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Flixocort

Fluticasone Propionate (Inhaler)

Inhaler 250 mcg/metered dose Allopathic Fluocinolone & Combined Preparations

Indications

Asthma

Indication detailsView

Fluticasone Propionate HFA is an inhaled corticosteroid (ICS) indicated for: Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Therapeutic classView

Fluocinolone & Combined Preparations, Respiratory corticosteroids

PharmacologyView

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown.

Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.

Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone propionate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (<1%), and the minimal pharmacological activity of the only metabolite detected in man.

DosageView

Adult and adolescent patients aged 12 Years and older: The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS) is 88 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The maximum recommended dosage for patients aged 12 years and older is 880 mcg twice daily.

Pediatric patients aged 4 to 11 years: The recommended dosage for patients aged 4 to 11 years is 88 mcg twice daily, approximately 12 hours apart.

AdministrationView

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

Take off the cap.
Shake the inhaler (at least six times) vigorously before each use.
If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
Breathe out as full as comfortably possible & hold the inhaler upright.
Place the actuator into mouth between the teeth and close lips around the mouthpiece.
While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Side effectsView

Most common adverse reactions (incidence >3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.

ContraindicationsView

The use of Fluticasone Propionate Inhaler is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients.

PrecautionsView

Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone propionate HFA.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone propionate HFA slowly.
Assess for decrease in bone mineral density initially and periodically thereafter.
Monitor growth of pediatric patients.
Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone propionate HFA long term.

InteractionsView

Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate HFA is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Pregnancy & lactationView

There are insufficient data on the use of Fluticasone propionate HFA in pregnant women. There are clinical considerations with the use of Fluticasone propionate HFA in pregnant women. There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk.

Pediatric usageView

Pediatric Use: The safety and effectiveness of Fluticasone Propionate Inhaler in children aged 4 years and older have been established

Overdose effectsView

Chronic overdosage may result in signs/symptoms of hypercorticism. Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

StorageView

Store at room temperature between 20°C and 25°C. Keep away from light & moisture. Keep out of the reach of children.

Flixonase

Fluticasone Propionate (Nasal Spray)

Nasal Spray 50 mcg/spray Allopathic Fluocinolone & Combined Preparations

Indications

Rhinitis

Indication detailsView

Fluticasone Propionate is indicated for-

The prophylaxis and treatment of seasonal allergic rhinitis including hay fever and perennial rhinitis.
It has potent anti-inflammatory activity on the nasal mucosa without detectable systemic activity.

Therapeutic classView

Fluocinolone & Combined Preparations, Nasal Steroid Preparations

PharmacologyView

Following topical administration into the nasal mucosa, Fluticasone propionate produces anti-inflammatory and vasoconstrictor effects. The exact mechanism of these actions remains unknown but may involve a reduction in the following: number of mediator cells (basophil, leukocytes and mast cells) at the epithelial level, number of eosinophils, the sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity. Other mechanisms may involve - inhibition of capillary dilation and permeability, stabilization of lysosomal membranes and subsequent prevention of release of proteolytic enzymes.

DosageView

Adults & children over 12 years: 2 sprays in each nostril once a day preferably in the morning. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.

Children under 12 years (4-11 years): 1 spray in each nostril once a day. The maximum total daily dosage should not exceed 4 sprays. For perennial rhinitis in children, there are insufficient clinical data to recommend its use.

Children below 4 years: The safety and effectiveness of Fluticasone Propionate nasal spray in children below 4 years of age have not been established.

Patients should use Fluticasone Propionate Nasal Spray at regular intervals as directed since its effectiveness depends on its regular use. Or as directed by the physician.

AdministrationView

How to use the Nasal Spray-

Shake the bottle gently and remove the dust cover.
Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
Gently blow the nose to clear the nostrils.
Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
Breathe out through your mouth.
Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

Remove the dust cover.
Gently pull off the nasal applicator.
Wash the applicator and dust cover in warm water.
Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Side effectsView

Fluticasone Propionate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and throat, unpleasant taste and smell and an increase in the incidence of nosebleeds may occur.

ContraindicationsView

Fluticasone Propionate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

PrecautionsView

Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Propionate. Although systemic effects have been minimal with recommended doses of Fluticasone Propionate nasal spray. Potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Propionate nasal spray should be avoided.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Fluticasone Propionate is excreted in human breast milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone Propionate nasal spray is administered to a nursing woman.

StorageView

Keep all medicines out of reach of the children. Store in a cool and dry place protected from light.

Flocet

Ofloxacin (Oral & Injection)

IV Infusion 200 mg/100 ml Allopathic Aural Anti-bacterial preparations

Indications

Uncomplicated cystitis

Indication detailsView

Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.

Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
Gastrointestinal Tract: Enteric fever, shigellosis.
Multi-drug-resistant Tuberculosis.
Skin and skin structures: Uncomplicated skin and skin structure infections.
Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Therapeutic classView

4-Quinolone preparations, Aural Anti-bacterial preparations

PharmacologyView

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

DosageView

Intravenous (Adult):

Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
Shigellosis: 400 mg single dose.
Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Ofloxacin is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

AdministrationView

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side effectsView

Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

ContraindicationsView

Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

PrecautionsView

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

InteractionsView

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

Pregnancy & lactationView

The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.

Pediatric usageView

Renal Impairment:

CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Overdose effectsView

Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).

Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.

StorageView

Store between 15-30° C. Protect from light.

Flocet

Ofloxacin (Oral & Injection)

Tablet 400 mg Allopathic Aural Anti-bacterial preparations

Indications

Uncomplicated cystitis

Indication detailsView

Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.

Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
Gastrointestinal Tract: Enteric fever, shigellosis.
Multi-drug-resistant Tuberculosis.
Skin and skin structures: Uncomplicated skin and skin structure infections.
Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Therapeutic classView

4-Quinolone preparations, Aural Anti-bacterial preparations

PharmacologyView

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

DosageView

Intravenous (Adult):

Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
Shigellosis: 400 mg single dose.
Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Ofloxacin is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

AdministrationView

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side effectsView

Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

ContraindicationsView

Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

PrecautionsView

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

InteractionsView

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

Pregnancy & lactationView

The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.

Pediatric usageView

Renal Impairment:

CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Overdose effectsView

Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).

Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.

StorageView

Store between 15-30° C. Protect from light.

Flocet

Ofloxacin (Oral & Injection)

Tablet 200 mg Allopathic Aural Anti-bacterial preparations

Indications

Uncomplicated cystitis

Indication detailsView

Ofloxacin are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.

Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
Gastrointestinal Tract: Enteric fever, shigellosis.
Multi-drug-resistant Tuberculosis.
Skin and skin structures: Uncomplicated skin and skin structure infections.
Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Therapeutic classView

4-Quinolone preparations, Aural Anti-bacterial preparations

PharmacologyView

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

DosageView

Intravenous (Adult):

Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
Shigellosis: 400 mg single dose.
Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Ofloxacin is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

AdministrationView

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side effectsView

Ofloxacin is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

ContraindicationsView

Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

PrecautionsView

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

InteractionsView

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

Pregnancy & lactationView

The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.

Pediatric usageView

Renal Impairment:

CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Overdose effectsView

Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).

Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.

StorageView

Store between 15-30° C. Protect from light.

Flocip

Ciprofloxacin

Powder for Suspension 250 mg/5 ml Allopathic Anti-diarrhoeal Antimicrobial drugs

Indications

Urinary tract infection

Indication detailsView

Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.

Therapeutic classView

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

PharmacologyView

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

DosageView

Tablet: Adult:

Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
Typhoid fever: 500 mg twice daily (7 days)
Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
Gonorrhea: 500 mg as a single dose
Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
Meningitis: 500 mg as a single dose.
Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

AdministrationView

Instruction for the use of Ciprofloxacin IV infusion-

Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible bags in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of bag.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend bag from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
Open flow control clamp to expel air from set.Close clamp.
Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effectsView

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

ContraindicationsView

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

PrecautionsView

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

InteractionsView

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Pediatric usageView

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose effectsView

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Flocip

Ciprofloxacin

Tablet 500 mg Allopathic Anti-diarrhoeal Antimicrobial drugs

Indications

Urinary tract infection

Indication detailsView

Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.

Therapeutic classView

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

PharmacologyView

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

DosageView

Tablet: Adult:

Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
Typhoid fever: 500 mg twice daily (7 days)
Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
Gonorrhea: 500 mg as a single dose
Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
Meningitis: 500 mg as a single dose.
Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

AdministrationView

Instruction for the use of Ciprofloxacin IV infusion-

Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible bags in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of bag.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend bag from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
Open flow control clamp to expel air from set.Close clamp.
Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effectsView

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

ContraindicationsView

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

PrecautionsView

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

InteractionsView

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Pediatric usageView

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose effectsView

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Flogem

Gemifloxacin

Tablet 320 mg Allopathic 4-Quinolone preparations

Indications

Pneumonia

Indication detailsView

Gemifloxacin is indicated for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-

Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity): caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

Therapeutic classView

4-Quinolone preparations

PharmacologyView

Gemifloxacin is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.

Gemifloxacin is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.

Following oral administration of gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender

DosageView

Acute bacterial exacerbation of chronic bronchitis: 320 mg once daily for 5 days.

Community-acquired pneumonia (Mild to moderate severity):

Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection: One 320 mg tablet daily for 5 days.
Due to known or suspected multi-drug resistant Streptococcus pneumoniae, K.pneumoniae, or M. catarrhalis infection: One 320 mg tablet daily for 7 days.

Side effectsView

The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.

ContraindicationsView

Known hypersensitivity to Gemifloxacin and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Gemifloxacin should not be used in children under 18 years of age.

PrecautionsView

For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Gemifloxacin should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Gemifloxacin may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination.

Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Gemifloxacin, but particularly in elderly patients or when corticosteroids are being co-administered. Gemifloxacin should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Gemifloxacin a small mean increase in QTc interval was observed. Gemifloxacin should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Gemifloxacin should be used with caution in patients with epilepsy.

InteractionsView

Gemifloxacin absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Gemifloxacin should be taken at least 2 hours before or 3 hours after these agents. Gemifloxacin should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Gemifloxacin was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.

Pregnancy & lactationView

Gemifloxacin should not be used in pregnant or lactating women. The safety and efficacy of Gemifloxacin in pregnant or lactating women have not been established.

Pediatric usageView

Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

Creatinine Clearance (>40 ml/min): See usual dosage
Creatinine Clearance (<40 ml/min): 160 mg once daily
Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily.

Hepatic impairment: Gemifloxacin may be given to patients with hepatic impairment, with no requirement for dose adjustment.

Elderly patients: Dose adjustment is not required.

Overdose effectsView

No specific antidote is known. Dialysis does not remove Gemifloxacin sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flomont

Montelukast Sodium

Tablet 10 mg Allopathic Leukotriene receptor antagonists

Indications

Rhinitis

Indication detailsView

Montelukast Sodium is indicated for:

Prophylaxis and chronic treatment of asthma
Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Therapeutic classView

Leukotriene receptor antagonists

PharmacologyView

Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT₁). The cysteinyl leukotrienes (LTC₄, LTD₄, LTE₄) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.

DosageView

Adults & adolescents (15 years & older)-

Asthma & Allergic Rhinitis: 10 mg/day
Exercise-Induced Bronchoconstriction: 10 mg/day

Pediatric patients (6 to 14 years)-

Asthma & Allergic Rhinitis: 5 mg/day
Exercise-Induced Bronchoconstriction: 5 mg/day

Pediatric patients (6 months to 5 years)-

Asthma & Allergic Rhinitis: 4 mg/day
Exercise-Induced Bronchoconstriction: Not recommended

Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.

AdministrationView

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

Side effectsView

Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.

Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.

Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.

ContraindicationsView

Montelukast is contraindicated in patients who are hypersensitive to any component of this product.

PrecautionsView

Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.

InteractionsView

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.

Overdose effectsView

There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

StorageView

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Flomox

Moxifloxacin Hydrochloride (Injection)

IV Infusion 400 mg/250 ml Allopathic 4-Quinolone preparations

Indications

Skin and skin sructure infections

Indication detailsView

Moxifloxacin infusion is indicated for treating following infections in adults >18 years of age caused by designated, susceptible bacteria.

Acute Bacterial Sinusitis
Acute Bacterial Exacerbation of Chronic Bronchitis
Community Acquired Pneumonia
Skin and Skin Structure Infections: Uncomplicated and Complicated
Complicated Intra-Abdominal Infections.

