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DRUGS & SUPPLEMENTS
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How old is patient? |
Cefixime Anhydrous:
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for E-Fix LB (Cefixime Anhydrous) than for the comparator .
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of E-Fix LB (Cefixime Anhydrous) should be administered for at least 10 days.
Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because E-Fix LB (Cefixime Anhydrous) for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).
PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration
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| SUPRAX ( E-Fix LB (Cefixime Anhydrous) ) for oral suspension
| SUPRAX ( E-Fix LB (Cefixime Anhydrous) ) chewable tablet
| |||
| 100 mg / 5 mL
| 200 mg / 5 mL
| 500 mg / 5 mL
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Patient Weight ( kg )
| Dose / Day ( mg )
| Dose / Day ( mL )
| Dose / Day ( mL )
| Dose / Day ( mL )
| Dose
|
5 to 7.5 | 50 | 2.5 | -- | -- | -- |
7.6 to 10 | 80 | 4 | 2 | -- | -- |
10.1 to 12.5 | 100 | 5 | 2.5 | 1 | 1 tablet of 100 mg |
12.6 to 20.5 | 150 | 7.5 | 4 | 1.5 | 1 tablet of 150 mg |
20.6 to 28 | 200 | 10 | 5 | 2 | 1 tablet of 200 mg |
28.1 to 33 | 250 | 12.5 | 6 | 2.5 | 1 tablet of 100 mg and 1 tablet of 150 mg |
33.1 to 40 | 300 | 15 | 7.5 | 3 | 2 tablets of 150 mg |
40.1 to 45 | 350 | 17.5 | 9 | 3.5 | 1 tablet of 150 mg and 1 tablet of 200 mg |
45.1 or greater | 400 | 20 | 10 | 4 | 2 tablets of 200 mg |
Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose.
Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media .
In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of E-Fix LB (Cefixime Anhydrous) should be administered for at least 10 days.
Renal Dysfunction
| SUPRAX ( E-Fix LB (Cefixime Anhydrous) ) for oral suspension
| Tablet
| Chewable Tablet
| ||
Creatinine Clearance (mL/min) | 100 mg / 5 mL | 200 mg / 5 mL | 500 mg / 5 mL | 400 mg
| 200 mg
|
| Dose/Day (mL) | Dose/Day (mL) | Dose/Day (mL) | Dose/Day | Dose/Day |
60 or greater | Normal dose | Normal dose | Normal dose | Normal dose | Normal dose |
21 to 59 OR renal hemodialysis | 13 | 6.5 | 2.6 | Not Appropriate | Not Appropriate |
20 or less OR continuous peritoneal dialysis | 8.6 | 4.4 | 1.8 | 0.5 tablet | 1 tablet |
Strength
| Bottle Size
| Reconstitution Directions
|
100 mg/5 mL and 200 mg/5 mL | 100 mL | To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
100 mg/5 mL and 200 mg/5 mL | 75 mL | To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
100 mg/5 mL and 200 mg/5 mL | 50 mL | To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
200 mg/5 mL | 37.5 mL | To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
200 mg/5 mL | 25 mL | To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
500 mg/5 mL | 20 mL | To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
500 mg/5 mL | 10 mL | To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. |
Before therapy with E-Fix LB (Cefixime Anhydrous) is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to E-Fix LB (Cefixime Anhydrous) occurs, discontinue the drug.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Phenylalanine can be harmful to patients with phenylketonuria (PKU). E-Fix LB (Cefixime Anhydrous) chewable tablets contain aspartame, a source of phenylalanine. Each 100 mg, 150 mg and 200 mg strength contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine, respectively. Before prescribing E-Fix LB (Cefixime Anhydrous) chewable tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including E-Fix LB (Cefixime Anhydrous) chewable tablets.
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharma at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.
Gastrointestinal
Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.
Hepatic
Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.
Renal
Transient elevations in BUN or creatinine, acute renal failure.
Central Nervous System
Headaches, dizziness, seizures.
Hemic and Lymphatic System
Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia.
Abnormal Laboratory Tests
Hyperbilirubinemia.
Other Adverse Reactions
Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.
Adverse Reactions Reported for Cephalosporin-class Drugs
Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced . If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
The administration of E-Fix LB (Cefixime Anhydrous) may result in a false-positive reaction for glucose in the urine using Clinitest ®**, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ®** or TesTape ®**) be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.
**Clinitest ® and Clinistix ® are registered trademarks of Ames Division, Miles Laboratories, Inc. Tes-Tape ® is a registered trademark of Eli Lilly and Company.
Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to E-Fix LB (Cefixime Anhydrous). There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C 16H 15N 5O 7S 2.3H 2O
The structural formula for E-Fix LB (Cefixime Anhydrous) is:
E-Fix LB (Cefixime Anhydrous) tablets and suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of E-Fix LB (Cefixime Anhydrous) produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Two hundred and 400 mg doses of oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the oral suspension than with the tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the oral suspension is to be substituted for the tablet. Because of the lack of bioequivalence, tablets should not be substituted for oral suspension in the treatment of otitis media . Cross-over studies of tablet versus suspension have not been performed in children.
The 400 mg capsule is bioequivalent to the 400 mg tablet under fasting conditions. However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on C max.
Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of E-Fix LB (Cefixime Anhydrous) suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule.
Distribution
Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of E-Fix LB (Cefixime Anhydrous) are not available.
Metabolism and Excretion
There is no evidence of metabolism of E-Fix LB (Cefixime Anhydrous) in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that E-Fix LB (Cefixime Anhydrous) is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of E-Fix LB (Cefixime Anhydrous) in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.
Special Populations
Geriatrics: Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of E-Fix LB (Cefixime Anhydrous) once daily for 5 days are summarized as follows:
Pharmacokinetic Parameters ( mean ± SD ) for Cefixime in Both Young & Elderly Subjects
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Pharmacokinetic parameter
| Young
| Elderly
|
C m a x (mg/L) | 4.74 ± 1.43 | 5.68 ± 1.83 |
T m a x (h) | 3.9 ± 0.3 | 4.3 ± 0.6 |
AUC (mg.h/L) | 34.9 ± 12.2 | 49.5 ± 19.1 |
T ½ (h) | 3.5 ± 0.6 | 4.2 ± 0.4 |
C a v e (mg/L) | 1.42 ±0.50 | 1.99 ± 0.75 |
Renal Impairment: In subjects with moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of E-Fix LB (Cefixime Anhydrous) is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60 mL/min.
As with other cephalosporins, the bactericidal action of E-Fix LB (Cefixime Anhydrous) results from inhibition of cell wall synthesis. E-Fix LB (Cefixime Anhydrous) is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to E-Fix LB (Cefixime Anhydrous).
Resistance
Resistance to E-Fix LB (Cefixime Anhydrous) in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). E-Fix LB (Cefixime Anhydrous) may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Pseudomonas species, Enterococcus species, strains of Group D streptococci, Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains), most strains of Enterobacter species, most strains of Bacteroides fragilis, and most strains of Clostridium species are resistant to E-Fix LB (Cefixime Anhydrous).
Antimicrobial Activity
E-Fix LB (Cefixime Anhydrous) has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections .
Gram-positive Bacteria
Streptococcus pneumoniae
Streptococcus pyogenes
Gram-negative Bacteria
Escherichia coli
Haemophilus influenzae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus mirabilis
The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for E-Fix LB (Cefixime Anhydrous) against isolates of similar genus or organism group. However, the efficacy of E-Fix LB (Cefixime Anhydrous) in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.
Gram-positive Bacteria
Streptococcus agalactiae
Gram-negative Bacteria
Citrobacter amalonaticus
Citrobacter diversus
Haemophilus parainfluenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Pasteurella multocida
Proteus vulgaris
Providencia species
Salmonella species
Serratia marcescens
Shigella species
Susceptibility Test Methods
When available, the clinical microbiology laboratory should provide cumulative reports of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.
Dilution Techniques
Quantitative methods are used to determine antimicrobial MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method 1,2(broth and/or agar). The MIC values should be interpreted according to criteria provided in Table 3.
Diffusion Techniques
Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. 2.3 This procedure uses paper disks impregnated with 5 mcg E-Fix LB (Cefixime Anhydrous) to test the susceptibility of bacteria to E-Fix LB (Cefixime Anhydrous). The disk diffusion breakpoints are provided in Table 3.
Pathogen
| Minimum Inhibitory Concentrations ( mcg / mL )
| Disk Diffusion Zone Diameters ( mm )
| ||||
| S
| I
| R
| S
| I
| R
|
Enterobacteriaceae | <1 | 2 | > 4 | > 19 | 16 to 18 | < 15 |
Haemophilus influenzae | <1 | NA | NA | > 21 | NA | NA |
Neisseria gonorrhoeae | < 0.25 | NA | NA | > 31 | NA | NA |
Quality Control:
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1,2,3 Standard E-Fix LB (Cefixime Anhydrous) powder should provide the following range of MIC values noted in Table 4. For the diffusion technique using the 5 mcg disk, the criteria in Table 4 should be achieved.
