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Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction

Ophthalmic Non-Steroid drugs

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.

Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks

Children: Use and dose must be determined by the doctor.

Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.

The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients

Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.

All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.

Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.

Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light.  Do not use more than 4 weeks after opening.

Ketotifen eye drop is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.

Ophthalmic Non-Steroid drugs

Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.

Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.

Children under 3 years of age: Consult with a doctor.

Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.

Hypersensitivity to Ketotifen or any of the components

The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

There are no adequate data from the use of ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women. Although animal data following oral administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. ketotifen 0.25% eye drops can be used during lactation.

No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of Ketotifen which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.

Store in a cool and dry place protected from light and moisture. Keep out of reach of children. Do not touch the dropper tip to any surface since this may contaminate the solution. Do not use after 30 days of first opening.

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

Store in a cool and dry place, protect from light. Keep out of the reach of children.

Mefenamic Acid is indicated for-

• Fever
• Toothache
• Headache
• Migraine
• Primary dysmenorrhoea
• Menorrhagia
• Mild to moderate pain in rheumatoid arthritis and osteoarthritis
• Traumatic pain
• Low-back pain
• Juvenile chronic arthritis in children etc.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.

Adult:

• 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
• In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.

Children:

• 6 months to 1 year: 5 ml three times/day.
• 2-4 years: 10 ml three times/day.
• 5-8 years: 10 ml four times /day.
• 9-12 years: 15 ml four times/day.

Treatment should not be continued for more than 7 days except on the advice of a physician.

The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.

It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.

It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.

Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.

Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy

The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.

Keep away from light, store in a cool and dry place. Keep out of 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.

In the long-term management of psychotic disorders including:

• Schizophrenia
• Mania and
• Organic brain syndrome.

Phenothiazine drugs

Fluphenazine blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain; depresses the release of hypothalamic and hypophyseal hormones and is believed to depress the reticular activating system thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone, and emesis.

Fluphenazine Decanoate by deep intramuscular injection into the gluteal muscle, test dose 12.5 mg (6.25 mg in elderly), then after 4-7 days 12.5-100 mg repeated at intervals of 14-35 days, adjusted according to response; it is not recommended for children.

The side effects include tardive dyskinesia, sedation, mental confusion; hypotension; hyperprolactinaemia leading to galactorrhoea and amenorrhoea in women; loss of libido, impotence and sterility in males. Also include allergic reactions, cholestatic jaundice, corneal and lens deposists, skin pigmentation. Other potential adverse reactions are agranulocytosis; neuroleptic syndrome.

Fluphenazine Decanoate oily Injection is contraindicated in patients with hypersensitivity to the drug. Also contraindicated in comatose or severely depressed states, blood dyscrasias, liver disease, pregnancy (3rd trimester), lactation.

Special precaution should be practiced in presence of convulsive disorders; hepatic, renal, cerebrovascular, respiratory and cardiovascular diseases. Also precaution should be observed in case of phenochromocytoma; bone marrow suppression; elderly or debilitated patients.

Fluphenazine reverses antihypertensive effects of Guanethidine, Methyldopa and Clonidine. It also causes lithium toxicity by interacting with it. Antacids may reduce bioavailability of phenothiazines. Additive CNS depressant effects produced with alcohol, barbiturates, hypnotics, sedatives, opiates and antihistamines.

The safety for the use of Fluphenazine decanoate during pregnancy has not yet been established; therefore the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.

Store at 15-30°C.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Sedating Anti-histamine

Pheniramine competes with histamine for the histamine H1 receptor, acting as an inverse agonist once bound. The reduction in H1 receptor activity is responsible for reduced itching as well as reduced vasodilation and capillary leakage leading to less redness and edema. This can be seen in the suppression of the histamine-induced wheal (swelling) and flare (vasodilation) response. Inverse agonism of the H1 receptor in the CNS is also responsible for the sedation produced by first-generation antihistamines like pheniramine. The binding of pheniramine to H4 receptors, and subsequent inverse agonism, may also contribute to reduced itching by antagonizing inflammation.