Therapeutic classView

4-Quinolone preparations

DosageView

The dose of Moxifloxacin is 400 mg once daily. The duration of therapy depends on the type of infection as described in following:

Acute Bacterial Sinusitis: 400 mg once daily for 10 days.
Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg once daily for 5 days.
Community Acquired Pneumonia: 400 mg once daily for 7-14 days.
Uncomplicated Skin and Skin Structure Infections: 400 mg once daily for 7 days.
Complicated Skin and Skin Structure Infections: 400 mg once daily for 7-21 days.
Complicated Intra-Abdominal Infections: 400 mg once daily for 5-14 days.

AdministrationView

Moxifloxacin injection should be administered by intravenous infusion over a period of 60 minutes. Avoid bolus or rapid infusion.

Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible bags in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of bag.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend bag from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Moxifloxacin 400 mg intravenous infusion.
Open flow control clamp to expel air from set. Close clamp.
Regulate the rate of administration with flow control clamp.

Side effectsView

Treatment with Moxifloxacin (oral, IV or sequential therapy) may cause some side effects. Common (>1%) side effects include headache, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dizziness, pyrexia and insomnia etc. Less common (0.1 to <1%) side effects include neutropenia, palpitations, tachycardia, bradycardia, vertigo, tinnitus, dry mouth, gastritis, edema, fatigue, malaise, hyperglycemia, anorexia, hyperlipidemia, hypoglycemia, dehydration, back pain and arthralgia etc.

ContraindicationsView

Moxifloxacin is contraindicated in persons with known hypersensitivity to Moxifloxacin or other quinolone antibacterials .

PrecautionsView

Fluoroquinolones, including Moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.

InteractionsView

There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Quinolones, including Moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. Although not observed with Moxifloxacin in predinical and clinical trials, the concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions. There is limited information available on the potential for a pharmacodynamic interaction in humans between Moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) Moxifloxacin in dogs. Therefore, Moxifloxacin should be avoided with Class IA and Class III antiarrhythmics.

Pregnancy & lactationView

Pregnancy Category C. Because no adequate or well controlled studies have been conducted in pregnant women, Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin is excreted in the breast milk of rats. Moxifloxacin may also be excreted in human milk. Because of the potential for serious adverse reactions in infants who are nursing from mothers taking Moxifloxacin, 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 usageView

Pediatric patients: Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established.

Geriatric patients: These patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy.

StorageView

Store below 25°C and protect from light. Avoid extreme heat and freezing. Keep out of reach of children.

Flomox

Moxifloxacin Hydrochloride (Ophthalmic)

Ophthalmic Solution 0.50% Allopathic Ophthalmic antibacterial drugs

Indications

Ocular infections

Indication detailsView

The ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
Aerobic Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilus parainfluenzae.
Other microorganisms: Chlamydia trachomatis.

Therapeutic classView

Ophthalmic antibacterial drugs

PharmacologyView

The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

DosageView

Eye Drops: One drop in the affected eye 3 times per day for 7 days.

Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.

Side effectsView

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

ContraindicationsView

Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.

PrecautionsView

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

InteractionsView

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

Pregnancy & lactationView

Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin Hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin hydrochloride ophthalmic solution is administered to a nursing mother.

StorageView

Store bellow 25°C. Do not freeze. Store in cool and dry place, protected from light. Keep out of the reach of children. Do not touch dropper tip to any surface as this may contaminate this preparation. Do not use after one month of first opening.

Flomox D

Moxifloxacin Hydrochloride + Dexamethasone

Ophthalmic Solution 0.5%+0.1% Allopathic Ophthalmic Steroid preparations

Indications

Steroid-responsive inflammatory ocular conditions

Indication detailsView

Moxifloxacin & Dexamethasone eye drop is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.

Therapeutic classView

Ophthalmic Steroid preparations

PharmacologyView

This Eye Drops is a combination of a fourth generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexmethasone. Moxifloxacin controls infection by inhibitting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls the inflammation by inhibiting the release inflammatory mediators.

DosageView

In the prevention of infection and post-surgical ocular inflammation: Instill 1 drop, 4 times a day, in the eye to be operated, from 1 day before surgery until 15 days after surgery.

In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.

In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.

In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.

Side effectsView

Moxifloxacin: Conjunctivitis decreased visual acuity, dry eye, keratitis, Ocular discomfort, hyperemia, pain, Subconjunctival hemorrhage and tearing.

Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.

ContraindicationsView

Hypersensitivity to quinolones. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella & other viral diseases of cornea & conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Glaucoma & diseases causing thinning of cornea or sclera.

PrecautionsView

For ophthalmic use only. The solution should not be injected under the conjunctiva, nor introduced directly into the anterior chamber of the eye. Prolonged use of steroids may result in ocular hypertension

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when Moxifloxacin & Dexamethasone combination eye drops is given to nursing women.

Pediatric usageView

Use in the elderly: No change in dosage is required when the product is administered in elderly patients.

Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.

Overdose effectsView

No information is available on overdosage with this product in humans.

StorageView

Store in a cool place, below 30°C, protected from light. Once the container is opened the contents must be used within 28 days and may be stored at room temperature up to 30°C. Discard after the 28 days. Keep out of reach of children.

Flomox XG

Moxifloxacin Hydrochloride + Xanthan Gum

Ophthalmic Solution 0.5%+0.4% Allopathic Ophthalmic antibacterial drugs

Indications

Conjunctivitis

Indication detailsView

This ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms-

Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumonia, Streptococcus viridans group.

Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenza, Haemophilus parainfluenzae.

Therapeutic classView

Ophthalmic antibacterial drugs

PharmacologyView

The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

DosageView

One drop in the affected eye(s) 2 times daily for 7 days.

Side effectsView

In 1-6% patients the most frequently reported ocular adverse events are eye irritation, pyrexia, conjunctivitis, decreased visual acuity, dry eye, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing.

PrecautionsView

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi with other anti-infective.

InteractionsView

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride.

Pregnancy & lactationView

Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin is administered to a breast feeding mother.

Pediatric usageView

Pediatric Use: The safety and effectiveness of Moxifloxacin in infants below four months of age was not proven. However, several clinical studies show that the drug may be used safely in children even younger than one month of age.

Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Overdose effectsView

There is practically no risk of adverse effects due to accidental ingestion, since a bottle of 5 ml eye drops solution contains only 25 mg Moxifloxacin that is much lower than recommended daily oral dose.

StorageView

Store in a cool and dry place away from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the first opening do not use the medicine of dropper.

Flomyst F

Fluticasone Propionate + Formoterol Fumarate

Inhaler (50 mcg+5 mcg)/puff Allopathic Respiratory corticosteroids

Indications

COPD

Indication detailsView

Asthma: This fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting ß2 agonist. Or,
For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler are indicated in adults and adolescents aged 12 years and above.

COPD: Fluticasone Propionate and Formoterol Fumarate is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other long-acting ß2 agonist/Inhaled corticosteroid.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.

Therapeutic classView

Respiratory corticosteroids

PharmacologyView

This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:

Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.

DosageView

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
Children under 12 years: No data are available for this strength of this inhaler in children.
This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

AdministrationView

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

Take off the cap.
Shake the inhaler (at least six times) vigorously before each use.
If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
Breathe out as full as comfortably possible & hold the inhaler upright.
Place the actuator into mouth between the teeth and close lips around the mouthpiece.
While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Side effectsView

Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

ContraindicationsView

this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

InteractionsView

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

Pregnancy & lactationView

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Pediatric usageView

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

Overdose effectsView

There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:

FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

StorageView

Store in a cool and dry place, protected from light.

Flomyst F

Fluticasone Propionate + Formoterol Fumarate

Inhaler (125 mcg+5 mcg)/puff Allopathic Respiratory corticosteroids

Indications

COPD

Indication detailsView

Asthma: This fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting ß2 agonist. Or,
For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler are indicated in adults and adolescents aged 12 years and above.

COPD: Fluticasone Propionate and Formoterol Fumarate is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other long-acting ß2 agonist/Inhaled corticosteroid.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.

Therapeutic classView

Respiratory corticosteroids

PharmacologyView

This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:

Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.

DosageView

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
Children under 12 years: No data are available for this strength of this inhaler in children.
This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

AdministrationView

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

Take off the cap.
Shake the inhaler (at least six times) vigorously before each use.
If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
Breathe out as full as comfortably possible & hold the inhaler upright.
Place the actuator into mouth between the teeth and close lips around the mouthpiece.
While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Side effectsView

Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

ContraindicationsView

this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

InteractionsView

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

Pregnancy & lactationView

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Pediatric usageView

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

Overdose effectsView

There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:

FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

StorageView

Store in a cool and dry place, protected from light.

Flomyst F

Fluticasone Propionate + Formoterol Fumarate

Inhaler (250 mcg+10 mcg)/puff Allopathic Respiratory corticosteroids

Indications

COPD

Indication detailsView

Asthma: This fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting ß2 agonist. Or,
For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler are indicated in adults and adolescents aged 12 years and above.

COPD: Fluticasone Propionate and Formoterol Fumarate is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other long-acting ß2 agonist/Inhaled corticosteroid.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.

Therapeutic classView

Respiratory corticosteroids

PharmacologyView

This inhaler (a pressurised inhalation, suspension) which contains two active ingredients:

Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast acting ‘reliever’ medicine such as salbutamol if this happens.

DosageView

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of this inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:
Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product- i.e. Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
Children under 12 years: No data are available for this strength of this inhaler in children.
This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler- two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.
This inhaler 250 microgram/10 microgram per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily normally taken in the morning and in the evening.

AdministrationView

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

Take off the cap.
Shake the inhaler (at least six times) vigorously before each use.
If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
Breathe out as full as comfortably possible & hold the inhaler upright.
Place the actuator into mouth between the teeth and close lips around the mouthpiece.
While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Side effectsView

Undesirable effects which have been associated with this inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

ContraindicationsView

this inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their this inhaler maintenance dose as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all ß2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

InteractionsView

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

Pregnancy & lactationView

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or FormoterolFumarateare excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Pediatric usageView

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

Overdose effectsView

There are no data available from clinical trials on overdose with this inhaler, however, data on overdose with both single drugs are given below:

FormoterolFumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for ß2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

StorageView

Store in a cool and dry place, protected from light.

Flonasin

Azelastine Hydrochloride + Fluticasone Propionate

Nasal Spray (137 mcg+50 mcg)/spray Allopathic Nasal Steroid Preparations

Indications

Perennial or seasonal allergic rhinitis

Indication detailsView

Azelastine and Fluticasone Nasal Spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both Azelastine Hydrochloride and Fluticasone Propionate for symptomatic relief.

Therapeutic classView

Nasal Steroid Preparations

PharmacologyView

Azelastine Hydrochloride exhibits histamine H1-receptor antagonist activity in isolated tissues. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity. Fluticasone Propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which Fluticasone Propionate affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes etc.) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

DosageView

Adult: The recommended dosage is one spray each nostril twice daily.

Paediatric: The safety and effectiveness of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray has not been established for patients less than 6 years of age.

AdministrationView

How to use the Nasal Spray-

Shake the bottle gently and remove the dust cover.
Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
Gently blow the nose to clear the nostrils.
Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
Breathe out through your mouth.
Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

Remove the dust cover.
Gently pull off the nasal applicator.
Wash the applicator and dust cover in warm water.
Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Side effectsView

The most common adverse reactions (>2% incidence) are: dysgeusia, epistaxis, and headache.

ContraindicationsView

There is no known contraindication.

PrecautionsView

Engagement in hazardous occupations requiring complete mental alertness such as driving or operating machinery should be avoided when taking Azelastine and Fluticasone Nasal Spray. Concurrent use of alcohol or other central nervous system (CNS) depressants with this Nasal Spray should also be avoided because of further decreased alertness and impairment of CNS. Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals may appear. If such changes occur, the spray should be discontinued slowly.

Pregnancy & lactationView

Pregnancy category C. There are no adequate and well-controlled clinical trials of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Azelastine Hydrochloride only or Fluticasone Propionate only in pregnant women. It should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

Overdose effectsView

There have been no reported over dosages with Azelastine Hydrochloride. Acute Azelastine Hydrochloride overdosage by adults with this dosage form is unlikely to result in clinically significant adverse events, other than increased somnolence. Chronic Fluticasone Propionate overdosage may result in symptoms of hypercorticism.

