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FDA Facts About Generics

A generic drug is the same as a brand-name drug in: dosage, safety, strength, quality, the way it works, the way it is taken, the way it should be used US FDA Office

Ciprofloxacin

Drug Name: Generic Baycip (Ciprofloxacin equivalent)

Generic Baycip Ciprofloxacin is an antibiotic in a group of drugs called fluoroquinolones. Ciprofloxacin fights bacteria in the body. Tinidazole is used to treat certain intestinal infections, liver infections and sexually transmitted diseases.

Drug Uses:
Ciprofloxacin or Bycip is an antibiotic in a group of drugs called fluoroquinolones. Ciprofloxacin fights bacteria in the body. 

Drug Class Mechanism:
Baycip or Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. Ciprofloxacin inhibits bacterial DNA gyrase, an enzyme responsible for counteracting excessive supercoiling of DNA during replication or transcription."

Therapeutic indications:

Treatment of infections susceptible to ciprofloxacin, such as:

- Lower respiratory tract infections (acute exacerbation of chronic bronchitis, pneumonia with Gram-negative streptococci);

- Osteo-articular infections;

- Complicated and uncomplicated urinary tract;

- Gonococcal infections, endocervical and urethral;

- Prostatitis;

- Gastroenteritis;

- Skin and soft tissue infections;

- Typhoid fever;

- Şancru soft.

Contraindications:
Hypersensitivity to ciprofloxacin, the quinolone or other chemotherapy in any of the excipients; tendinopathy caused by fluoroquinolones in previous history.

Precautions:
Ciprofloxacin should be administered with caution in patients with severe stroke and cerebrovascular disease in history. Use of ciprofloxacin can cause crystalluria, if urine is alkaline. Therefore it is necessary to adequate hydration and urine alkalinization avoid. During treatment with ciprofloxacin tendinitis may occur rarely, which may progress to tendon rupture, particularly of the achilian. Signs of tendinitis requires discontinuation of the product and establish appropriate treatment. During therapy, because of the risk of photosensitivity should avoid exposure to sunlight or ultraviolet radiation. Especially during prolonged therapy and / or nosocomial infections can select resistant strains, especially among Staphylococcus and Pseudomonas. Ciprofloxacin should be administered with caution in patients with myasthenia gravis in patients with a history of seizures or the presence of factors that predispose to seizures.

Interaction:
In combination with ciprofloxacin, theophylline concentrations increase, with risk of overdose. As with other fluoroquinolones ciprofloxacin may increase the effects of oral anticoagulants, the risk of bleeding. Are required periodic determination of prothrombin concentration and dose adjustment of oral anticoagulant during concomitant after stopping treatment with ciprofloxacin.  Ciprofloxacin increases serum levels of caffeine, by decreasing its metabolism liver..

Special warnings:

Children:
Because it was observed that fluoroquinolones produce degenerative changes (arthropathy) in the joints of young animals generally not be administered to children. Ciprofloxacin can be administered to children only in exceptional cases of serious infections with bacteria resistant to other antibiotics.

Pregnancy and lactation:
In preclinical studies in animals have not revealed teratogenic effects. Since there were adequate and well controlled studies in pregnant women, during pregnancy only if the product should be given the benefit justifies the potential risk to the fetus. Because ciprofloxacin is excreted in breast milk in lactating women administered only if absolutely necessary in this case is interrupting breastfeeding.

The ability to drive or operate machinery:
Drivers of vehicles or those operating machinery should be warned of the potential risk of neuropsychiatric events.

Dosage and Administration: 

Adults:
In case of osteo-articular infections, bacterial pneumonia with Gram-negative infections, skin or soft tissue, the dose is 2-3 tablets (500-750 mg ciprofloxacin) every 12 hours for 7-14 days . Severe or complicated infections may require extended treatment. If the bone infection may be necessary to administer the product for 4-6 weeks or more. The bacterial gastroenteritis is given by 2 tablets (500 mg ciprofloxacin) every 12 hours for 5-7 days. If gonococcal infection, endocervical or urethral dose is one tablet (250 mg ciprofloxacin) in a single dose. In typhoid fever is given by 2 tablets (500 mg ciprofloxacin) every 12 hours for 10 days. In urinary tract infections dose is 1-2 tablets (250-500 mg ciprofloxacin) every 12 hours for 7-14 days. In case of severe or complicated infections may require extended therapy.

Children up to 18 years:
Because ciprofloxacin cause arthropathy in immature animals in general not be used in children and adolescents up to 18 years. However, ciprofloxacin can be administered to children in doses of 10-20 mg / kg every 12 hours if absolutely necessary (serious infections unresponsive to other drugs or if other can not be used).

Adverse Reactions: 

- Pathological digestive: epygastralgia, abdominal pain, anorexia, nausea, vomiting, diarrhea, flatulence;

- Skin reactions: rash erythematous, maculopapular, rarely photosensitivity, purpura vascular rarely erythema multiforme, Stevens-Johnson syndrome, Lyell;

- Pathological conditions of muscles, joints, bones and connective tissue disorders: myalgia and / or arthralgia, tendinitis rarely achiliană especially likely to occur within 48 hours after beginning treatment and may become bilateral, rarely tendon rupture;

- Neurological and psychiatric pathological conditions: convulsions, confusion, hallucinations, headache, fatigue, blurred vision, insomnia, feeling ebrioasă, paresthesia, intracranial hypertension, possibly worsening myasthenia gravis;

- Pathological kidney: the elderly have been reported cases of reversible acute renal failure in nephropathy tubulointerstiţială;

- Allergic reactions: urticaria, Quincke edema and rarely anaphylaxis;

- Pathological liver: rarely elevated transaminases, bilirubin, alkaline phosphatase, rarely hepatitis.

Overdose:
In case of voluntary ingestion of very high doses have reported reversible acute renal failure. Unabsorbed drug should be removed by gastric lavage or emesis. Clinical supervision are necessary, symptomatic and supportive, also adequate hydration to reduce risk crystalluria. In addition to these measures of renal function monitoring is recommended. Less than 10% of the dose can be removed by hemodialysis and peritoneal dialysis.

Storage:
Do not use after expiry date stated on the packaging. Do not store above 25 º C in original packaging. Keep ciprofloxacin away from children. 

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