Ceprolen-D

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Ceprolen-D uses


Ceprolen-D chemical diagram dexamethasone chemical diagram wash warm sick eardrop up back tragus carton

1 INDICATIONS AND USAGE

Ceprolen-D is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:


Ceprolen-D is a combination of Ceprolen-D, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

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2 DOSAGE AND ADMINISTRATION

Ceprolen-D is for topical use only, and not for ophthalmic use, or for injection.

2.1 Important Administration Instructions

2.2 Dosage

For the treatment of Acute Otitis Media in pediatric patients (age 6 months and older) with tympanostomy tubes

The recommended dosage regimen through tympanostomy tubes is as follows:


For the treatment of Acute Otitis Externa (age 6 months and older )

The recommended dosage regimen is as follows:

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3 DOSAGE FORMS AND STRENGTHS

Otic Suspension: Each mL of Ceprolen-D contains Ceprolen-D hydrochloride 0.3 % (equivalent to 3 mg Ceprolen-D base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone.

Otic Suspension: Each mL of Ceprolen-D contains Ceprolen-D hydrochloride 0.3 % (equivalent to 3 mg Ceprolen-D base) and dexamethasone 0.1 % (equivalent to 1 mg dexamethasone). (3)

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Ceprolen-D should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching.

5.2 Potential for Microbial Overgrowth with Prolonged Use

Prolonged use of Ceprolen-D may result in overgrowth of non-susceptible, bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3 Continued or Recurrent Otorrhea

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:


Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Alcon at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phases II and III clinical trials, a total of 937 patients were treated with Ceprolen-D. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported adverse reactions are listed below:

Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes

The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.

Adverse Reactions Incidence (N=400)
Ear discomfort 3.0%
Ear pain 2.3%
Ear precipitate (residue) 0.5%
Irritability 0.5%
Taste Perversion 0.5%

The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes

Adverse Reactions Incidence (N=537)
Ear pruritus 1.5%
Ear debris 0.6%
Superimposed ear infection 0.6%
Ear congestion 0.4%
Ear pain 0.4%
Erythema 0.4%

The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Ceprolen-D. Because these reactions are reported voluntarily from a population of unknown size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects. Pregnancy Category C:

No adequate and well controlled studies with Ceprolen-D have been performed in pregnant women. Caution should be exercised when Ceprolen-D is used by a pregnant woman.

Animal reproduction studies have not been conducted with Ceprolen-D.

Reproduction studies with Ceprolen-D have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus. In rabbits, Ceprolen-D produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

8.3 Nursing Mothers

Ceprolen-D and corticosteroids, as a class, appear in milk following oral administration. Dexamethasone in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical otic administration of Ceprolen-D or dexamethasone could result in sufficient systemic absorption to produce detectable quantities in human milk. Because of the potential for unwanted effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and efficacy of Ceprolen-D have been established in pediatric patients 6 months and older (937 patients) in adequate and well-controlled clinical trials.

No clinically relevant changes in hearing function were observed in 69 pediatric patients (age 4 to 12 years) treated with Ceprolen-D and tested for audiometric parameters.

10 OVERDOSAGE

Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.

11 DESCRIPTION

Ceprolen-D (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the quinolone antimicrobial, Ceprolen-D hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of Ceprolen-D contains Ceprolen-D hydrochloride (equivalent to 3 mg Ceprolen-D base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.

Ceprolen-D, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C17H18FN3O3·HCl·H2O. The molecular weight is 385.82 and the structural formula is:

Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C22H29FO5. The molecular weight is 392.46 and the structural formula is:

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ceprolen-D is a fluoroquinolone antibacterial .

Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

12.3 Pharmacokinetics

Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg Ceprolen-D, 0.28 mg dexamethasone) topical otic dose of Ceprolen-D to pediatric patients after tympanostomy tube insertion, measurable plasma concentrations of Ceprolen-D and dexamethasone were observed at 6 hours following administration in 2 of 9 patients and 5 of 9 patients, respectively.

Mean ± SD peak plasma concentrations of Ceprolen-D were 1.39 ± 0.880 ng/mL (n=9). Peak plasma concentrations ranged from 0.543 ng/mL to 3.45 ng/mL and were on average approximately 0.1% of peak plasma concentrations achieved with an oral dose of 250-mg. Peak plasma concentrations of Ceprolen-D were observed within 15 minutes to 2 hours post dose application.

Mean ± SD peak plasma concentrations of dexamethasone were 1.14 ± 1.54 ng/mL (n=9). Peak plasma concentrations ranged from 0.135 ng/mL to 5.10 ng/mL and were on average approximately 14% of peak concentrations reported in the literature following an oral 0.5-mg tablet dose. Peak plasma concentrations of dexamethasone were observed within 15 minutes to 2 hours post dose application.

Dexamethasone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection (such as otorrhea in pediatric patients with acute otitis media with tympanostomy tubes).

12.4 Microbiology

Mechanism of Action

The bactericidal action of Ceprolen-D results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA.

Resistance

Cross-resistance has been observed between Ceprolen-D and other fluoroquinolones. There is generally no cross-resistance between Ceprolen-D and other classes of antibacterial agents such as beta-lactams or aminoglycosides.

