Cronocef

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Cronocef uses


INDICATIONS AND USAGE

Cronocef is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Upper Respiratory Tract

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes.

NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cronocef is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of Cronocef in the subsequent prevention of rheumatic fever are not available at present.

Otitis Media

caused by Streptococcus pneumoniae, Haemophilusinfluenzae, and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES .)

NOTE: In the treatment of otitis media due to β-lactamase-producing organisms, Cronocef had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of ceprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors.

Acute Sinusitis

caused by Streptococcus pneumoniae, Haemophilusinfluenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).

Lower Respiratory Tract

Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis

caused by Streptococcus pneumoniae, Haemophilus influenza, and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains).

Skin and Skin Structure

Uncomplicated Skin and Skin-Structure Infections

caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cronocef and other antibacterial drugs, Cronocef should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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CONTRAINDICATIONS

Cronocef is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

WARNINGS

BEFORE THERAPY WITH Cronocef IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cronocef, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Cronocef OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cronocef, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to the overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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PRECAUTIONS

General

Prescribing Cronocef in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be done prior to and during therapy. The total daily dose of Cronocef should be reduced in these patients because high and/or prolonged plasma antibiotic concentrations can occur in such individuals from usual doses. Cephalosporins, including Cronocef, should be given with caution to patients receiving concurrent treatment with potent diuretics since these agents are suspected of adversely affecting renal function.

Prolonged use of Cronocef may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential.

If superinfection occurs during therapy, appropriate measures should be taken.

Cronocef should be prescribed with caution in individuals with a history of gastrointestinal disease particularly colitis.

Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.

Information for Patients

Phenylketonurics

Cronocef for oral suspension contains phenylalanine 28 mg per 5 mL constituted suspension for both the 125 mg/5 mL and 250 mg/5 mL dosage forms.

Patients should be counseled that antibacterial drugs including Cronocef should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cronocef is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cronocef or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for Cronocef.

The bioavailability of the capsule formulation of Cronocef was not affected when administered 5 minutes following an antacid.

Drug/Laboratory Test Interactions

Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with copper reduction tests, but not with enzyme-based tests for glycosuria (e.g., Clinistix®). A false negative reaction may occur in the ferricyanide test for blood glucose. The presence of Cronocef in the blood does not interfere with the assay of plasma or urine creatinine by the alkaline picrate method.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long term in vivo studies have not been performed to evaluate the carcinogenic potential of Cronocef.

Cronocef was not found to be mutagenic in either the Ames Salmonella or E. coli WP2 urvA reversion assays or the Chinese hamster ovary cell HGPRT forward gene mutation assay and it did not induce chromosomal abnormalities in Chinese hamster ovary cells or unscheduled DNA synthesis in rat hepatocytes in vitro. Chromosomal aberrations were not observed in bone marrow cells from rats dosed orally with over 30 times the highest recommended human dose based upon mg/m2.

Impairment of fertility was not observed in male or female rats given oral doses of Cronocef up to 18.5 times the highest recommended human dose based upon mg/m2.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rabbits, mice, and rats using oral doses of Cronocef of 0.8, 8.5, and 18.5 times the maximum daily human dose based upon mg/m2, and have revealed no harm to the fetus. There are, however, 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.

Labor and Delivery

Cronocef has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Small amounts of Cronocef have been detected in human milk following administration of a single 1 gram dose to lactating women. The average levels over 24 hours ranged from 0.25 to 3.3 mcg/mL. Caution should be exercised when Cronocef is administered to a nursing woman, since the effect of Cronocef on nursing infants is unknown.

Pediatric Use

(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .)

The safety and effectiveness of Cronocef in the treatment of otitis media have been established in the age groups 6 months to 12 years. Use of Cronocef for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of Cronocef in pediatric patients. (See CLINICAL STUDIES .)

The safety and effectiveness of Cronocef in the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections have been established in the age groups 2 to 12 years. Use of Cronocef for the treatment of these infections is supported by evidence from adequate and well-controlled studies of Cronocef in pediatric patients. The safety and effectiveness of Cronocef in the treatment of acute sinusitis have been established in the age groups 6 months to 12 years. Use of Cronocef in these age groups is supported by evidence from adequate and well-controlled studies of Cronocef in adults.

Safety and effectiveness in pediatric patients below the age of 6 months have not been established for the treatment of otitis media or acute sinusitis, or below the age of 2 years for the treatment of pharyngitis/tonsillitis or uncomplicated skin and skin-structure infections. However, accumulation of other cephalosporin antibiotics in newborn infants (resulting from prolonged drug half-life in this age group) has been reported.

Geriatric Use

Of the more than 4500 adults treated with Cronocef in clinical studies, 14% were 65 years and older, while 5% were 75 years and older. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to clinical efficacy and safety in nongeriatric adult patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals to the effects of Cronocef cannot be excluded (see CLINICAL PHARMACOLOGY ).

Cronocef is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. See DOSAGE AND ADMINISTRATION for dosing recommendations for patients with impaired renal function.

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ADVERSE REACTIONS

The adverse reactions to Cronocef are similar to those observed with other orally administered cephalosporins. Cronocef was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued Cronocef therapy due to adverse events.

The most common adverse effects observed in patients treated with Cronocef are:

Gastrointestinal

Diarrhea, nausea (3.5%), vomiting (1%), and abdominal pain (1%).

Hepatobiliary

Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.

Hypersensitivity

Rash, urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.

CNS

Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible.

Hematopoietic

Decreased leukocyte count, eosinophilia (2.3%).

Renal

Elevated BUN (0.1%), serum creatinine (0.1%).

Other

Diaper rash and superinfection, genital pruritus and vaginitis (1.6%).

The following adverse events, regardless of established causal relationship to Cronocef, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.

Cephalosporin Class Paragraph

In addition to the adverse reactions listed above which have been observed in patients treated with Cronocef, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH, pancytopenia, neutropenia, agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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OVERDOSAGE

Single 5000 mg/kg oral doses of Cronocef caused no mortality or signs of toxicity in adult, weanling, or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus monkeys, but no mortality.

Cronocef is eliminated primarily by the kidneys. In case of severe overdosage, especially in patients with compromised renal function, hemodialysis will aid in the removal of Cronocef from the body.

DOSAGE AND ADMINISTRATION

Cronocef is administered orally.

Population/Infection Dosage

Duration

(days)


ADULTS (13 years and older)


UPPER RESPIRATORY TRACT


Pharyngitis/Tonsillitis


500 q24h


10In the treatment of infections due to Streptococcus pyogenes, Cronocef should be administered for at least 10 days.


Acute Sinusitis

(For moderate to severe infections, the higher dose

should be used)


250 q12h or

500 q12h


10


LOWER RESPIRATORY TRACT


Secondary Bacterial Infection of Acute Bronchitis

and Acute Bacterial Exacerbation of Chronic

Bronchitis


500 q12h


10


SKIN AND SKIN STRUCTURE


Uncomplicated Skin and Skin Structure Infections


250 q12h or

500 q24h or

500 q12h


10


CHILDREN (2 years – 12 years)


UPPER RESPIRATORY TRACTNot to exceed recommended adult doses.


Pharyngitis/Tonsillitis


7.5 mg/kg

q12h


10


SKIN AND SKIN STRUCTURE


Uncomplicated Skin and Skin Structure Infections


20 mg/kg

q24h


10


INFANTS ( CHILDREN (6 months – 12 years)


UPPER RESPIRATORY TRACT


Otitis Media (See INDICATIONS AND USAGE and

CLINICAL STUDIES)


15 mg/kg

q12h


10


Acute Sinusitis

(For moderate to severe infections, the higher dose

should be used)


7.5 mg/kg

q12h or

15 mg/kg

q12h


10

Renal Impairment

Cronocef may be administered to patients with impaired renal function.

The following dosage schedule should be used.


Creatinine Clearance

(mL/min)


Dosage

(mg)


Dosing Interval


30–120


Standard


standard


0–29Cronocef is in part removed by hemodialysis; therefore, Cronocef should be administered after the completion of hemodialysis.


50% of standard


standard

Hepatic Impairment

No dosage adjustment is necessary for patients with impaired hepatic function.

Reconstitution Directions for Oral Suspension

Prepare the suspension at the time of dispensing; for ease in preparation, add water in two portions and shake well after each aliquot.


Bottle Size


Final Concentration

125 mg/5 mL


Final Concentration

250 mg/5 mL


50 mL


36 mL


36 mL


75 mL


54 mL


54 mL


100 mL


72 mL


72 mL


After mixing, store in a refrigerator and discard unused portion after 14 days.

Store dry powder at 20° to 25°C (68° to 77°F) prior to constitution.

