Tofedex

Uses

Symptomatic treatment of pain and inflammation of mild or moderate intensity, such as musculo-skeletal pain, menstrual pain, & dental pain.

Tofedex is also used to associated treatment for these conditions: Ankylosing Spondylitis (AS), Extra-Articular Rheumatism, Gouty Arthritis, Inflammation, Menstrual Distress (Dysmenorrhea), Musculoskeletal Pain, Osteoarthritis (OA), Pain, Post-traumatic pain, Postoperative pain, Renal Colic, Rheumatoid Arthritis, Soreness, Muscle, Spasms, Spinal pain, Inflammation localized, Localized pain, Mild to moderate pain

How Tofedex works

It is a non-steroidal anti-inflammatory drug (NSAID) that reduces prostaglandin synthesis via inhibition of cyclooxygenase pathway (both COX-1 and COX-2) activity .

Dosage

Tofedex dosage

Adult: 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max: 75 mg/day.

Elderly: Initial total daily dose should not exceed 50 mg/day. May increase to the doses recommended for general population only if well tolerated.

Mild renal impairment: Reduce initial dose to 50 mg/day. Not to be used in moderate to severe renal impairment.

Mild to moderate impairment: Reduce initial dose to 50 mg/day. Not to be used in severe hepatic impairment.

Side Effects

Tofedex may cause some unwanted effects in some patients. These are described below and are characteristic of non steroidal anti-inflammatory drugs:

• Common (1 - 10%): nausea, vomiting, diarrhoea, stomach pain or heartburn.
• Uncommon (0.1 - 1%): sleep disorders, nervousness, headache, dizziness,vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, general malaise.
• Rare (0.01-0.1%): stomach ulceration, gastric haemorrhage or perforation, pins and needles, high blood pressure, water retention, slowed breathing rate, increased hepatic enzymes, increased sweating.
• Very rare / isolated cases (<0.01%): blurred vision, ringing in the ear, low blood pressure, haematological reactions, hepatic or renal damage, dermatological and photosensitivity reactions, bronchospasm or anaphylaxis.

In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medicines may rarely cause isolated cases of fever, headache and rigidity of the nape (back of the neck).

Toxicity

Nausea and/or vomiting, stomach pain, diarrhea, digestive problems (dyspepsia) are the most common symptoms of toxicity. More toxicity symptoms include dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, and malaise.

Severe toxicity can lead to thrombocytopenia and anemia with bleeding episodes. Tofedex is associated with a small increased risk of myocardial infarction .

Precaution

The medicine should be used with caution in conditions mentioned below:

• Allergic to any other medicines.
• Kidney disease, liver disease, heart disease or fluid retention conditions.
• Blood disorder, systemic lupus erythematosus or mixed connective tissue disease.

Interaction

Any of the following drugs cannot be used at the same time while taking Tofedex. Other non-steroidal anti-inflammatory drugs, anticoagulant medicines; lithium; methotrexate; hydantoins (a type of medicine used for epilepsy) or some antibiotics of sulphonamide type (e.g. sulfamethoxazole); medications used to treat high blood pressure (ACE inhibitors, diuretics and beta blockers); pentoxifylline; zidovudine; cyclosporine or tacrolimus; some oral medicines for diabetes (sulphonylureas); thrombolytic medicines; probenecid; cardiac glycosides; mifepristone; and quinolone antibiotics.

Volume of Distribution

3

Elimination Route

After oral ingestion, the Tofedex onset of action is within 30 minutes. The plasma half-life of Tofedex is about 4-6 hours. The Cmax is about 30 minutes [L1204]

Half Life

1.65 h

Clearance

Mainly cleared via glucuronide conjugation and followed by renal excretion, mainly unchanged .

Elimination Route

Approximately 70 to 80% of the ingested dose is recovered in the urine during the first 12 hours post-ingestion, mainly as the acyl-conjugated form of the drug .

Pregnancy & Breastfeeding use

The use of Tofedex tablets during pregnancy or breast-feeding is not recommended

Contraindication

Hypersensitivity to Tofedex, or other NSAIDs. Patients with history of asthma attacks, bronchospasm, angioedema, urticaria, acute rhinitis or nasal polyps that were precipitated by Aspirin or other NSAIDs. Active/suspected/recurrent peptic ulcer or haemorrhage. Chronic dyspepsia; GI bleeding or other active bleedings; Crohn's disease or ulcerative colitis; bronchial asthma; severe heart failure; severe hepatic impairment; moderate to severe renal impairment; haemorrhagic diathesis and other coagulation disorders. Pregnancy and lactation.

Special Warning

Should not be given to children.

Acute Overdose

Administer activated charcoal if more than 5 mg/kg has been ingested by an adult or a child within an hr. Symptomatic therapy should be provided. Tofedex is dialysable.

Storage Condition

Store at a cool & dry place protected from light and moisture. Keep out of reach of children.

Innovators Monograph

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