Profen400 mg

Profen 400 mg oral dosage form is indicated in 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 ... Read moreProfen 400 mg oral dosage form is indicated in 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.Profen 400 mg topical gel contains Profen 400 mg and belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs). These medicines reduce pain and inflammation and bring down a high temperature. Profen 400 mg 5% gel is used to treat a number of painful conditions affecting the joints and muscles, such as backache, rheumatic and muscular pain, sprains, strains and sports injuries. It is also used to treat pain from non-serious arthritic conditions and nerve pain (neuralgia).

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

Profen 400 mg is a non-selective inhibitor of cyclooxygenase, an enzyme invovled in prostaglandin synthesis via the arachidonic acid pathway. Its pharmacological effects are believed to be due to inhibition cylooxygenase-2 (COX-2) which decreases the synthesis of prostaglandins involved in mediating inflammation, pain, fever and swelling. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation. Inhibition of COX-1 is thought to cause some of the side effects of Profen 400 mg including GI ulceration. Profen 400 mg is administered as a racemic mixture. The R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo. The S-enantiomer is believed to be the more pharmacologically active enantiomer.

Oral Administrations- For Children: 20 mg per kg body weight daily in divided doses. In children weighing less than 30 kg the total daily dosage should not exceed 500 mg. If gastrointestinal disturbances occur Profen 400 mg should be given with food or milk. 1-2 years: 1/2 tea spoonful (2.5 ml) 3-4 times daily 3-7 years: 1 tea spoonful (5 ml) 3-4 times daily 8-12 years: 2 tea spoonful (10 ml) 3-4 times daily Profen 400 mg is not recommended for children under 1 year. For adult: For arthritic pain: The dosage range is from 0.9 to 2.4 g per day. The usual dose is 400 mg, 3-4 times per day, preferably after food. The dose may be raised to a maximum of 2.4 g daily depending on the severity of symptom at the time of initiating drug therapy or as patients fail to respond. After a satisfactory response has been achieved the patients dose should be reviewed and adjusted as required and tapered gradually. For mild to moderate pain: 400 mg 6 hourly or as demanded by the condition. For dysmenorrhoea: 400 mg every 4 hours or as demanded by the condition. Topical Administrations- Pain and inflammation associated with musculoskeletal and joint disorder: As 5% cream, foam, gel, spray soln or 10% gel: Apply onto affected area.

Oral dosage form: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.Topical gel:Adults: Squeeze 4 to 10cm (i.e. 1.6 to 4 inches) of gel from the tube on affected area. Massage until absorbed. This dose should not be repeated more frequently than every four hours and no more than four times a day in any 24 hour period. The amount of gel squeezed would be equivalent to 50 to 125 mg of Profen 400 mg. Profen 400 mg 5% gel should only be used on healthy, unbroken skin. Do not use it on or near cuts or grazes or under dressings such as plasters. Also, do not use it on the genital area. Do not let any gel come in contact with your eyes. If it does, rinse your eyes with cold water and consult your doctor. Hands should be washed after applying Profen 400 mg 5% gel, unless they are the site of treatment. If the condition does not improve after two weeks use, or becomes worse at any time, speak to your doctor or pharmacist.Use in children: Profen 400 mg 5% gel is not recommended for use in children under 12 years.

Increased risk of GI bleeding with warfarin, corticosteroids, SSRIs and aspirin. May reduce the natriuretic effects of diuretics. Reduced antihypertensive effect of ACE inhibitors and angiotensin II receptor antagonists. May increase toxicity of lithium and methotrexate. Increased nephrotoxicity with ciclosporin and tacrolimus.

Profen 400 mg is contraindicated in patients who have shown the previous hypersensitivity to Profen 400 mg, and in patients with severe or active peptic ulceration.

Upset stomach, vomiting, heartburn, nausea may occur.

Profen 400 mg is not recommended during pregnancy or for use in nursing mothers.

Profen 400 mg 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 Profen 400 mg 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 Profen 400 mg. Profen 400 mg should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Gastric lavage, correction of blood electrolytes (if necessary). There is no specific antidote for Profen 400 mg

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

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

Profen 400 mg has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Profen 400 mg are due to both a peripheral and a central effect. Profen 400 mg is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Profen 400 mg also inhibits the synthesis of some lipo-oxygenase products. Profen 400 mg thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

Adverse effects of Profen 400 mg on the developing fetus cannot be fully excluded. Profen 400 mg should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.