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Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

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Overview

What is SYMFI?

SYMFI tablets contain efavirenz, an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate or tenofovir DF (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. tenofovir DF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase.

SYMFI tablets are for oral administration. Each film-coated tablet contains 600 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium chloride, sodium lauryl sulfate, talc and titanium dioxide.

Efavirenz:

S

H

Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).

Lamivudine:

R

S

-

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

Tenofovir Disoproxil Fumarate:

Tenofovir DF is a white to off-white powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C.



What does SYMFI look like?



What are the available doses of SYMFI?

Tablets: 600 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?

How should I use SYMFI?

SYMFI™ (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 40 kg.

Prior to initiation of SYMFI, 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 and during therapy in all patients as clinically appropriate

Monitor hepatic function prior to and during treatment with SYMFI .


What interacts with SYMFI?

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What are the warnings of SYMFI?

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What are the precautions of SYMFI?

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What are the side effects of SYMFI?

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What should I look out for while using SYMFI?

SYMFI is contraindicated:


What might happen if I take too much SYMFI?

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?

Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.SYMFI (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets 600 mg/300 mg/300 mg are white, film-coated, capsule shaped, debossed with on one side of the tablet and plain on the other side. They are available as follows:NDC 49502-475-93cartons containing bottles of 30 tablets with desiccant, induction seal and child-resistant capStore below 30°C (86°F).Keep the bottle tightly closed.Dispense in original container.Do not use if seal over bottle opening is broken or missing.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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

Non-Clinical Toxicology
SYMFI is contraindicated:

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.

In vitro

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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