Doses must be individually determined in all cases and should be taken with or soon after food. Treatment should be commenced at the lowest possible dose because experience has shown that antihistamines are often effective at low doses. The maximum dose of 3 mg/kg per day should not be exceeded. Elderly patients should use the adult dose with caution.

To prevent travel sickness, it is recommended that the first dose be taken at least 30 minutes before traveling. Due to the risk of drowsiness, the patient should not drive a motor vehicle or operate machinery after taking a dose.

Pheniramine Maleate tablets:

• In adults and children over 10 years of age: Treatment is commenced with half a tablet taken up to three times daily. This dose may be increased to one tablet taken up to three times daily if required.
• Children 5-10 years of age: Half a tablet up to three times daily. Pheniramine Maleate tablets are not recommended in children under 5 years of age.

The most common adverse reaction is sedation, which often disappears after a few days if tolerance is acquired. Hypersensitivity reactions have been reported.

• Central Nervous System: Lassitude, dizziness, tinnitus, inability to concentrate, incoordination, irritability, insomnia and tremors. Agitation and convulsions, especially in children and restlessness, disorientation and hallucinations in adults, are common symptoms following overdose.
• Gastrointestinal: Nausea, vomiting, diarrhoea, colic, epigastric pain, anorexia, dryness of mouth and constipation.
• Genitourinary: Urinary retention.
• Cardiovascular: Palpitations, headache.
• Ocular: Blurred vision, increased intraocular pressure.
• Musculoskeletal: Muscular weakness.
• Haematological: Rare cases of blood dyscrasias including agranulocytosis and haemolytic anaemia have been reported.

pregnancy Category A. Use only if strictly indicated. Use only if strictly indicated.

Symptoms: Antihistamine drugs in toxic doses produce a complex of CNS excitatory and depressant effects. Accidental ingestion in small children has resulted in convulsions and sometimes death.

Management: As there is no specific antidote, treatment should be symptomatic and supportive. Induction of vomiting should only be used immediately after ingestion as the sedative action of any absorbed antihistamine can lead to life-threatening pulmonary aspiration during emesis. Gastric lavage with a cuffed endotracheal tube in situ may be useful for some time after ingestion of antihistamines as their anticholinergic action slows down gastric emptying. Stimulants should not be used as they may precipitate convulsions. Diazepam or short-acting barbiturates may be used to control convulsions. Vasopressors may be used to treat hypotension. Mechanical support of respiration may be required if respiration is seriously depressed. Continuous ECG monitoring is recommended if cardiac toxicity develops, which can be treated with centrally-acting anticholinesterases such as physostigmine.

Store in a cool and dry place, protected from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.

Baclofen is indicated in-

• spasticity resulting from multiple sclerosis
• flexor spasms and concomitant pain, clonus and muscular rigidity
• skeletal muscle spasm resulting from rheumatic disorders
• spinal cord injuries and other spinal cord diseases
• cerebrovascular accidents or neoplastic or degenerative brain disease

Centrally acting Skeletal Muscle Relaxants

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_B receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

• Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Gastric lavage is important in case of severe overdose.

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

Baclofen is indicated in-

• spasticity resulting from multiple sclerosis
• flexor spasms and concomitant pain, clonus and muscular rigidity
• skeletal muscle spasm resulting from rheumatic disorders
• spinal cord injuries and other spinal cord diseases
• cerebrovascular accidents or neoplastic or degenerative brain disease

Centrally acting Skeletal Muscle Relaxants

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_B receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

• Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Gastric lavage is important in case of severe overdose.

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

Baclofen is indicated in-

• spasticity resulting from multiple sclerosis
• flexor spasms and concomitant pain, clonus and muscular rigidity
• skeletal muscle spasm resulting from rheumatic disorders
• spinal cord injuries and other spinal cord diseases
• cerebrovascular accidents or neoplastic or degenerative brain disease

Centrally acting Skeletal Muscle Relaxants

Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA_B receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.

• Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.

Gastric lavage is important in case of severe overdose.

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