increased weekly to a maximum of 60 mg by the third week, depending on individual response to treatment.
  • The patientu2019s regular school teacher completed the teachersu2019 version of the Connersu2019 Global Index Scale (TCGIS), a scale for assessing ADHD symptoms, in the morning and again in the afternoon on three alternate days of each treatment week. The change from baseline of the overall average (i.e., an average of morning and afternoon scores over 3 days) of the total TCGIS scores during the last week of treatment was analyzed as the primary efficacy parameter. Patients treated with methylphenidate capsules (CD) showed a statistically significant improvement in symptom scores from baseline over patients who received placebo (see ). Separate analyses of TCGIS scores in the morning and afternoon revealed superiority in improvement with methylphenidate capsules (CD) over placebo during both time periods (see ). This demonstrates that a single morning dose of methylphenidate capsules (CD) exerts a treatment effect in both the morning and the afternoon.
  • FIGURE 2: Least Squares Mean Change From Baseline in TCGIS Scoresn
  • FIGURE 3: Least Squares Mean Change From Baseline in TCGIS Scores, Morning/Afternoon Groupsn
  • FIGURES 2 & 3
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  • The premarketing development program for methylphenidate capsules (CD) included exposures in a total of 228 participants in clinical trials (188 pediatric patients with ADHD, 40 healthy adult subjects). These participants received methylphenidate capsules (CD) 20, 40, and/or 60 mg/day. The 188 patients (ages 6 to 15) were evaluated in one controlled clinical study, one controlled, crossover clinical study, and one uncontrolled clinical study. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.
  • Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events.
  • The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
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  • Methylphenidate capsules (CD) are administered once daily in the morning, before breakfast.
  • Methylphenidate capsules (CD) may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g., water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see , ). Patients should be advised to avoid alcohol while taking methylphenidate capsules (CD).
  • Dosage should be individualized according to the needs and responses of the patient.
  • Methylphenidate hydrochloride extended-release capsules (CD) are available as follows:
  • 10 mg: Hard gelatin capsule with a white opaque body and light green opaque cap, imprinted with u201c93u201d over u201c5295u201d on both the body and cap, in bottles of 100 (NDC 0093-5295-01).
  • 20 mg: Hard gelatin capsule with a white opaque body and light turquoise blue opaque cap, imprinted with u201c93u201d over u201c5296u201d on both the body and cap, in bottles of 100 (NDC 0093-5296-01).
  • 30 mg: Hard gelatin capsule with a white opaque body and light brown opaque cap, imprinted with u201c93u201d over u201c5297u201d on both the body and cap, in bottles of 100 (NDC 0093-5297-01).
  • 40 mg: Hard gelatin capsule with a white opaque body and light brown opaque cap, imprinted with u201c93u201d over u201c5298u201d on both the body and cap, in bottles of 100 (NDC 0093-5298-01).
  • 50 mg: Hard gelatin capsule with a white opaque body and light blue opaque cap, imprinted with u201c93u201d over u201c5292u201d on both the body and cap, in bottles of 100 (NDC 0093-5292-01).
  • 60 mg: Hard gelatin capsule with a white opaque body and white opaque cap, imprinted with u201c93u201d over u201c5293u201d on both the body and cap, in bottles of 100 (NDC 0093-5293-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Keep out of the reach of children.
  • American Psychiatric Association. . American Psychiatric Association 1994. 4th ed. Washington D.C.
  • For more information call 1-888-838-2872.
  • Distributed By:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. N 1/2017
  • Methylphenidate (METH-il-FEN-i-date) Hydrochloride Extended-Release Capsules (CD) CII
  • Rx only
  • Read the Medication Guide that comes with methylphenidate hydrochloride extended-release capsules (CD) before you or your child starts taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your childu2019s treatment with methylphenidate hydrochloride extended-release capsules (CD).
  • What are methylphenidate hydrochloride extended-release capsules (CD)?
  • Methylphenidate hydrochloride extended-release capsules (CD) are a central nervous system stimulant prescription medicine. n
  • Methylphenidate hydrochloride extended-release capsules (CD) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
  • Methylphenidate hydrochloride extended-release capsules (CD) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
  • Who should not take methylphenidate hydrochloride extended-release capsules (CD)?
  • Methylphenidate hydrochloride extended-release capsules (CD) should not be taken if you or your child:
  • Methylphenidate hydrochloride extended-release capsules (CD) should not be used in children less than 6 years old because they have not been studied in this age group.
  • Methylphenidate hydrochloride extended-release capsules (CD) may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules (CD) tell your or your childu2019s doctor about all health conditions (or a family history of) including:
  • Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
  • Can methylphenidate hydrochloride extended-release capsules (CD) be taken with other medicines?
  • Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.
  • Your doctor will decide whether methylphenidate hydrochloride extended-release capsules (CD) can be taken with other medicines.
  • Especially tell your doctor if you or your child takes:
  • Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
  • Do not start any new medicine while taking methylphenidate hydrochloride extended-release capsules (CD) without talking to your doctor first.
  • How should methylphenidate hydrochloride extended-release capsules (CD) be taken?
  • What are possible side effects of methylphenidate hydrochloride extended-release capsules (CD)?
  • See u201cu201d for information on reported heart and mental problems.
  • Other serious side effects include:
  • Common side effects include:
  • Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
  • This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
  • 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 methylphenidate hydrochloride extended-release capsules (CD)?
  • General information about methylphenidate hydrochloride extended-release capsules (CD)
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release capsules (CD) for a condition for which they were not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (CD) to other people, even if they have the same condition. They may harm them and it is against the law.
  • This Medication Guide summarizes the most important information about methylphenidate hydrochloride extended-release capsules (CD). If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride extended-release capsules (CD) that was written for healthcare professionals. For more information about methylphenidate hydrochloride extended-release capsules (CD) call 1-888-838-2872.
  • What are the ingredients in methylphenidate hydrochloride extended-release capsules (CD)?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distributed By:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. G 4/2015
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