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Concerta (Methylphenidate ER)

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Description

What is Concerta (Methylphenidate ER)?

Concerta (methylphenidate extended release tablets) is a central nervous system stimulant used for treating attention deficit hyperactivity disorder (ADHD).

Concerta (Methylphenidate ER) is a central nervous system (CNS) stimulant. CONCERTA is
available in four tablet strengths. Each extended-release tablet for once-a-day oral
administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is
designed to have a 12-hour duration of effect.

INDICATIONS

CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Need For Comprehensive Treatment Program
CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

DOSAGE AND ADMINISTRATION

General Dosing Information
CONCERTA should be administered orally once daily in the morning with or without food.

CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed .

Patients New To Methylphenidate
The recommended starting dose of CONCERTA® for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults

Patients Currently Using Methylphenidate
The recommended dose of CONCERTA® for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.

Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.

Dose Titration

Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.

A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.

Maintenance/Extended Treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with CONCERTA. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with CONCERTA. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.

The effectiveness of CONCERTA for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use CONCERTA® for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose Reduction And Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued

Side effects of Concerta

stomach pain,
loss of appetite,
headache,
dry mouth,
nausea,
vomiting,
sleep problems (insomnia),
anxiety,
dizziness,
weight loss,
irritability,
vision problems,
skin rash,
nervousness,
numbness/tingling/cold feeling in the hands or feet, and
sweating.
Chronic use of Concerta may lead to dependency. Severe depression may occur upon discontinuation of Concerta.
The recommended dose of Concerta is 18-72 mg daily. Concerta may interact with MAO inhibitors, blood thinners, clonidine, dobutamine, epinephrine, isoproterenol, cold/allergy medicine that contains phenylephrine (a decongestant), potassium citrate, sodium acetate, sodium bicarbonate, citric acid and potassium citrate, sodium citrate and citric acid, medications to treat high or low blood pressure, stimulant medications, diet pills, seizure medicines, or antidepressants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Concerta; it is unknown if Concerta will harm a fetus. It is unknown if Concerta passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

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