Cpnhelp.org

 horses- Levaquin does not "kill all," nor does any single antibiotic (protein synthase inhibitor). It inhibits replication and kills some, some but not all of the replicating form of Cpni called RB's, but the organism survives by converting to cryptic non-metabolizing form. And, Levaquin has no, absolutely no effect on EBi's which are the infectious spore-like form of Cpn. Take a look through the Getting Started tab at the top of the page as it will explain this.

CAPi for Cpn 11/04. Dx: 25yrs CFSi & FMSi. Protocol: 200mg Doxyi, 300mg Roxithromycin, Tinii 1000mg/day pulses; Vit D1000 units, Iodoral 50mg, T4 & T3

___________________________________________________________

 

CAPi for Cpni 11/04. Dx: 25yrs CFSi & FMSi. Currently: 150mg BID Roxithromycin, Doxycycline 100mg BID, Tinii 1000mg/day pulses; Vit D2000 units, T4 & T3

Horses, Some antibioticsi have more proven track records for safety, especially the long term use that these CAPs suggest. 

I found the following on a search.   

Levaquin

Warnings & Precautions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including LEVAQUIN®. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. LEVAQUIN® should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated [see ADVERSE REACTIONS; Patient Counseling Information].

Other Serious and Sometimes Fatal Reactions

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including LEVAQUIN®. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);

vasculitisi; arthralgia; myalgia; serum sickness;

allergic pneumonitis;

interstitial nephritis; acute renal insufficiency or failure;

hepatitis; jaundice; acute hepatic necrosisi or failure;

anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see ADVERSE REACTIONS; Patient Counseling Information].

Tendon Effects

Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN®. Postmarketing surveillance reports indicate that this risk is increased in patients receiving concomitant corticosteroids, especially the elderly. LEVAQUIN® should be discontinued if the patient experiences pain, inflammationi, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including LEVAQUIN® [see ADVERSE REACTIONS; Patient Counseling Information].

Central Nervous System Effects

Convulsions and toxic psychoses have been reported in patients receiving quinolones, including LEVAQUIN®. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving LEVAQUIN®, the drug should be discontinued and appropriate measures instituted. As with other quinolones, LEVAQUIN® should be used with caution in patients with a known or suspected central nervous system (CNSi) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction.) [see ADVERSE REACTIONS; DRUG INTERACTIONS; Patient Counseling Information].

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LEVAQUIN®, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infectionsi can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see ADVERSE REACTIONS, Patient Counseling Information].

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including LEVAQUIN®. LEVAQUIN® should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition [see ADVERSE REACTIONS, Patient Counseling Information].

Prolongation of the QT Interval

Some quinolones, including LEVAQUIN®, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving quinolones, including LEVAQUIN®. LEVAQUIN® should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval [see ADVERSE REACTIONS, Use in Specific Populations, and Patient Counseling Information].

Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

LEVAQUIN® is not indicated for pediatric patients (less than 18 years of age). An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving LEVAQUIN® [see Use in Specific Populations].

In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species [see Nonclinical Toxicology].

Blood Glucose Disturbances

As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with LEVAQUIN®, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with LEVAQUIN®, LEVAQUIN® should be discontinued and appropriate therapy should be initiated immediately [see ADVERSE REACTIONS; DRUG INTERACTIONS; Patient Counseling Information].

Phototoxicity

Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight while receiving drugs in this class. Excessive exposure to sunlight should be avoided. However, in clinical trials with LEVAQUIN®, phototoxicity has been observed in less than 0.1% of patients. Therapy should be discontinued if phototoxicity (e.g., a skin eruption) occurs [see ADVERSE REACTIONS; Patient Counseling Information].

Development of Drug Resistant Bacteria

Prescribing LEVAQUIN® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Patient Counseling Information].

Patient Counseling Information

See FDA-Approved Patient Labeling

Antibacterial Resistance

Antibacterial drugs including LEVAQUIN® should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When LEVAQUIN® is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by LEVAQUIN® or other antibacterial drugs in the future.

Administration with Food, Fluids, and Concomitant Medications

Patients should be informed that LEVAQUIN® Tablets may be taken with or without food. LEVAQUIN® Oral Solution should be taken 1 hour before or 2 hours after eating. The tablet and oral solution should be taken at the same time each day.

