Emsidon Dosage

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Dosage of Emsidon in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Emsidon Dosage

Generic name: Emsidon hydrochloride 20mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Schizophrenia

The recommended starting dose of Emsidon is 40 mg once daily. Initial dose titration is not required. Emsidon has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day.

Depressive Episodes Associated with Bipolar I Disorder

The recommended starting dose of Emsidon is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Emsidon has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Clinical Studies (14.2).

Administration Instructions

Emsidon should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Emsidon. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Emsidon was administered with food.

Dose Modifications in Special Populations

Renal Impairment

Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. The recommended starting dose is 20 mg per day. The dose in these patients should not exceed 80 mg per day.

Hepatic Impairment

Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per day and the dose in severe hepatic impairment patients should not exceed 40 mg/day.

Dose Modifications Due to Drug Interactions

Concomitant Use with CYP3A4 Inhibitors

Emsidon should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).

If Emsidon is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Emsidon dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Emsidon is added to the therapy, the recommended starting dose of Emsidon is 20 mg per day, and the maximum recommended dose of Emsidon is 80 mg per day.

Grapefruit and grapefruit juice should be avoided in patients taking Emsidon, since these may inhibit CYP3A4 and alter Emsidon concentrations.

Concomitant Use with CYP3A4 Inducers

Emsidon should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Emsidon is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Emsidon dose after chronic treatment (7 days or more) with the CYP3A4 inducer.

More about Emsidon (Emsidon)

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What other drugs will affect Emsidon?

Before you take Emsidon, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Emsidon.

Many drugs can interact with Emsidon. Below is just a partial list. Tell your doctor if you are using:

This list is not complete and other drugs may interact with Emsidon. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Emsidon interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Emsidon, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Potential for Other Drugs to Affect Emsidon

Emsidon is predominantly metabolized by CYP3A4. Emsidon should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). The Emsidon dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.). If Emsidon is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Emsidon dose.

Lithium: It is not necessary to adjust the Emsidon dose when used concomitantly with lithium (Figure 1).

Valproate: It is not necessary to adjust the Emsidon dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Emsidon. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Emsidon, and Emsidon concentrations were not affected by valproate.

Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Emsidon, since these may inhibit CYP3A4 and alter Emsidon concentrations.

Figure 1: Impact of Other Drugs on Emsidon Pharmacokinetics

Potential for Emsidon to Affect Other Drugs

No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Emsidon. ).

Figure 2: Impact of Emsidon on Other Drugs

Drug Abuse And Dependence

Controlled Substance

Emsidon is not a controlled substance.

Abuse

Emsidon has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with Emsidon did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of Emsidon misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).


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References

  1. DailyMed. "LURASIDONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "22IC88528T: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Antipsychotic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Emsidon 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 Emsidon. 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.

User reports

4 consumers reported frequency of use

How frequently do I need to take Emsidon?
It was reported by ndrugs.com website users that Emsidon should ideally be taken Once in a day as the most common frequency of the Emsidon. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Emsidon should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
Users%
Once in a day4
100.0%


5 consumers reported doses

What doses of Emsidon 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 Emsidon 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.
Users%
51-100mg2
40.0%
11-50mg2
40.0%
101-200mg1
20.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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