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ACTIFLOX – 200 Tablet

Justeen Pharm
197, Muyibi Street, Olodi-Apapa, Lagos. 57B, Coker Road, Ilupeju, Lagos
Tel: 234-80-34731163, 234-1-7765232

Brand Name

ACTIFLOX – 200 Tablet

Manufacturer

Saga Laboratories Ltd. Survey No. 198/2 & 198/3, Chachrawadi Vasna., Ta. Sanand, Dist. Ahmedabad 382210, India.

Therapeutic Class

Antibacterial, Quinolones

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN:     ): Each film coated tablet contains Sparfloxacin 200 mg. Colour: Yellow oxide of iron.

Pack size: Pack of 1x10 Tablets.

Actiflox 200

Pharmacology

THERAPEUTIC CATEGORY: Quinolone antibiotic

Sparfloxacin is a fluoroquinonolone antibacterial agent with activity against a broad range of gram negative and gram positive organisms including streptococcus pneumonia. It prevents bacterial growth primarily by inhibiting the action of DNA gyrase. Sparfloxacin is reported to be more active in vitro than ciprofloxacin against mycobacteria and against Gram-positive bacteria, including streptococcus pneumonia and other streptococci.

Sparfloxacin is well absorbed from the gastrointestinal tract following oral administration with a reported bioavailability of about 90%. Peak plasma concentrations are achieved 3 to 6 hours after a dose. Sparfloxacin is widely distributed into body tissues and fluids, including respiratory tissue, but is only about 45% bound to plasma proteins. It is metabolized in the liver by glucuronidation and has an elimination half-life of about 20 hours. It is excreted in equal amounts in the faeces and urine as unchanged drug and as the glucoronide metabolite.

Indications

Sparfloxacin is indicated in:

1. Community – acquired pneumonia caused by Chlamydia pneumonia, Haemophilus influenza. Haemophilus parainfluenzae, Moraxella catarrhalis, mycoplasma pneumonia, or streptococcus pneumonia.

2. Acute Bacterial exacerbations of chronic bronchitis caused by Chlamydia pneumonia, Enterobacter colacea, Haemophilus influenza, Haemophilius parainfluenzae. Klebsiella pneumonia, Moraxella catarrhalis, staphylococcus aureus, or streptococcus pneumonia. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to sparfloxacin.

Therapy with sparfloxacin may be initiated before results of these rests are known; once results become available, appropriate therapy should be selected. Culture and susceptibility testing performed periodically during therapy will provide information on the continued susceptibility of the pathogen to the anti-microbial agents and also on the possible emergence of bacteria resistance.

Contra-indications

Sparfloxacin is contraindicated for individuals with a history of hypersensitivity or photosensitivity reactions. Infants, children and growing adolescents because of the risk of arthropathy, history of hypersensitivity reactions to it and other quinolones; history of photosensitivity reactions. Patients with known QT prolongation and in patients receiving drugs known to prolong the QT interval.

Precautions/Warnings

Adequate hydration of patients receiving sparfloxacin should be maintained to prevent the formation of highly concentrated urine.

Patients should be advised: - To avoid exposure to direct or indirect sunlight (including through glass, while using sunscreen and sun blocks, reflected sunlight and cloudy weather) and exposure to artificial ultraviolet light (e.g sunlamps) during treatment with sparfloxacin and for five days after therapy.

If brief exposure to the sun cannot be avoided, patients should cover as much of their skin as possible with clothing: -To discontinue sparfloxacin therapy at the first sign or symptom of photo-toxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching or dermatitis: - That a patient who has experienced a photo-toxic reaction with sparfloxacin should be advised to avoid further exposure to sunlight and artificial ultraviolet light until the photo-toxicity reaction has resolved and he or she has completely recovered from the reaction for five days whichever is longer.

In rare cases, reactions have occurred up to several weeks after stopping sparfloxacin therapy.

