Apo-Methylphenidate

The dose of methylphenidate needs to be individualized according to the needs of the person taking the medication. The dose is usually started low and increased gradually to the dose that works best for the person.

The usual starting dose for this medication is 5 mg to 10 mg, taken 2 or 3 times daily for the regular release tablets**.** The sustained release tablets are usually taken once daily. Doses above 60 mg daily are not recommended. If symptoms worsen or if side effects occur, contact your doctor for further instruction. In many cases for children, the medication does not need to be continued after puberty.

Methylphenidate may be taken with or without food.

If you are taking the sustained-release (SR) tablets, swallow the medication whole and do not crush or split the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones above, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. Avoid taking this medication late in the day, as it may cause difficulty sleeping. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

5 mg
Each round, peach, unscored tablet, engraved "APO" on one side and "MTP" over "5" on the other side, contains 5 mg of methylphenidate hydrochloride. *Nonmedicinal ingredients: *anhydrous lactose, magnesium stearate, and sunset yellow aluminum lake 40%.

10 mg
Each pale blue, round, scored tablet, identified "MTP" bisect "10" on one side and "APO" on the other, contains 10 mg of methylphenidate hydrochloride. Nonmedicinal ingredients: anhydrous lactose, D&C Yellow No. 10, FD&C Blue No. 1, and magnesium stearate.

20 mg
Each pale yellow, round, scored tablet, imprinted "MTP" bisect "20" on one side and "APO" on the other, contains 20 mg of methylphenidate hydrochloride. Nonmedicinal ingredients: anhydrous lactose, D&C Yellow No. 10, and magnesium stearate.

Do not take this medication if you:

• are allergic to methylphenidate or any ingredients of the medication

• are taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days

• have advanced hardening of the arteries (arteriosclerosis)

• have anxiety, tension, or agitation

• have glaucoma (increased pressure in the eye)

• have heart disease

• have moderate-to-severe high blood pressure

• have motor tics, Tourette's syndrome, or a family history of Tourette's syndrome

• have an overactive thyroid gland

• have pheochromocytoma (a condition that causes excess production of epinephrine and norepinephrine hormones)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• agitation, nervousness, or anxiety

• bedwetting

• breast swelling in men

• changed ability or interest in sexual activity

• cold-like symptoms (e.g., runny nose, sore throat, nasal congestion)

• constipation

• cough

• diarrhea

• dizziness

• drowsiness

• dry mouth

• fatigue

• grinding teeth

• hair loss

• headache

• heartburn

• increased sweating

• joint pain

• loss of appetite

• muscle pain or cramps

• nausea

• red blotches on skin

• restlessness

• skin rash or itching (mild)

• stomach pain

• stuttering

• tremor

• trouble sleeping

• vomiting

• weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal thoughts or behaviour (aggressiveness, hostility)

• chest pain

• fast heartbeat

• increased blood pressure

• itchy rash, hives

• manic behavior (e.g., paranoia, unusual or inappropriate sense of excitement)

• mood changes

• muscle twitching or tics

• palpitations (feeling your heart beat quickly or irregularly)

• pinpoint-sized red spots on skin or unusual bruising

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)

• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)

• slowed growth

• spasm of jaw muscles (making it difficult open your mouth)

• symptoms of depression (e.g., losing interest in your usual activities, feeling sad, having thoughts of suicide)

• symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, loss of appetite, pale stools, dark urine)

• symptoms of Raynaud's syndrome (e.g., discolouration, coldness or numbness of fingers or toes)

• symptoms of Tourette's syndrome (involuntary, sudden body movements or uncontrolled vocal outbursts)

• uncond movements (twitching, jerking)

• vision changes (blurred trollevision, double vision, dilated pupils)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• convulsions (seizures)

• hallucinations (hearing, seeing, or feeling things that are not actually there)

• inappropriate or prolonged (longer than 4 hours) erection

• signs of a serious allergic reaction (difficulty breathing; hives; swelling of the face, lips, eyes, mouth, or throat)

• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)

• signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Behaviour or mood changes: There have been reports of agitation, hallucinations, symptoms of depression, and thoughts of self-harm in people taking this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

If you have a history of depression or bipolar disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood pressure: Methylphenidate may increase blood pressure. If you have high blood pressure or heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Methylphenidate may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Drug dependence: There does not appear to be an increased risk of dependence or addiction with the use of methylphenidate by children and adolescents. However, abuse of methylphenidate is possible by certain individuals. Regular, long-term abuse can lead to high levels of tolerance and psychological dependence, and a wide range of abnormal behaviours. People with a history of drug or alcohol dependence should be carefully monitored by their doctors while using this medication.

Exercise: People participating in strenuous exercise or activities should consult their doctor before taking methylphenidate. Strenuous exercise combined with the effects of methylphenidate on the heart and blood pressure may increase the risk of sudden death.

Heart problems and blood pressure: This medication can increase heart rate and blood pressure. It may also increase the risk of sudden death for people with heart problems. This medication should generally not be used by people with known heart problems, including an irregular heartbeat, established structural heart abnormalities (such as abnormal size, missing or poorly functioning heart valves, or problems with blood vessels connected to the heart), or a family history of sudden death related to heart disease. Misuse of methylphenidate may also be associated with sudden death and other serious heart-related effects.

Long-term use: If you will be using methylphenidate for a long period of time, your doctor will want you to have regular heart checkups, blood pressure checks and lab tests to check your liver and blood.

Prolonged erection: Rarely, methylphenidate may cause a painful or prolonged erection, also called priapism. Priapism occurs when blood becomes trapped in the penis, resulting in a prolonged (longer than 4 hours) erection. If not treated, this may cause permanent damage to the penis. If this occurs, seek medical help immediately.

Seizures: This medication may increase the risk of seizures. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when methylphenidate is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations may cause muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Check with your doctor before stopping this medication.

Suppression of growth: Growth suppression (i.e., less increase in height or weight than usual) has been reported for children using stimulants such as methylphenidate for long periods of time. It is not known if the medication causes the growth suppression. However, children who need long-term therapy should be carefully monitored for growth. Their doctor may also recommend a "drug holiday," where the medication is not given on weekends or during school holidays.

Surgery: This medication can affect the way certain anaesthetics work in the body. If you (or your child) are scheduled for surgery, let all the people on the health care team know that you (or your child) are taking methylphenidate.

Stroke: This medication may increase the risk of stroke, particularly for people who have already had a stroke or are at risk of having a stroke. If you have heart disease, are taking other medications that increase blood pressure or high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience signs of a stroke or mini-stroke, such as confusion, difficulty speaking, loss of coordination, sudden headache or vision changes, contact your doctor as soon as possible.

Tics: This medication may cause tics or worsening of motor or verbal tics. If you have Tourette's syndrome or develop tics while on this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication.

Vision: Rarely, people taking methylphenidate have experienced vision changes. If you notice any changes in your vision, such as blurred vision, or difficulty focusing, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and taking methylphenidate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for and should not be used by children under 6 years of age.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Methylphenidate