Anilic

Approved Uses:

• Acute migraine attacks (with or without aura)
• Dysmenorrhea (menstrual pain)
• Musculoskeletal pain (e.g., sprains, back pain)
• Osteoarthritis and rheumatoid arthritis (symptomatic relief)
• Postoperative pain
• Dental pain (e.g., after tooth extraction)

Clinically Accepted Off-Label Uses:

• Fever management when paracetamol or ibuprofen is not suitable
• Short-term analgesia in minor surgeries
• Adjunctive treatment in certain inflammatory conditions under specialist supervision

রেজিস্টার্ড চিকিৎসকের পরামর্শ ছাড়া ওষুধ সেবন করবেন না।

Adults:

• Migraine attacks: 200 mg orally at onset of attack; may repeat once after 1–2 hours if needed (maximum 400 mg/day)
• General pain or dysmenorrhea: 200 mg orally every 8 hours as needed, with food
  Maximum daily dose: 600 mg

Children and Adolescents:

• Not routinely recommended under 18 years. In some clinical practices:
• 1 mg/kg/dose orally every 8 hours (max 3 doses/day)
• Use only under medical supervision

Elderly:

• Use the lowest effective dose
• Monitor renal and gastrointestinal function
• Avoid prolonged use

Renal Impairment:

• Mild to moderate: use with caution, monitor renal function
• Severe impairment: avoid use

Hepatic Impairment:

• Avoid in severe liver dysfunction
• Use the lowest dose possible with monitoring in mild to moderate impairment

Administration Notes:

• Administer with meals to reduce gastrointestinal side effects
• Swallow tablets whole with water

Tolfenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) of the fenamate class. It works by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are responsible for the conversion of arachidonic acid to prostaglandins. These prostaglandins mediate inflammation, pain, and fever. By reducing prostaglandin synthesis, tolfenamic acid exerts analgesic, antipyretic, and anti-inflammatory effects. It may also inhibit thromboxane and leukotriene formation, contributing to its efficacy in migraine and inflammatory pain.

• Absorption: Rapidly absorbed after oral administration; peak plasma concentration achieved in ~1 hour
• Bioavailability: Moderate to high; affected by food intake
• Distribution: Highly protein-bound (>99%), primarily to albumin
• Metabolism: Extensively metabolized in the liver via hydroxylation and conjugation
• Excretion: Primarily excreted in the urine as metabolites
• Half-life: Approximately 2 to 3 hours
• Onset of action: Typically within 30–60 minutes
• Duration of action: 4 to 6 hours

Pregnancy:

• Contraindicated during the third trimester due to risk of fetal renal dysfunction, premature closure of the ductus arteriosus, and prolonged labor
• Use during the first and second trimesters only if clearly needed and under physician supervision

Lactation:

• Excreted in breast milk in small amounts
• Not recommended during breastfeeding unless benefit outweighs risk
• Monitor infant for gastrointestinal discomfort if used

• Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
• Subclass: Anthranilic acid derivative (Fenamate group)

• Hypersensitivity to tolfenamic acid or any NSAID
• Active peptic ulcer or gastrointestinal bleeding
• Severe hepatic impairment
• Severe renal impairment
• Severe heart failure
• History of NSAID-induced asthma, urticaria, or allergic-type reactions
• Use in third trimester of pregnancy
• Concomitant use with other NSAIDs or salicylates

• Gastrointestinal risk: May cause ulceration, bleeding, or perforation, especially with prolonged use
• Cardiovascular risk: NSAIDs may increase the risk of thrombotic events, myocardial infarction, and stroke
• Renal effects: Can impair renal function; monitor creatinine and urine output in high-risk patients
• Hepatic effects: Periodic liver function tests recommended during long-term use
• Skin reactions: Rare but serious reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur; discontinue at first sign of rash
• Asthma exacerbation: May induce bronchospasm in susceptible individuals

Common:

• Nausea
• Indigestion (dyspepsia)
• Abdominal pain
• Diarrhea or constipation
• Headache
• Dizziness

Less Common:

• Skin rash or itching
• Drowsiness
• Flatulence
• Photosensitivity

Serious (Rare):

• Gastrointestinal bleeding or perforation
• Hepatitis or liver enzyme elevation
• Anaphylaxis or severe hypersensitivity
• Bronchospasm
• Renal dysfunction or failure
• Severe cutaneous reactions (SJS, TEN)

• Anticoagulants (e.g., warfarin): Increased risk of bleeding
• Other NSAIDs or corticosteroids: Increased risk of GI side effects
• Antihypertensives (e.g., ACE inhibitors, beta-blockers, diuretics): May reduce effectiveness; increased risk of renal impairment
• Lithium: Decreased renal clearance; monitor lithium levels
• Methotrexate: Increased toxicity due to reduced renal elimination
• Alcohol: Increased risk of gastrointestinal bleeding

Enzyme involvement: Mainly hepatic glucuronidation and hydroxylation; not primarily CYP-mediated

• NSAIDs including tolfenamic acid are under continuing review for GI and cardiovascular safety
• Current recommendations emphasize lowest effective dose for shortest possible duration
• Not recommended for chronic use in high-risk patients (e.g., elderly, cardiac, GI disease)
• Updated pregnancy guidance emphasizes complete avoidance during the third trimester

• Store tablets at 20–25°C (68–77°F)
• Protect from excessive moisture and direct sunlight
• Do not freeze
• Keep out of reach of children
• Do not use if tablets are discolored or crumbling