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Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nalbuphine Hydrochloride is indicated for the relief of moderate to severe pain. It is used for relief of moderate to severe pain associated with myocardial infarction (MI). Nalbuphine Hydrochloride can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

Opioid analgesics

Nalbuphine Hydrochloride is a synthetic potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that Nalbuphine binds to mu, kappa, and delta receptors, but not to sigma receptors. Nalbuphine is primarily a kappa agonist/partial mu antagonist analgesic.

The usual recommended adult dose is 10 mg for a 70 kg individual, administered subcutaneously, intramuscularly or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be
receiving.

Moderate to severe pain: by intravenous or intramuscular injection 10-20 mg for 70 kg patient, adjusted as required; child up to 0.3 mg/kg repeated once or twice as necessary.

Preoperative anesthesia: by intravenous or intramuscular injection 0.1-0.2 mg/kg.

Obstetrical analgesia during labor & delivery: by intravenous injection 0.3-1 mg/kg over 10-15 minutes with maintenance doses of 0.25-0.5 mg/kg in single intravenous administration as required.

Intraoperative analgesia: by intravenous injection 0.25-0.5 mg/kg at 30 minutes intervals.

Myocardial infarction: By slow intravenous injection 10-20 mg, repeated after 30 minutes if necessary. Larger dose is required when used as supplement of anesthesia than that required for analgesia.

Children from 18 months to 15 years old: usually 0.2 mg/ kg body-weight, given preferably by intravenous or intramuscular injection. Maintenance doses may be given at intervals of 4 to 6 hours or the dose must be determined by the physician.

Generally Nalbuphine is well tolerated. However few side-effects like sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, dyspnea and asthma may be seen.

Known hypersensitivity to Nalbuphine Hydrochloride.

Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, billiary tract surgery, myocardial infarction and hypotension.

No hazardous interactions have been identified with Nalbuphine; however, interactions described with other opioids may be anticipated. Patient receiving a narcotic analgesic, general anesthesia, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Nalbuphine may exhibit an additive effect.

Pregnancy category B. The placental transfer of Nalbuphine is high and rapid. There are no well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Limited data suggest that Nalbuphine is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when Nalbuphine is administered to a nursing woman.

Sleepiness & mild dyspnea may occur due to overdose. The immediate intravenous administration of an opiate antagonist such as Naloxone or Nalmefene is a specific antidote. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated

Keep it in a cool and dry place, protected from light and moisture.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

Nabumetone is a naphthylalkanone. Is is a non-selective prostaglandin G/H synthase (a.k.a. cyclooxygenase or COX) inhibitor that acts on both prostaglandin G/H synthase 1 and 2 (COX-1 and -2). Prostaglandin G/H synthase catalyzes the conversion of arachidonic acid to prostaglandin G2 and prostaglandin G2 to prostaglandin H2. Prostaglandin H2 is the precursor to a number of prostaglandins involved in fever, pain, swelling, inflammation, and platelet aggregation. The parent compound is a prodrug that undergoes hepatic biotransformation to the active compound, 6-methoxy-2-naphthylacetic acid (6MNA). The analgesic, antipyretic and anti-inflammatory effects of NSAIDs occur as a result of decreased prostaglandin synthesis.

The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis, most likely through binding to the COX-2 and COX-1 receptors.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.  Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus, rash

Special Senses: Tinnitus

Miscellaneous: Edema

Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Nabumetone in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone on labor and delivery in pregnant women are unknown.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Store at 25°C; excursions permitted to 15-30°C in well-closed container; dispense in light-resistant container.

Famotidine is indicated in-

• Gastric ulcer
• Duodenal ulcer
• Anastomotic ulcer
• Acute stress ulcer
• Reflux esophagitis and
• Zollinger-Ellison syndrome.

Famotidine is also indicated for the treatment of acute gastritis, chronic gastritis in the acute exacerbation stage.

Famotidine is a histamine H2-receptor antagonist. Famotidine completely inhibits the action of histamine on H2- receptors of parietal cell. It inhibits basal, overnight and pentagastrin stimulated gastric acid secretion. The H2- receptor antagonist activity of Famotidine is slowly reversible, since the drug dissociates slowly from H2-receptor.

Tablet:

• For gastric ulcer, duodenal ulcer, anastomotic ulcer, upper gastro-intestinal hemorrhage, reflux esophagitis and Zollinger-Ellison syndrome: Usual dose for adults: Famotidine 20 mg twice daily (after breakfast and after supper or before bed time) or Famotidine 40 mg can be administered orally once daily at bed time.
• For the treatment of acute gastritis, chronic gastritis in acute exacerbation stage: Usual dosage for adults is Famotidine 20 mg orally twice a day (after breakfast and after supper or before bed time). Also Famotidine 40 mg can be orally administered once a day (before bed time), dosage should be adjusted according to age and symptoms. Most ulcer patients heal within 4-8 weeks. For maintenance therapy the recommended oral dose is 20 mg once daily. Or, as directed by the registered physician.

Powder for Suspension: Gastroesophageal Reflux Disease(GERD):

• <1 year of age: 0.5 mg/kg/dose of famotidine oral suspension up to 8 weeks once daily in patients
• Age 3 to 11 months: 0.5 mg/kg/dose twice daily up to 8 weeks
• Age 1 to 2 months: 0.5 mg/kg/dose once daily up to 8 weeks
• Neonates: 0.5 mg/kg/dose maximum once daily up to 8 weeks

Patients 1-16 years of age:

• Gastroesophageal Reflux Disease(GERD): 1 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.
• Duodonal ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Peptic ulcer: 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.
• Maintenance therapy: 40 mg at daily night.
• Reflux esophagitis: 2 mg/kg/day
• Zollinger-Ellison Syndrome: 40 mg 3 times daily.

Intravenous Injection: In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection Premixed or Famotidine Injection may be administered until oral therapy can be instituted. The recommended dosage for Famotidine Injection Premixed and Famotidine Injection in adult patients is 20 mg intravenously q 12 h. The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients: Pediatric Patients suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day. While published uncontrolled clinical studies suggest the effectiveness of famotidine in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h. No pharmacokinetic or pharmacodynamic data are available on pediatric patients under 1 year of age.

Eruption, constipation, diarrhoea, dry mouth, nausea, vomiting, tachycardia, high blood pressure, headache, drowsiness or insomnia may rarely occur.

Known hypersensitivity to any component of the drug.

The drug should be used in the minimum required amount depending upon the conditions of the diseases. The drug should be administered carefully with elderly patients, patients with renal failure and hepatic disorders.

No clinically important drug interactions have been identified. Famotidine does not interact with the cytochrome P450-linked drug-metabolizing enzyme system.

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Famotid is administered to a nursing woman.

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

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglycate 2% sterile Eye Drops inhibits the release of chemical mediators from sensitised mast cells and is capable of rapid phosphorylation of mast cell protein. The exact mechanism of action of the drug remains to be elucidated but Sodium Cromoglycate appears to modulate the allergic response to antigen antibody interactions in a way which prevents the subsequent formation or release of toxic or inflammatory mediators. Sodium Cromoglycate 2% Eye Drops appears to act mainly through a local effect on the mucous of the eye. Approximately 0.03% of an ophthalmic dose of Sodium Cromoglycate 2% Eye Drops is absorbed systemically. Sodium Cromoglycate 2% Eye Drops prevent, release of mediators of type-I allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitised mast cells after the antigen antibody union has taken place. The drug does not inhibit the binding of IgE to mast cells nor the interaction between cell bound IgE and the specific antigen; instead Sodium Cromoglycate suppresses the release of substances (e.g. histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthus) reactions.

The usual dosage of Sodium Cromoglycate 2% Eye Drops in adults and children over 4 years of age or older is 1 or 2 drops in each eye 4-6 times daily at regular intervals. The recommended frequency of administration should not be exceeded. Patients should be advised that the therapeutic effects of Sodium Cromoglycate 2% Eye Drops depend on administration of the drug at regular intervals.

The most frequent adverse effect reported with use of Sodium Cromoglycate 2% Eye Drops is transient ocular stinging or burning upon instillation of the drug.

Sodium Cromoglycate 2% Eye Drops is contraindicated in individuals who have shown hypersensitivity to the drug or any of the ingredients.

Sodium Cromoglycate 2% Eye Drops contains benzalkonium chloride and patients should be advised not to wear soft contact lenses during treatment with Sodium Cromoglycate 2% Eye Drops.

Sodium Cromoglycate has no known drug interactions.

