Oroflox L Side effects

• Side effects of Oroflox L in details
• Oroflox L contraindications
• Oroflox L reviews

What are the possible side effects of Oroflox L?

Get emergency medical help if you have any of these signs of an allergic reaction: hives, or the first sign of a skin rash; rapid heart rate, difficult breathing; swelling of your face, lips, tongue, or throat.

Oroflox L may cause swelling or tearing of (rupture) a tendon. Oroflox L can also have serious effects on your nerves, and may cause permanent nerve damage. Stop taking this medicine and call your doctor at once if you have:

• signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions); or

• nerve symptoms--numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position.

Stop using Oroflox L and call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• muscle weakness or trouble breathing;

• diarrhea that is watery or bloody;

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding;

• depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;

• severe eye redness, small white or yellow patches on the surface of your eye;

• seizure (convulsions); or

• increased pressure inside the skull-- severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

• constipation, mild diarrhea;

• mild dizziness; or

• mild headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Oroflox L in details

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

• Tendon Effects
• Exacerbation of Myasthenia Gravis
• Hypersensitivity Reactions
• Other Serious and Sometimes Fatal Reactions
• Hepatotoxicity
• Central Nervous System Effects
• Clostridium difficile-Associated Diarrhea
• Peripheral Neuropathy that may be irreversible
• Prolongation of the QT Interval
• Musculoskeletal Disorders in Pediatric Patients
• Blood Glucose Disturbances
• Photosensitivity/Phototoxicity [see
• Development of Drug Resistant Bacteria

Hypotension has been associated with rapid or bolus intravenous infusion of Oroflox L. Oroflox L should be infused slowly over 60 to 90 minutes, depending on dosage.

Crystalluria and cylindruria have been reported with quinolones, including Oroflox L. Therefore, adequate hydration of patients receiving Oroflox L should be maintained to prevent the formation of a highly concentrated urine.

Clinical Trial 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Oroflox L in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Oroflox L for a wide variety of infectious diseases. Patients received Oroflox L doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving Oroflox L doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Oroflox L due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).

Adverse reactions occurring in ≥1% of Oroflox L-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Oroflox L-treated patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including Oroflox L. The relationship of the drugs to these events is not presently established.

Postmarketing Experience

Table 8 lists adverse reactions that have been identified during post-approval use of Oroflox L. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

What is the most important information I should know about Oroflox L?

• Oroflox L drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Oroflox L drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Be sure to use Oroflox L drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Oroflox L drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once.
• Diabetes patients - Oroflox L drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Oroflox L drops should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oroflox L drops while you are pregnant. Oroflox L drops is found in breast milk. If you are or will be breast-feeding while you take Oroflox L drops, check with your doctor. Discuss any possible risks to your baby.

Oroflox L contraindications

Patients hypersensitive to Oroflox L or any other quinolones or any excipients of Oroflox L. Patients with epilepsy and those with history of tendon disorder related to fluoroquinolone administration.

Use in pregnancy: Oroflox L caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day. It was not teratogenic in rats at oral doses as high as 810 mg/kg/day or at IV dose up to 160 mg/kg/day. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day.

In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Oroflox L must not be used in pregnant women or women suspected of being pregnant.

Use in lactation: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Oroflox L must not be used in breastfeeding women.

Use in children: Safety and effectiveness in pediatric patients and adolescents <16 years have not been established. Quinolones, including Oroflox L, cause arthropathy and osteochondrosis in juvenile animals of several species.

Use in

Elderly: The pharmacokinetic properties of Oroflox L in younger adults and elderly do not differ significantly when creatinine clearance is taken into consideration. However, since Oroflox L is known to be substantially excreted by the kidney, the risk of toxic reactions to Oroflox L 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.

References

1. DailyMed. "LEVOFLOXACIN: 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/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "LEVOFLOXACIN: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Oroflox L are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Oroflox L. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology