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This is indicated for-

• Internal and external hemorrhoids
• Post-partum hemorrhoidal condition
• Anal pruritus, peri-anal eczema, anal fissures and proctitis 
• Post-hemorrhoidectomy application to relieve pain and discomfort

Compound steroidal preparations, Drugs used in Ano-rectal region

Cinchocaine is a local anesthetic which relieves severe pain and relaxes sphincteric spasm. Hydrocortisone acts as an anti-inflammatory and anti-pruritic agent and thereby eliminates itching and inflammation. Neomycin is a broad-spectrum antibiotic which eradicates most infections which may already be present or arise in lesions of the anorectal area. Esculin improves skin vasculature and is effective in management of cellulitis.

Ointment: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing.

Suppository: One suppository in the morning and one in the evening, and one after each stool.

Use in children: Not recommended for children.

Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using this preparation.

Contraindicated in patients hypersensitive to any component of the product.

Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur. Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence this preparation should not be given to extensively damaged skin.

Use in pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established.

Keep in a cool dry place protected from light. Keep out of reach of children.

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

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

Tramadol is used for the treatment of moderate to severe painful conditions. These include:

• Postoperative pain
• Colic and spastic pain
• Cancer pain
• Joint pain
• Neck and back pain
• Pain associated with osteoporosis.

Opioid analgesics

Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.

Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.

Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.

In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

This is indicated for the treatment of:

• Chronic hepatitis B virus infection in adults
• HIV infected adults in combination with other anti retroviral agents

Drugs for HIV / Anti-retroviral drugs, Hepatic viral infections (Hepatitis B)

Tenofovir Disoproxil Fumarate, an acyclic nucleotide analogue of adenosine monophosphate, is a pro-drug of Tenofovir. It shows activity against hepatitis B virus polymerase and HIV reverse transcriptase after phosphorylation to the active diphosphate form. Tenofovir diphosphate inhibits viral polymerase (reverse transcriptase) by directly competing with the natural substrate deoxyribonucleotide and by causing DNA chain termination after its incorporation into viral DNA.

The recommended dose of Tenofovir in chronic hepatitis B virus infection in adults 18 years of age and older with adequate renal function is 300 mg once daily with or without food.

The most common side effects are nausea, vomiting, diarrhea and flatulence.

Tenofovir is contraindicated in patients with known hypersensitivity to Tenofovir or any component of the product.

Co-administration with other drugs: Tenofovir should not be administered concurrently with Emtricitabine & Tenofovir combination or Adefovir Dipivoxil.

Lactic Acidosis & Severe Hepatomegaly with Steatosis: Though the risk of occurrence of lactic acidosis is low for Tenofovir, treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity.

Exacerbation of hepatitis after discontinuation of treatment: Discontinuation of Tenofovir
therapy may be associated with severe acute exacerbation of hepatitis.

Co-administration of Tenofovir with anti-retroviral, entecavir, lamivudine, methadone, oral contraceptives, ribavirin and tacrolimus did not result in significant drug interactions. The effects of co-administration of Tenofovir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.

Pregnancy: Pregnancy category B. It should be used during pregnancy only if clearly needed.

Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Tenofovir.

Pediatric use: Safety and effectiveness of Tenofovir in pediatric patients below the age of 18 years have not been established.

Geriatrics use: Clinical studies of Tenofovir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment: Haemodialysis patients: 300 mg once every 7 days or after a cumulative total of 12 hr of dialysis.

• CrCl (10-29 mL/min): 300 mg 72-96 hrly.
• CrCl (30-49 mL/min): 300 mg 48 hrly.

Hepatic impairment: No dose adjustment is required in patients with hepatic impairment.

There is no experience of Tenofovir overdose reported in patients

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

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Indomethacin is indicated in-

• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis (degenerative joint disease)
• Gout
• Acute non-articular rheumatism (bursitis, synovitis, tendinitis).

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

Indomethacin is NSAID having property of antipyretic and analgesic effect. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic, and antipyretic properties. Unlike the corticosteriods, the effect of Indomethacin is not related to the pituitary gland or the adrenals. Indomethacin is absorbed promptly following oral administration and peak plasma levels occur within 2 hours. Approximately two thirds of this amount is excreted in the urine and the remainder is excreted in the feces. About 90% of a single dose is excreted in 24-48 hours. In a number of controlled clinical trials, Indomethacin has proved to be of great value in the treatment of rheumatic diseases, It relieves pain, reduces joints swelling edema and improves joint mobility.

75 mg sustained-release capsule:

• Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease): The initial dose is 75 mg sustained-release capsule once daily. If severe then twice daily is required.
• Acute attacks of gout: May control with a dose of 75 mg sustained-release capsule twice daily.
• Acute non-articular rheumatism (bursitis, synovitis, tendinitis): 1-2 sustained-release capsule daily according to the severity of this case.

25 mg capsule:

• Rheumatic diseases: 50-200 mg daily in divided doses
• Acute gout: 150-200 mg daily in divided doses
• Dysmenorrhea: up to 75 mg daily 

Headaches, usually in the morning and kild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Rare case of mild psychic disturbances was also reported which subsided after few days of treatment, Gastrointestinal reactions such as nausea, vomiting, diarrhoea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced. Administration of the capsule immediately after meals with an antacid it necessary, minimize the frequency and the severity of these untoward effects.

Indomethacin is contraindicated in patients with ulcer, gastritis, active ulcerative colitis, and it should be used with caution in patients with a history of these disorders. In these cases, administration of Indomethacin suppositories should be preferred. It is also contraindicated in the previously hypersensitive patients.

Indomethacin capsule should be used with caution with psychiatric problems, epilepsy or parkinsonism since the drug may aggravate these conditions. It is not recommended for pregnant women, because at the present time clinical studies are insufficient. Indomethacin is not given nomally in neonates except when used to assist closure of a patent ductus arteriosus.

It may interact with anticoagulants, Lithium, diuretics, antihypertensive drugs, diflunisal and sulfonylureas.

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

Indomethacin is indicated in-

• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis (degenerative joint disease)
• Gout
• Acute non-articular rheumatism (bursitis, synovitis, tendinitis).

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

Indomethacin is NSAID having property of antipyretic and analgesic effect. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic, and antipyretic properties. Unlike the corticosteriods, the effect of Indomethacin is not related to the pituitary gland or the adrenals. Indomethacin is absorbed promptly following oral administration and peak plasma levels occur within 2 hours. Approximately two thirds of this amount is excreted in the urine and the remainder is excreted in the feces. About 90% of a single dose is excreted in 24-48 hours. In a number of controlled clinical trials, Indomethacin has proved to be of great value in the treatment of rheumatic diseases, It relieves pain, reduces joints swelling edema and improves joint mobility.

75 mg sustained-release capsule:

• Rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis (degenerative joint disease): The initial dose is 75 mg sustained-release capsule once daily. If severe then twice daily is required.
• Acute attacks of gout: May control with a dose of 75 mg sustained-release capsule twice daily.
• Acute non-articular rheumatism (bursitis, synovitis, tendinitis): 1-2 sustained-release capsule daily according to the severity of this case.

25 mg capsule:

• Rheumatic diseases: 50-200 mg daily in divided doses
• Acute gout: 150-200 mg daily in divided doses
• Dysmenorrhea: up to 75 mg daily 

Headaches, usually in the morning and kild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Rare case of mild psychic disturbances was also reported which subsided after few days of treatment, Gastrointestinal reactions such as nausea, vomiting, diarrhoea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced. Administration of the capsule immediately after meals with an antacid it necessary, minimize the frequency and the severity of these untoward effects.

Indomethacin is contraindicated in patients with ulcer, gastritis, active ulcerative colitis, and it should be used with caution in patients with a history of these disorders. In these cases, administration of Indomethacin suppositories should be preferred. It is also contraindicated in the previously hypersensitive patients.

Indomethacin capsule should be used with caution with psychiatric problems, epilepsy or parkinsonism since the drug may aggravate these conditions. It is not recommended for pregnant women, because at the present time clinical studies are insufficient. Indomethacin is not given nomally in neonates except when used to assist closure of a patent ductus arteriosus.