- That sparfloxacin may cause neurologic adverse effect (e.g. Dizziness, light-headedness) and that patients should know how they react to sparfloxacin before they operate an automobile or machine or engage in other activities requiring mental alertness and coordination.

- To discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of tendon, and to rest and refrain from exercise until the diagnoses, tendonitits, or tendon rupture has been confidently excluded.

- That sparfloxacin can be taken with food or milk or caffeine-containing products.

- That mineral supplemetns or vitamins with iron or zinc or calcium may be taken 4 hours after sparfloxacin administration.

- That sucralfate or magnesium and alluminium containing antacids may be taken 4 hours after sparfloxacin administration.

- That sparfloxacin may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.

- To drink fluids liberally.

WARNINGS:

Moderate to severe phototoxic reactions has occurred in patients exposed to direct or indirect sunlight or to artificial ultraviolet (e.g. sunlamps) during or following treatment.

These reactions have also occurred in patents exposed to shaded or diffuse light, including exposure through glass or during cloudy weather; patients should be advised to discontinue sparfloxacin therapy at the first signs or symptoms of a phot-toxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching or dermatitis.

Keep this and all medicines out of reach of children.

Interactions

As Sparfloxacin may prolong the QT interval, it should not be used with other drugs known to have this effect (such as the antihistamines and astemizole and terfenadine, cisapride, erythromycin, pentamidine, phenothiaznes, or tricyclic antidepressants). Sparfloxacin does not appear to interact with theophylline or caffeine, nor with warfarin or cimetidine. Probenecid does not alter the pharmacokinetics of sparfloxacin.

Because absorption of sparfloxacin is reduced by antacids containing Alluminium/Magnesium and also by ferrous sulphate and sucralfate, staggered drug administration is recommended. Cimetidine has no effect on Sparfloxacin disposition. Sucralfate reduces the bioavailability of Sparfloxacin whereas Cisapride accelerates absorption without affecting bioavailability.

Adverse Effects

GI disturbances (diarrhoae, nausea and vomiting) and CNS effects are more common. Insomnia and other sleep disorders are the more frequent CNS adverse events. There have been some reports of convulsions during Sparfloxacin therapy. Photosensitivity occurs more frequently than with other fluoroquinolones. Tendinitis or tendor rupture has been reported during Sparfloxacin therapy.

There are infrequent reports of prolonged QT interval. Concern over photo toxicity associated with sparfloxacin has led to restriction of its used in some countries; patients should be advised to avoid exposure to sunlight during and for a few days after sparfloxacin therapy and to discontinue the drug immediately if photo-toxicity occurs. Sparfloxacin may prolong the QT interval and various cardiac arrhythmias have been reported.

Dosage & Administration

Sparfloxacin is a fluroquinolone antibacterial with actions similar to ciprofloxacin. It is used in the treatment of community

– acquired pneumonia and acute bacterial exacerbations of chronic bronchitis including those caused by pneumonia.

- Lower respiratory tract infections: 400 mg as a single loading dose on first day followed by 200 mg once daily for 10 days.

- The long elimination half-life permits once daily dosage.

- Acute bacterial sinusitis: 400 mg as a single loading dose, followed by 200 mg once daily for 10 days.

- Sexually transmitted diseases.

- Gonococcal urethritis: Single dose of 200 mg followed by 100 mg daily for 10 days.

- Non-gonococcal urethritis: 200 mg loading dose, followed by 100 mg daily for 10 days.

- The usual adult dose in general infections: 400 mg on first day, followed by 200 mg daily for 10 days.

- Dose should be reduced in patients with renal impairment: 200 mg may be given on alternate days for maintenance.

OVERDOSAGE AND TREATMENT:

Clinical symptoms following overdosage include diarrhoea, nausea, vomiting as well as photosensitivity reactions.

TREATMENT:

In the event of overdosage, adequate hydration, haemodialysis or peritoneal dialysis is recommended.

Storage/Handling Recommendations

Store in a cool, dry and dark place. Protect from light.

Review Date

2015-11-03 05:22:22