Dosage of Almetamin in details
Prior to treating patients with Almetamin, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Almetamin use.
Dosing Considerations For All Patients
Almetamin may be taken with or without food. Individualize the dosage according to the therapeutic needs and response of the patient.
Almetamin should be taken as follows:
- The tablet should remain in the blister pack until the patient is ready to take it.
- The patient or caregiver should use dry hands to open the blister.
- Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. The tablet should not be pushed through the foil.
- As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
- The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing.
- The tablet will disintegrate in saliva so that it can be swallowed.
The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years.
The recommended dose is Almetamin 12.5 mg daily.
Switching From Other Amphetamine Products
Patients taking ADDERALL XR may be switched to Almetamin at the equivalent dose taken once daily. Refer to Table 1 for equivalent doses of Almetamin and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).
Table 1: Equivalent Doses of Almetamin and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules
|Almetamin||3.1 mg||6.3 mg||9.4 mg||12.5 mg||15.7 mg||18.8 mg|
|Amphetamine extended-release orally disintegrating tablets|
|ADDERALL XR||5 mg||10 mg||15 mg||20 mg||25 mg||30 mg|
|Mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER)|
If switching from any other amphetamine products, discontinue that treatment, and titrate with Almetamin using the titration schedule.
Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.
Dosage Modifications Due To Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Almetamin dosage accordingly.
Dosage Forms And Strengths
Almetamin 3.1 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side)
Almetamin 6.3 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side)
Almetamin 9.4 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side)
Almetamin 12.5 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side)
Almetamin 15.7 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side)
Almetamin 18.8 mg Amphetamine Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side)
Storage And Handling
Almetamin 3.1 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30
Almetamin 6.3 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30
Almetamin 9.4 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30
Almetamin 12.5 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30
Almetamin 15.7 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30
Almetamin 18.8 mg Extended Release
Orally Disintegrating Tablet: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30
Store at 20°C to 25° C (68°F to 77° F). Excursions permitted to 15-30° C (59-86° F)
Store Almetamin blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-XXX-XXX-XXXX.
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Almetamin at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Almetamin with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Almetamin in the household trash.
Manufactured by: Neos Therapeutics, LP., Grand Prairie, TX 75050. Made in USA. Revised: Jan 2016
What other drugs will affect Almetamin?
Many drugs can interact with amphetamine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
lithium, or other medicine to treat mental illness;
reserpine, or other blood pressure medication;
an antacid or other stomach acid medicine (including Alka-Seltzer or baking soda);
a blood thinner such as warfarin (Coumadin, Jantoven);
a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine;
a diuretic or "water pill";
narcotic pain medicine; or
This list is not complete. Other drugs may interact with amphetamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Drugs Having Clinically Important Interactions With Amphetamines
Table 2: Drugs having clinically important interactions with amphetamines.
|MAO Inhibitors (MAOI)|
|Clinical Impact||MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.|
|Intervention||Do not administer Almetamin during or within 14 days following the administration of MAOI.|
|Examples||selegiline, isocarboxazid, phenelzine, tranylcypromine|
|Clinical Impact||Increase blood levels and potentiate the action of amphetamine.|
|Intervention||Co-administration of Almetamin and gastrointestinal alkalinizing agents should be avoided.|
|Examples||Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate). Urinary alkalinizing agents (e.g. acetazolamide, some thiazides).|
|Clinical Impact||Lower blood levels and efficacy of amphetamines.|
|Intervention||Increase dose based on clinical response.|
|Examples||Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid). Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).|
|Clinical Impact||May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.|
|Intervention||Monitor frequently and adjust or use alternative therapy based on clinical response.|
|Proton Pump Inhibitors|
|Clinical Impact||Time to maximum concentration (Tmax) of amphetamine is increased compared to when administered alone.|
|Intervention||Monitor patients for changes in clinical effect and adjust therapy based on clinical response.|
Drug/Laboratory Test Interactions
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.
Drug Abuse And Dependence
Almetamin contains amphetamine, which is a Schedule II controlled substance in the U.S. Controlled Substance Act (CSA).
Almetamin, is a CNS stimulant that contains amphetamine which has a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.
Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death.
To reduce the abuse of Almetamin, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and re-evaluate the need for Almetamin use.
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including Almetamin.
Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Almetamin. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
ReviewsThe results of a survey conducted on ndrugs.com for Almetamin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Almetamin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
37 consumers reported frequency of useHow frequently do I need to take Almetamin?
It was reported by ndrugs.com website users that Almetamin should ideally be taken Once in a day as the most common frequency of the Almetamin. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Almetamin should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
|Once in a day||18||48.6%|
|Twice in a day||14||37.8%|
|3 times in a day||4||10.8%|
|4 times in a day||1||2.7%|
36 consumers reported dosesWhat doses of Almetamin drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Almetamin drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
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Information checked by Dr. Sachin Kumar, MD Pharmacology