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Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fenofibrate is indicated for hyperlipidemias of type lla, llb, III, IV & V in patients who have not responded adequately to diet & other appropriate measures.

Fibrates

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII. Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid. The micronised form of Nofiate (Fenofibrate) has enhanced absorption over the non-micronised formulation.

Gastro-intestinal (e.g. nausea, anorexia, gastric pain), pruritus, urticaria, impotence, also headache, dizziness, vertigo, fatigue, hair loss; myotoxicity.

Fenofibrate is contraindicated in patients with hypersensitivity to Fenofibrate, severe renal or hepatic impairment, existing gall bladder disease, breast feeding mothers, photosensitivity to ketoprofen.

Special care needed in patients with renal disease, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity; discontinue if myotoxicity suspected or creatinine kinase concentration increases significantly. Liver function tests recommended every 3 months for first year.

Fenofibrate has been reported to potentiate the anticoagulant effects of warfarin. When administered with antidiabetic drug it may improve glucose tolerance and have additive effect. Fenofibrate may also increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors. However, the use of low-dose statins with Fenofibrate appears to be well tolerated.

Fenofibrate is not recommended for pregnant women.

There is no specific treatment for overdose with Fenofibrate. General supportive care of the patients is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because Fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Do not store above 30°C. Keep away from light and out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Opioid analgesics

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.

Oral-

• Starting Dose: The initial dose of Fentanyl should be 100 mcg.
• Re-dosing patients within a single episode:  Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
• Increasing the dose:  Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
• Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.

Injection-

• Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.

• Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.

• Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.

• Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH

• Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.

Transdermal-
Intractable chronic pain:

• Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
• Elderly: Dose reduction may be needed.

Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.

As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.

Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. 

Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.

Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.

In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.

Store between 20-25°C. Protect from light.

Opioid analgesics

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.

Oral-

• Starting Dose: The initial dose of Fentanyl should be 100 mcg.
• Re-dosing patients within a single episode:  Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
• Increasing the dose:  Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
• Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.

Injection-

• Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.

• Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.

• Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.

• Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH

• Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.

Transdermal-
Intractable chronic pain:

• Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
• Elderly: Dose reduction may be needed.

Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.

As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.

Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. 

Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.

Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.

In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.

Store between 20-25°C. Protect from light.

Fenticonazole Nitrate is used for the treatment of vulvovaginal candidiasis.

Topical Antifungal preparations

Fenticonazole is a broad-spectrum antimycotic agent with activity against dermatophytes and yeasts. Fenticonazole has also been shown to exhibit antibacterial action, with a spectrum of activity that includes bacteria commonly associated with vaginal infections and antiparasitic action against the protozoan Trichomonas vaginalis. Therefore, Fenticonazole may be an ideal topical alternative to multi-agent treatment of mixed infections involving mycotic, bacterial, dermatophyte and/or Trichomonas spp.

Route of application is intravaginal. For adults, one applicator full (about 5 gm) is to be administered into the vagina in the morning and evening for three days.

After each application, clean it carefully with warm water and soap. Do not use water which is hotter than 50°C or solvents. Then wipe the applicator and store in its packet. Always wash your hands with mild soap and warm water afterwards. Fenticonazole is not greasy and can easily be removed with water.

Follow the instructions to use Fenticonazole cream-

• Screw the applicator onto the tube in place of the cap.
• Squeeze the tube gently at its lower end, so as to fill the applicator at 5 gm mark. Unless prescribed by the physician, the applicator must be completely filled up to 5 gm.
• After taking measured amount cream, remove the applicator from the tube, which should be closed immediately with the cap.
• In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston to penetrate cream completely, then pull out the applicator without touching the piston.

After intravaginal administration, slight transient burning may occasionally occur, which usually disappears rapidly.

Hypersensitivity to Fenticonazole or any component of the formulation.

It should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and take physician consultation.

Not investigated. Since systemic absorption of Fenticonazole after application is low, interactions with other drugs are unlikely.

Since there is no data of use during pregnancy or lactation, So Fenticonazole should not be used without physician's advice.

The use of Fenticonazole vaginal cream in children is not recommended.

Because of the low systemic absorption after vaginal application, overdosage is unlikely.

Protect from light & moisture. Keep below 30° C temperature, protected from light & moisture. Do not freeze. Keep out of the reach of children.

