Tofocom Dosage

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Dosage of Tofocom 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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Tofocom Dosage

Generic name: Emtricitabine (Tofocom) 200mg, Tenofovir (Tofocom) disoproxil fumarate 300mg

Dosage form: tablet, film coated

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

Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More

The recommended dose of Tofocom in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of Emtricitabine (Tofocom) and 300 mg of Tenofovir (Tofocom) disoproxil fumarate) once daily taken orally with or without food.

Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Whole Tablet

​The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one Tofocom low strength tablet (Emtricitabine (Tofocom) [FTC]/Tenofovir (Tofocom) disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food.

​The recommended oral dosage of Tofocom low strength tablets is presented in Table 1. Weight should be monitored periodically and the Tofocom dose adjusted accordingly.

Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using Tofocom Low Strength Tablets
​Body Weight (kg) Dosing of FTC (mg)/TDF (mg)
​17 to less than 22 one 100/150 tablet once daily
​22 to less than 28 one 133/200 tablet once daily
​28 to less than 35 one 167/250 tablet once daily

Recommended Dose for Pre-exposure Prophylaxis

The dose of Tofocom in HIV-1 uninfected adults is one tablet (containing 200 mg of Emtricitabine (Tofocom) and 300 mg of Tenofovir (Tofocom) disoproxil fumarate) once daily taken orally with or without food.

Dose Adjustment for Renal Impairment

Treatment of HIV-1 Infection

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment. Therefore, adjust the dosing interval of Tofocom in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 2. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients.

No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.

Table 2 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min)*
≥50 30–49 <30

(Including Patients Requiring Hemodialysis)

*
Calculated using ideal (lean) body weight
Recommended Dosing Interval Every 24 hours Every 48 hours Tofocom should not be administered.

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment.

Pre-exposure Prophylaxis

Do not use Tofocom for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Tofocom for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

More about Tofocom (Emtricitabine (Tofocom) / Tenofovir (Tofocom))

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What other drugs will affect Tofocom?

Tofocom can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medications, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with Tofocom, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Tofocom 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 Tofocom, 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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No drug interaction trials have been conducted using Tofocom tablets. Drug interaction trials have been conducted with Tofocom disoproxil fumarate, the components of Tofocom. This section describes clinically relevant drug interactions observed with Tofocom disoproxil fumarate.

Didanosine

Coadministration of Tofocom and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosineassociated adverse reactions. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions.

When Tenofovir (Tofocom) disoproxil fumarate was administered with didanosine the Cmax and AUC of didanosine increased significantly. The mechanism of this interaction is unknown. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving Tenofovir (Tofocom) DF with didanosine 400 mg daily.

In patients weighing greater than 60 kg, the didanosine dose should be reduced to 250 mg when it is coadministered with Tofocom. Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg. When coadministered, Tofocom and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% fat).

HIV-1 Protease Inhibitors

Tenofovir (Tofocom) decreases the AUC and Cmin of atazanavir. When coadministered with Tofocom, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. Tofocom should not be coadministered with atazanavir without ritonavir.

Lopinavir/ritonavir, atazanavir coadministered with ritonavir, and darunavir coadministered with ritonavir have been shown to increase Tenofovir (Tofocom) concentrations. Tenofovir (Tofocom) disoproxil fumarate is a substrate of Pglycoprotein (Pgp) and breast cancer resistance protein (BCRP) transporters. When Tenofovir (Tofocom) disoproxil fumarate is co-administered with an inhibitor of these transporters, an increase in absorption may be observed. Patients receiving Tofocom concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir should be monitored for Tenofovir (Tofocom) disoproxil fumarate-associated adverse reactions. Tofocom should be discontinued in patients who develop Tenofovir (Tofocom) disoproxil fumarate -associated adverse reactions.

Hepatitis C Antiviral Agents

Coadministration of Tenofovir (Tofocom) disoproxil fumarate and HARVONI® (ledipasvir/sofosbuvir) has been shown to increase Tenofovir (Tofocom) exposure.

In patients receiving Tofocom concomitantly with HARVONI without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, monitor for adverse reactions associated with Tenofovir (Tofocom) disoproxil fumarate.

In patients receiving Tofocom concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative HCV or antiretroviral therapy, as the safety of increased Tenofovir (Tofocom) concentrations in this setting has not been established. If coadministration is necessary, monitor for adverse reactions associated with Tenofovir (Tofocom) disoproxil fumarate.

Drugs Affecting Renal Function

Tofocom are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion. No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration of Tofocom with drugs that are eliminated by active tubular secretion may increase concentrations of Emtricitabine (Tofocom), Tenofovir (Tofocom), and/or the coadministered drug. Some examples include, but are not limited to acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs. Drugs that decrease renal function may increase concentrations of Emtricitabine (Tofocom) and/or Tenofovir (Tofocom).


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References

  1. DailyMed. "EMTRICITABINE: 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. "G70B4ETF4S: 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. European Chemicals Agency - ECHA. "2(1H)-Pyrimidinone, 4-amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).

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