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Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

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Overview

What is SYMFI LO?

SYMFI LO (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a fixed-dose combination tablet for oral administration. Each tablet contains 400 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

S

H

Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).

R

S

Lamivudine is a white to off-white solid with a solubility of approximately 70 mg per mL in water at 20°C.

In vivo

The chemical name of tenofovir disoproxil fumarate is 9-[()-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of CHNOP•CHO and a molecular weight of 635.51. It has the following structural formula:

Tenofovir disoproxil fumarate is a white to off-white powder that is freely soluble in dimethylformamide and soluble in methanol. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C.



What does SYMFI LO look like?



What are the available doses of SYMFI LO?

Tablets: 400 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). ()

What should I talk to my health care provider before I take SYMFI LO?

How should I use SYMFI LO?

SYMFI LO™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.

Prior to initiation of SYMFI LO, test patients for hepatitis B virus infection .

It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating SYMFI LO and during therapy in all patients as clinically appropriate

Monitor hepatic function prior to and during treatment with SYMFI LO .


What interacts with SYMFI LO?

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What are the warnings of SYMFI LO?

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What are the precautions of SYMFI LO?

Sorry No Records found


What are the side effects of SYMFI LO?

Sorry No records found


What should I look out for while using SYMFI LO?

SYMFI LO is contraindicated:


What might happen if I take too much SYMFI LO?

If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Efavirenz:

Treatment of overdose with EFV should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with efavirenz. Since efavirenz is highly protein bound, dialysis is unlikely to significantly remove the drug from blood.

Lamivudine:

Tenofovir Disoproxil Fumarate:

Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir disoproxil fumarate, a 4-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.


How should I store and handle SYMFI LO?

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.SYMFI LO tablets are supplied as fixed-dosed combination tablets containing 400 mg of efavirenz, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil. SYMFI LO tablets are white to off-white, film-coated, oval tablets debossed with “” on one side and “” on the other side. They are supplied as – unit of use cartons containing bottles of 30 tablets with desiccant, induction seal, and child-resistant cap.Store below 30°C (86°F). Dispense in original container.SYMFI LO tablets are supplied as fixed-dosed combination tablets containing 400 mg of efavirenz, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil. SYMFI LO tablets are white to off-white, film-coated, oval tablets debossed with “” on one side and “” on the other side. They are supplied as – unit of use cartons containing bottles of 30 tablets with desiccant, induction seal, and child-resistant cap.Store below 30°C (86°F). Dispense in original container.SYMFI LO tablets are supplied as fixed-dosed combination tablets containing 400 mg of efavirenz, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil. SYMFI LO tablets are white to off-white, film-coated, oval tablets debossed with “” on one side and “” on the other side. They are supplied as – unit of use cartons containing bottles of 30 tablets with desiccant, induction seal, and child-resistant cap.Store below 30°C (86°F). Dispense in original container.SYMFI LO tablets are supplied as fixed-dosed combination tablets containing 400 mg of efavirenz, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil. SYMFI LO tablets are white to off-white, film-coated, oval tablets debossed with “” on one side and “” on the other side. They are supplied as – unit of use cartons containing bottles of 30 tablets with desiccant, induction seal, and child-resistant cap.Store below 30°C (86°F). Dispense in original container.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

SYMFI LO is a fixed-dose combination of antiviral drugs EFV, 3TC, and TDF with antiviral activity against HIV-1

Non-Clinical Toxicology
SYMFI LO is contraindicated:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs and other antiretrovirals. Treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)

The following adverse reactions are discussed in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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