ATCC = American Type Culture Collection | ||
Quality Control Organisms
| Minimum Inhibitory Concentrations ( mcg / mL )
| Disk Diffusion Zone Diameters ( mm )
|
E . coli ATCC 25922 | 0.25 to 1 | 23 to 27 |
H . influenzae ATCC 49247
| 0.12 to 1 | 25 to 33 |
N . gonorrhoeae ATCC 49226 | 0.004 to 0.03 | 37 to 45 |
S . pneumoniae ATCC 49619
| NA | 16 to 23 |
S . aureus ATCC 29213 | 8 to 32 | NA |
The overall response rate of Streptococcus pneumoniae to E-Fix LB (Cefixime Anhydrous) was approximately 10% lower and that of Haemophilus influenzae or Moraxella catarrhalis approximately 7% higher (12% when beta-lactamase positive isolates of H. influenzae are included) than the response rates of these organisms to the active control drugs.
In these studies, patients were randomized and treated with either E-Fix LB (Cefixime Anhydrous) at dose regimens of 4 mg/kg twice a day or 8 mg/kg once a day, or with a comparator. Sixty-nine to 70% of the patients in each group had resolution of signs and symptoms of otitis media when evaluated 2 to 4 weeks post-treatment, but persistent effusion was found in 15% of the patients. When evaluated at the completion of therapy, 17% of patients receiving E-Fix LB (Cefixime Anhydrous) and 14% of patients receiving effective comparative drugs (18% including those patients who had Haemophilus influenzae resistant to the control drug and who received the control antibacterial drug) were considered to be treatment failures. By the 2 to 4 week follow-up, a total of 30%-31% of patients had evidence of either treatment failure or recurrent disease.
(a)Number eradicated/number isolated. | |||
(b)An additional 20 beta-lactamase positive isolates of Haemophilus influenzae were isolated, but were excluded from this analysis because they were resistant to the control antibacterial drug. In nineteen of these, the clinical course could be assessed and a favorable outcome occurred in 10. When these cases are included in the overall bacteriological evaluation of therapy with the control drugs, 140/185 (76%) of pathogens were considered to be eradicated. | |||
Bacteriological Outcome of Otitis Media at Two to Four Weeks Post - Therapy Based on Repeat Middle Ear Fluid Culture or Extrapolation from Clinical Outcome
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Organism | E-Fix LB (Cefixime Anhydrous) ( a ) 4 mg / kg BID
| E-Fix LB (Cefixime Anhydrous) ( a ) 8 mg / kg QD
| Control ( a ) drugs
|
Streptococcus pneumoniae
| 48/70 (69%) | 18/22 (82%) | 82/100 (82%) |
Haemophilus influenzae beta-lactamase negative | 24/34 (71%) | 13/17 (76%) | 23/34 (68%) |
Haemophilus influenzae beta-lactamase positive | 17/22 (77%) | 9/12 (75%) | 1/1 (b) |
Moraxella catarrhalis
| 26/31 (84%) | 5/5 | 18/24 (75%) |
S . pyogenes
| 5/5 | 3/3 | 6/7 |
All Isolates | 120/162 (74%) | 48/59 (81%) | 130/166 (78%) |
400 mg
Size “00EL” capsules with pink opaque cap and pink opaque body, imprinted with “LU” on cap and “U43” on body in black
Bottle of 1 capsules
Store at 20 to 25°C
(68 to 77°F)
[See USP Controlled
Room Temperature].
Counsel patients with phenylketonuria that E-Fix LB (Cefixime Anhydrous) chewable tablets contain aspartame, a source of phenylalanine as follows: Each E-Fix LB (Cefixime Anhydrous) chewable tablet contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine per 100 mg, 150 mg and 200 mg strength, respectively.
Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
Products
| Manufactured for :
| Manufactured by :
|
E-Fix LB (Cefixime Anhydrous) ® (cefixime) tablets, 400 mg | | |
E-Fix LB (Cefixime Anhydrous) ® (cefixime) capsules, 400 mg | Lupin Pharma | |
E-Fix LB (Cefixime Anhydrous) ® (cefixime) chewable tablets, 100 mg, 150 mg and 200 mg | Baltimore, Maryland 21202 | Lupin Limited |
E-Fix LB (Cefixime Anhydrous) ® (cefixime) for oral suspension, 200 mg/5 mL | United States. | Mandideep 462 046 |
E-Fix LB (Cefixime Anhydrous) ® (cefixime) for oral suspension, 500 mg/5 mL | | India. |
E-Fix LB (Cefixime Anhydrous) ® (cefixime) for oral suspension, 100 mg/5 mL | Lupin Pharmaceuticals , Inc . Baltimore, Maryland 21202 United States. | |
E-Fix LB (Cefixime Anhydrous) ® E-Fix LB (Cefixime Anhydrous) CAPSULES
400 mg
Rx only
Bottle of 1 Capsules
Depending on the reaction of the E-Fix LB after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider E-Fix LB not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is E-Fix LB addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology