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TARO-CIPROFLOXACIN/DEXAMETHASONE is a brand name for Ciprofloxacin, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE.............................................................................. 3 CONTRAINDICATIONS................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In Phase II and III clinical trials, a total of 537 patients with acute otitis externa patients were treated with ciprofloxacin/ dexamethasone otic suspension.
4% or more of the patients with intact tympanic membranes. 4% The following treatment-related adverse events were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling). Post-Market Adverse Drug Reactions Adverse reactions identified from subsequent clinical trials are listed below.
Ear and labyrinth disorders: ear infection fungal, otorrhea; Gastrointestinal disorders: vomiting; General disorders and administration site conditions: device occlusion; Nervous system disorders: headache; Skin and subcutaneous tissue disorders: skin exfoliation.
Adverse reactions identified via spontaneous reporting are listed below. Ear and labyrinth disorders: auricular swelling; Immune system disorders: hypersensitivity. Page 8 of
Taro-Ciprofloxacin / Dexamethasone is contraindicated in patients with: Hypersensitivity to ciprofloxacin, dexamethasone or to any ingredient in the formulation or component of the container. For a complete listing, see Dosage Forms, Composition and Packaging section.
Hypersensitivity to other quinolones, including nalidixic acid. Hypersensitivity to other corticosteroids. Viral infections of the external canal, including herpes simplex infections. Fungal otic infections. Parasitic otic infections.
WARNINGS AND PRECAUTIONS FOR TOPICAL OTIC USE ONLY. NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. General Ciprofloxacin/dexamethasone otic suspension 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, urticarial and itching.
Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. Corticosteroids may reduce resistance to and aid in the establishment of non-susceptible bacterial, fungal, parasitic or viral infections and mask the clinical signs of infection.
If the infection is not improved after one week of treatment, alternate therapy should be considered. If otorrhea persists after a full course of therapy, or if 2 or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition, such as cholesteatoma, foreign body, or a tumor.
The systemic administration of quinolones, including ciprofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight- Page 5 of 20 bearing joints and other signs of arthropathy in immature animals of various species.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ciprofloxacin in Canada.
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Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy, including ciprofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore, treatment with ciprofloxacin/dexamethasone otic suspension should be discontinued at the first sign of tendon inflammation.
8% in the ciprofloxacin/dexamethasone otic suspension treatment group in the clinical trials. Taro-Ciprofloxacin / Dexamethasone contains the preservative benzalkonium chloride, which may be an irritant and cause skin reactions. Sexual Function/Reproduction Studies have not been performed to evaluate the effect of topical administration of the combination of ciprofloxacin and dexamethasone on human fertility.
Topical dermal studies in animals have shown effects on male sex organs following long-term use of dexamethasone at high doses (see TOXICOLOGY, Reproduction & Teratology).
Special Populations Pregnant Women:
Reproduction studies 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 as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) 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 20mg/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. The teratogenic potential of dexamethasone after topical (ophthalmic) treatment has been investigated in New Zealand white rabbits.
3% incidence of fetal anomalies in two groups of rabbits. Animal reproduction studies have not been conducted with ciprofloxacin/dexamethasone otic suspension. No adequate and well controlled studies have been performed in pregnant women.
Prolonged or repeated systemic corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Caution should be exercised when ciprofloxacin/dexamethasone otic suspension is used by a pregnant woman.
Page 6 of 20 Nursing Women:
Ciprofloxacin 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 ciprofloxacin 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 and the low dose used in topical otic therapy.
Pediatrics (< 6 months of age):
The safety and effectiveness of ciprofloxacin/ dexamethasone otic suspension have not been established in pediatric patients < 6 months of age.
Pediatrics (≥ 6 months of age):
The safety and efficacy of ciprofloxacin/dexamethasone otic suspension have been established in pediatric patients 6 months and older (937 patients) in clinical trials. No clinically relevant changes in hearing function were […]