HOW SUPPLIED

Cronocef Tablets USP, 250 mg are oval-shaped, white to cream tinged, unscored, film-coated tablets, debossed 347 on one side and 250 on the reverse side and are supplied as follows:

NDC 0781-5043-01 in bottles of 100 tablets

Ceprozil Tablets USP, 500 mg are oval-shaped, beige, unscored, film-coated tablets, debossed 348 on one side and 500 on the reverse side and are supplied as follows:

NDC 0781-5044-50 in bottles of 50 tablets

NDC 0781-5044-01 in bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F).

Dispense in a tight, light-resistant container as defined in the USP.

Cronocef for Oral Suspension, USP, 125 mg/5 mL is supplied as follows:

NDC 0781-6202-91 50 mL bottle

NDC 0781-6202-57 75 mL bottle

NDC 0781-6202-46 100 mL bottle

Cronocef for Oral Suspension, USP, 250 mg/5 mL is supplied as follows:

NDC 0781-6203-91 50 mL bottle

NDC 0781-6203-57 75 mL bottle

NDC 0781-6203-46 100 mL bottle

All powder formulations for oral suspension contain Cronocef in a fruity flavored mixture. Cronocef powder is slightly cream tinged to beige. After reconstitution the suspension is light orange and of a fruity odor and flavor.

CLINICAL STUDIES

Study One

In a controlled clinical study of acute otitis media performed in the United States where significant rates of β-lactamase-producing organisms were found, Cronocef was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes and safety results were obtained:


EFFICACY:


Pathogen


% of Cases with

Pathogen (n=155)


Outcome


S. pneumoniae


48.4%


Cronocef success rate

5% better than control


H. influenzae


35.5%


Cronocef success rate

17% less than control


M. catarrhalis


13.5%


Cronocef success rate

12% less than control


S. pyogenes


2.6%


Cronocef equivalent to control


Overall


100.0%


Cronocef success rate

5% less than control


SAFETY:


The incidences of adverse events, primarily diarrhea and rashThe majority of these involved the diaper area in young children., were clinically and statistically significantly higher in the control arm versus the Cronocef arm.


Age Group


Cronocef


Control


6 months – 2 years


21%


41%


3–12 years


10%


19%

Study Two

In a controlled clinical study of acute otitis media performed in Europe, Cronocef was compared to an oral antimicrobial agent that contained a specific β-lactamase inhibitor. As expected in a European population, this study population had a lower incidence of β-lactamase-producing organisms than usually seen in U.S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10 to 16 days post-therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (ie clinical success) were obtained:


EFFICACY:


Pathogen


% of Cases with

Pathogen (n=47)


Outcome


S. pneumoniae


51%


Cronocef equivalent to control


H. influenzae


29.8%


Cronocef equivalent to control


M. catarrhalis


6.4%


Cronocef equivalent to control


S. pyogenes


12.8%


Cronocef equivalent to control


Overall


100%


Cronocef equivalent to control


SAFETY:


The incidence of adverse events in the Cronocef arm was comparable to the incidence of adverse events in the control arm (agent that contained a specific β-lactamase inhibitor).

REFERENCES


Clinitest® and Clinistix® are registered trademarks of the Bayer HealthCare LLC.

05-2014

46135881

Manufactured in Austria by Sandoz GmbH

for Sandoz Inc., Princeton, NJ 08540

NDC 0781-5043-01

Cronocef

Tablets, USP

250 mg*

(Film-Coated Tablets)

Rx only

100 Tablets

SANDOZ

NDC 0781-5044-50

Cronocef

Tablets, USP

500 mg*

(Film-Coated Tablets)

Rx only

50 Tablets

SANDOZ

NDC 0781-6202-91

Cronocef

for Oral

Suspension, USP

125 mg/5 mL*

when constituted

according to directions

Rx only

50 mL

(when mixed)

SANDOZ

NDC 0781-6203-91

Cronocef

for Oral

Suspension, USP

250 mg/5 mL*

when constituted

according to directions

Rx only

50 mL

(when mixed)

SANDOZ

Cronocef pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Cronocef available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Cronocef destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Cronocef Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Cronocef pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CEFPROZIL: 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/dailym... (accessed August 28, 2018).
  3. "cefprozil". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Cronocef?

Depending on the reaction of the Cronocef after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cronocef 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 Cronocef 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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Review

sdrugs.com conducted a study on Cronocef, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cronocef consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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