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DRUGS & SUPPLEMENTS
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How is the drug helping you? |
Cyprin-D is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Cyprin-D is a combination of Cyprin-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:
Cyprin-D is for topical use only, and not for ophthalmic use, or for injection.
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:
Otic Suspension: Each mL of Cyprin-D contains Cyprin-D hydrochloride 0.3 % (equivalent to 3 mg Cyprin-D base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone.
Otic Suspension: Each mL of Cyprin-D contains Cyprin-D hydrochloride 0.3 % (equivalent to 3 mg Cyprin-D base) and dexamethasone 0.1 % (equivalent to 1 mg dexamethasone). (3)
Cyprin-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.
Prolonged use of Cyprin-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.
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.
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.
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 Cyprin-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) |
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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) |
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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).
The following adverse reactions have been identified during post approval use of Cyprin-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.
Teratogenic Effects. Pregnancy Category C:
No adequate and well controlled studies with Cyprin-D have been performed in pregnant women. Caution should be exercised when Cyprin-D is used by a pregnant woman.
Animal reproduction studies have not been conducted with Cyprin-D.
Reproduction studies with Cyprin-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, Cyprin-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.
Cyprin-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 Cyprin-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.
The safety and efficacy of Cyprin-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 Cyprin-D and tested for audiometric parameters.
Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.
Cyprin-D (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the quinolone antimicrobial, Cyprin-D hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of Cyprin-D contains Cyprin-D hydrochloride (equivalent to 3 mg Cyprin-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.
Cyprin-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:
Cyprin-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.
Following a single bilateral 4-drop (total dose = 0.28 mL, 0.84 mg Cyprin-D, 0.28 mg dexamethasone) topical otic dose of Cyprin-D to pediatric patients after tympanostomy tube insertion, measurable plasma concentrations of Cyprin-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 Cyprin-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 Cyprin-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).
Mechanism of Action
The bactericidal action of Cyprin-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 Cyprin-D and other fluoroquinolones. There is generally no cross-resistance between Cyprin-D and other classes of antibacterial agents such as beta-lactams or aminoglycosides.
Antimicrobial Activity
Cyprin-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
Long-term carcinogenicity studies in mice and rats have been completed for Cyprin-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 Cyprin-D had any carcinogenic or tumorigenic effects in these species. No long term studies of Cyprin-D have been performed to evaluate carcinogenic potential.
Eight in vitro mutagenicity tests have been conducted with Cyprin-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 Cyprin-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 Cyprin-D based upon body surface area, assuming total absorption of Cyprin-D from the ear of a patient treated with Cyprin-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.
Guinea pigs dosed in the middle ear with Cyprin-D for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles.
In a randomized, multicenter, controlled clinical trial, Cyprin-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 Cyprin-D compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for Cyprin-D compared to 82% for ofloxacin solution, 0.3%.
In 2 randomized multicenter, controlled clinical trials, Cyprin-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 Cyprin-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 Cyprin-D compared to 85% and 85%, respectively, for neo/poly/HC.
How Supplied:
Cyprin-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).
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Avoid freezing. Protect from light.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
Advise patients that Cyprin-D is for otic use only. This product is not approved for use in the eye.
Patients should be instructed to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using.
Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs.
Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources.
Advise patients that it is very important to use the ear drops for as long as their doctor has instructed, even if the symptoms improve.
Advise patients to protect the product from light.
Advise patients to discard unused portion after therapy is completed.
PATIENT INFORMATION Cyprin-D (CI-PRO-DEX) (ciprofloxacin and dexamethasone) otic suspension | ||||
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This Patient Information has been approved by the U.S. Food and Drug Administration | ||||
Revised: December 2015 | ||||
What is Cyprin-D? | ||||
Cyprin-D is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called Cyprin-D and a corticosteroid medicine called dexamethasone. Cyprin-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 Cyprin-D is safe and effective in children under 6 months of age. | ||||
Who should not use Cyprin-D? | ||||
Do not use Cyprin-D if you: | ||||
● | are allergic to ciprofloxin, quinolones, or any of the ingredients in Cyprin-D. See the end of this Patient Information leaflet for a complete list of ingredients in Cyprin-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 Cyprin-D? | ||||
Before using Cyprin-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 Cyprin-D will harm your unborn baby. | |||
● | are breastfeeding or plan to breastfeed. Cyprin-D can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use Cyprin-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 Cyprin-D? | ||||
● | Read the detailed Instructions for Use that come with Cyprin-D. | |||
● | Use Cyprin-D exactly as your doctor tells you to. | |||
● | Cyprin-D is for use in the ear only (otic use). Do not inject Cyprin-D or use Cyprin-D in the eye. | |||
● | Apply 4 drops of Cyprin-D into the affected ear 2 times a day for 7 days. | |||
● | Do not stop using Cyprin-D unless your doctor tells you to, even if your symptoms improve. | |||
If your symptoms do not improve after 7 days of treatment with Cyprin-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 Cyprin-D | |||
○ | you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with Cyprin-D | |||
What are the possible side effects of Cyprin-D? | ||||
Cyprin-D may cause serious side effects, including: | ||||
● | allergic reactions. Stop using Cyprin-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 Cyprin-D include: | ||||
● | ear discomfort | |||
● | ear pain | |||
● | ear itching (pruritus) | |||
These are not all the possible side effects of Cyprin-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 Cyprin-D? | ||||
● | Store Cyprin-D at room temperature between 68°F to 77°F (20°C to 25°C). | |||
● | Do not freeze Cyprin-D. | |||
● | Keep Cyprin-D out of light. | |||
Keep Cyprin-D and all medicines out of the reach of children. | ||||
General information about the safe and effective use of Cyprin-D. | ||||
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Cyprin-D for a condition for which it was not prescribed. Do not give Cyprin-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 Cyprin-D that is written for health professionals. | ||||
What are the ingredients in Cyprin-D? | ||||
Active ingredients: Cyprin-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 Cyprin-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 Cyprin-D (CI-PRO-DEX) (ciprofloxacin and dexamethasone) otic suspension | ||||
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Read this Instructions for Use that comes with Cyprin-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 Cyprin-D : | ||||
● | Use Cyprin-D exactly as your doctor tells you to use it. | |||
● | Cyprin-D is for use in the ear only (otic use). Do not inject Cyprin-D or use Cyprin-D in the eye. | |||
● | Shake Cyprin-D well before each use . | |||
● | Do not touch your ear, fingers or other surfaces with the tip of the Cyprin-D bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection. | |||
How should I use Cyprin-D? | ||||
Step 1. Wash your hands with soap and water. | ||||
Figure A | ||||
Step 2. Warm the bottle of Cyprin-D by rolling the bottle between your hands for 1 to 2 minutes. Shake the bottle of Cyprin-D well. | ||||
Step 3. Remove the Cyprin-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 Cyprin-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 Cyprin-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 Cyprin-D to enter the affected part of your ear. | ||||
Step 8 . | ||||
If you use Cyprin-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 Cyprin-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 Cyprin-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 Cyprin-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 Cyprin-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 Cyprin-D doses, there may be some Cyprin-D left in the bottle. Throw the bottle away. | ||||
How should I store Cyprin-D? | ||||
● | Store Cyprin-D at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C). | |||
● | Do not freeze Cyprin-D. | |||
● | Keep Cyprin-D out of light. | |||
Keep Cyprin-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 Cyprin-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 | ||||
Cyprin-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
Depending on the reaction of the Cyprin-D after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cyprin-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 Cyprin-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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The information was verified by Dr. Rachana Salvi, MD Pharmacology