Fenticonazole Nitrate is used for the treatment of vulvovaginal candidiasis.

Topical Antifungal preparations

Fenticonazole is a broad-spectrum antimycotic agent with activity against dermatophytes and yeasts. Fenticonazole has also been shown to exhibit antibacterial action, with a spectrum of activity that includes bacteria commonly associated with vaginal infections and antiparasitic action against the protozoan Trichomonas vaginalis. Therefore, Fenticonazole may be an ideal topical alternative to multi-agent treatment of mixed infections involving mycotic, bacterial, dermatophyte and/or Trichomonas spp.

Route of application is intravaginal. For adults, one applicator full (about 5 gm) is to be administered into the vagina in the morning and evening for three days.

After each application, clean it carefully with warm water and soap. Do not use water which is hotter than 50°C or solvents. Then wipe the applicator and store in its packet. Always wash your hands with mild soap and warm water afterwards. Fenticonazole is not greasy and can easily be removed with water.

Follow the instructions to use Fenticonazole cream-

• Screw the applicator onto the tube in place of the cap.
• Squeeze the tube gently at its lower end, so as to fill the applicator at 5 gm mark. Unless prescribed by the physician, the applicator must be completely filled up to 5 gm.
• After taking measured amount cream, remove the applicator from the tube, which should be closed immediately with the cap.
• In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston to penetrate cream completely, then pull out the applicator without touching the piston.

After intravaginal administration, slight transient burning may occasionally occur, which usually disappears rapidly.

Hypersensitivity to Fenticonazole or any component of the formulation.

It should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and take physician consultation.

Not investigated. Since systemic absorption of Fenticonazole after application is low, interactions with other drugs are unlikely.

Since there is no data of use during pregnancy or lactation, So Fenticonazole should not be used without physician's advice.

The use of Fenticonazole vaginal cream in children is not recommended.

Because of the low systemic absorption after vaginal application, overdosage is unlikely.

Protect from light & moisture. Keep below 30° C temperature, protected from light & moisture. Do not freeze. Keep out of the reach of children.

Fenticonazole Nitrate vaginal tablet is indicated for:

• Genital candidiasis (vulvovaginitis, colpitis, infectious fluor)
• Trichomonasis
• Vaginal infections sustained by mixed forms of Trichomonas vaginalis and Candida albicans.

Topical Antifungal preparations

Fenticonazole is a potent broad-spectrum antimycotic agent. It exerts fungistatic and fungicidal actions on dermatophytes, pathogenic yeasts, dimorphous fungi and molds. In addition, Fenticonazole is active against gram-positive bacteria and is therefore indicated in mycoses associated with bacterial super infections. Fenticonazole is also active, both in vitro and in vivo, against Trichomonas vaginalis. Fenticonazole exerts its unique antimycotic action through following three ways:

• Inhibiting the biosynthesis of ergosterol leading to the damage of fungal cell membrane.
• Causing certain changes in oxidative and peroxidative enzyme activities inside fungal cell. This leads to an intracellular build-up of toxic concentrations of hydrogen peroxide resulting in cell necrosis.
• Inhibiting the secretion of aspartic proteases (responsible for pathogenicity) by Candida albicans.

The amount of Fenticonazole absorbed by the transcutaneous route is negligible.

Trichomonas or mixed (Trichomonas and Candida albicans) vaginal infections: One 600 mg VT (followed by a second administration 24 hours later, if necessary).

Candida albicans infections: One single 600 mg VT administration in the evening. Should the symptoms persist, a second administration may be repeated after three days. The tablet must be introduced deep into the vagina and pushed well up to the fornix. To avoid re-infection, it is recommended that the partner undergoes concurrent treatment with Fenticonazole Cream or similar Azole Cream.

After intravaginal administration slight transient burning (which usually disappears rapidly) may occasionally happen. Prolonged topical application may cause sensitisation reactions. Fenticonazole is generally well tolerated by the mucous membranes; only exceptionally mild and transient erythematous reactions have been reported. After topical application or intravaginal administration, a slight burning sensation may occur, usually subsiding soon. Should more persistent irritation occur or resistant micro-organism develop, suspend the treatment and seek the doctor's advice. Due to poor absorption of Fenticonazole, no systemic effects should occur, provided the above instructions are carefully observed.