In animal studies, Sodium Cromoglycate has produced adverse effects on the foetus only in high parenteral doses. There was no evidence of impaired fertility in reproduction studies in animals. Healthy infants have been born to women who received Sodium Cromoglycate throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety in pregnancy. It should be used during pregnancy only when clearly needed. Since it is not known if Sodium Cromoglycate is distributed into milk in humans, the drug should be used with caution in nursing women.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Sodium Cromoglycate 2% Eye Drops should be protected from direct sunlight and stored at a temperature less than 30˚C; any unused ophthalmic solution should be discarded 4 weeks after opening the cap of the bottle.

Antidote preparations, Cough expectorants & mucolytics

Effervescent tablet or Dispersible tablet: Adults and children above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day (preferably in the evening). The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician. Dissolve the tablets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Effervescent Granules:

• Adults and children above 6 years: 1 sachet Acetylcysteine 200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
• Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg from 2 to 4 times a day, according to the age.

The duration of treatment should be 5 to 10 days in the acute treatment, whereas it may be continued in the chronic states for several months, according to the advice of the physician.

Dissolve the contents of the sachets in a glass containing a small quantity of water; mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from the glass.

Nebuliser Solution: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for injection, Sodium Chloride for inhalation, sterile water for injection, or sterile water for inhalation.

• Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8 hr PRN.
• Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• 12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution by Nebuliser every 6-8 hr PRN.
• Below 12 years: 5-10 ml of 10/20% solution by Nebuliser every 6-8 hr PRN.

** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10% solution 2-3 times by Nebulisation or by instillation intratracheally prior to procedure.

** Nebulisation tent or croupette: This form of administration requires very large volumes of the solution, occasionally as much as 300 ml during a single treatment period. If a tent or croupette must be used, the recommended dose is the volume of acetylcysteine (using 20%) that will maintain a very heavy mist in the tent or croupette for the desired period. Administration for intermittent or continuous prolonged periods, including overnight, may be desirable.

** Direct Instillation: When used by direct instillation, 1-2 ml of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution may be given every 1-4 hours by instillation into the tracheostomy.

Like all medicines, Acetylcysteine can cause side effects, although not everybody gets them. In very rare cases, severe immune reactions may occur such as anaphylactic shock and severe skin reaction. In rare cases the oral administration can be followed by shortness of breath, upset stomach and bronchospasm. The most frequent side effects are headache, increased heart rate, stomatitis, pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the blood pressure, diarrhoea and noises in the ears.

Known hypersensitivity to Acetylcysteine. Acetylcysteine contains aspartame, thus it is contraindicated in patients suffering from phenylketonuria.

Patients suffering from bronchial asthma must be strictly controlled during the therapy; should bronchospasm occur, the treatment must immediately be suspended. Caution should be taken in patients suffering from or with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose) this has to be taken into consideration by patients on a controlled sodium diet. The possible presence of a sulphureous odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in this preparation. It is preferable not to mix other drugs with the Viscotin solution.

The thiol group of Acetylcysteine can reduce the efficacy of certain antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins, aminoglycosides and amphotericin. Concomitant use of Acetylcysteine and amoxicillin will increase the level of the antibiotic in tissues. It is, therefore, advisable to use the two medicines 2 hours apart from each other. Acetylcysteine can increase the inhibitory effect of thrombocyte aggregation and vasodialation by nitroglycerine.

In case of pregnancy & lactation the medicine should be taken consulting physician or pharmacist.

Overdose of Acetylcysteine may cause nausea, vomiting or diarrhoea.

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

Drugs for subcutaneous and mycoses, Drugs used in Vaginal and Vulval condition

Nystatin is an antifungal antibiotic. Which has fungistatic or fungicidal activity against variety of pathogenic and nonpathogenic yeast and fungi, including Candida albicans. Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. As a result of binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost. It is poorly absorbed from the gastrointestinal tract.

Children:

• In intestinal and oral candidiasis (thrush): 1,00,000 units (1 ml) should be dropped into the mouth four times daily.The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
• For prophylaxis in the newborn: The suggested dose is 1,00,000 units (1 ml) once daily or as prescribed by the physician.