Antimicrobial Activity

Ceprolen-D has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections .

Aerobic Bacteria

Gram-positive Bacteria


Gram-negative Bacteria

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in mice and rats have been completed for Ceprolen-D. After daily oral doses of 750 mg/kg and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that Ceprolen-D had any carcinogenic or tumorigenic effects in these species. No long term studies of Ceprolen-D have been performed to evaluate carcinogenic potential.

Eight in vitro mutagenicity tests have been conducted with Ceprolen-D, and the test results are listed below:


Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:


Fertility studies performed in rats at oral doses of Ceprolen-D up to 100 mg/kg/day revealed no evidence of impairment. This would be over 100 times the maximum recommended clinical dose of ototopical Ceprolen-D based upon body surface area, assuming total absorption of Ceprolen-D from the ear of a patient treated with Ceprolen-D twice per day according to label directions.

Long term studies have not been performed to evaluate the carcinogenic potential of topical otic dexamethasone. Dexamethasone has been tested for in vitro and in vivo genotoxic potential and shown to be positive in the following assays: chromosomal aberrations, sister-chromatid exchange in human lymphocytes, and micronuclei and sister-chromatid exchanges in mouse bone marrow. However, the Ames/Salmonella assay, both with and without S9 mix, did not show any increase in His+ revertants.

The effect of dexamethasone on fertility has not been investigated following topical otic application. However, the lowest toxic dose of dexamethasone identified following topical dermal application was 1.802 mg/kg in a 26-week study in male rats and resulted in changes to the testes, epididymis, sperm duct, prostate, seminal vessicle, Cowper's gland and accessory glands. The relevance of this study for short-term topical otic use is unknown.

13.2 Animal Toxicology and/or Pharmacology

Guinea pigs dosed in the middle ear with Ceprolen-D for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles.

14 CLINICAL STUDIES

In a randomized, multicenter, controlled clinical trial, Ceprolen-D dosed 2 times per day for 7 days demonstrated clinical cures in the per protocol analysis in 86% of Acute Otitis Media with Tympanostomy Tubes (AOMT) patients compared to 79% for ofloxacin solution, 0.3%, dosed 2 times per day for 10 days. Among culture positive patients, clinical cures were 90% for Ceprolen-D compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for Ceprolen-D compared to 82% for ofloxacin solution, 0.3%.

In 2 randomized multicenter, controlled clinical trials, Ceprolen-D dosed 2 times per day for 7 days demonstrated clinical cures in 87% and 94% of per protocol evaluable Acute Otitis Externa (AOE) patients, respectively, compared to 84% and 89%, respectively, for otic suspension containing neomycin 0.35%, polymyxin B 10,000 IU/mL, and hydrocortisone 1.0% (neo/poly/HC). Among culture positive patients clinical cures were 86% and 92% for Ceprolen-D compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological eradication rates for these patients in the same clinical trials were 86% and 92% for Ceprolen-D compared to 85% and 85%, respectively, for neo/poly/HC.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied:

Ceprolen-D (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is a white-to off-white suspension supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

NDC 0065-8533-02, 7.5 mL fill

Storage:

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F).

.

Avoid freezing. Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

PATIENT INFORMATION

Ceprolen-D (CI-PRO-DEX)

(ciprofloxacin and dexamethasone)

otic suspension

This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: December 2015
What is Ceprolen-D?
Ceprolen-D is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called Ceprolen-D and a corticosteroid medicine called dexamethasone. Ceprolen-D is used in adults and children 6 months of age or older to treat certain types of infections caused by certain germs called bacteria. These bacterial infections include:
middle ear infection (known as acute otitis media) in people who have a tube in their eardrum known as a tympanostomy to prevent having too much fluid in the middle ear
outer ear canal infection (known as acute otitis externa)
It is not known if Ceprolen-D is safe and effective in children under 6 months of age.
Who should not use Ceprolen-D?
Do not use Ceprolen-D if you:
are allergic to ciprofloxin, quinolones, or any of the ingredients in Ceprolen-D. See the end of this Patient Information leaflet for a complete list of ingredients in Ceprolen-D.
have an outer ear canal infection caused by certain viruses including the herpes simplex virus
have an ear infection caused by a fungus
What should I tell my doctor before using Ceprolen-D?
Before using Ceprolen-D, tell your doctor about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if Ceprolen-D will harm your unborn baby.
are breastfeeding or plan to breastfeed. Ceprolen-D can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use Ceprolen-D or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Ceprolen-D?
Read the detailed Instructions for Use that come with Ceprolen-D.
Use Ceprolen-D exactly as your doctor tells you to.
Ceprolen-D is for use in the ear only (otic use). Do not inject Ceprolen-D or use Ceprolen-D in the eye.
Apply 4 drops of Ceprolen-D into the affected ear 2 times a day for 7 days.
Do not stop using Ceprolen-D unless your doctor tells you to, even if your symptoms improve.
If your symptoms do not improve after 7 days of treatment with Ceprolen-D, call your doctor.
Call your doctor right away if:
you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with Ceprolen-D
you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with Ceprolen-D
What are the possible side effects of Ceprolen-D?
Ceprolen-D may cause serious side effects, including:
allergic reactions. Stop using Ceprolen-D and call your doctor if you have any of the following signs or symptoms of an allergic reaction:
hives (urticaria)
swelling of your face, lips, mouth, or tongue
rash
itching
trouble breathing
dizziness, fast heartbeat, or pounding in your chest
The most common side effects of Ceprolen-D include:
ear discomfort
ear pain
ear itching (pruritus)
These are not all the possible side effects of Ceprolen-D. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Ceprolen-D?
Store Ceprolen-D at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze Ceprolen-D.
Keep Ceprolen-D out of light.
Keep Ceprolen-D and all medicines out of the reach of children.
General information about the safe and effective use of Ceprolen-D.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ceprolen-D for a condition for which it was not prescribed. Do not give Ceprolen-D to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Ceprolen-D that is written for health professionals.
What are the ingredients in Ceprolen-D?
Active ingredients: Ceprolen-D hydrochloride, dexamethasone, and benzalkonium chloride as a preservative
Inactive ingredients: boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH
Distributed by:

