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APTENSIO XR is a central nervous system (CNS) stimulant. APTENSIO XR capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. APTENSIO XR is available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2piperidineacetate hydrochloride. Its molecular formula is C14H19NO2•HCl
APTENSIO XR™ (methylphenidate hydrochloride) Structural Formula Illustration
Methylphenidate hydrochloride USP is a white to off-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. Its molecular weight is 269.77.
Avoid drinking alcohol. Alcohol may cause extended-release methylphenidate to be released into the bloodstream too fast.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs methylphenidate, and may increase side effects.
Many drugs can affect methylphenidate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
DOSAGE OF APTENSIO XR
As with all medications, follow your Aptensio XR prescription instructions exactly. Aptensio XR is taken orally, with or without food, once daily. The first dose is typically taken first thing in the morning; it should be taken at the same time each day for the best results.
Do not drink alcohol while taking this medication.
Capsules should be swallowed whole with water or other liquids. If your child is unable to swallow the capsule, it can be opened and sprinkled over a spoonful of applesauce. Taken this way, the mixture should be swallowed whole without chewing, followed by a drink of water or other liquid. Capsules should never by crushed or chewed.
Capsules are available in 10mg, 15mg, 20mg, 25mg, 30mg, 40mg, 50mg, and 60mg dosages. The time-release formulation is designed to maintain a steady level of medication in your body throughout the day.
The optimal dosage varies patient by patient; is not determined by age, weight, or height, but rather by how a person metabolizes the medication. Your doctor may adjust your daily dosage by 10mg increments until you or your child experiences the best response — that is, the lowest dosage at which you experience the greatest improvement in symptoms without side effects.
The FDA recommends screening for the presence of cardiac disease and substance-abuse problems before beginning treatment with Aptensio XR.
During treatment, your doctor may periodically ask you to stop taking your Aptensio XR so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.
Some patients report developing a tolerance to Aptensio XR after long-term usage. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action.
Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud’s disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette’s syndrome), overactive thyroid (hyperthyroidism), seizure disorder, throat/stomach/intestinal problems (such as narrowing/blockage).
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Some brands of this medication may contain sugar. Caution is advised if you have diabetes, fructose intolerance, or any other condition that requires you to limit/avoid sugar in your diet. Ask your doctor or pharmacist about using this medication safely.
If used for a long time, this drug may affect a child’s growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child’s weight and height regularly, and consult your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping, weight loss, or chest pain.
During pregnancy, methylphenidate should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
signs of heart problems–chest pain, trouble breathing, feeling like you might pass out;
signs of psychosis–hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
signs of circulation problems–numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
a seizure (convulsions);
muscle twitches (tics);
changes in your vision; or
penis erection that is painful or lasts 4 hours or longer (rare).
Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
mood changes, feeling nervous or irritable, sleep problems (insomnia);
fast heart rate, increased blood pressure;loss of appetite, weight loss;nausea, stomach pain; or headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects
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