StorageView

Store below 25° C. Protected from light. Do not store in the refrigerator. Keep out of the reach of children.

Flonaspray

Fluticasone Propionate (Nasal Spray)

Nasal Spray 50 mcg/spray Allopathic Fluocinolone & Combined Preparations

Indications

Rhinitis

Indication detailsView

Fluticasone Propionate is indicated for-

The prophylaxis and treatment of seasonal allergic rhinitis including hay fever and perennial rhinitis.
It has potent anti-inflammatory activity on the nasal mucosa without detectable systemic activity.

Therapeutic classView

Fluocinolone & Combined Preparations, Nasal Steroid Preparations

PharmacologyView

Following topical administration into the nasal mucosa, Fluticasone propionate produces anti-inflammatory and vasoconstrictor effects. The exact mechanism of these actions remains unknown but may involve a reduction in the following: number of mediator cells (basophil, leukocytes and mast cells) at the epithelial level, number of eosinophils, the sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity. Other mechanisms may involve - inhibition of capillary dilation and permeability, stabilization of lysosomal membranes and subsequent prevention of release of proteolytic enzymes.

DosageView

Adults & children over 12 years: 2 sprays in each nostril once a day preferably in the morning. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.

Children under 12 years (4-11 years): 1 spray in each nostril once a day. The maximum total daily dosage should not exceed 4 sprays. For perennial rhinitis in children, there are insufficient clinical data to recommend its use.

Children below 4 years: The safety and effectiveness of Fluticasone Propionate nasal spray in children below 4 years of age have not been established.

Patients should use Fluticasone Propionate Nasal Spray at regular intervals as directed since its effectiveness depends on its regular use. Or as directed by the physician.

AdministrationView

How to use the Nasal Spray-

Shake the bottle gently and remove the dust cover.
Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
Gently blow the nose to clear the nostrils.
Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
Breathe out through your mouth.
Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

Remove the dust cover.
Gently pull off the nasal applicator.
Wash the applicator and dust cover in warm water.
Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Side effectsView

Fluticasone Propionate nasal spray is absorbed less into the rest of the body, therefore fewer side effects are seen. With the nasal spray, drying of the nose and throat, unpleasant taste and smell and an increase in the incidence of nosebleeds may occur.

ContraindicationsView

Fluticasone Propionate nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

PrecautionsView

Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including Fluticasone Propionate. Although systemic effects have been minimal with recommended doses of Fluticasone Propionate nasal spray. Potential risk increases with larger doses. Therefore, larger than recommended doses of Fluticasone Propionate nasal spray should be avoided.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Fluticasone Propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Fluticasone Propionate is excreted in human breast milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Fluticasone Propionate nasal spray is administered to a nursing woman.

StorageView

Keep all medicines out of reach of the children. Store in a cool and dry place protected from light.

Flonor

Tamsulosin Hydrochloride

Capsule (Modified Release) 0.4 mg Allopathic BPH/ Urinary retention/ Urinary incontinence

Indications

Benign prostatic hyperplasia (BPH)

Indication detailsView

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

Therapeutic classView

BPH/ Urinary retention/ Urinary incontinence

PharmacologyView

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

DosageView

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

Side effectsView

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

ContraindicationsView

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

PrecautionsView

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

InteractionsView

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Pregnancy & lactationView

Use of Tamsulosin in pregnancy and lactation is not recommended.

Overdose effectsView

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

StorageView

Store in a cool and dry place, below 30°C, protected from light.

Flontin

Ciprofloxacin

IV Infusion 200 mg/100 ml Allopathic Anti-diarrhoeal Antimicrobial drugs

Indications

Urinary tract infection

Indication detailsView

Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.

Therapeutic classView

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

PharmacologyView

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

DosageView

Tablet: Adult:

Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
Typhoid fever: 500 mg twice daily (7 days)
Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
Gonorrhea: 500 mg as a single dose
Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
Meningitis: 500 mg as a single dose.
Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

AdministrationView

Instruction for the use of Ciprofloxacin IV infusion-

Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible bags in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of bag.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend bag from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
Open flow control clamp to expel air from set.Close clamp.
Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effectsView

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

ContraindicationsView

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

PrecautionsView

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

InteractionsView

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Pediatric usageView

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose effectsView

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

StorageView

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.