It may interact with anticoagulants, Lithium, diuretics, antihypertensive drugs, diflunisal and sulfonylureas.

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

This is indicated in-

• Rheumatoid arthritis
• Lumbago
• Sciatica

Herbal and Nutraceuticals

Prasarani (Paederia foetida): It contains iridiod glycosides, paederolone, paederone, paederine and paederinine. It has tonic, anti-inflammatory (antiphlogistic) and astringent activities. It is mainly used for arthritis and rheumatic ailments.

Rason (Allium sativum): It contains protein, minerals, thiamine, riboflavin, niacin, folic acid and amino acids- leucin & methionine. It is very useful drug for rheumatism and is used as an effective long term preventive treatment for all rheumatic conditions. It is effective in gout and sciatica.

Chitamul (Plumbago rosea): It contains plubbagin, sitosterol and glucoside. It is acrid, abortifacient, vesicant and stimulant. It is used in the treatment of rheumatism and paralytic affections.

2 tea-spoonful's 2-3 times daily after meal or as directed by the registered physician.

No side effect or adverse effect if used at recommended dose.

Not reported.

Not recommended.

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

Indomethacin is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative joint disease), gout, acute non-articular rheumatism (bursitis, synovitis, tendinitis).

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

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) having properties of antipyretic and analgesic effects. A great number of pharmacological studies have proved that Indomethacin has strong anti-inflammatory, analgesic and antipyretic properties. Unlike the corticosteroids, the effect of Indomethacin is not related to the pituitary gland or the adrenals.

100 mg at night and in the morning if required.

Headache, usually in the morning and mild vertigo may occur during the early weeks of therapy. These symptoms are transient and usually disappear with continued use or by reduction of the dose. Gastrointestinal reactions such as nausea, vomiting, diarrhea, epigastric and abdominal pain are often due to large doses of the drug and disappear when the dose is reduced.

It is contraindicated in previously hypersensitive patient.

It may interact with anticoagulants, lithium, diuretics, Beta-blockers, diflunisal, aspirin, probenecid and sulfonylureas.

Not recommended for pregnant women, because at the present time clinical studies are insufficient.

Use in children: Not recommended for children.

Keep in a cool place, away from light & moisture. Keep out of the reach of children.

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Ibuprofen is indicated in the following indications-

• Rheumatoid arthritis
• Osteoarthritis
• Gouty arthritis
• Juvenile polyarthritis
• Ankylosing spondylitis
• Synovitis
• Low back pain
• Dysmenorrhoea
• Fever
• Migraine
• Soft tissue injuries
• Pain & Inflammation in dental and musculoskeletal origin.

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

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

• 3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
• 7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
• 10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Upset stomach, vomiting, heartburn, nausea may occur.

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

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

Hydroxychloroquine Sulphate is indicated in-

• Acute and chronic rheumatoid arthritis
• Systemic Lupus Erythematosus (SLE)
• Malaria

Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis

Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.

Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.

Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.

Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.

Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.

• First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
• Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
• Third dose: 5 mg base/kg 18 hours after second dose.
• Fourth dose: 5 mg base/kg 24 hours after third dose.

Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.

Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.

During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.

Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.

Store below 30° C.

Drugs for Irritable Bowel Syndrome, Drugs used for Rheumatoid Arthritis, Ulcerative Colitis

The mode of action of Sulfasalazine is still under investigation, but may be related to the anti inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine, Sulfapyridine and 5-Aminosalyclic Acid have indicated that the major therapeutic action may reside in the 5-Aminosalyclic Acid moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown.

The dosage of Sulfasalazine tablets should be individually adjusted according to the patient's tolerance and response to the treatment and taken in evenly divided doses preferably after meals.

Adult dose for crohn’s disease: 500 mg orally 2 to 4 times a day with food.

Pediatric use (6 years or older) for Ulcerative Colitis: The initial dose 40 to 60 mg/kg/day orally divided into 3 to 6 doses. 