Patients should drink fluids liberally while taking LEVAQUIN® to avoid formation of a highly concentrated urine and crystal formation in the urine.

Antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or two hours after oral LEVAQUIN® administration.

Serious and Potentially Serious Adverse Reactions

Patients should be informed of the following serious adverse reactions that have been associated with LEVAQUIN® or other quinolone use:

Hypersensitivity Reactions: Patients should be informed that LEVAQUIN® can cause hypersensitivity reactions, even following the first dose. Patients should discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.

Tendon Disorders: Patients should discontinue LEVAQUIN® treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. The risk of serious tendon disorders is higher in those over 65 years of age, especially those on corticosteroids.

Convulsions: Convulsions have been reported in patients taking quinolones, including LEVAQUIN®. Patients should notify their physician before taking this drug if they have a history of convulsions.

Neurologic Adverse Effects (e.g., dizziness, lightheadedness): Patients should know how they react to LEVAQUIN® before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination.

Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Peripheral Neuropathies: If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, patients should discontinue treatment and contact their physician.

Prolongation of the QT Interval: Patients should inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. Patients should notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.

Phototoxicity: Patients should be advised to avoid excessive sunlight or artificial ultraviolet light while receiving LEVAQUIN® and to discontinue therapy if phototoxicity (i.e., skin eruption) occurs.

Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin

Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue LEVAQUIN® and consult a physician.

Patients should be informed that concurrent administration of warfarin and LEVAQUIN® has been associated with increases of the International Normalized Ratio (INR) or prothrombin time and clinical episodes of bleeding. Patients should notify their physician if they are taking warfarin, be monitored for evidence of bleeding, and also have their anticoagulation tests closely monitored while taking warfarin concomitantly.

Nonclinical Toxicology

Carcinogenesis Mutagenesis, Impairment of Fertility

In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day) was 1.4 times the highest recommended human dose (750 mg) based upon relative body surface area. Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study. Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 µg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. By comparison, dermal levofloxacin concentrations in human subjects receiving 750 mg of LEVAQUIN® averaged approximately 11.8 µg/g at Cmax.

Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and sister chromatid exchange (CHL/IU cell line) assays.

Levofloxacin caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day, corresponding to 4.2 times the highest recommended human dose based upon relative body surface area and intravenous doses as high as 100 mg/kg/day, corresponding to 1.2 times the highest recommended human dose based upon relative body surface area.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to 1.9 times the highest recommended human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area, or when dosed intravenously as high as 25 mg/kg/day, corresponding to 0.5 times the highest recommended human dose based upon relative body surface area.

There are, however, no adequate and well-controlled studies in pregnant women. LEVAQUIN® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Based on data on other quinolones and very limited data on LEVAQUIN®, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from LEVAQUIN® 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.

Pediatric Use

LEVAQUIN® is not indicated for pediatric patients (less than 18 years of age) (See Warnings and PRECAUTIONS).

In clinical trials, 1534 children (6 months to 16 years of age) were treated with oral and intravenous LEVAQUIN®. Children 6 months to 5 years of age received LEVAQUIN® 10 mg/kg twice a day and children greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days.

A subset of children in the clinical trials (1340 LEVAQUIN®-treated and 893 non-fluoroquinolone-treated) enrolled in a prospective, long-term surveillance study to assess the incidence of protocol-defined musculoskeletal disorders (arthralgia, arthritis, tendonopathy, gait abnormality) during 60 days and 1 year following the first dose of study drug. Children treated with LEVAQUIN® had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in Table 8.

Table 8: Incidence of Musculoskeletal Disorders in Pediatric Clinical Trial

 

Follow-up Period LEVAQUIN®

N = 1340 Non-Fluoroquinolonea

N = 893 p-valueb

60 days 28 (2.1%) 8 (0.9%) p = 0.038

1 yearc 46 (3.4%) 16 (1.8%) p = 0.025

a Non-Fluoroquinolone: ceftriaxone, amoxicillini/ clavulanate, clarithromycin

b 2-sided Fisher's Exact Test

c There were 1199 LEVAQUIN®-treated and 804 non-fluoroquinolone-treated children who had a one-year evaluation visit. However, the incidence of musculoskeletal disorders were calculated using all reported events during the specified period for all children enrolled regardless of whether they completed the 1-year evaluation visit.