Contraindicated in case of hypersensitivity to Fenticonazole and other Imidazoles.

It is not recommended in pregnancy. Safety in breastfeeding has not been established.

Fenticonazole Nitrate is not recommended for children.

As systemic absorption is very low, the possibility of overdose is rare. In case of accidental swallowing, emesis or gastric lavage should be done. After vomiting, active charcoal along with water/lemon juice and laxative should be given to the patient.

Store below 25°C. Protect from light & moisture.

Fenticonazole Nitrate is used for the treatment of vulvovaginal candidiasis.

Topical Antifungal preparations

Fenticonazole is a broad-spectrum antimycotic agent with activity against dermatophytes and yeasts. Fenticonazole has also been shown to exhibit antibacterial action, with a spectrum of activity that includes bacteria commonly associated with vaginal infections and antiparasitic action against the protozoan Trichomonas vaginalis. Therefore, Fenticonazole may be an ideal topical alternative to multi-agent treatment of mixed infections involving mycotic, bacterial, dermatophyte and/or Trichomonas spp.

Route of application is intravaginal. For adults, one applicator full (about 5 gm) is to be administered into the vagina in the morning and evening for three days.

After each application, clean it carefully with warm water and soap. Do not use water which is hotter than 50°C or solvents. Then wipe the applicator and store in its packet. Always wash your hands with mild soap and warm water afterwards. Fenticonazole is not greasy and can easily be removed with water.

Follow the instructions to use Fenticonazole cream-

• Screw the applicator onto the tube in place of the cap.
• Squeeze the tube gently at its lower end, so as to fill the applicator at 5 gm mark. Unless prescribed by the physician, the applicator must be completely filled up to 5 gm.
• After taking measured amount cream, remove the applicator from the tube, which should be closed immediately with the cap.
• In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston to penetrate cream completely, then pull out the applicator without touching the piston.

After intravaginal administration, slight transient burning may occasionally occur, which usually disappears rapidly.

Hypersensitivity to Fenticonazole or any component of the formulation.

It should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and take physician consultation.

Not investigated. Since systemic absorption of Fenticonazole after application is low, interactions with other drugs are unlikely.

Since there is no data of use during pregnancy or lactation, So Fenticonazole should not be used without physician's advice.

The use of Fenticonazole vaginal cream in children is not recommended.

Because of the low systemic absorption after vaginal application, overdosage is unlikely.

Protect from light & moisture. Keep below 30° C temperature, protected from light & moisture. Do not freeze. Keep out of the reach of children.

Fenticonazole Nitrate vaginal tablet is indicated for:

• Genital candidiasis (vulvovaginitis, colpitis, infectious fluor)
• Trichomonasis
• Vaginal infections sustained by mixed forms of Trichomonas vaginalis and Candida albicans.

Topical Antifungal preparations

Fenticonazole is a potent broad-spectrum antimycotic agent. It exerts fungistatic and fungicidal actions on dermatophytes, pathogenic yeasts, dimorphous fungi and molds. In addition, Fenticonazole is active against gram-positive bacteria and is therefore indicated in mycoses associated with bacterial super infections. Fenticonazole is also active, both in vitro and in vivo, against Trichomonas vaginalis. Fenticonazole exerts its unique antimycotic action through following three ways:

• Inhibiting the biosynthesis of ergosterol leading to the damage of fungal cell membrane.
• Causing certain changes in oxidative and peroxidative enzyme activities inside fungal cell. This leads to an intracellular build-up of toxic concentrations of hydrogen peroxide resulting in cell necrosis.
• Inhibiting the secretion of aspartic proteases (responsible for pathogenicity) by Candida albicans.

The amount of Fenticonazole absorbed by the transcutaneous route is negligible.

Trichomonas or mixed (Trichomonas and Candida albicans) vaginal infections: One 600 mg VT (followed by a second administration 24 hours later, if necessary).

Candida albicans infections: One single 600 mg VT administration in the evening. Should the symptoms persist, a second administration may be repeated after three days. The tablet must be introduced deep into the vagina and pushed well up to the fornix. To avoid re-infection, it is recommended that the partner undergoes concurrent treatment with Fenticonazole Cream or similar Azole Cream.