Adult dose for rheumatoid arthritis: 2 g daily in two evenly divided doses. It is advisable to initiate therapy with a lower dosage e.g. 0.5 to 1.0 g daily, to reduce possible gastrointestinal intolerance. A suggested dosing schedule is given bellow:

• First week: One tablet in the evening
• Second week: One tablet in the morning & One tablet in the evening
• Third week: One tablet in the morning & two tablet in the evening
• Fourth week: Two tablet in the morning & two tablet in the evening

In case of rheumatoid arthritis 6 years or older: initial dose 10 mg/kg/day orally in 2 equally divided doses.

Juvenile rheumatoid arthritis-polyarticular course: Children 6 years of age and older: 30 to 50 mg/kg/day in two evenly divided doses. Typically the maximum dose is 2 g per day.

For other indications:
Initial therapy:

• Adults: 3 to 4 g daily in divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage e.g. 1 to 2 g daily to reduce possible gastrointestinal intolerance.
• Children 6 years of age and older: 40 to 60 mg/kg/day in to 3 to 6 divided doses.

Maintenance therapy:

• Adults: 2 g daily.
• Children 6 years of age and older: 30 mg/kg/day in 4 divided doses.

The common adverse reactions are anorexia, headache, nausea, vomiting, gastric distress, dyspepsia, abdominal pain, dizziness, apparently reversible oligospermia etc.

Hypersensitivity to Sulfasalazine, its metabolites, sulfonamides or salicylates, patients with intestinal or urinary obstruction and porphyria.

Hepatic/renal impairment, G6PD deficiency, allergic bronchial asthma, lactation.

Reduced absorption of folic acid and digoxin has been reported when those agents were administered concomitantly with sulfasalazine.

Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed.

Use in lactation: Caution should be exercised when sulfasalazine is administered to a nursing mother.

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

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.

Ophthalmic Non-Steroid drugs

Diclofenac Eye Drops contains Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug with analgesic property. Diclofenac Sodium produces anti-inflammatory effect by inhibiting cyclooxygenase activity with a reduction in the tissue prostaglandin ( such as PgE2 and Pg F2α) .

Ophthalmic (Adult)-

• Postoperative ocular inflammation: Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.
• Inflammation and discomfort after strabismus surgery: Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk.
• Pain and discomfort after radial keratotomy: Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
• Pain after accidental trauma: Instill 1 drop 4 times daily for up to 2 days.
• Control of inflammation after argon laser trabeculoplasty: Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure.
• Prophylaxis of intra-operative miosis: Instill into appropriate eye 4 times w/in 2 hr before surgery.
• Post-photorefractive keratectomy pain: Instill into the affected eye twice, an hr before surgery, then 1 drop twice at 5-min intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.
• Seasonal allergic conjunctivitis: Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.

Mild to moderate burning sensation in 5-15% patients which is transient in nature and almost never necessitated discontinuation of treatment. Other less common side-effects are sensitivity to light, bad taste, feeling of pressure, allergic reactions etc.

Hypersensitivity to any of the components Like other non steroidal anti-inflammatory agents, Diclofenac Sodium eye drops is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis have been observed following application of acetyl salicylic acid or other cyclo-oxygenase inhibitors

Diclofenac eye drops may mask the signs of infection. So physicians should be alert to the development of infections in patients receiving the drug. During prolonged use, it is recommended that physicians conduct periodic examinations of the eye, including measurement of the intraocular pressure. Contact lenses should not be worn during treatment.

No drug interaction is reported. There should be at least 5 minutes interval when another ophthalmic solution (e.g., steroid) is given.

The safety of Diclofenac eye drops in pregnancy & lactation has not been established and its use therefore is not recommended unless the potential benefit to the mother outweighs the possible risk to the child.

Accidental ingestion of Diclofenac Sodium presents virtually no risk of unwanted effects, since one 5 ml bottle of eye drop solution contains only 5 mg of Diclofenac Sodium, which is equivalent to about 3% of the recommended maximum oral dose for adults.

Close the bottle immediately after use. Do not use for more than four weeks after opening. Store at room temperature.