 

Arthralgia was the most frequently occurring musculoskeletal disorder in both treatment groups. Most of the musculoskeletal disorders in both groups involved multiple weight- bearing joints. Disorders were moderate in 8/46 (17%) children and mild in 35/46 (76%) LEVAQUIN®-treated children and most were treated with analgesics. The median time to resolution was 7 days for LEVAQUIN®-treated children and 9 for non-fluoroquinolone- treated children (approximately 80% resolved within 2 months in both groups). No child had a severe or serious disorder and all musculoskeletal disorders resolved without sequelae.

Vomiting and diarrhea were the most frequently reported adverse events, occurring in similar frequency in the LEVAQUIN®-treated and non-fluoroquinolone-treated children.

In addition to the events reported in pediatric patients in clinical trials, events reported in adults during clinical trials or post-marketing experience may also be expected to occur in pediatric patients.

Geriatric Use

In phase 3 clinical trials, 1,945 LEVAQUIN®-treated patients (26%) were ≥ 65 years of age. Of these, 1,081 patients (14%) were between the ages of 65 and 74 and 864 patients (12%) were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using LEVAQUIN® with concomitant drugs that can result in prolongation of the QT interval (e.g., class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia) [see Warnings and PRECAUTIONS].

Patients over 65 are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as LEVAQUIN®. This risk is further increased with concomitant steroid therapy. Tendon rupture usually involves the Achilles, hand or shoulder tendons and can occur during therapy or up to a few months post completion of therapy. Caution should be used when prescribing LEVAQUIN® to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue therapy and inform their physicians if any tendon symptoms occur [see Warnings and PRECAUTIONS].

The pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration. However, since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug 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 [see CLINICAL PHARMACOLOGY].

Renal Impairment

Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance < 50 mL/min), requiring dosage adjustment in such patients to avoid accumulation. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of LEVAQUIN® are not required following hemodialysis or CAPD [see DOSAGE AND ADMINISTRATION].

Hepatic Impairment

Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment

Louise

CFSi/ME.CPnPositive.BbPositive.WheldonCAPbegan6/24/07. NowNAC,Doxyi, Roxi, Full TiniPulses. Cholestyramine at BedtimeforPhorphoria&liposacarideEndotoxinDie-OffExperiences.

___________________________________________________________

Louise  CFSi,CPNi+/Bb+(Lyme) Cholestyramine 1-2 pks @ HS for Porphyriai +fattyEndotoxins HS PRN, Wheldon CAPi 6/07,all supps, Doxyi 200QD, Roxi 300BID, Tinidazole 500 BIDx20day Pulses, VitD3-10,000IU,Iodoral25mg,SAM-e100mgQD+B-vits, Pyruvate3.75Gm at 1PM

yoi! well, that is quite the laundry list of "side effects".  Now I know why jeanneroz wont ever take that again!

CFIDSi/ME 26yrs, FMSi, IBSi, EBVi, CMV, Cpni, chronic insomnia, Lymes, HME, Natural HRT peri-M, NACi 2.5 gm, 6-07 Doxy 200 mg day pm, Azith 375 mg M/W/Fday, Pulse#9 750mg 5.5 day, 4-25-8

___________________________________________________________

CFIDSi/ME 32 yrs, FMSi, IBSi, EBVi, CMV, Cpni, H1, chronic insomnia, Lymes, HME, Natural HRT peri-M, NAC 3 gm, Full CAP 6-2-08, all supplementsi +Sea Kelp, Chitosan Pulse 16 1-4-09 1gm Flagyli/day-3 days

  jimk- YIKES!!!                                                                                                        I can't thank you enough for your information. my doctor insisteed on Levaquin and after looking through Getting Started tab I have prined the infor. to give to my doc.   I'm so tired of dealing with doctors who think they know it all and feeling horrible all the time.  I have started the vitamin protocol and NACi maybe this is adding to my feeling like the flu.  Thanks again for pointing me back to the correct protocol.     Bonnie

___________________________________________________________

started Wheldon capi 4/21/08 for Cpni, CMV, EBVi, CFSi. Currently on: all supplementsi,Doxy200, added Azith.250mgs M/W/F on 6/30/08. Naci up to 1200mgs.as tol.Vit.B12 injections daily, cholest. prn. Start Tinii. in Jan. if all goes well.