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Ceprolen-D® is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property GmbH


©2003, 2004, 2008, 2009, 2012, 2015 Novartis

U.S. Pat.: www.alconpatents.com

For more information, call 1-800-757-9785.

Instructions for Use

Ceprolen-D (CI-PRO-DEX)

(ciprofloxacin and dexamethasone)

otic suspension

Read this Instructions for Use that comes with Ceprolen-D before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
Important information about Ceprolen-D :
Use Ceprolen-D exactly as your doctor tells you to use it.
Ceprolen-D is for use in the ear only (otic use). Do not inject Ceprolen-D or use Ceprolen-D in the eye.
Shake Ceprolen-D well before each use .
Do not touch your ear, fingers or other surfaces with the tip of the Ceprolen-D bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection.
How should I use Ceprolen-D?
Step 1. Wash your hands with soap and water.

Figure A

Step 2. Warm the bottle of Ceprolen-D by rolling the bottle between your hands for 1 to 2 minutes. Shake the bottle of Ceprolen-D well.
Step 3. Remove the Ceprolen-D cap. Put the cap in a clean and dry area. Do not let the tip of the bottle touch your ear, fingers or other surfaces.

Figure B

Step 4. Lie down on your side so that the affected ear faces upward.

Figure C

Step 5. Hold the bottle of Ceprolen-D between your thumb and index finger (See Figure C). Place the tip of the bottle close to your ear. Be careful not to touch your fingers or ear with the tip of the bottle.
Step 6. Gently squeeze the bottle and let 4 drops of Ceprolen-D fall into the affected ear. If a drop misses your ear, follow the instructions in Step 5 again.
Step 7. Stay on your side with the affected ear facing upward
It is important that you follow the instructions below for your specific ear infection, to allow Ceprolen-D to enter the affected part of your ear.
Step 8 .
If you use Ceprolen-D to treat a middle ear infection and you have a tube in your eardrum known as a tympanostomy :
Gently press the part of the ear known as the tragus 5 times using a pumping motion (See Figure D). This will allow the drops of Ceprolen-D to enter your middle ear.
Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure D

If you use Ceprolen-D to treat an outer ear canal infection:
Gently pull the outer ear lobe upward and backward (See Figure E). This will allow the drops of Ceprolen-D to enter your ear canal.
Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure E

Step 9. If your doctor has told you to use Ceprolen-D in both ears, repeat steps 5-8 for your other ear.
Step 10. Put the cap back on the bottle and close it tightly.
Step 11. After you have used all of your Ceprolen-D doses, there may be some Ceprolen-D left in the bottle. Throw the bottle away.
How should I store Ceprolen-D?
Store Ceprolen-D at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C).
Do not freeze Ceprolen-D.
Keep Ceprolen-D out of light.
Keep Ceprolen-D and all medicines out of the reach of children.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about Ceprolen-D that is written for health professionals.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by:

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

U.S. Pat.: www.alconpatents.com
Ceprolen-D® is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property GmbH.
©2003, 2004, 2008, 2009, 2015 Novartis
Revised: December 2015

9012314-1115

Ceprolen-D 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.


Ceprolen-D 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.


Ceprolen-D 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.


Ceprolen-D 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.


Ceprolen-D 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."DEXAMETHASONE TABLET [PHYSICIANS TOTAL CARE, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."DEXAMETHASONE: 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).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ceprolen-D?

Depending on the reaction of the Ceprolen-D after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ceprolen-D 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 Ceprolen-D 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 Ceprolen-D, 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 Ceprolen-D 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.

Visitor reports

One visitor reported useful

How is the drug Ceprolen-D useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Useful1
100.0%

Visitor reported side effects

No survey data has been collected yet

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Ceprolen-D is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Not expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Ceprolen-D drug as prescribed by the doctor?

Few medications can be taken 3 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Ceprolen-D is mentioned below.
Visitors%
3 times in a day1
100.0%

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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

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