After intravaginal administration slight transient burning (which usually disappears rapidly) may occasionally happen. Prolonged topical application may cause sensitisation reactions. Fenticonazole is generally well tolerated by the mucous membranes; only exceptionally mild and transient erythematous reactions have been reported. After topical application or intravaginal administration, a slight burning sensation may occur, usually subsiding soon. Should more persistent irritation occur or resistant micro-organism develop, suspend the treatment and seek the doctor's advice. Due to poor absorption of Fenticonazole, no systemic effects should occur, provided the above instructions are carefully observed.

Contraindicated in case of hypersensitivity to Fenticonazole and other Imidazoles.

It is not recommended in pregnancy. Safety in breastfeeding has not been established.

Fenticonazole Nitrate is not recommended for children.

As systemic absorption is very low, the possibility of overdose is rare. In case of accidental swallowing, emesis or gastric lavage should be done. After vomiting, active charcoal along with water/lemon juice and laxative should be given to the patient.

Store below 25°C. Protect from light & moisture.

Opioid analgesics

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor but also binds to kappa and delta-type opioid receptors. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues. In clinical settings, Fentanyl exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Fentanyl may increase the patient's tolerance for pain and decrease the perception of suffering, although the presence of the pain itself may still be recognized. In addition to analgesia, alterations in mood, euphoria and dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils.

Oral-

• Starting Dose: The initial dose of Fentanyl should be 100 mcg.
• Re-dosing patients within a single episode:  Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.
• Increasing the dose:  Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose. To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.
• Dosage Adjustment: Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.

Injection-

• Fentanyl injection can be administered intravenously either as a bolus or by infusion & by intramuscular route also. The dose of fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia.

• Doses in excess of 200mcg are for use in anesthesia only. As a premedicant, 1-2 ml fentanyl may be given intramuscularly 45 minutes before induction of anesthesia. After IV administration in unpremedicated adult patients, 2ml fentanyl may be expected to provide sufficient analgesia for 10-20 minutes in surgical procedures involving low pain intensity. 10 ml fentanyl injected as a bolus gives analgesia lasting about one hour. The analgesia produced is sufficient for surgery involving moderately painful procedures. Giving a dose of 50mcglkg fentanyl will provide intense analgesia for some four to six hours, for intensely stimulating surgery.

• Fentanyl may also be given as an infusion. In ventilated patients, a loading dose of fentanyl may be given as a fast infusion of approximately 1 mcg/kg/min for the first 10 minutes followed by an infusion of approximately 0.1 mcg/kg/min. Alternatively the loading dose of fentanyl may be given as a bolus. Infusion rates should be titrated to individual patient response; lower infusion rates may be adequate. Unless it is planned to ventilate post operatively, the infusion should be terminated at about 40 minutes before the end of surgery.

• Lower infusion rates, e.g. 0.05-0.08 mcg/kg/min. are necessary if spontaneous ventilation .is to be maintained. Higher infusion rates (up to 3 mcg/kg/min) have been used in cardiac surgery. Fentanyl is chemically incompatible with the induction agents thiopentone & methohexitone because of wide differences in pH

• Use in elderly and debilitated patients: It is wise to reduce the dosage in the elderly and debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses.

Transdermal-
Intractable chronic pain:

• Adult: Patches deliver fentanyl in doses that range from: 12-100 mcg/hr. Doses should be individually titrated based on previous use of opioids. Opioid-naive patients: Initially, ≤25 mcg/hr; it is recommended to initially titrate w/ low doses of short-acting opioids before starting fentanyl patches. Patients receiving a strong opioid analgesic: Initial dose should be based on the previous 24-hr opioid requirements. During transfer to fentanyl patches, previous opioid treatment should be phased out gradually. If patient requires doses >100 mcg/hr, >1 patch may be used; consider alternative or additional therapy if doses >300 mcg/hr are required. Replace patch every 72 hr and apply the new patch to a different site; avoid using the same area of skin for a few days.
• Elderly: Dose reduction may be needed.

Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowed with a glass of water.

As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.

Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.

Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease: Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression. 

Head injuries and increased intracranial pressure: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease: Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease: Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.

Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.

In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.

Store between 20-25°C. Protect from light.

It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.

Adult: One Capsule daily before food or as directed by the physician.

Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.

It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.

Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.