Adult:

• For the treatment of intestinal or esophageal candidiasis: 5,00,000 units (5 ml) by mouth 3 or 4 times daily. The dose may be doubled, if required.
• For prophylaxis of intestinal candidiasis in adults: 10,00,000 units (10 ml) daily.
• For prophylaxis to suppress the over growth of Candida albicans in patients receiving broad spectrum antibiotic therapy: 10,00,000 units (10 ml) daily.
• For the treatment of dental sores and oral infection: 1,00,000 units (1 ml) suspension should be dropped into the mouth four times daily.

Elderly: Older people with intestinal candidiasis who are unable to swallow tablets should be given 5,00,000 units (5 ml) suspension four times daily.

Nausea, vomiting and diarrhoea have occasionally been reported with high doses of Nystatin. No systemic effects or allergic reactions have been associated with its oral dose.

There is no known contraindication to the use of Nystatin.

Absorption from the gastrointestinal tract is negligible, therefore no special precaution is required to apply in pregnancy and lactation.

Absorption of Nystatin from the gastrointestinal tract is negligible, therefore no special precautions apply in pregnancy.

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

Naftifine cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum

Topical Antifungal preparations

Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

For topical use only. Naftifine Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks

The most common adverse reaction (≥1%) is pruritus.

If redness or irritation develops with the use of Naftifine Cream treatment should be discontinued.

Pregnancy Category B. There are no adequate and well-controlled studies of Naftifine Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftifine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Cream is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Naftifine Cream have been established in the age group 12-17 with interdigital tinea pedis and tinea cruris. Safety and effectiveness in pediatric patients <12 years of age have not been established. 

Geriatric Use: Clinical studies of Naftifine Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Store at 25°C; excursions permitted to 15-30°C

5-HT Agonists

Naftidrofuryl oxalate possesses a 5HT2-blocking activity and counteracts both the vasoconstrictor effect and the effect promoting platelet aggregation due to serotonin. Naftidrofuryl oxalate has a direct effect on intracellular metabolism. Thus it increases ATP level, decreases lactic acid level in ischemic conditions and enhances the cellular oxidative capacity. Also, Naftidrofuryl oxalate is a powerful spasmolytic agent.

One or two Naftidrofuryl oxalate capsules three times daily during meals for a minimum of three months or at the discretion of the physician.

Hypersensitivity to the active substance or to any of the excipients. Patients with a history of hyperoxaluria or recurrent calcium-containing kidney stones.

The administration of Naftidrofuryl Oxalate may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones. The administration of Naftidrofuryl Oxalate without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water. Cases of liver damage have been reported.

In the absence of any relevant clinical data, the use of Naftidrofuryl Oxalate is not advisable during pregnancy. In the absence of specific data concerning the excretion of the drug in human milk, Naftidrofuryl Oxalate should not be used by breastfeeding women.

Depression of cardiac conduction and convulsions may occur.

Store below 25°C. Protect from light & moisture. Keep the medicine out of reach of children.

Naftifine cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum

Topical Antifungal preparations

Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

For topical use only. Naftifine Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks

The most common adverse reaction (≥1%) is pruritus.

If redness or irritation develops with the use of Naftifine Cream treatment should be discontinued.

Pregnancy Category B. There are no adequate and well-controlled studies of Naftifine Cream in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftifine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Cream is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Naftifine Cream have been established in the age group 12-17 with interdigital tinea pedis and tinea cruris. Safety and effectiveness in pediatric patients <12 years of age have not been established. 

Geriatric Use: Clinical studies of Naftifine Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Store at 25°C; excursions permitted to 15-30°C

Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.

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

Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.

Naproxen Tablet-

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
• Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
• Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

• For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

• Is to be applied 2-6 times a day as required and is not recommended for use in children.

Most frequently reported side effects include following:

• Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
• Central Nervous System: Headache, vertigo, drowsiness.
• Dermatological: Pruritus (itching), purpura.
• Cardiovascular: Edema, palpitation.
• Others: Visual disturbances, hearing disturbances.

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.

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

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

Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.

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

Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.

Naproxen Tablet-

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
• Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
• Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

• For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

• Is to be applied 2-6 times a day as required and is not recommended for use in children.

Most frequently reported side effects include following:

• Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
• Central Nervous System: Headache, vertigo, drowsiness.
• Dermatological: Pruritus (itching), purpura.
• Cardiovascular: Edema, palpitation.
• Others: Visual disturbances, hearing disturbances.

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.

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

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